(124 days)
Synthes Pre-Amendment Cerclage Wires
No
The device descriptions and intended uses focus on mechanical components and their function in bone stabilization and distraction. There is no mention of software, algorithms, or data processing that would indicate the presence of AI/ML. The performance studies are related to MR compatibility, not algorithmic performance.
Yes
The devices are intended for various medical interventions such as stabilizing, lengthening, and reconstructing bones in the maxillofacial region, which are therapeutic actions to address trauma, defects, and deformities.
No
Explanation: The devices described are intended for surgical procedures such as stabilization, lengthening, reconstruction, and fixation of bones in the maxillofacial region. They are therapeutic or surgical devices, not diagnostic devices which are used to identify a condition or disease.
No
The device descriptions clearly indicate that these are physical implants and external fixation devices made of materials like titanium alloy and stainless steel, intended for surgical procedures. There is no mention of software as the primary or sole component of any of the listed devices.
Based on the provided information, none of the listed DePuy Synthes devices are IVDs (In Vitro Diagnostics).
Here's why:
- IVDs are used to examine specimens derived from the human body. This includes things like blood, urine, tissue samples, etc., to provide information for diagnosis, monitoring, or screening.
- The intended use and device descriptions for all the listed DePuy Synthes devices clearly indicate they are surgical implants and external fixation devices. They are used in the body (or attached to the body externally) to stabilize, lengthen, or reconstruct bone and tissue. They do not involve the examination of bodily specimens in vitro (outside the body).
The information provided focuses on the mechanical function and placement of the devices within the body for therapeutic purposes, not on diagnostic testing using biological samples.
N/A
Intended Use / Indications for Use
DePuy Synthes IMF Screws: The DePuy Synthes IMF Screws are intended to provide indirect stabilization of the maxilla and mandible following maxillofacial and mandibular trauma or reconstruction.
DePuy Synthes Titanium Multi-Vector Distractor: The DePuy Synthes Titanium Multi-Vector is intended for use in mandbular bone lengthening for conditions such as mandibular hypoplasia or post-traumatic defects such as tumor resections, severe trauma, bone grafting defects, severe open mandible fractures where gradual distraction is required. Where bone loss is a result of the condition, bone transport can be performed as an alternative to free flaps or bone grafts.
DePuy Synthes Low Profile Neuro System - 3 mm Screws: The DePuy Synthes Low Profile Neuro System - 3 mm Screws is intended for use in selective trauma of the midface and maxillofacial skeleton; maxillofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.
DePuy Synthes External Midface Distractor: The DePuy Synthes External Midface Distractor is intended for use in maxillofacial surgery, reconstructive procedures, and selective orthognathic surgery of the maxilla. Specifically, it is intended for distraction of the maxilla utilizing a LeFort I osteotomy and/or the midface utilizing a LeFort II or III osteotomy in adult and pediations where gradual bone distraction is required.
DePuy Synthes 1.0/1.2 mm Craniofacial Screws: The DePuy Synthes 1.0/1.2 mm Craniofacial Screws are intended for use as follows: General Indications: · Maxillofacial surgery
DePuy Synthes Alveolar Distractor: The DePuy Synthes Alveolar Distractor is intended for vertical bone lengthening of the alveolar ridge in the mandible and the maxilla where gradual bone distraction is required, including deficiency in bone height as a result of trauma, resorption after dental extraction, periodontal disease, tumor resection, and congenital deformity.
DePuy Synthes Craniomaxillofacial Distraction System (CMF Distraction System): The DePuy Synthes Craniomaxillofacial Distraction System (CMF Distraction System) is intended for use as a bone stabilizer and lengthening (and/or transport) device for correction of congenital deficiencies or post-traumatic defects of the mandibular body and ramus where gradual bone distraction is required. The DePuy Synthes CMF Distraction System is intended for single use only. The DePuy Synthes Pediatric CMF Distraction System is intended for use as a bone stabilizer and lengthening (and/or transport) device for correction of congenital deficiencies or post-traumatic defects of the mandibular body and ramus where gradual bone distraction is required in children under the age of 12 months. The DePuy Synthes Pediatric CMF Distraction System is intended for single use only.
DePuy Synthes Condylar Head Add-On System: The DePuy Synthes Condylar Head Add-On System is intended for temporary reconstruction in patients undergoing ablative tumor surgery requiring the removal of the mandibular condyle. This device is not for permanent implantation, for patients with TMJ or traumatic injuries, or for treatment of temporomandibular joint disease (TMD).
DePuy Synthes Curvilinear Distraction System (K080153): The DePuy Synthes Curvilinear Distraction System is intended for use as a bone stabilizer and lengthening (and/or transport) device for correction of congenital deficiencies or post-traumatic defects of the mandibular body and ramus where gradual bone distraction is required. This system is intended for use in either adults or pediatric patients over 1 year old. The DePuy Synthes Curvilinear Distraction System is intended for single use only.
Modification to DePuy Synthes Condylar Head Add-On System: The DePuy Synthes Condylar Head Add-On System Intended for temporary reconstruction in patients undergoing ablative tumor surgery requiring the removal of the mandibular condyle. This device is not for permanent implantation. for patients with TMJ or traumatic injuries, or for treatment of temporomandibular joint disease (TMD).
DePuy Synthes Orthodontic Bone Anchor (OBA) System: The DePuy Synthes Orthodontic Bone Anchor (OBA) System screw anchors are intended to be implanted intraorally and used as an anchor for orthodontic procedures in adolescents greater than age 12 and adults. The DePuy Synthes Orthodontic Bone Anchor (OBA) System plate anchors are intended to be implanted intraorally and used as an anchor for orthodontic procedures in adults.
DePuy Synthes Curvilinear Distraction System (K121502): The DePuy Synthes Curvilinear Distraction System is intended for use as a bone stabilizer and lengthening (and/or transport) device. The DePuy Synthes Curvilinear Distraction System is indicated for correction of congenital deficiencies or posttraumatic defects of the mandibular body and ramus where gradual bone distraction is required. The 2.0 mm Curvilinear Distractor is intended for use in adult and pediatric patients more than 1 year old. The 1.3 mm Curvilinear Distractor is intended for use in pediatric patients 4 years of age and younger. The DePuy Synthes Curvilinear Distraction System is intended for single use only.
DePuy Synthes Mandible Distractor: The DePuy Synthes Mandible Distractor is intended to be used in the mandible for conditions such as mandibular deficiency or post-traumatic effects of the mandible, where gradual bone distraction is required.
DePuy Synthes SMF Stainless Steel Bone Screws: The DePuy Synthes SMF Stainless Steel Bone Screws are intended for maxillofacial and mandbular trauma and reconstruction. The longer screw lengths (24-38mm) are specifically intended for symphysial fractures, parasymphyseal fractures, and angle fractures where the lag screw technique is being followed. The lag screw technique involves overdrilling the near cortex, thus the screw glides through the near cortical and cancellous bone and purchases only into the far cancellous and cortical bone.
DePuy Synthes 1.5 mm/2.0 mm Orthognathic Maxillary Plates and Screws: The DePuy Synthes 1.5 mm/2.0 mm Orthognathic Maxillary Plates and Screws are generally intended for a variety of pan facial indications. Specifically, it is intended for selective trauma of the midface and maxillofacial skeleton; maxillofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.
DePuy Synthes Single Vector Distractor with Detachable Feet: The DePuy Synthes Single Vector Distractor with Detachable Feet is intended for use as a bone stabilizer and lengthener for conditions such as mandibular hypoplasia or post-traumatic defects of the mandible, where gradual bone distraction is required. The device is ideal for treating fonns of clefts of the lip and palate, and congenital mandibular hypoplasia, such as Hemifacial Microsomia, Treacher Collins Syndrome, Pierre Robin Syndrome, Goldenhar Syndrome, Apert Syndrome, and Crouzon Syndrome. The DePuy Synthes Single Vector Distractor with Detachable Feet is also ideal for treating hypoplasias of an acquired origin such as from post-traumatic growth disorders associated with injury to the temporomandibular joint, temporomandibular ankylosis, and segmental loss of bone.
DePuy Synthes External Multi Vector Mandible Distractor (MVMD): The DePuy Synthes External Multi Vector Mandible Distractor (MVMD) is intended for use as a bone stabilizer and lengthener for conditions such as mandibular hypoplasia or posttraumatic defects of the mandible, where gradual bone distraction is required. The device is ideal for treating any form of congenital mandibular hypoplasia, such as Hemifacial Micorsomia, Treacher Collins Syndrome, Nagers Syndrome, Pierre Robin Syndrome, Goldenhar Syndrome, Apert Syndrome, and Crouzon Syndrome. The DePuy Synthes External MVMD is also ideal for treating hypoplasias of an acquired origin such as from post-traumatic growth disorders associated with injury to the temporomandibular joint, temporomandibular ankylosis, and segmental loss of bone.
DePuy Synthes Locking Reconstruction Plate (LRP) with Condylar Head: The DePuy Synthes Locking Reconstruction Plate with Condylar Head is intended for temporary reconstruction in patients undergoing ablative tumor surgery requiring the removal of the mandibular condyle. This device is not for permanent implantation, for patients with TMJ or traumatic injuries, or for treatment of temporomandibular joint disease (TMD).
DePuy Synthes Cerclage Wires: The DePuy Synthes Cerclage Wires are indicated for use in adults and children to directly wire bony segments together, for the fixation of arch bars or splints to the teeth, for stabilization of bony segments, or for wiring the teeth together maxillomandibular fixation).
Product codes (comma separated list FDA assigned to the subject device)
MON, DZL, NEI, OAT, DZK
Device Description
DePuy Synthes IMF Screws: This document is regarding the DePuy Synthes IMF Screws, which are a subset of the DePuy Synthes Maxillofacial Portfolio - MR Conditional. The DePuy Synthes IMF Screws are designed with cross-axial through holes and a circumferential relief groove to accommodate wire or elastic bands. The IMF Screws are self-drilling, 2.0 mm in diameter, and available in thread lengths of 6mm to 12mm. The devices in scope of K183113 are being reviewed for MR Conditional labeling for maxillofacial indications.
DePuy Synthes Titanium Multi-Vector Distractor: This document is regarding the DePuy Synthes Titanium Multi-Vector Distractor, which are a supset of the DePuy Synthes Maxillofacial Portfolio-MR Conditional. The DePuy Synthes Titanium Multi-Vector Distractor (MVD) is a bone lengthening and distraction device that functions by gradually activating the device in a linear, angular, and/or transverse fashion. Bone stabilization may also be accomplished with this device after distraction. The device is comprised of interchangeable distraction arms, various pin clamps, socket and hex head screws, rods, and activation nuts. All MVD pin clamps accommodate 2.0mm k-wires. The devices in scope of K183113 are being reviewed for MR Conditional labeling for maxillofacial indications.
DePuy Synthes Low Profile Neuro System - 3 mm Screws: This document is regarding the DePuy Synthes Low Profile Neuro System - 3 mm Screws, which are a subset of the DePuy Synthes Maxillofacial Portfolio – MR Conditional. Synthes ø1.6 mm Low Profile Neuro System self-drilling, self-tapping, and ø1.9 mm emergency self-tapping screws in 3 mm lengths are to be added to the system. The devices in scope of K183113 are being reviewed for MR Conditional labeling for maxillofacial indications.
DePuy Synthes External Midface Distractor: This document is regarding the DePuy Synthes External Midface Distractor, which are a subset of the DePuy Synthes Maxillofacial Portfolio - MR Conditional. The DePuy Synthes External Midface Distractor is an external distraction osteogenesis device that attaches to the midface and is used to gradually lengthen the midface at the LeFort I, II, and III levels. The device consists of an external headframe, a central adjustment mechanism, a veridical central rod, horizontal crosspieces containing distraction screws, and separate footplates assemblies that attach to the zygoma and maxilla. The devices in scope of K183113 are being reviewed for MR Conditional labeling for maxillofacial indications.
DePuy Synthes 1.0/1.2 mm Craniofacial Screws: This document is regarding the DePuy Synthes 1.0/1.2 mm Craniofacial Screws, which are a subset of the DePuy Synthes Maxillofacial Portfolio - MR Conditional. The DePuy Synthes 1.0/1.2 mm Craniofacial Screws are either self-drilling or self tapping, have a flat head profile with rounded edges with a cruciform recess, and are available in various lengths. The devices in scope of K183113 are being reviewed for MR Conditional labeling for maxillofacial indications.
DePuy Synthes Alveolar Distractor: This document is regarding the DePuy Synthes Alveolar Distractor, which are a subset of the DePuy Synthes Maxillofacial Portfolio – MR Conditional. The DePuy Synthes Alveolar Distractor is an extraosseous distraction device consisting of a distractor body, a transport plate, a base plate, and a vector control mechanism. It is intended to be placed submucosally, with the base plate fastened to the stationary segment of the mandible or maxilla and the transport plate fastened to the mobile bone segment. The plates are fixed to the bone using 1.5 mm cortex screws. The devices in scope of K183113 are being reviewed for MR Conditional labeling for maxillofacial indications.
DePuy Synthes Craniomaxillofacial Distraction System (CMF Distraction System): This document is regarding the DePuy Synthes Craniomaxillofacial Distraction System (CMF Distraction System), which are a subset of the DePuy Synthes Maxillofacial Portfolio - MR Conditional. The DePuy Synthes Craniomaxillofacial Distraction System, which includes the Pediatric CMF Distraction System, is a modular family of internal distraction osteogenesis devices that are used to gradually lengthen the mandible body and ramus. Each device, when assembled, is comprised of a distractor body, two footplates, and a machine screw to secure the assembly. The system also includes optional activation arms, which can be attached to the activation end of the device to move the point of activation to an area accessible by the activation instrument. The devices in scope of K183113 are being reviewed for MR Conditional labeling for maxillofacial indications.
DePuy Synthes Condylar Head Add-On System: This document is regarding the DePuy Synthes Condylar Head Add-On System, which are a subset of the DePuy Synthes Maxillofacial Portfolio - MR Conditional. The DePuy Synthes Condylar Head Add-On System is an adjustable height system intended for use with DePuy Synthes' 2.4 mm Locking Reconstruction Plate (LRP) System. The system consists of an elliptical shaped condylar head, four different fixation plates which allow the surgeon to adjust the height of the condylar head, and two fixation screws for mounting the condylar head and fixation plate onto a 2.4 mm locking reconstruction plate. The devices in scope of K183113 are being reviewed for MR Conditional labeling for maxillofacial indications.
DePuy Synthes Curvilinear Distraction System (K080153): This document is regarding the DePuy Synthes Curvilinear Distraction System, which are a subset of the DePuy Synthes Maxillofacial Portfolio - MR Conditional. The DePuy Synthes Curvilinear Distraction System is an internal distraction osteogenesis device that gradually advances the mandible along a specific path of distraction. The system features various curved and straight distractors which are fixed to the mandible with bone screws. The distractors accept extension arms which move the point of activation that is easily accessible with the activation instrument. The devices in scope of K183113 are being reviewed for MR Conditional labeling for maxillofacial indications.
Modification to DePuy Synthes Condylar Head Add-On System: This document is regarding the DePuy Synthes Modification to Synthes Condylar Head Add-On System, which are a subset of the DePuy Synthes Maxillofacial Portfolio – MR Conditional. The DePuy Synthes Condylar Head Add-On System is an adjustable height add-on system for use with the 2.4 mm Locking Reconstruction Plate System and MatrixMANDIBLE Plate System. It consists of a condylar head, 2 screws, and one of four (4) fixation plates, each with a different screw hole spacing that determines the height of the condylar head. The devices in scope of K183113 are being reviewed for MR Conditional labeling for maxillofacial indications.
DePuy Synthes Orthodontic Bone Anchor (OBA) System: This document is regarding the DePuy Synthes Orthodontic Bone Anchor (OBA) System, which are a subset of the DePuy Synthes Maxillofacial Portfolio – MR Conditional. The DePuy Synthes Orthodontic Bone Anchor (OBA) System is intended to be implanted intraorally and used as an anchor for orthodontic procedures. The System includes screw anchors, plate anchors, instruments, and a module case for storage and sterilization. Screw Anchors: The screw anchor portion of the system consists of 1.55 nun self-drilling and selftapping screw anchors which incorporate a non-treaded gingival collar beneath the screw head to protect the soft tissue. Once implanted, orthodontic appliances such as archwires, elastics, and springs can be attached to the head of the anchor. The screw anchors are manufactured from titanium alloy (Ti-6A1-7Nb). Plate Anchors: The plate anchor portion of the system consists of T-shaped plate anchors which are attached to the bone via 1.55 mim cortex screws and 1.85 mma emergency screws. The plate anchors are offered in three designs (mesh, bracket, and domed)to allow attachment of orthodontic devices such as brackets, archwires, elastics, and springs. The plate anchors are manufactured from commercially pure titanium. The screws used to fix the plate anchors to the bone are manufactured from titanium alloy (Ti-6A-7Nb). The devices in scope of K183113 are being reviewed for MR Conditional labeling for maxillofacial indications.
DePuy Synthes Curvilinear Distraction System (K121502): This document is regarding the DePuy Synthes Curvilinear Distraction System, which are a subset of the DePuy Synthes Maxillofacial Portfolio - MR Conditional. The DePuy Synthes Curvilinear Distraction System is a family of internal distraction osteogenesis devices that gradually advance the mandible along a specific trajectory of distraction. The system features various curved and straight distractors in two sizes; the 1.3mm Curvillinear Distractor and the 2.0mm Curvilinear Distractor. The distractors accept extension arms which move the point of activation to a location that is easily accessible with the activation instrument. The DePuy Synthes Curvilinear Distraction devices are manufactured from, titanium alloy and chromium cobalt alloy. Devices are supplied non-sterilized prior to use. The distractor features a worm gear that is activated to move the distractor along a curved or straight track. The distractor consists of three main components: Track: The track has grooves in Imm intervals which may be placed in a straight line (for a straight distractor) or on a centerline radius (for a curved distractor). The track is manufactured with a crimp that serves as a functional stop to prevent the distractor from separating at the end of the track is 35mm in length and can be cut to the desired length for each particular patient by the surgeon. After cutting, the track is crimped to re-establish the functional stop to prevent separation. Worm gear activation assembly: The worm activation assembly consists of the worm gear and a universal joint activation hex. The universal joint is capable of + or - 35 degree of angulation. The worm gear has a 1 mm pitch and rides along the grooves cut into the track. The worm gear activation assembly is inserted into the housing and the track with grooves is threaded through a slot in the side of the housing. Housing: The housing includes a tab that lays on the activation assembly to prevent the distractor from reversing due to micromotion. The devices in scope of K183113 are being reviewed for MR Conditional labeling for maxillofacial indications.
DePuy Synthes Mandible Distractor: This document is regarding the DePuy Synthes Mandible Distractor, which are a subset of the DePuy Synthes Maxillofacial Portfolio – MR Conditional. The DePuy Synthes Mandible Distractor is intended to be used in the mandible for conditions such as mandibular deficiency or posttraumatic effects of the mandible, where gradual bone distraction is required. The Mandible Distractor is a subcutaneous bone distractor. It features two telescoping components activated by a jack screw, fixed to the bone via subcutaneous plates and secured with 2.0 mrn or 2.4 mm bone screws. A hex driver is used to activate the required distraction. The devices in scope of K183113 are being reviewed for MR Conditional labeling for maxillofacial indications.
DePuy Synthes SMF Stainless Steel Bone Screws: This document is regarding the DePuy Synthes SMF Stainless Steel Bone Screws, which are a subset of the DePuy Synthes Maxillofacial Portfolio – MR Conditional. SMF Stainless Steel Bone Screws are intended for maxillofacial and mandibular trauma and reconstruction. The screws feature self-tapping tips and a cruciform drive recess. The screws are available in various lengths ranging from 4 to 38 mm. The longer screw lengths (24 - 38 mm) are specifically intended for symphyseal fractures, parasymphyseal fractures, and angle fractures where the lag screw technique is being followed. The lag screw technique involves over-drilling the near cortex, thus the screw glides through the near cortical and cancellous bone and purchases only into the far cancellous and cortical bone. The devices in scope of K183113 are being reviewed for MR Conditional labeling for maxillofacial indications.
DePuy Synthes 1.5 mm/2.0 mm Orthognathic Maxillary Plates and Screws: This document is regarding the DePuy Synthes 1.5 mm/2.0 mm Orthognathic Maxillary Plates and Screws, which are a subset of the DePuy Synthes Maxillofacial Portfolio – MR Conditional. The DePuy Synthes 1.5 mm /2.0 mm Orthognathic Maxillary Plates are available in Mesh-, T-, L, and Z- plate configurations, and attach to bone via 1.5 mm and 2.0 mm self-tapping screws, and 2.0 mm and 2.4 mm emergency screws. The devices in scope of K183113 are being reviewed for MR Conditional labeling for maxillofacial indications.
DePuy Synthes Single Vector Distractor with Detachable Feet: This document is regarding the DePuy Synthes External Mandibular Fixator And/Or Distractor, which are a subset of the DePuy Synthes Maxillofacial Portfolio – MR Conditional. The DePuy Synthes Single Vector Distractor with Detachable Feet is a subcutaneous bone distractor activated by a drive component. It features two telescoping components activated by a jack screw, fixed to the bone with bone screws. Bone lengthening and distraction are achieved by gradually activating the device. Upon removal, the telescoping components and jack screw are disengaged and removed, leaving the subcutaneous foot plates in the patient. The devices in scope of K183113 are being reviewed for MR Conditional labeling for maxillofacial indications.
DePuy Synthes External Multi Vector Mandible Distractor (MVMD): This document is regarding the DePuy Synthes External Multi Vector Mandible Distractor (MVMD), which are a subset of the DePuy Synthes Maxillofacial Portfolio – MR Conditional. The DePuy Synthes External Multi Vector Mandible Distractor (MVMD) is a bone lengthening and distraction device which is achieved by gradually activating the device in a linear, angular, and/or transverse fashion. Bone stabilization may also be achieved with this device after distraction. The DePuy Synthes External MVMD is comprised of two interchangeable distraction arms, pin clamps, universal clamps, rods, flat head screws, and activation nuts. The pin clamps can accept 2.0mm k-wires. The devices in scope of K183113 are being reviewed for MR Conditional labeling for maxillofacial indications.
DePuy Synthes Locking Reconstruction Plate (LRP) with Condylar Head: This document is regarding the DePuy Synthes Locking Reconstruction Plate (LRP) with Condylar Head, which are a subset of the DePuy Synthes Maxillofacial Portfolio – MR Conditional. The DePuy Synthes Locking Reconstruction Plate (LRP) with Condylar Head is a one piece reconstruction plate with a solid condylar head. The plate features compression screw holes that are internally threaded to accept the 2.4 - 3.0mm locking screws or standard 2.4 mm selftapping cortex screws and has notched sides and undersides to facilitate contouring. The plates are available in three sizes for right and left placement. The devices in scope of K183113 are being reviewed for MR Conditional labeling for maxillofacial indications.
DePuy Synthes Cerclage Wires: This document is regarding the DePuy Synthes Cerclage Wires, which are a subset of the DePuy Synthes Maxillofacial Portfolio – MR Conditional. The DePuy Synthes Cerclage Wires are used to augment fracture stabilization with or without plates. The wire is available in a variety of diameters. The wires are pre-cut to a usable length or available in coils allowing the surgeon to cut the length to his patient's needs. The devices in scope of K183113 are being reviewed for MR Conditional labeling for maxillofacial indications.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxilla, mandible, midface, maxillofacial skeleton, chin, alveolar ridge, mandibular body, ramus, temporomandibular joint, teeth, cranium
Indicated Patient Age Range
Adult and pediatric populations.
DePuy Synthes Pediatric CMF Distraction System: children under the age of 12 months.
DePuy Synthes Curvilinear Distraction System (K080153): adults or pediatric patients over 1 year old.
DePuy Synthes Orthodontic Bone Anchor (OBA) System screw anchors: adolescents greater than age 12 and adults.
DePuy Synthes Orthodontic Bone Anchor (OBA) System plate anchors: adults.
DePuy Synthes Curvilinear Distraction System (K121502): The 2.0 mm Curvilinear Distractor is intended for use in adult and pediatric patients more than 1 year old. The 1.3 mm Curvilinear Distractor is intended for use in pediatric patients 4 years of age and younger.
DePuy Synthes Cerclage Wires: adults and children.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing is provided to support the conditional safety of the devices in the MR environment including assessment of magnetically induced displacement force (ASTM F2052-14) and torque (ASTM F2213-06), radio frequency (RF) heating (ASTM F2182-11a and DUKE model), and image artifacts (ASTM F2119-07). The DUKE model places devices in the clinically relevant anatomic position. The DUKE results will be used for labeling of RF heating.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K010527, K010690, K031807, K040083, K041887, K043555, K060138, K063181, K080153, K081747, K093299, K121502, K962272, K964261, K980199, K981075, K981362, K990637, K092530
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Synthes Pre-Amendment Cerclage Wires
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below.
March 13, 2019
Synthes (USA) Products LLC Rebecca Reiter Regulatory Affairs Project Leader 1301 Goshen Parkway West Chester, Pennsylvania 19380
Re: K183113
Trade/Device Name: DePuv Synthes Maxillofacial Portfolio - MR Conditional Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: Class II Product Code: MON, DZL, NEI, OAT, DZK Dated: February 14, 2019 Received: February 15, 2019
Dear Rebecca Reiter:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Andrew I. Steen -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known) K183113
Device Name
DePuy Synthes Maxillofacial Portfolio - MR Conditional
Indications for Use (Describe) DePuy Synthes IMF Screws (originally cleared per K010527)
The DePuy Synthes IMF Screws are intended to provide indirect stabilization of the maxilla and mandible following maxillofacial and mandibular trauma or reconstruction.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
3
510(k) Number (if known) K183113
Device Name
DePuy Synthes Maxillofacial Portfolio - MR Conditional
Indications for Use (Describe) DePuy Synthes Titanium Multi-Vector Distractor (originally cleared per K010690)
The DePuy Synthes Titanium Multi-Vector is intended for use in mandbular bone lengthening for conditions such as mandibular hypoplasia or post-traumatic defects such as tumor resections, severe trauma, bone grafting defects, severe open mandible fractures where gradual distraction is required. Where bone loss is a result of the condition, bone transport can be performed as an alternative to free flaps or bone grafts.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
4
510(k) Number (if known) K183113
Device Name
DePuy Synthes Maxillofacial Portfolio - MR Conditional
Indications for Use (Describe) DePuy Synthes Low Profile Neuro System - 3 mm Screws (originally cleared via K031807)
The DePuy Synthes Low Profile Neuro System - 3 mm Screws is intended for use in selective trauma of the midface and maxillofacial skeleton; maxillofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
5
510(k) Number (if known) K183113
Device Name
DePuy Synthes Maxillofacial Portfolio - MR Conditional
Indications for Use (Describe) DePuy Synthes External Midface Distractor (originally cleared via K040083)
The DePuy Synthes External Midface Distractor is intended for use in maxillofacial surgery, reconstructive procedures, and selective orthognathic surgery of the maxilla. Specifically, it is intended for distraction of the maxilla utilizing a LeFort I osteotomy and/or the midface utilizing a LeFort II or III osteotomy in adult and pediations where gradual bone distraction is required.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
6
510(k) Number (if known) K183113
Device Name
DePuy Synthes Maxillofacial Portfolio - MR Conditional
Indications for Use (Describe) DePuy Synthes 1.0/1.2 mm Craniofacial Screws (originally cleared per K041887)
The DePuy Synthes 1.0/1.2 mm Craniofacial Screws are intended for use as follows:
General Indications:
· Maxillofacial surgery
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ---------------------------------------------- | --------------------------------------------- |
| > Prescription Use (Part 21 CFR 801 Subpart D)
|__ | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
7
510(k) Number (if known) K183113
Device Name
DePuy Synthes Maxillofacial Portfolio - MR Conditional
Indications for Use (Describe) DePuy Synthes Alveolar Distractor (originally cleared per K043555)
The DePuy Synthes Alveolar Distractor is intended for vertical bone lengthening of the alveolar ridge in the mandible and the maxilla where gradual bone distraction is required, including deficiency in bone height as a result of trauma, resorption after dental extraction, periodontal disease, tumor resection, and congenital deformity.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
8
510(k) Number (if known) K183113
Device Name
DePuy Synthes Maxillofacial Portfolio - MR Conditional
Indications for Use (Describe)
DePuy Synthes Craniomaxillofacial Distraction System (CMF Distraction System) (originally cleared per K060138)
The DePuy Synthes Craniomaxillofacial Distraction System (CMF Distraction System) is intended for use as a bone stabilizer and lengthening (and/or transport) device for correction of congenital deficiencies or post-traumatic defects of the mandibular body and ramus where gradual bone distraction is required. The DePuy Synthes CMF Distraction System is intended for single use only.
The DePuy Synthes Pediatric CMF Distraction System is intended for use as a bone stabilizer and lengthening (and/or transport) device for correction of congenital deficiencies or post-traumatic defects of the mandibular body and ramus where gradual bone distraction is required in children under the age of 12 months. The DePuy Synthes Pediativ CMF Distraction System is intended for single use only.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
9
510(k) Number (if known) K183133
Device Name
DePuy Synthes Maxillofacial Portfolio - MR Conditional
Indications for Use (Describe) DePuy Synthes Condylar Head Add-On System (originally cleared per K063181)
The DePuy Synthes Condylar Head Add-On System is intended for temporary reconstruction in patients undergoing ablative tumor surgery requiring the removal of the mandibular condyle. This device is not for permanent implantation, for patients with TMJ or traumatic injuries, or for treatment of temporomandibular joint disease (TMD).
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
10
510(k) Number (if known) K183113
Device Name
DePuy Synthes Maxillofacial Portfolio - MR Conditional
Indications for Use (Describe) DePuy Synthes Curvilinear Distraction System (originally cleared per K080153)
The DePuy Synthes Curvilinear Distraction System is intended for use as a bone stabilizer and lengthening (and/or transport) device for correction of congenital deficiencies or post-traumatic defects of the mandibular body and ramus where gradual bone distraction is required. This system is intended for use in either adults or pediatric patients over 1 year old. The DePuy Synthes Curvilinear Distraction System is intended for single use only.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
11
510(k) Number (if known) K183113
Device Name
DePuy Synthes Maxillofacial Portfolio - MR Conditional
Indications for Use (Describe) Modification to DePuy Synthes Condylar Head Add-On System (originally cleared per K081747)
The DePuy Synthes Condylar Head Add-On System Intended for temporary reconstruction in patients undergoing ablative tumor surgery requiring the removal of the mandibular condyle. This device is not for permanent implantation. for patients with TMJ or traumatic injuries, or for treatment of temporomandibular joint disease (TMD).
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
12
510(k) Number (if known) K183113
Device Name
DePuy Synthes Maxillofacial Portfolio - MR Conditional
Indications for Use (Describe) DePuy Synthes Orthodontic Bone Anchor (OBA) System (originally cleared per K093299)
The DePuy Synthes Orthodontic Bone Anchor (OBA) System screw anchors are intended to be implanted intraorally and used as an anchor for orthodontic procedures in adolescents greater than age 12 and adults.
The DePuy Synthes Orthodontic Bone Anchor (OBA) System plate anchors are intended to be implanted intraorally and used as an anchor for orthodontic procedures in adults.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
13
510(k) Number (if known) K183113
Device Name
DePuy Synthes Maxillofacial Portfolio - MR Conditional
Indications for Use (Describe) DePuy Synthes Curvilinear Distraction System (originally cleared per K121502)
The DePuy Synthes Curvilinear Distraction System is intended for use as a bone stabilizer and lengthening (and/or transport) device. The DePuy Synthes Curvilinear Distraction System is indicated for correction of congenital deficiencies or posttraumatic defects of the mandibular body and ramus where gradual bone distraction is required.
The 2.0 mm Curvilinear Distractor is intended for use in adult and pediatric patients more than 1 year old.
The 1.3 mm Curvilinear Distractor is intended for use in pediatric patients 4 years of age and younger.
The DePuy Synthes Curvilinear Distraction System is intended for single use only.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
14
510(k) Number (if known) K183113
Device Name
DePuy Synthes Maxillofacial Portfolio - MR Conditional
Indications for Use (Describe) DePuy Synthes Mandible Distractor (originally cleared per K962272)
The DePuy Synthes Mandible Distractor is intended to be used in the mandible for conditions such as mandibular deficiency or post-traumatic effects of the mandible, where gradual bone distraction is required.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
15
510(k) Number (if known) K183113
Device Name
DePuy Synthes Maxillofacial Portfolio - MR Conditional
Indications for Use (Describe) DePuy Synthes SMF Stainless Steel Bone Screws (originally cleared via K964261)
The DePuy Synthes SMF Stainless Steel Bone Screws are intended for maxillofacial and mandbular trauma and reconstruction. The longer screw lengths (24-38mm) are specifically intended for symphysial fractures, parasymphyseal fractures, and angle fractures where the lag screw technique is being followed. The lag screw technique involves overdrilling the near cortex, thus the screw glides through the near cortical and cancellous bone and purchases only into the far cancellous and cortical bone.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
16
510(k) Number (if known) K183113
Device Name
DePuy Synthes Maxillofacial Portfolio - MR Conditional
Indications for Use (Describe)
DePuy Synthes 1.5 mm/2.0 mm Orthognathic Maxillary Plates and Screws (originally cleared per K980199)
The DePuy Synthes 1.5 mm/2.0 mm Orthognathic Maxillary Plates and Screws are generally intended for a variety of pan facial indications. Specifically, it is intended for selective trauma of the midface and maxillofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | ☑ |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) | ☐ |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
17
510(k) Number (if known) K183113
Device Name
DePuy Synthes Maxillofacial Portfolio - MR Conditional
Indications for Use (Describe)
DePuy Synthes Single Vector Distractor with Detachable Feet (originally cleared per K981075)
The DePuy Synthes Single Vector Distractor with Detachable Feet is intended for use as a bone stabilizer and lengthener for conditions such as mandibular hypoplasia or post-traumatic defects of the mandible, where gradual bone distraction is required. The device is ideal for treating fonns of clefts of the lip and palate, and congenital mandibular hypoplasia, such as Hemifacial Microsomia, Treacher Collins Syndrome, Pierre Robin Syndrome, Goldenhar Syndrome, Apert Syndrome, and Crouzon Syndrome.
The DePuy Synthes Single Vector Distractor with Detachable Feet is also ideal for treating hypoplasias of an acquired origin such as from post-traumatic growth disorders associated with injury to the temporomandibular joint, temporomandibular ankylosis, and segmental loss of bone.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
18
510(k) Number (if known) K183113
Device Name
DePuy Synthes Maxillofacial Portfolio - MR Conditional
Indications for Use (Describe) DePuy Synthes External Multi Vector Mandible Distractor (MVMD) (originally cleared via K981362)
The DePuy Synthes External Multi Vector Mandible Distractor (MVMD) is intended for use as a bone stabilizer and lengthener for conditions such as mandibular hypoplasia or posttraumatic defects of the mandible, where gradual bone distraction is required. The device is ideal for treating any form of congenital mandibular hypoplasia, such as Hemifacial Micorsomia, Treacher Collins Syndrome, Nagers Syndrome, Pierre Robin Syndrome, Goldenhar Syndrome, Apert Syndrome, and Crouzon Syndrome.
The DePuy Synthes External MVMD is also ideal for treating hypoplasias of an acquired origin such as from posttraumatic growth disorders associated with injury to the temporomandibular joint, temporomandibular ankylosis, and segmental loss of bone.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
19
510(k) Number (if known) K183113
Device Name
DePuy Synthes Maxillofacial Portfolio - MR Conditional
Indications for Use (Describe)
DePuy Synthes Locking Reconstruction Plate (LRP) with Condylar Head (originally cleared per K990637)
The DePuy Synthes Locking Reconstruction Plate with Condylar Head is intended for temporary reconstruction in patients undergoing ablative tumor surgery requiring the removal of the mandibular condyle. This device is not for permanent implantation, for patients with TMJ or traumatic injuries, or for treatment of temporomandibular joint disease (TMD).
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
20
510(k) Number (if known) K183113
Device Name
DePuy Synthes Maxillofacial Portfolio - MR Conditional
Indications for Use (Describe) DePuy Synthes Cerclage Wires (originally Pre-Amendment)
The DePuy Synthes Cerclage Wires are indicated for use in adults and children to directly wire bony segments together, for the fixation of arch bars or splints to the teeth, for stabilization of bony segments, or for wiring the teeth together maxillomandibular fixation).
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
21
Image /page/21/Picture/0 description: The image shows the logo for DePuy Synthes, which is part of the Johnson & Johnson family of companies. The logo includes a symbol that looks like two overlapping circles, followed by the company name in blue, and the tagline "People inspired" in gold. The text "PART OF THE Johnson+Johnson FAMILY OF COMPANIES" is written in a smaller font below the company name.
510(k) Summary 1.
Date Prepared: March 7, 2019
1.1. Submitter
Primary Contact: Rebecca Reiter Regulatory Affairs Project Leader DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: 610-719-1268 Email: rreiter@its.jnj.com
Alternate Contact:
Elizabeth Jacobs Regulatory Affairs Project Leader DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5768 Email: ejacob10@its.jnj.com
1.2. Device
Trade Name: DePuy Synthes Maxillofacial Portfolio - MR Conditional
Name of Device: DePuy Synthes IMF Screws
Classification Name(s): Screw, Fixation, Intraosseous
Regulatory Class: Class II; 872.4880
Product Code(s): DZL
- 1.3. Predicate Device
K010527 Synthes IMF Screws
Device Description 1.4.
This document is regarding the DePuy Synthes IMF Screws, which are a subset of the DePuy Synthes Maxillofacial Portfolio - MR Conditional. The DePuy Synthes IMF Screws are designed with cross-axial through holes and a circumferential relief groove to accommodate wire or elastic bands. The IMF Screws are self-drilling, 2.0 mm in diameter, and available in thread lengths of 6mm to 12mm. The devices in scope of K183113 are being reviewed for MR Conditional labeling for maxillofacial indications.
22
Image /page/22/Picture/0 description: The image shows the logo for DePuy Synthes, which is part of the Johnson & Johnson family of companies. The logo includes a symbol of two overlapping circles, followed by the company name in blue text. Below the company name is the phrase "PART OF THE Johnson & Johnson FAMILY OF COMPANIES" in smaller text. To the right of the company name is the phrase "People inspired" in a cursive font.
The DePuy Synthes IMF Screws are intended to provide indirect stabilization of the maxilla and mandible following maxillofacial and mandibular trauma or reconstruction.
Substantial Equivalence 1.6.
The purpose of this submission is to add MR Conditional information to the device labeling for the DePuy Synthes IMF Screws. Changes in the Indications for Use Statement are to remove language not specific to maxillofacial surgeries, as these (e.g., craniofacial) indications are not reviewed by the Dental Review Panel. The technological characteristics of the devices remains unchanged. The device name has been updated to reflect the current company name, DePuy Synthes. An indications for use comparison table is provided below.
| K183113 | K010527 |
|---|---|
| The DePuy Synthes IMF Screws are intended | |
| to provide indirect stabilization of the maxilla | |
| and mandible following maxillofacial and | |
| mandibular trauma or reconstruction. | To provide indirect stabilization of the maxilla |
| and mandible following craniofacial and | |
| mandibular trauma or reconstruction. |
Non-Clinical Testing Summary 1.7.
Non-clinical testing is provided to support the conditional safety of the DePuy Synthes IMF Screws in the MR environment including assessment of magnetically induced displacement force (ASTM F2052-14) and torque (ASTM F2213-06), radio frequency (RF) heating (ASTM F2182-11a and DUKE model), and image artifacts (ASTM F2119-07). The DUKE model places devices in the clinically relevant anatomic position. The DUKE results will be used for labeling of RF heating.
23
Image /page/23/Picture/0 description: The image shows the logo for DePuy Synthes, which is part of the Johnson & Johnson family of companies. The logo consists of a circular symbol with two curved lines inside, followed by the text "DePuy Synthes" in a dark blue sans-serif font. To the right of the company name, the phrase "People inspired" is written in a cursive, gold-colored font.
510(k) Summarv 1.
Date Prepared: March 7, 2019
1.1. Submitter
Primary Contact: Rebecca Reiter Regulatory Affairs Project Leader DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: 610-719-1268 Email: rreiter@its.jnj.com
Alternate Contact: Elizabeth Jacobs Regulatory Affairs Project Leader DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5768 Email: ejacob10@its.jnj.com
1.2. Device
Trade Name: DePuy Synthes Maxillofacial Portfolio - MR Conditional
Name of Device: DePuy Synthes Titanium Multi-Vector Distractor
Classification Name(s): Screw, Fixation, Intraosseous
Regulatory Class: Class II; 872.4880
Product Code(s): DZL
1.3. Predicate Device
K010690 Synthes Titanium Multi-Vector Distractor
Device Description 1.4.
This document is regarding the DePuy Synthes Titanium Multi-Vector Distractor, which are a supset of the DePuy Synthes Maxillofacial Portfolio-MR Conditional. The DePuy Synthes Titanium Multi-Vector Distractor (MVD) is a bone lengthening and distraction device that functions by gradually activating the device in a linear, angular, and/or transverse fashion. Bone stabilization may also be accomplished with this device after distraction. The device is comprised of interchangeable distraction arms, various pin clamps, socket and hex head screws, rods, and activation nuts. All MVD pin clamps accommodate 2.0mm k-wires. The
24
Image /page/24/Picture/0 description: The image shows the logo for DePuy Synthes, which is part of the Johnson & Johnson family of companies. The logo features a stylized, circular symbol to the left of the company name, "DePuy Synthes," written in a bold, blue font. To the right of the company name, the phrase "People inspired" is written in a cursive, gold font. Below the company name, there is a smaller line of text that reads "PART OF THE Johnson & Johnson FAMILY OF COMPANIES".
devices in scope of K183113 are being reviewed for MR Conditional labeling for maxillofacial indications.
Indications for Use 1.5.
The DePuy Synthes Titanium Multi-Vector Distractor is intended for use in mandibular bone lengthening for conditions such as mandibular hypoplasia or post-traumatic defects such as tumor resections, severe trauma, bone grafting defects, severe open mandible fractures where gradual distraction is required. Where bone loss is a result of the condition, bone transport can be performed as an alternative to free flaps or bone grafts.
Substantial Equivalence 1.6.
The purpose of this submission is to add MR Conditional information to the device labeling for the DePuy Synthes Titanium Multi-Vector Distractor. The intended use and technological characteristics of the devices remains unchanged. The device name has been updated to reflect the current company name, DePuy Synthes. An indications for use comparison table is provided below.
| K183113 | K010690 |
|---|---|
| The DePuy Synthes Titanium Multi-Vector | |
| Distractor is intended for use in mandibular | |
| bone lengthening for conditions such as | |
| mandibular hypoplasia or post-traumatic | |
| defects such as tumor resections, severe | For use in mandibular bone lengthening for |
| conditions such as mandibular hypoplasia or | |
| post-traumatic defects such as tumor | |
| resections, severe trauma, bone grafting | |
| defects, severe open mandible fractures | |
| trauma, bone grafting defects, severe open | |
| mandible fractures where gradual distraction | |
| is required. Where bone loss is a result of the | |
| condition, bone transport can be performed as | |
| an alternative to free flaps or bone grafts. | where gradual distraction is required. Where |
| bone loss is a result of the condition, bone | |
| transport can be performed as an alternative | |
| to free flaps or bone grafts. |
25
Image /page/25/Picture/0 description: The image shows the logo for DePuy Synthes, which is part of the Johnson & Johnson family of companies. The logo features a symbol of two overlapping circles in a tan color, followed by the company name in blue, "DePuy Synthes". To the right of the company name is the phrase "People inspired" in a cursive font and tan color. Below the company name is the phrase "PART OF THE Johnson-Johnson FAMILY OF COMPANIES" in a smaller font size.
Non-Clinical Testing Summary 1.7.
Non-clinical testing is provided to support the conditional safety of the DePuy Synthes Titanium Multi-Vector Distractor in the MR environment including assessment of magnetically induced displacement force (ASTM F2052-14) and torque (ASTM F2213-06), radio frequency (RF) heating (ASTM F2182-11a and DUKE model), and image artifacts (ASTM F2119-07). The DUKE model places devices in the clinically relevant anatomic position. The DUKE results will be used for labeling of RF heating.
26
Image /page/26/Picture/0 description: The image shows the logo for DePuy Synthes, which is part of the Johnson & Johnson family of companies. The logo consists of a symbol that looks like two overlapping circles, followed by the text "DePuy Synthes" in blue. Below the text is the phrase "PART OF THE Johnson & Johnson FAMILY OF COMPANIES" in a smaller font. To the right of the company name is the phrase "People inspired" in a cursive font.
510(k) Summary 1.
Date Prepared: March 7, 2019
1.1. Submitter
Primary Contact: Rebecca Reiter Regulatory Affairs Project Leader DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: 610-719-1268 Email: rreiter@its.jnj.com
Alternate Contact: Elizabeth Jacobs Regulatory Affairs Project Leader DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5768 Email: ejacob10@its.jnj.com
1.2. Device
Trade Name: DePuy Synthes Maxillofacial Portfolio - MR Conditional
Name of Device: DePuy Synthes Low Profile Neuro System - 3 mm Screws
Classification Name(s): Screw, Fixation, Intraosseous
Regulatory Class: Class II; 872.4880
Product Code(s): DZL
1.3. Predicate Device
K031807 Synthes Low Profile Neuro System - 3 mm Screws
Device Description 1.4.
This document is regarding the DePuy Synthes Low Profile Neuro System - 3 mm Screws, which are a subset of the DePuy Synthes Maxillofacial Portfolio – MR Conditional. Synthes ø1.6 mm Low Profile Neuro System self-drilling, self-tapping, and ø1.9 mm emergency self-tapping screws in 3 mm lengths are to be added to the system. The devices in scope of K183113 are being reviewed for MR Conditional labeling for maxillofacial indications.
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Image /page/27/Picture/0 description: The image shows the logo for DePuy Synthes, which is part of the Johnson & Johnson family of companies. The logo includes a symbol of two overlapping circles in gold, followed by the company name in blue. Below the company name, there is a tagline in gold that says "People inspired". The text "PART OF THE Johnson&Johnson FAMILY OF COMPANIES" is in a smaller font size and is located below the company name.
The DePuy Synthes Low Profile Neuro System -3 mm Screws is intended for use in selective trauma of the midface and maxillofacial skeleton; maxillofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.
Substantial Equivalence 1.6.
The purpose of this submission is to add MR Conditional information to the device labeling for the DePuy Synthes Low Profile Neuro System - 3 mm Screws. Changes in the Indications for Use Statement are to remove language not specific to maxillofacial surgeries, as these (e.g., craniofacial) indications are not reviewed by the Dental Review Panel. The technological characteristics of the devices remains unchanged. The device name has been updated to reflect the current company name, DePuy Synthes. An indications for use comparison table is provided below.
| K183113 | K031807 |
|---|---|
| The DePuy Synthes Low Profile Neuro System - Synthes Low Profile Neuro System is intended | |
| 3 mm Screws is intended for use in selective | for use in selective trauma of the midface and |
| trauma of the midface and | craniofacial skeleton; craniofacial surgery; |
| maxillofacial skeleton; maxillofacial surgery; | reconstructive procedures; and selective |
| reconstructive procedures; and selective | orthognathic surgery of the maxilla and chin. |
| orthognathic surgery of the maxilla and chin. |
Non-Clinical Testing Summary 1.7.
Non-clinical testing is provided to support the conditional safety of the DePuy Synthes Low Profile Neuro System - 3 mm Screws in the MR environment including assessment of magnetically induced displacement force (ASTM F2052-14) and torque (ASTM F2213-06), radio frequency (RF) heating (ASTM F2182-11a and DUKE model), and image artifacts (ASTM F2119-07). The DUKE model places devices in the clinically relevant anatomic position. The DUKE results will be used for labeling of RF heating.
28
Image /page/28/Picture/0 description: The image shows the logo for DePuy Synthes, which is part of the Johnson & Johnson family of companies. The logo features a stylized symbol to the left of the company name, "DePuy Synthes," which is written in a bold, blue font. To the right of the company name, the phrase "People inspired" is written in a cursive, gold font. Below the company name, there is a smaller line of text that reads "PART OF THE Johnson & Johnson FAMILY OF COMPANIES."
510(k) Summarv 1.
Date Prepared: March 7, 2019
1.1. Submitter
Primary Contact: Rebecca Reiter Regulatory Affairs Project Leader DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: 610-719-1268 Email: rreiter@its.jnj.com
Alternate Contact: Elizabeth Jacobs Regulatory Affairs Project Leader DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5768 Email: ejacob10@its.jnj.com
1.2. Device
Trade Name: DePuy Synthes Maxillofacial Portfolio - MR Conditional
Name of Device: DePuy Synthes External Midface Distractor
Classification Name(s): External Mandibular Fixator And/Or Distractor
Regulatory Class: Class II; 872.4760
Product Code(s): MQN
1.3. Predicate Device
K040083 Synthes External Midface Distractor
Device Description 1.4.
This document is regarding the DePuy Synthes External Midface Distractor, which are a subset of the DePuy Synthes Maxillofacial Portfolio - MR Conditional. The DePuy Synthes External Midface Distractor is an external distraction osteogenesis device that attaches to the midface and is used to gradually lengthen the midface at the LeFort I, II, and III levels. The device consists of an external headframe, a central adjustment mechanism, a veridical central rod, horizontal crosspieces containing distraction screws, and separate footplates assemblies that attach to the zygoma and maxilla. The devices in scope of K183113 are being reviewed for MR Conditional labeling for maxillofacial indications.
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Image /page/29/Picture/0 description: The image shows the logo for DePuy Synthes, which is part of the Johnson & Johnson family of companies. The logo features a stylized symbol resembling interconnected circles in a gold color, followed by the company name "DePuy Synthes" in a bold, dark blue font. To the right of the company name, the phrase "People inspired" is written in an elegant, cursive font, also in a gold color.
The DePuy Synthes External Midface Distractor is intended for use in maxillofacial surgery, reconstructive procedures, and selective orthognathic surgery of the maxilla. Specifically, it is intended for distraction of the maxilla utilizing a LeFort I osteotomy and/or the midface utilizing a LeFort II or III osteotomy in adult and pediatric populations where gradual bone distraction is required.
Substantial Equivalence 1.6.
The purpose of this submission is to add MR Conditional information to the device labeling for the DePuy Synthes External Midface Distractor. Changes in the Indications for Use Statement are to remove language not specific to maxillofacial surgeries, as these (e.g., craniofacial) indications are not reviewed by the Dental Review Panel. The technological characteristics of the devices remains unchanged. The device name has been updated to reflect the current company name, DePuy Synthes. An indications for use comparison table is provided below.
| K183113 | K040083 |
|---|---|
| The DePuy Synthes External Midface | |
| Distractor is intended for use in maxillofacial | |
| surgery, reconstructive procedures, and | |
| selective orthognathic surgery of the maxilla. | |
| Specifically, it is intended for distraction of the | |
| maxilla utilizing a LeFort I osteotomy and/ | |
| or the midface utilizing a LeFort II or III | |
| osteotomy in adult and pediatric populations | |
| where gradual bone distraction is required. | The Synthes External Midface Distractor is |
| intended for use in craniofacial surgery, | |
| reconstructive procedures, and selective | |
| orthognathic surgery of the maxilla. | |
| Specifically, it is intended for distraction of the | |
| maxilla utilizing a LeFort I osteotomy, the | |
| midface utilizing a LeFort II or III osteotomy, | |
| and / or the cranium utilizing a monobloc | |
| osteotomy in adult and pediatric populations | |
| where gradual bone distraction is required. |
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Image /page/30/Picture/0 description: The image shows the logo for DePuy Synthes, which is part of the Johnson & Johnson family of companies. The logo features a stylized eye symbol in gold, followed by the company name in blue, and the tagline "People inspired" in a cursive font. The text "PART OF THE Johnson & Johnson FAMILY OF COMPANIES" is located below the company name in a smaller font.
Non-Clinical Testing Summary 1.7.
Non-clinical testing is provided to support the conditional safety of the DePuy Synthes External Midface Distractor in the MR environment including assessment of magnetically induced displacement force (ASTM F2052-14) and torque (ASTM F2213-06), radio frequency (RF) heating (ASTM F2182-11a and DUKE model), and image artifacts (ASTM F2119-07). The DUKE model places devices in the clinically relevant anatomic position. The DUKE results will be used for labeling of RF heating.
31
Image /page/31/Picture/0 description: The image shows the logo for DePuy Synthes, which is part of the Johnson & Johnson family of companies. The logo features a stylized symbol to the left of the company name, "DePuy Synthes," which is written in a bold, blue font. To the right of the company name, the phrase "People inspired" is written in a cursive, gold font. Below the company name, there is a smaller line of text that reads "PART OF THE Johnson & Johnson FAMILY OF COMPANIES."
510(k) Summary 1.
Date Prepared: March 7, 2019
1.1 Submitter
Primary Contact: Rebecca Reiter Regulatory Affairs Project Leader DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: 610-719-1268 Email: rreiter@its.jnj.com
Alternate Contact: Elizabeth Jacobs Regulatory Affairs Project Leader DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5768 Email: ejacob10@its.jnj.com
1.2 Device
Trade Name: DePuy Synthes Maxillofacial Portfolio - MR Conditional
Name of Device: DePuy Synthes 1.0/1.2 mm Craniofacial Screws
Classification Name(s): Screw, Fixation, Intraosseous
Regulatory Class: Class II; 872.4880
Product Code(s): DZL
1.3 Predicate Device
K041887 Synthes 1.0/1.2 mm Craniofacial Screws
1.4 Device Description
This document is regarding the DePuy Synthes 1.0/1.2 mm Craniofacial Screws, which are a subset of the DePuy Synthes Maxillofacial Portfolio - MR Conditional. The DePuy Synthes 1.0/1.2 mm Craniofacial Screws are either self-drilling or self tapping, have a flat head profile with rounded edges with a cruciform recess, and are available in various lengths. The devices in scope of K183113 are being reviewed for MR Conditional labeling for maxillofacial indications.
32
Image /page/32/Picture/0 description: The image shows the logo for DePuy Synthes, which is part of the Johnson & Johnson family of companies. The logo includes a symbol that looks like two overlapping circles, followed by the company name in blue, and the tagline "People inspired" in gold. Below the company name, it says "PART OF THE Johnson & Johnson FAMILY OF COMPANIES" in smaller letters.
The DePuy Synthes 1.0/1.2 mm Craniofacial Screws are intended for use as follows:
General Indications:
- Maxillofacial surgery
Substantial Equivalence 1.6
The purpose of this submission is to add MR Conditional information to the device labeling for the DePuy Synthes 1.0/1.2 mm Craniofacial Screws. Changes in the Indications for Use Statement are to remove language not specific to maxillofacial surgeries, as these (e.g., craniofacial) indications are not reviewed by the Dental Review Panel. The technological characteristics of the devices remains unchanged. The device name has been updated to reflect the current company name, DePuy Synthes. An indications for use comparison table is provided below.
| K183113 | K041887 |
|---|---|
| The DePuy Synthes 1.0/1.2 mm Craniofacial | The Synthes 1.0/1.2 mm Craniofacial Screws |
| Screws are intended for use as follows: | are intended for use as follows: |
| General Indications: | |
| • Maxillofacial surgery | Specific Indications: |
| • Nasoethmoidal fractures | |
| • Infraorbital area fractures | |
| • Frontal sinus wall fractures | |
| • Infant craniofacial surgery | |
| General Indications: | |
| • Maxillofacial surgery |
33
Image /page/33/Picture/0 description: The image shows the logo for DePuy Synthes, which is part of the Johnson & Johnson family of companies. The logo consists of a symbol resembling two overlapping circles in a light brown color, followed by the name "DePuy Synthes" in a dark blue, sans-serif font. Below the name, there is a smaller text indicating that it is "PART OF THE Johnson & Johnson FAMILY OF COMPANIES".
Non-Clinical Testing Summary 1.7
Non-clinical testing is provided to support the conditional safety of the DePuy Synthes 1.0/1.2 mm Craniofacial Screws in the MR environment including assessment of magnetically induced displacement force (ASTM F2052-14) and torque (ASTM F2213-06), radio frequency (RF) heating (ASTM F2182-11a and DUKE model), and image artifacts (ASTM F2119-07). The DUKE model places devices in the clinically relevant anatomic position. The DUKE results will be used for labeling of RF heating.
34
Image /page/34/Picture/0 description: The image shows the logo for DePuy Synthes, which is part of the Johnson & Johnson family of companies. The logo features a stylized symbol to the left of the text "DePuy Synthes" in a dark blue font. To the right of the company name, the phrase "People inspired" is written in a cursive, gold-colored font. Below the company name, there is smaller text indicating that DePuy Synthes is part of the Johnson & Johnson family of companies.
510(k) Summary 1.
Date Prepared: March 7, 2019
1.1. Submitter
Primary Contact: Rebecca Reiter Regulatory Affairs Project Leader DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: 610-719-1268 Email: rreiter@its.jnj.com
Alternate Contact: Elizabeth Jacobs Regulatory Affairs Project Leader DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5768 Email: ejacob10@its.jnj.com
1.2. Device
Trade Name: DePuy Synthes Maxillofacial Portfolio - MR Conditional
Name of Device: DePuy Synthes Alveolar Distractor
Classification Name(s): External Mandibular Fixator And/Or Distractor
Regulatory Class: Class II; 872.4760
Product Code(s): MQN
1.3. Predicate Device
K043555 Synthes Alveolar Distractor
Device Description 1.4.
This document is regarding the DePuy Synthes Alveolar Distractor, which are a subset of the DePuy Synthes Maxillofacial Portfolio – MR Conditional. The DePuy Synthes Alveolar Distractor is an extraosseous distraction device consisting of a distractor body, a transport plate, a base plate, and a vector control mechanism. It is intended to be placed submucosally, with the base plate fastened to the stationary segment of the mandible or maxilla and the transport plate fastened to the mobile bone segment. The plates are fixed to the bone using 1.5 mm cortex screws. The devices in scope of K183113 are being reviewed for MR Conditional labeling for maxillofacial indications.
35
Image /page/35/Picture/0 description: The image shows the logo for DePuy Synthes, which is part of the Johnson & Johnson family of companies. The logo includes a symbol of two overlapping circles in gold, followed by the company name in blue. Below the company name, it says "Part of the Johnson & Johnson family of companies" in a smaller font. To the right of the company name, the words "People inspired" are written in a cursive gold font.
The DePuy Synthes Alveolar Distractor is intended for vertical bone lengthening of the alveolar ridge in the mandible and the maxilla where gradual bone distraction is required, including deficiency in bone height as a result of trauma, resorption after dental extraction, periodontal disease, tumor resection, and congenital deformity.
1.6. Substantial Equivalence
The purpose of this submission is to add MR Conditional information to the device labeling for the DePuy Synthes Alveolar Distractor. The intended use and technological characteristics of the devices remains unchanged. The device name has been updated to reflect the current company name, DePuy Synthes. An indications for use comparison table is provided below.
| K183113 | K043555 |
|---|---|
| The DePuy Synthes Alveolar Distractor is intended for vertical bone lengthening of the alveolar ridge in the mandible and the maxilla where gradual bone distraction is required, including deficiency in bone height as a result of trauma, resorption after dental extraction, periodontal disease, tumor resection, and congenital deformity. | The Synthes Alveolar Distractor is intended for vertical bone lengthening of the alveolar ridge in the mandible and the maxilla where gradual bone distraction is required, including deficiency in bone height as a result of trauma, resorption after dental extraction, periodontal disease, tumor resection, and congenital deformity. |
Non-Clinical Testing Summary 1.7.
Non-clinical testing is provided to support the conditional safety of the DePuy Synthes Alveolar Distractor in the MR environment including assessment of magnetically induced displacement force (ASTM F2052-14) and torque (ASTM F2213-06), radio frequency (RF) heating (ASTM F2182-11a and DUKE model), and image artifacts (ASTM F2119-07). The DUKE model places devices in the clinically relevant anatomic position. The DUKE results will be used for labeling of RF heating.
36
Image /page/36/Picture/0 description: The image shows the logo for DePuy Synthes, which is part of the Johnson & Johnson family of companies. The logo includes a symbol that looks like two overlapping circles, followed by the company name in blue, and the tagline "People inspired" in gold. The text "PART OF THE Johnson+Johnson FAMILY OF COMPANIES" is written in a smaller font below the company name.
510(k) Summary 1.
Date Prepared: March 7, 2019
1.1. Submitter
Primary Contact: Rebecca Reiter Regulatory Affairs Project Leader DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: 610-719-1268 Email: rreiter@its.jnj.com
Alternate Contact:
Elizabeth Jacobs Regulatory Affairs Project Leader DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5768 Email: ejacob10@its.jnj.com
1.2. Device
Trade Name: DePuy Synthes Maxillofacial Portfolio - MR Conditional
Name of Device: DePuy Synthes Craniomaxillofacial Distraction System (CMF Distraction System)
Classification Name(s): External Mandibular Fixator And/Or Distractor
Regulatory Class: Class II; 872.4760
Product Code(s): MQN
1.3. Predicate Device
K060138 Synthes Craniomaxillofacial Distraction System (CMF Distraction System)
Device Description 1.4.
This document is regarding the DePuy Synthes Craniomaxillofacial Distraction System (CMF Distraction System), which are a subset of the DePuy Synthes Maxillofacial Portfolio - MR Conditional. The DePuy Synthes Craniomaxillofacial Distraction System, which includes the Pediatric CMF Distraction System, is a modular family of internal distraction osteogenesis devices that are used to gradually lengthen the mandible body and ramus. Each device, when assembled, is comprised of a distractor body, two footplates, and a machine screw to secure
37
Image /page/37/Picture/0 description: The image shows the logo for DePuy Synthes, which is part of the Johnson & Johnson family of companies. The logo features a stylized symbol to the left of the text "DePuy Synthes" in blue. To the right of the company name is the text "People inspired" in a cursive font. Below the company name is the text "PART OF THE Johnson & Johnson FAMILY OF COMPANIES".
the assembly. The system also includes optional activation arms, which can be attached to the activation end of the device to move the point of activation to an area accessible by the activation instrument. The devices in scope of K183113 are being reviewed for MR Conditional labeling for maxillofacial indications.
1.5 Indications for Use
The DePuy Synthes Craniomaxillofacial Distraction System (CMF Distraction System) is intended for use as a bone stabilizer and lengthening (and/or transport) device for correction of congenital deficiencies or post-traumatic defects of the mandibular body and ramus where gradual bone distraction is required. The DePuy Synthes CMF Distraction System is intended for single use only.
The DePuy Synthes Pediatric CMF Distraction System is intended for use as a bone stabilizer and lengthening (and/or transport) device for correction of congenital deficiencies or posttraumatic defects of the mandibular body and ramus where gradual bone distraction is required in children under the age of 12 months. The DePuy Synthes Pediatric CMF Distraction System is intended for single use only.
Substantial Equivalence 1.6
The purpose of this submission is to add MR Conditional information to the device labeling for the DePuy Synthes Craniomaxillofacial Distraction System. The intended use and technological characteristics of the devices remains unchanged. The device name has been updated to reflect the current company name, DePuy Synthes. An indications for use comparison table is provided below.
38
Image /page/38/Picture/0 description: The image shows the alphanumeric string "K183113" in a clear, sans-serif font. The text is horizontally oriented and appears to be a code or identifier. The background is plain white, providing a stark contrast that makes the text easily readable.
Image /page/38/Picture/1 description: The image shows the logo for DePuy Synthes, which is part of the Johnson & Johnson family of companies. The logo features a stylized symbol to the left of the company name, "DePuy Synthes," which is written in a bold, blue font. To the right of the company name, the phrase "People inspired" is written in a cursive, gold font. Below the company name, there is a smaller line of text that indicates the company is part of the Johnson & Johnson family of companies.
| K183113 | K060138 |
|---|---|
| The DePuy Synthes Craniomaxillofacial | The Synthes Craniomaxillofacial Distraction |
| Distraction System (CMF Distraction System) is | System (CMF Distraction System) is intended |
| intended for use as a bone stabilizer and | for use as a bone stabilizer and lengthening |
| lengthening (and/or transport) device for | (and/or transport) device for correction of |
| correction of congenital deficiencies or post- | congenital deficiencies or post-traumatic |
| traumatic defects of the mandibular body and | defects of the mandibular body and ramus |
| ramus where gradual bone distraction is | where gradual bone distraction is required. |
| required. The DePuy Synthes CMF Distraction | The Synthes CMF Distraction System is |
| System is intended for single use only. | intended for single use only. |
| The DePuy Synthes Pediatric CMF Distraction | The Synthes Pediatric CMF Distraction System |
| System is intended for use as a bone stabilizer | is intended for use as a bone stabilizer and |
| and lengthening (and/or transport) device for | lengthening (and/or transport) device for |
| correction of congenital deficiencies or post- | correction of congenital deficiencies or post- |
| traumatic defects of the mandibular body and | traumatic defects of the mandibular body and |
| ramus where gradual bone distraction is | ramus where gradual bone distraction is |
| required in children under the age of 12 | required in children under the age of 12 |
| months. The DePuy Synthes Pediatric CMF | months. The Synthes Pediatric CMF |
| Distraction System is intended for single use | Distraction System is intended for single use |
| only. | only. |
Non-Clinical Testing Summary 1.7
Non-clinical testing is provided to support the conditional safety of the DePuy Synthes Craniomaxillofacial Distraction System in the MR environment including assessment of magnetically induced displacement force (ASTM F2052-14) and torque (ASTM F2213-06), radio frequency (RF) heating (ASTM F2182-11a and DUKE model), and image artifacts (ASTM F2119-07). The DUKE model places devices in the clinically relevant anatomic position. The DUKE results will be used for labeling of RF heating.
39
Image /page/39/Picture/0 description: The image shows the logo for DePuy Synthes, which is part of the Johnson & Johnson family of companies. The logo consists of a symbol that looks like two overlapping circles, followed by the text "DePuy Synthes" in blue. Below the text is the phrase "PART OF THE Johnson-Johnson FAMILY OF COMPANIES" in smaller letters. To the right of the main logo, the words "People inspired" are written in a cursive font.
1. 510(k) Summarv
Date Prepared: March 7, 2019
1.1 Submitter
Primary Contact: Rebecca Reiter Regulatory Affairs Project Leader DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: 610-719-1268 Email: rreiter@its.jnj.com
Alternate Contact: Elizabeth Jacobs Regulatory Affairs Project Leader DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5768 Email: ejacob10@its.jnj.com
1.2 Device
Trade Name: DePuy Synthes Maxillofacial Portfolio - MR Conditional
Name of Device: DePuy Synthes Condylar Head Add-On System
Classification Name(s): Prosthesis, Condyle, Mandibular, Temporary
Regulatory Class: Class II; 872.4770
Product Code(s): NEI
1.3 Predicate Device
K063181 Synthes Condylar Head Add-On System
Device Description 1.4
This document is regarding the DePuy Synthes Condylar Head Add-On System, which are a subset of the DePuy Synthes Maxillofacial Portfolio - MR Conditional. The DePuy Synthes Condylar Head Add-On System is an adjustable height system intended for use with DePuy Synthes' 2.4 mm Locking Reconstruction Plate (LRP) System. The system consists of an elliptical shaped condylar head, four different fixation plates which allow the surgeon to adjust the height of the condylar head, and two fixation screws for mounting the condylar head and fixation plate onto a 2.4 mm locking reconstruction plate. The devices in scope of K183113 are being reviewed for MR Conditional labeling for maxillofacial indications.
40
Image /page/40/Picture/0 description: The image shows the logo for DePuy Synthes, which is part of the Johnson & Johnson family of companies. The logo consists of a circular symbol to the left, followed by the text "DePuy Synthes" in a bold, dark blue font. To the right of the company name, the phrase "People inspired" is written in a cursive, gold font.
The DePuy Synthes Condylar Head Add-On System is intended for temporary reconstruction in patients undergoing ablative tumor surgery requiring the removal of the mandibular condyle. This device is not for permanent implantation, for patients with TMJ or traumatic injuries, or for treatment of temporomandibular joint disease (TMD).
Substantial Equivalence 1.6
The purpose of this submission is to add MR Conditional information to the device labeling for the DePuy Synthes Condylar Head Add-On System. The intended use and technological characteristics of the devices remains unchanged. The device name has been updated to reflect the current company name, DePuy Synthes. An indications for use comparison table is provided below.
| K183113 | K063181 |
|---|---|
| The DePuy Synthes Condylar Head Add-On System is intended for temporary reconstruction in patients undergoing ablative tumor surgery requiring the removal of the mandibular condyle. This device is not for permanent implantation, for patients with TMJ or traumatic injuries, or for treatment of temporomandibular joint disease (TMD). | The Synthes Condylar Head Add-On System is intended for temporary reconstruction in patients undergoing ablative tumor surgery requiring the removal of the mandibular condyle. This device is not for permanent implantation, for patients with TMJ or traumatic injuries, or for treatment of temporomandibular joint disease (TMD). |
Non-Clinical Testing Summary 1.7
Non-clinical testing is provided to support the conditional safety of the DePuy Synthes Condylar Head Add-On System in the MR environment including assessment of magnetically induced displacement force (ASTM F2052-14) and torque (ASTM F2213-06), radio frequency (RF) heating (ASTM F2182-11a and DUKE model), and image artifacts (ASTM F2119-07). The DUKE model places devices in the clinically relevant anatomic position. The DUKE results will be used for labeling of RF heating.
41
Image /page/41/Picture/0 description: The image shows the logo for DePuy Synthes, which is part of the Johnson & Johnson family of companies. The logo consists of a symbol that looks like two overlapping circles, followed by the text "DePuy Synthes" in blue. Below the text is the phrase "PART OF THE Johnson-Johnson FAMILY OF COMPANIES" in smaller letters. To the right of the main logo, the words "People inspired" are written in a cursive font.
1. 510(k) Summarv
Date Prepared: March 7, 2019
1.1 Submitter
Primary Contact: Rebecca Reiter Regulatory Affairs Project Leader DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: 610-719-1268 Email: rreiter@its.jnj.com
Alternate Contact: Elizabeth Jacobs Regulatory Affairs Project Leader DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5768 Email: ejacob10@its.jnj.com
1.2 Device
Trade Name: DePuy Synthes Maxillofacial Portfolio - MR Conditional
Name of Device: DePuy Synthes Curvilinear Distraction System
Classification Name(s): External Mandibular Fixator And/Or Distractor
Regulatory Class: Class II; 872.4760
Product Code(s): MQN
1.3 Predicate Device
K080153 Synthes Curvilinear Distraction System
1.4 Device Description
This document is regarding the DePuy Synthes Curvilinear Distraction System, which are a subset of the DePuy Synthes Maxillofacial Portfolio - MR Conditional. The DePuy Synthes Curvilinear Distraction System is an internal distraction osteogenesis device that gradually advances the mandible along a specific path of distraction. The system features various curved and straight distractors which are fixed to the mandible with bone screws. The distractors accept extension arms which move the point of activation that is easily accessible with the activation instrument. The devices in scope of K183113 are being reviewed for MR Conditional labeling for maxillofacial indications.
42
Image /page/42/Picture/0 description: The image shows the logo for DePuy Synthes. The logo consists of a gold-colored symbol on the left, followed by the company name in blue. To the right of the company name, the words "People inspired" are written in a gold script font. Below the company name, there is a smaller line of text that reads "PART OF THE Johnson & Johnson FAMILY OF COMPANIES".
The DePuy Synthes Curvilinear Distraction System is intended for use as a bone stabilizer and lengthening (and/or transport) device for correction of congenital deficiencies or posttraumatic defects of the mandibular body and ramus where gradual bone distraction is required. This system is intended for use in either adults or pediatric patients over 1 year old. The DePuy Synthes Curvilinear Distraction System is intended for single use only.
1.6 Substantial Equivalence
The purpose of this submission is to add MR Conditional information to the device labeling for the DePuy Synthes Curvilinear Distraction System. The intended use and technological characteristics of the devices remains unchanged. The device name has been updated to reflect the current company name, DePuy Synthes. An indications for use comparison table is provided below.
| K183113 | K080153 |
|---|---|
| The DePuy Synthes Curvilinear Distraction | |
| System is intended for use as a bone stabilizer | |
| and lengthening (and/or transport) device for | |
| correction of congenital deficiencies or post- | |
| traumatic defects of the mandibular body and | |
| ramus where gradual bone distraction is | |
| required. This system is intended for use in | |
| either adults or pediatric patients over 1 year | |
| old. The DePuy Synthes Curvilinear Distraction | |
| System is intended for single use only. | The Synthes Curvilinear Distraction System is |
| intended for use as a bone stabilizer and | |
| lengthening (and/or transport) device for | |
| correction of congenital deficiencies or post- | |
| traumatic defects of the mandibular body and | |
| ramus where gradual bone distraction is | |
| required. This system is intended for use in | |
| either adults or pediatric patients over 1 year | |
| old. The DePuy Synthes Curvilinear Distraction | |
| System is intended for single use only. |
1.7 Non-Clinical Testing Summarv
Non-clinical testing is provided to support the conditional safety of the DePuy Synthes Curvilinear Distraction System in the MR environment including assessment of magnetically induced displacement force (ASTM F2052-14) and torque (ASTM F2213-06), radio frequency (RF) heating (ASTM F2182-11a and DUKE model), and image artifacts (ASTM F2119-07). The DUKE model places devices in the clinically relevant anatomic position. The DUKE results will be used for labeling of RF heating.
43
Image /page/43/Picture/0 description: The image shows the logo for DePuy Synthes, which is part of the Johnson & Johnson family of companies. The logo consists of a symbol that looks like two overlapping circles, followed by the text "DePuy Synthes" in blue. Below the text is the phrase "PART OF THE Johnson & Johnson FAMILY OF COMPANIES" in smaller letters. To the right of the main logo, the phrase "People inspired" is written in a cursive font.
1. 510(k) Summary
Date Prepared: March 7, 2019
1.1 Submitter
Primary Contact: Rebecca Reiter Regulatory Affairs Project Leader DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: 610-719-1268 Email: rreiter@its.jnj.com
Alternate Contact: Elizabeth Jacobs Regulatory Affairs Project Leader DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5768 Email: ejacob10@its.jnj.com
1.2 Device
Trade Name: DePuy Synthes Maxillofacial Portfolio - MR Conditional
Name of Device: Modification to DePuy Synthes Condylar Head Add-On System
Classification Name(s): Prosthesis, Condyle, Mandibular, Temporary
Regulatory Class: Class II; 872.4770
Product Code(s): NEI
1.3 Predicate Device
K081747 Modification to Synthes Condylar Head Add-On System
Device Description 1.4
This document is regarding the DePuy Synthes Modification to Synthes Condylar Head Add-On System, which are a subset of the DePuy Synthes Maxillofacial Portfolio – MR Conditional. The DePuy Synthes Condylar Head Add-On System is an adjustable height add-on system for use with the 2.4 mm Locking Reconstruction Plate System and MatrixMANDIBLE Plate System. It consists of a condylar head, 2 screws, and one of four (4) fixation plates, each with a different screw hole spacing that determines the height of the condylar head. The devices in scope of K183113 are being reviewed for MR Conditional labeling for maxillofacial indications.
44
Image /page/44/Picture/0 description: The image shows the logo for DePuy Synthes, which is part of the Johnson & Johnson family of companies. The logo consists of a gold-colored symbol on the left, followed by the company name in blue. To the right of the company name, the phrase "People inspired" is written in a cursive font and gold color.
The DePuy Synthes Condylar Head Add-On System Intended for temporary reconstruction in patients undergoing ablative tumor surgery requiring the removal of the mandibular condyle. This device is not for permanent implantation, for patients with TMJ or traumatic injuries, or for treatment of temporomandibular joint disease (TMD).
Substantial Equivalence 1.6
The purpose of this submission is to add MR Conditional information to the device labeling for the DePuy Synthes Condylar Head Add-On System. The intended use and technological characteristics of the devices remains unchanged. The device name has been updated to reflect the current company name, DePuy Synthes. An indications for use comparison table is provided below.
| K183113 | K081747 |
|---|---|
| The DePuy Synthes Condylar Head Add-On System Intended for temporary reconstruction in patients undergoing ablative tumor surgery requiring the removal of the mandibular condyle. This device is not for permanent implantation, for patients with TMJ or traumatic injuries, or for treatment of temporomandibular joint disease (TMD). | The Synthes Condylar Head Add-On System Intended for temporary reconstruction in patients undergoing ablative tumor surgery requiring the removal of the mandibular condyle. This device is not for permanent implantation, for patients with TMJ or traumatic injuries, or for treatment of temporomandibular joint disease (TMD). |
Non-Clinical Testing Summary 1.7
Non-clinical testing is provided to support the conditional safety of the DePuy Synthes Condylar Head Add-On System in the MR environment including assessment of magnetically induced displacement force (ASTM F2052-14) and torque (ASTM F2213-06), radio frequency (RF) heating (ASTM F2182-11a and DUKE model), and image artifacts (ASTM F2119-07). The DUKE model places devices in the clinically relevant anatomic position. The DUKE results will be used for labeling of RF heating.
45
Image /page/45/Picture/0 description: The image shows the logo for DePuy Synthes, which is part of the Johnson & Johnson family of companies. The logo consists of a symbol that looks like two overlapping circles, followed by the company name in blue, and the phrase "People inspired" in gold. The text "PART OF THE Johnson & Johnson FAMILY OF COMPANIES" is written in a smaller font size below the company name.
1. 510(k) Summary
Date Prepared: March 7, 2019
1.1 Submitter
Primary Contact: Rebecca Reiter Regulatory Affairs Project Leader DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: 610-719-1268 Email: rreiter@its.jnj.com
Alternate Contact: Elizabeth Jacobs Regulatory Affairs Project Leader DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5768 Email: ejacob10@its.jnj.com
1.2 Device
Trade Name: DePuy Synthes Maxillofacial Portfolio - MR Conditional
Name of Device: DePuy Synthes Orthodontic Bone Anchor (OBA) System
Classification Name(s): Implant, Endosseous, Orthodontic
Regulatory Class: Class II; 872.3640
Product Code(s): OAT
1.3 Predicate Device
K093299 Synthes Orthodontic Bone Anchor (OBA) System
Device Description 1.4
This document is regarding the DePuy Synthes Orthodontic Bone Anchor (OBA) System, which are a subset of the DePuy Synthes Maxillofacial Portfolio – MR Conditional. The DePuy Synthes Orthodontic Bone Anchor (OBA) System is intended to be implanted intraorally and used as an anchor for orthodontic procedures. The System includes screw anchors, plate anchors, instruments, and a module case for storage and sterilization.
46
Image /page/46/Picture/0 description: The image shows the logo for DePuy Synthes, which is part of the Johnson & Johnson family of companies. The logo consists of a gold-colored abstract symbol on the left, followed by the company name "DePuy Synthes" in blue. To the right of the company name, there is a tagline "People inspired" in a cursive font, also in gold. Below the company name, there is a smaller text indicating that it is part of the Johnson & Johnson family of companies.
Screw Anchors
The screw anchor portion of the system consists of 1.55 nun self-drilling and selftapping screw anchors which incorporate a non-treaded gingival collar beneath the screw head to protect the soft tissue. Once implanted, orthodontic appliances such as archwires, elastics, and springs can be attached to the head of the anchor. The screw anchors are manufactured from titanium alloy (Ti-6A1-7Nb).
Plate Anchors
The plate anchor portion of the system consists of T-shaped plate anchors which are attached to the bone via 1.55 mim cortex screws and 1.85 mma emergency screws. The plate anchors are offered in three designs (mesh, bracket, and domed)to allow attachment of orthodontic devices such as brackets, archwires, elastics, and springs. The plate anchors are manufactured from commercially pure titanium. The screws used to fix the plate anchors to the bone are manufactured from titanium alloy (Ti-6A-7Nb).
The devices in scope of K183113 are being reviewed for MR Conditional labeling for maxillofacial indications.
1.5 Indications for Use
The DePuy Synthes Orthodontic Bone Anchor (OBA) System screw anchors are intended to be implanted intraorally and used as an anchor for orthodontic procedures in adolescents greater than age 12 and adults.
The DePuy Synthes Orthodontic Bone Anchor (OBA) System plate anchors are intended to be implanted intraorally and used as an anchor for orthodontic procedures in adults.
47
Image /page/47/Picture/0 description: The image shows the logo for DePuy Synthes, which is a company that specializes in medical devices. The logo consists of a symbol that looks like a stylized eye, followed by the company name in blue text. Below the company name, there is a tagline that reads "PART OF THE Johnson & Johnson FAMILY OF COMPANIES" in smaller text. To the right of the company name, there is a phrase that reads "People inspired" in a cursive font.
Substantial Equivalence 1.6
The purpose of this submission is to add MR Conditional information to the device labeling for the DePuy Synthes Orthodontic Bone Anchor (OBA) System. The intended use and technological characteristics of the devices remains unchanged. The device name has been updated to reflect the current company name, DePuy Synthes. An indications for use comparison table is provided below.
| K183113 | K093299 |
|---|---|
| The DePuy Synthes Orthodontic Bone Anchor (OBA) System screw anchors are intended to be implanted intraorally and used as an anchor for orthodontic procedures in adolescents greater than age 12 and adults. | |
| The DePuy Synthes Orthodontic Bone Anchor (OBA) System plate anchors are intended to be implanted intraorally and used as an anchor for orthodontic procedures in adults. | The Synthes Orthodontic Bone Anchor (OBA) System screw anchors are intended to be implanted intraorally and used as an anchor for orthodontic procedures in adolescents greater than age 12 and adults. |
| The Synthes Orthodontic Bone Anchor (OBA) System plate anchors are intended to be implanted intraorally and used as an anchor for orthodontic procedures in adults. |
Non-Clinical Testing Summary 1.7
Non-clinical testing is provided to support the conditional safety of the DePuy Synthes Orthodontic Bone Anchor (OBA) System in the MR environment including assessment of magnetically induced displacement force (ASTM F2052-14) and torque (ASTM F2213-06), radio frequency (RF) heating (ASTM F2182-11a and DUKE model), and image artifacts (ASTM F2119-07). The DUKE model places devices in the clinically relevant anatomic position. The DUKE results will be used for labeling of RF heating.
48
Image /page/48/Picture/0 description: The image shows the logo for DePuy Synthes, which is part of the Johnson & Johnson family of companies. The logo consists of a symbol that looks like two overlapping circles, followed by the text "DePuy Synthes" in blue. Below the text is the phrase "PART OF THE Johnson & Johnson FAMILY OF COMPANIES" in smaller letters. To the right of the main logo, the phrase "People inspired" is written in a cursive font.
1. 510(k) Summarv
Date Prepared: March 7, 2019
1.1 Submitter
Primary Contact: Rebecca Reiter Regulatory Affairs Project Leader DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: 610-719-1268 Email: rreiter@its.jnj.com
Alternate Contact: Elizabeth Jacobs Regulatory Affairs Project Leader DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5768 Email: ejacob10@its.jnj.com
1.2 Device
Trade Name: DePuy Synthes Maxillofacial Portfolio - MR Conditional
Name of Device: DePuy Synthes Curvilinear Distraction System
Classification Name(s): External Mandibular Fixator And/Or Distractor
Regulatory Class: Class II; 872.4760
Product Code(s): MQN
1.3 Predicate Device
K121502 Synthes Curvilinear Distraction System
Device Description 1.4
This document is regarding the DePuy Synthes Curvilinear Distraction System, which are a subset of the DePuy Synthes Maxillofacial Portfolio - MR Conditional. The DePuy Synthes Curvilinear Distraction System is a family of internal distraction osteogenesis devices that gradually advance the mandible along a specific trajectory of distraction. The system features various curved and straight distractors in two sizes; the 1.3mm Curvillinear Distractor and the 2.0mm Curvilinear Distractor. The distractors accept extension arms which move the point of activation to a location that is easily accessible with the activation instrument.
49
Image /page/49/Picture/1 description: The image shows the logo for DePuy Synthes, which is part of the Johnson & Johnson family of companies. The logo includes a symbol of two overlapping circles in gold, followed by the company name in blue. To the right of the company name, the phrase "People inspired" is written in a cursive font in gold. Below the company name, the phrase "PART OF THE Johnson & Johnson FAMILY OF COMPANIES" is written in a smaller font.
The DePuy Synthes Curvilinear Distraction devices are manufactured from, titanium alloy and chromium cobalt alloy. Devices are supplied non-sterilized prior to use. The distractor features a worm gear that is activated to move the distractor along a curved or straight track. The distractor consists of three main components:
- . Track: The track has grooves in Imm intervals which may be placed in a straight line (for a straight distractor) or on a centerline radius (for a curved distractor). The track is manufactured with a crimp that serves as a functional stop to prevent the distractor from separating at the end of the track is 35mm in length and can be cut to the desired length for each particular patient by the surgeon. After cutting, the track is crimped to re-establish the functional stop to prevent separation.
- Worm gear activation assembly: The worm activation assembly consists of the worm gear and a universal joint activation hex. The universal joint is capable of + or - 35 degree of angulation. The worm gear has a 1 mm pitch and rides along the grooves cut into the track. The worm gear activation assembly is inserted into the housing and the track with grooves is threaded through a slot in the side of the housing.
- . Housing: The housing includes a tab that lays on the activation assembly to prevent the distractor from reversing due to micromotion.
The devices in scope of K183113 are being reviewed for MR Conditional labeling for maxillofacial indications.
Indications for Use 1.5
The DePuy Synthes Curvilinear Distraction System is intended for use as a bone stabilizer and lengthening (and/or transport) device. The DePuy Synthes Curvilinear Distraction System is indicated for correction of congenital deficiencies or posttraumatic defects of the mandibular body and ramus where gradual bone distraction is required.
The 2.0 mm Curvilinear Distractor is intended for use in adult and pediatric patients more than 1 year old.
The 1.3 mm Curvilinear Distractor is intended for use in pediatric patients 4 years of age and younger.
The DePuy Synthes Curvilinear Distraction System is intended for single use only.
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Image /page/50/Picture/0 description: The image shows the logo for DePuy Synthes, a company that is part of the Johnson & Johnson family of companies. The logo consists of a symbol that looks like two overlapping circles, followed by the company name in blue text. Below the company name is the text "PART OF THE Johnson & Johnson FAMILY OF COMPANIES" in a smaller font size. To the right of the company name is the phrase "People inspired" in a cursive font.
Substantial Equivalence 1.6
The purpose of this submission is to add MR Conditional information to the device labeling for the DePuy Synthes Curvilinear Distraction System. The intended use and technological characteristics of the devices remains unchanged. The device name has been updated to reflect the current company name, DePuy Synthes. An indications for use comparison table is provided below.
| K183113 | K121502 |
|---|---|
| The DePuy Synthes Curvilinear Distraction | |
| System is intended for use as a bone stabilizer | |
| and lengthening (and/or transport) device. | |
| The DePuy Synthes Curvilinear Distraction | |
| System is indicated for correction of | |
| congenital deficiencies or posttraumatic | |
| defects of the mandibular body and ramus | |
| where gradual bone distraction is required. | The Synthes Curvilinear Distraction System is |
| intended for use as a bone stabilizer and | |
| lengthening (and/or transport) device. The | |
| Synthes Curvilinear Distraction System is | |
| indicated for correction of congenital | |
| deficiencies or posttraumatic defects of the | |
| mandibular body and ramus where gradual | |
| bone distraction is required. | |
| The 2.0 mm Curvilinear Distractor is intended | |
| for use in adult and pediatric patients more | |
| than 1 year old. | The 2.0 mm Curvilinear Distractor is intended |
| for use in adult and pediatric patients more | |
| than 1 year old. | |
| The 1.3 mm Curvilinear Distractor is intended | |
| for use in pediatric patients 4 years of age and | |
| younger. | The 1.3 mm Curvilinear Distractor is intended |
| for use in pediatric patients 4 years of age and | |
| younger. | |
| The DePuy Synthes Curvilinear Distraction | |
| System is intended for single use only. | The Synthes Curvilinear Distraction System is |
| intended for single use only. |
51
Image /page/51/Picture/0 description: The image shows the logo for DePuy Synthes, which is part of the Johnson & Johnson family of companies. The logo consists of a symbol that looks like two overlapping circles, followed by the company name in blue text. To the right of the company name is the phrase "People inspired" in a cursive font. Below the company name is the phrase "PART OF THE Johnson & Johnson FAMILY OF COMPANIES" in a smaller font.
Non-Clinical Testing Summary 1.7
Non-clinical testing is provided to support the conditional safety of the DePuy Synthes Curvilinear Distraction System in the MR environment including assessment of magnetically induced displacement force (ASTM F2052-14) and torque (ASTM F2213-06), radio frequency (RF) heating (ASTM F2182-11a and DUKE model), and image artifacts (ASTM F2119-07). The DUKE model places devices in the clinically relevant anatomic position. The DUKE results will be used for labeling of RF heating.
52
Image /page/52/Picture/0 description: The image shows the logo for DePuy Synthes, which is part of the Johnson & Johnson family of companies. The logo consists of a symbol that looks like two overlapping circles, followed by the text "DePuy Synthes" in blue. Below the text is the phrase "PART OF THE Johnson & Johnson FAMILY OF COMPANIES" in smaller letters. To the right of the main logo, the phrase "People inspired" is written in a cursive font.
1. 510(k) Summary
Date Prepared: March 7, 2019
1.1 Submitter
Primary Contact: Rebecca Reiter Regulatory Affairs Project Leader DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: 610-719-1268 Email: rreiter@its.jnj.com
Alternate Contact: Elizabeth Jacobs Regulatory Affairs Project Leader DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5768 Email: ejacob10@its.jnj.com
1.2 Device
Trade Name: DePuy Synthes Maxillofacial Portfolio - MR Conditional
Name of Device: DePuy Synthes Mandible Distractor
Classification Name(s): External Mandibular Fixator And/Or Distractor
Regulatory Class: Class II; 872.4760
Product Code(s): MQN
1.3 Predicate Device
K962272 Synthes Mandible Distractor
Device Description 1.4
This document is regarding the DePuy Synthes Mandible Distractor, which are a subset of the DePuy Synthes Maxillofacial Portfolio – MR Conditional. The DePuy Synthes Mandible Distractor is intended to be used in the mandible for conditions such as mandibular deficiency or posttraumatic effects of the mandible, where gradual bone distraction is required. The Mandible Distractor is a subcutaneous bone distractor. It features two telescoping components activated by a jack screw, fixed to the bone via subcutaneous plates and secured with 2.0 mrn or 2.4 mm bone screws. A hex driver is used to activate the required distraction. The devices in scope of K183113 are being reviewed for MR Conditional labeling for maxillofacial indications.
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Image /page/53/Picture/0 description: The image shows the logo for DePuy Synthes, which is part of the Johnson & Johnson family of companies. The logo includes a symbol that looks like two overlapping circles, followed by the company name in blue text. To the right of the company name, the words "People inspired" are written in a cursive font. Below the company name, the words "PART OF THE Johnson & Johnson FAMILY OF COMPANIES" are written in a smaller font.
The DePuy Synthes Mandible Distractor is intended to be used in the mandible for conditions such as mandibular deficiency or post-traumatic effects of the mandible, where gradual bone distraction is required.
Substantial Equivalence 1.6
The purpose of this submission is to add MR Conditional information to the device labeling for the DePuy Synthes Mandible Distractor. The intended use and technological characteristics of the devices remains unchanged. The device name has been updated to reflect the current company name, DePuy Synthes. An indications for use comparison table is provided below.
| K183113 | K962272 |
|---|---|
| The DePuy Synthes Mandible Distractor is intended to be used in the mandible for conditions such as mandibular deficiency or post-traumatic effects of the mandible, where gradual bone distraction is required. | The Synthes Mandible Distractor is intended to be used in the mandible for conditions such as mandibular deficiency or post-traumatic effects of the mandible, where gradual bone distraction is required. |
Non-Clinical Testing Summary 1.7
Non-clinical testing is provided to support the conditional safety of the DePuy Synthes Mandible Distractor in the MR environment including assessment of magnetically induced displacement force (ASTM F2052-14) and torque (ASTM F2213-06), radio frequency (RF) heating (ASTM F2182-11a and DUKE model), and image artifacts (ASTM F2119-07). The DUKE model places devices in the clinically relevant anatomic position. The DUKE results will be used for labeling of RF heating.
54
Image /page/54/Picture/0 description: The image shows the logo for DePuy Synthes, which is part of the Johnson & Johnson family of companies. The logo consists of a symbol that looks like two overlapping circles, followed by the text "DePuy Synthes" in blue. Below the text is the phrase "PART OF THE Johnson-Johnson FAMILY OF COMPANIES" in smaller letters. To the right of the main logo, the words "People inspired" are written in a cursive font.
1. 510(k) Summarv
Date Prepared: March 7, 2019
1.1 Submitter
Primary Contact: Rebecca Reiter Regulatory Affairs Project Leader DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: 610-719-1268 Email: rreiter@its.jnj.com
Alternate Contact: Elizabeth Jacobs Regulatory Affairs Project Leader DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5768 Email: ejacob10@its.jnj.com
1.2 Device
Trade Name: DePuy Synthes Maxillofacial Portfolio - MR Conditional
Name of Device: DePuy Synthes SMF Stainless Steel Bone Screws
Classification Name(s): Screw, Fixation, Intraosseous
Regulatory Class: Class II; 872.4880
Product Code(s): DZL
1.3 Predicate Device
K964261 Synthes SMF Stainless Steel Bone Screws
Device Description 1.4
This document is regarding the DePuy Synthes SMF Stainless Steel Bone Screws, which are a subset of the DePuy Synthes Maxillofacial Portfolio – MR Conditional. SMF Stainless Steel Bone Screws are intended for maxillofacial and mandibular trauma and reconstruction. The screws feature self-tapping tips and a cruciform drive recess. The screws are available in various lengths ranging from 4 to 38 mm. The longer screw lengths (24 - 38 mm) are specifically intended for symphyseal fractures, parasymphyseal fractures, and angle fractures where the lag screw technique is being followed. The lag screw technique involves over-drilling the near cortex, thus the screw glides through the near cortical and cancellous bone and purchases only
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Image /page/55/Picture/0 description: The image shows the alphanumeric string "K183113" in a clear, sans-serif font. The characters are uniformly sized and spaced, making the string easily readable. The text is presented against a plain white background, ensuring high contrast and clarity.
Image /page/55/Picture/1 description: The image contains the logo for DePuy Synthes, which is part of the Johnson & Johnson family of companies. The logo features a stylized symbol to the left of the text "DePuy Synthes" in a bold, dark blue font. To the right of the company name, the phrase "People inspired" is written in a cursive, gold-colored font. Below the company name, there is smaller text indicating that DePuy Synthes is part of the Johnson & Johnson family of companies.
into the far cancellous and cortical bone. The devices in scope of K183113 are being reviewed for MR Conditional labeling for maxillofacial indications.
Indications for Use 1.5
The DePuy Synthes SMF Stainless Steel Bone Screws are intended for maxillofacial and mandibular trauma and reconstruction. The longer screw lengths (24-38mm) are specifically intended for symphysial fractures, parasymphyseal fractures, and angle fractures where the lag screw technique is being followed. The lag screw technique involves overdrilling the near cortex, thus the screw glides through the near cortical and cancellous bone and purchases only into the far cancellous and cortical bone.
Substantial Equivalence 1.6
The purpose of this submission is to add MR Conditional information to the device labeling for the DePuy Synthes SMF Stainless Steel Bone Screws. Changes in the Indications for Use Statement are to remove language not specific to maxillofacial surgeries, as these (e.g., craniofacial) indications are not reviewed by the Dental Review Panel. The technological characteristics of the devices remains unchanged. The device name has been updated to reflect the current company name, DePuy Synthes. An indications for use comparison table is provided below.
| K183113 | K964261 |
|---|---|
| The DePuy Synthes SMF Stainless Steel Bone | The Synthes SMF Stainless Steel Bone Screws |
| Screws are intended for maxillofacial and | are intended for craniofacial and mandibular |
| mandibular trauma and reconstruction. The | trauma and reconstruction. The longer screw |
| longer screw lengths (24-38mm) are | lengths (24-38mm) are specifically intended |
| specifically intended for symphysial fractures, | for symphysial fractures, parasymphyseal |
| parasymphyseal fractures, and angle fractures | fractures, and angle fractures where the lag |
| where the lag screw technique is being | screw technique is being followed. The lag |
| followed. The lag screw technique involves | screw technique involves overdrilling the near |
| overdrilling the near cortex, thus the screw | cortex, thus the screw glides through the near |
| glides through the near cortical and cancellous | cortical and cancellous bone and purchases |
| bone and purchases only into the far | only into the far cancellous and cortical bone. |
| cancellous and cortical bone. |
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Image /page/56/Picture/0 description: The image shows the logo for DePuy Synthes, which is part of the Johnson & Johnson family of companies. The logo includes a symbol of two interlocking circles, followed by the company name in blue text. To the right of the company name is the phrase "People inspired" in a cursive font. Below the company name is the phrase "PART OF THE Johnson & Johnson FAMILY OF COMPANIES" in smaller text.
Non-Clinical Testing Summary 1.7
Non-clinical testing is provided to support the conditional safety of the DePuy Synthes SMF Stainless Steel Bone Screws in the MR environment including assessment of magnetically induced displacement force (ASTM F2052-14) and torque (ASTM F2213-06), radio frequency (RF) heating (ASTM F2182-11a and DUKE model), and image artifacts (ASTM F2119-07). The DUKE model places devices in the clinically relevant anatomic position. The DUKE results will be used for labeling of RF heating.
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Image /page/57/Picture/0 description: The image shows the logo for DePuy Synthes, which is part of the Johnson & Johnson family of companies. The logo consists of a symbol that looks like two overlapping circles, followed by the text "DePuy Synthes" in blue. Below the text is the phrase "PART OF THE Johnson-Johnson FAMILY OF COMPANIES" in smaller letters. To the right of the main logo, the words "People inspired" are written in a cursive font.
1. 510(k) Summarv
Date Prepared: March 7, 2019
1.1 Submitter
Primary Contact: Rebecca Reiter Regulatory Affairs Project Leader DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: 610-719-1268 Email: rreiter@its.jnj.com
Alternate Contact: Elizabeth Jacobs Regulatory Affairs Project Leader DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5768 Email: ejacob10@its.jnj.com
1.2 Device
Trade Name: DePuy Synthes Maxillofacial Portfolio - MR Conditional
Name of Device: DePuy Synthes 1.5 mm/2.0 mm Orthognathic Maxillary Plates and Screws
Classification Name(s): Screw, Fixation, Intraosseous
Regulatory Class: Class II; 872.4880
Product Code(s): DZL
1.3 Predicate Device
K980199 Synthes 1.5 mm/2.0 mm Orthognathic Maxillary Plates and Screws
Device Description 1.4
This document is regarding the DePuy Synthes 1.5 mm/2.0 mm Orthognathic Maxillary Plates and Screws, which are a subset of the DePuy Synthes Maxillofacial Portfolio – MR Conditional. The DePuy Synthes 1.5 mm /2.0 mm Orthognathic Maxillary Plates are available in Mesh-, T-, L, and Z- plate configurations, and attach to bone via 1.5 mm and 2.0 mm self-tapping screws, and 2.0 mm and 2.4 mm emergency screws. The devices in scope of K183113 are being reviewed for MR Conditional labeling for maxillofacial indications.
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Image /page/58/Picture/0 description: The image shows the logo for DePuy Synthes, a company that is part of the Johnson & Johnson family of companies. The logo features a stylized eye symbol in gold, followed by the company name in blue, and the tagline "People inspired" in gold script. Below the company name, there is a smaller line of text that reads "PART OF THE Johnson & Johnson FAMILY OF COMPANIES".
The DePuy Synthes 1.5 mm/2.0 mm Orthognathic Maxillary Plates and Screws are generally intended for a variety of pan facial indications. Specifically, it is intended for selective trauma of the midface and maxillofacial skeleton; maxillofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.
Substantial Equivalence 1.6
The purpose of this submission is to add MR Conditional information to the device labeling for the DePuy Synthes 1.5 mm/2.0 mm Orthognathic Maxillary Plates and Screws. Changes in the Indications for Use Statement are to remove language not specific to maxillofacial surgeries, as these (e.g., craniofacial) indications are not reviewed by the Dental Review Panel. The technological characteristics of the devices remains unchanged. The device name has been updated to reflect the current company name, DePuy Synthes. An indications for use comparison table is provided below.
| K183113 | K980199 |
|---|---|
| The DePuy Synthes 1.5 mm/2.0 mm | |
| Orthognathic Maxillary Plates and Screws are | |
| generally intended for a variety of pan facial | |
| indications. Specifically, it is intended for | |
| selective trauma of the midface and | |
| maxillofacial skeleton; maxillofacial surgery; | |
| reconstructive procedures; and selective | |
| orthognathic surgery of the maxilla and chin. | The Synthes 1.5 mm/2.0 mm Orthognathic |
| Maxillary Plates and Screws are generally | |
| intended for a variety of pan facial indications. | |
| Specifically, it is intended for selective trauma | |
| of the midface and craniofacial skeleton; | |
| craniofacial surgery; reconstructive | |
| procedures; and selective orthognathic | |
| surgery of the maxilla and chin. |
Non-Clinical Testing Summary 1.7
Non-clinical testing is provided to support the conditional safety of the DePuy Synthes 1.5 mm/2.0 mm Orthognathic Maxillary Plates and Screws in the MR environment including assessment of magnetically induced displacement force (ASTM F2052-14) and torque (ASTM F2213-06), radio frequency (RF) heating (ASTM F2182-11a and DUKE model), and image artifacts (ASTM F2119-07). The DUKE model places devices in the clinically relevant anatomic position. The DUKE results will be used for labeling of RF heating.
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Image /page/59/Picture/0 description: The image shows the logo for DePuy Synthes, which is part of the Johnson & Johnson family of companies. The logo includes a symbol of two overlapping circles, followed by the company name in blue, and the tagline "People inspired" in gold script. Below the company name, there is a smaller text indicating that it is part of the Johnson & Johnson family of companies.
1. 510(k) Summary
Date Prepared: March 7, 2019
1.1 Submitter
Primary Contact: Rebecca Reiter Regulatory Affairs Project Leader DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: 610-719-1268 Email: rreiter@its.jnj.com
Alternate Contact:
Elizabeth Jacobs Regulatory Affairs Project Leader DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5768 Email: ejacob10@its.jnj.com
1.2 Device
Trade Name: DePuy Synthes Maxillofacial Portfolio - MR Conditional
Name of Device: DePuy Synthes Single Vector Distractor with Detachable Feet
Classification Name(s): External Mandibular Fixator And/Or Distractor
Regulatory Class: Class II; 872.4760
Product Code(s): MQN
1.3 Predicate Device
K981075 Synthes Single Vector Distractor with Detachable Feet
1.4 Device Description
This document is regarding the DePuy Synthes External Mandibular Fixator And/Or Distractor, which are a subset of the DePuy Synthes Maxillofacial Portfolio – MR Conditional. The DePuy Synthes Single Vector Distractor with Detachable Feet is a subcutaneous bone distractor activated by a drive component. It features two telescoping components activated by a jack screw, fixed to the bone with bone screws. Bone lengthening and distraction are achieved by gradually activating the device. Upon removal, the telescoping components and jack screw are
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Image /page/60/Picture/0 description: The image shows the text 'K183113' in a simple, sans-serif font. The text is presented in a single line and is left-aligned. The characters are uniformly sized and spaced, creating a clear and legible presentation of the alphanumeric string.
Image /page/60/Picture/1 description: The image shows the logo for DePuy Synthes, which is part of the Johnson & Johnson family of companies. The logo includes a symbol that looks like two overlapping circles, followed by the company name in blue text. To the right of the company name, the phrase "People inspired" is written in a cursive font.
disengaged and removed, leaving the subcutaneous foot plates in the patient. The devices in scope of K183113 are being reviewed for MR Conditional labeling for maxillofacial indications.
1.5 Indications for Use
The DePuy Synthes Single Vector Distractor with Detachable Feet is intended for use as a bone stabilizer and lengthener for conditions such as mandibular hypoplasia or post-traumatic defects of the mandible, where gradual bone distraction is required. The device is ideal for treating fonns of clefts of the lip and palate, and congenital mandibular hypoplasia, such as Hemifacial Microsomia, Treacher Collins Syndrome, Pierre Robin Syndrome, Goldenhar Syndrome, Apert Syndrome, and Crouzon Syndrome.
The DePuy Synthes Single Vector Distractor with Detachable Feet is also ideal for treating hypoplasias of an acquired origin such as from post-traumatic growth disorders associated with injury to the temporomandibular joint, temporomandibular ankylosis, and segmental loss of bone.
1.6 Substantial Equivalence
The purpose of this submission is to add MR Conditional information to the device labeling for the DePuy Synthes Single Vector Distractor with Detachable Feet. Changes in the Indications for Use Statement are to remove language not specific to maxillofacial surgeries, as these (e.g., craniofacial) indications are not reviewed by the Dental Review Panel. The technological characteristics of the devices remains unchanged. The device name has been updated to reflect the current company name, DePuy Synthes. An indications for use comparison table is provided below.
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Image /page/61/Picture/1 description: The image shows the logo for DePuy Synthes, a company that is part of the Johnson & Johnson family of companies. The logo consists of a circular symbol to the left of the company name, which is written in a dark blue, sans-serif font. To the right of the company name is the phrase "People inspired" in a cursive, gold font. Below the company name is the phrase "PART OF THE johnson johnson FAMILY OF COMPANIES" in a smaller, sans-serif font.
| K183113 | K981075 |
|---|---|
| The DePuy Synthes Single Vector Distractor | |
| with Detachable Feet is intended for use as a | |
| bone stabilizer and lengthener for conditions | |
| such as mandibular hypoplasia or post- | |
| traumatic defects of the mandible, where | |
| gradual bone distraction is required. The | |
| device is ideal for treating forms of clefts of | |
| the lip and palate, and congenital mandibular | |
| hypoplasia, such as Hemifacial Microsomia, | |
| Treacher Collins Syndrome, Nagers Syndrome, | |
| Pierre Robin Syndrome, Goldenhar Syndrome, | |
| Apert Syndrome, and Crouzon Syndrome. | The Synthes Single Vector Distractor with |
| Detachable Feet is intended for use as a bone | |
| stabilizer and lengthener for conditions such | |
| as mandibular hypoplasia or post-traumatic | |
| defects of the mandible, where gradual bone | |
| distraction is required. The device is ideal for | |
| treating forms of clefts of the lip and palate, | |
| and congenital mandibular hypoplasia, such as | |
| Hemifacial Microsomia, Treacher Collins | |
| Syndrome, Nagers Syndrome, Pierre Robin | |
| Syndrome, Goldenhar Syndrome, Apert | |
| Syndrome, and Crouzon Syndrome. | |
| The DePuy Synthes Single Vector Distractor | |
| with Detachable Feet is also ideal for treating | |
| hypoplasias of an acquired origin such as from | |
| post-traumatic growth disorders associated | |
| with injury to the temporomandibular joint, | |
| temporomandibular ankylosis, and segmental | |
| loss of bone. | The Synthes Single Vector Distractor with |
| Detachable Feet is also ideal for treating | |
| hypoplasias of an acquired origin such as from | |
| post-traumatic growth disorders associated | |
| with injury to the temporomandibular joint, | |
| temporomandibular ankylosis, and segmental | |
| loss of bone. | |
| The Synthes Single Vector Distractor with | |
| Detachable Feet can be used for stabilization | |
| and advancement of the mid-face, in which a | |
| deficiency of mid-facial bone requires gradual | |
| bone distraction. Such deficiencies include, | |
| but are not limited to Plagiocephaly, | |
| Trigonocephaly, Scaphocephaly, and | |
| Brachycephaly. |
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Image /page/62/Picture/0 description: The image shows the logo for DePuy Synthes, which is part of the Johnson & Johnson family of companies. The logo features a stylized eye symbol in gold, followed by the company name in blue, and the tagline "People inspired" in a cursive font. The text "PART OF THE Johnson & Johnson FAMILY OF COMPANIES" is located below the company name in a smaller font.
Non-Clinical Testing Summary 1.7
Non-clinical testing is provided to support the conditional safety of the DePuy Synthes Single Vector Distractor with Detachable Feet in the MR environment including assessment of magnetically induced displacement force (ASTM F2052-14) and torque (ASTM F2213-06), radio frequency (RF) heating (ASTM F2182-11a and DUKE model), and image artifacts (ASTM F2119-07). The DUKE model places devices in the clinically relevant anatomic position. The DUKE results will be used for labeling of RF heating.
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Image /page/63/Picture/0 description: The image shows the logo for DePuy Synthes, which is part of the Johnson & Johnson family of companies. The logo includes a symbol that looks like two overlapping circles, followed by the company name in blue, and the tagline "People inspired" in gold. The text "PART OF THE Johnson+Johnson FAMILY OF COMPANIES" is written in a smaller font below the company name.
510(k) Summary 1.
Date Prepared: March 7, 2019
1.1. Submitter
Primary Contact: Rebecca Reiter Regulatory Affairs Project Leader DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: 610-719-1268 Email: rreiter@its.jnj.com
Alternate Contact:
Elizabeth Jacobs Regulatory Affairs Project Leader DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5768 Email: ejacob10@its.jnj.com
1.2. Device
Trade Name: DePuy Synthes Maxillofacial Portfolio - MR Conditional
Name of Device: DePuy Synthes External Multi Vector Mandible Distractor (MVMD)
Classification Name(s): Screw, Fixation, Intraosseous
Regulatory Class: Class II; 872.4880
Product Code(s): DZL
Predicate Device 1.3.
K981362 Synthes External Multi Vector Mandible Distractor (MVMD)
Device Description 1.4.
This document is regarding the DePuy Synthes External Multi Vector Mandible Distractor (MVMD), which are a subset of the DePuy Synthes Maxillofacial Portfolio – MR Conditional. The DePuy Synthes External Multi Vector Mandible Distractor (MVMD) is a bone lengthening and distraction device which is achieved by gradually activating the device in a linear, angular, and/or transverse fashion. Bone stabilization may also be achieved with this device after distraction.
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Image /page/64/Picture/1 description: The image shows the logo for DePuy Synthes, which is part of the Johnson & Johnson family of companies. The logo features a stylized symbol resembling interconnected circles in a gold color, followed by the company name "DePuy Synthes" in blue. Below the company name, there is a tagline that reads "part of the Johnson & Johnson family of companies" in a smaller font size. To the right of the company name, there is a phrase "People inspired" in a cursive font and gold color.
The DePuy Synthes External MVMD is comprised of two interchangeable distraction arms, pin clamps, universal clamps, rods, flat head screws, and activation nuts. The pin clamps can accept 2.0mm k-wires.
The devices in scope of K183113 are being reviewed for MR Conditional labeling for maxillofacial indications.
1.5. Indications for Use
The DePuy Synthes External Multi Vector Mandible Distractor (MVMD) is intended for use as a bone stabilizer and lengthener for conditions such as mandibular hypoplasia or posttraumatic defects of the mandible, where gradual bone distraction is required. The device is ideal for treating any form of congenital mandibular hypoplasia, such as Hemifacial Micorsomia, Treacher Collins Syndrome, Nagers Syndrome, Pierre Robin Syndrome, Goldenhar Syndrome, Apert Syndrome, and Crouzon Syndrome.
The DePuy Synthes External MVMD is also ideal for treating hypoplasias of an acquired origin such as from post-traumatic growth disorders associated with injury to the temporomandibular joint, temporomandibular ankylosis, and segmental loss of bone.
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Image /page/65/Picture/0 description: The image shows the logo for DePuy Synthes. The logo consists of a circular symbol on the left, followed by the text "DePuy Synthes" in blue. Below the text is the phrase "PART OF THE Johnson & Johnson FAMILY OF COMPANIES" in smaller font. To the right of the company name is the phrase "People inspired" in a cursive font.
1.6. Substantial Equivalence
The purpose of this submission is to add MR Conditional information to the device labeling for the DePuy Synthes External Multi Vector Mandible Distractor (MVMD). The intended use and technological characteristics of the devices remains unchanged. The device name has been updated to reflect the current company name, DePuy Synthes. An indications for use comparison table is provided below.
| K183113 | K981362 |
|---|---|
| The DePuy Synthes External Multi Vector | The Synthes External Multi Vector Mandible |
| Mandible Distractor (MVMD) is intended for | Distractor (MVMD) is intended for use as a |
| use as a bone stabilizer and lengthener for | bone stabilizer and lengthener for conditions |
| conditions such as mandibular hypoplasia or | conditions such as mandibular hypoplasia or |
| posttraumatic defects of the mandible, where | posttraumatic defects of the mandible, where |
| gradual bone distraction is required. The | gradual bone distraction is required. The |
| device is ideal for treating any form ot | device is ideal for treating any form ot |
| congenital mandibular hypoplasia, such as | congenital mandibular hypoplasia, such as |
| Hemifacial Micorsomia, Treacher Collins | Hemifacial Micorsomia, Treacher Collins |
| Syndrome, Nagers Syndrome, Pierre Robin | Syndrome, Nagers Syndrome, Pierre Robin |
| Syndrome, Goldenhar Syndrome, Apert | Syndrome, Goldenhar Syndrome, Apert |
| Syndrome, and Crouzon Syndrome. | Syndrome, and Crouzon Syndrome. |
| The DePuy Synthes External MVMD is also | The Synthes External MVMD is also ideal for |
| ideal for treating hypoplasias of an acquired | treating hypoplasias of an acquired origin such |
| origin such as from post-traumatic growth | as from post-traumatic growth disorders |
| disorders associated with injury to the | disorders associated with injury to the |
| temporomandibular joint, temporomandibular | temporomandibular joint, temporomandibular |
| ankylosis, and segmental loss of bone. | ankylosis, and segmental loss of bone. |
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Image /page/66/Picture/0 description: The image shows the logo for DePuy Synthes, which is part of the Johnson & Johnson family of companies. The logo features a stylized eye symbol in gold, followed by the company name in blue, and the tagline "People inspired" in a cursive font. The text "PART OF THE Johnson & Johnson FAMILY OF COMPANIES" is located below the company name in a smaller font.
Non-Clinical Testing Summary 1.7.
Non-clinical testing is provided to support the conditional safety of the DePuy Synthes External Multi Vector Mandible Distractor (MVMD) in the MR environment including assessment of magnetically induced displacement force (ASTM F2052-14) and torque (ASTM F2213-06), radio frequency (RF) heating (ASTM F2182-11a and DUKE model), and image artifacts (ASTM F2119-07). The DUKE model places devices in the clinically relevant anatomic position. The DUKE results will be used for labeling of RF heating.
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Image /page/67/Picture/0 description: The image shows the logo for DePuy Synthes, which is part of the Johnson & Johnson family of companies. The logo features a stylized symbol to the left of the text "DePuy Synthes" in a dark blue font. To the right of the company name, the phrase "People inspired" is written in a cursive, gold-colored font. Below the company name, there is smaller text indicating that DePuy Synthes is part of the Johnson & Johnson family of companies.
510(k) Summarv 1.
Date Prepared: March 7, 2019
1.1 Submitter
Primary Contact: Rebecca Reiter Regulatory Affairs Project Leader DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: 610-719-1268 Email: rreiter@its.jnj.com
Alternate Contact: Elizabeth Jacobs Regulatory Affairs Project Leader DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5768 Email: ejacob10@its.jnj.com
1.2 Device
Trade Name: DePuy Synthes Maxillofacial Portfolio - MR Conditional
Name of Device: DePuy Synthes Locking Reconstruction Plate (LRP) with Condylar Head
Classification Name(s): Prosthesis, Condyle, Mandibular, Temporary
Regulatory Class: Class II; 872.4770
Product Code(s): NEI
1.3 Predicate Device
K990637 Synthes Locking Reconstruction Plate (LRP) with Condylar Head
Device Description 1.4
This document is regarding the DePuy Synthes Locking Reconstruction Plate (LRP) with Condylar Head, which are a subset of the DePuy Synthes Maxillofacial Portfolio – MR Conditional. The DePuy Synthes Locking Reconstruction Plate (LRP) with Condylar Head is a one piece reconstruction plate with a solid condylar head. The plate features compression screw holes that are internally threaded to accept the 2.4 - 3.0mm locking screws or standard 2.4 mm selftapping cortex screws and has notched sides and undersides to facilitate contouring. The plates are available in three sizes for right and left placement. The devices in scope of K183113 are being reviewed for MR Conditional labeling for maxillofacial indications.
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Image /page/68/Picture/0 description: The image shows the logo for DePuy Synthes, a Johnson & Johnson company. The logo features a stylized gold symbol resembling interconnected circles, followed by the company name in blue, "DePuy Synthes". To the right of the company name, the phrase "People inspired" is written in a cursive gold font. Below the company name, there is a smaller tagline that reads "PART OF THE Johnson & Johnson FAMILY OF COMPANIES".
The DePuy Synthes Locking Reconstruction Plate with Condylar Head is intended for temporary reconstruction in patients undergoing ablative tumor surgery requiring the removal of the mandibular condyle. This device is not for permanent implantation, for patients with TMJ or traumatic injuries, or for treatment of temporomandibular joint disease (TMD).
Substantial Equivalence 1.6
The purpose of this submission is to add MR Conditional information to the device labeling for the DePuy Synthes Locking Reconstruction Plate (LRP) with Condylar Head. The intended use and technological characteristics of the devices remains unchanged. The device name has been updated to reflect the current company name, DePuy Synthes. An indications for use comparison table is provided below.
| K183113 | K990637 |
|---|---|
| The DePuy Synthes Locking Reconstruction | |
| Plate with Condylar Head is intended for | |
| temporary reconstruction in patients | |
| undergoing ablative tumor surgery requiring | |
| the removal of the mandibular condyle. This | |
| device is not for permanent implantation, for | |
| patients with TMJ or traumatic injuries, or for | |
| treatment of temporomandibular joint disease | |
| (TMD). | The Synthes Locking Reconstruction Plate with |
| Condylar Head is intended for temporary | |
| reconstruction in patients undergoing ablative | |
| tumor surgery requiring the removal of the | |
| mandibular condyle. This device is not for | |
| permanent implantation, for patients with | |
| TMJ or traumatic injuries, or for treatment of | |
| temporomandibular joint disease (TMD). |
Non-Clinical Testing Summary 1.7
Non-clinical testing is provided to support the conditional safety of the DePuy Synthes Locking Reconstruction Plate (LRP) with Condylar Head in the MR environment including assessment of magnetically induced displacement force (ASTM F2052-14) and torque (ASTM F2213-06), radio frequency (RF) heating (ASTM F2182-11a and DUKE model), and image artifacts (ASTM F2119-07). The DUKE model places devices in the clinically relevant anatomic position. The DUKE results will be used for labeling of RF heating.
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Image /page/69/Picture/0 description: The image shows the logo for DePuy Synthes, which is part of the Johnson & Johnson family of companies. The logo features a stylized symbol to the left of the company name, "DePuy Synthes," written in a bold, dark blue font. To the right of the company name is the phrase "People inspired" in a cursive, gold font. Below the company name is the phrase "PART OF THE Johnson & Johnson FAMILY OF COMPANIES" in a smaller, gray font.
510(k) Summary 1.
Date Prepared: March 7, 2019
1.1 Submitter
Primary Contact: Rebecca Reiter Regulatory Affairs Project Leader DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: 610-719-1268 Email: rreiter@its.jnj.com
Alternate Contact: Elizabeth Jacobs Regulatory Affairs Project Leader DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5768 Email: ejacob10@its.jnj.com
1.2 Device
Trade Name: DePuy Synthes Maxillofacial Portfolio - MR Conditional
Name of Device: Cerclage Wires
Classification Name(s): Wire, Fixation, Intraosseous
Regulatory Class: Class II; 872.4880
Product Code(s): DZK
1.3 Predicate/Reference Devices
Primary Predicate: K092530 SPRYTIE, MODELS ST001, ST002 AND ST003
Reference Device: Synthes Pre-Amendment Cerclage Wires
Device Description 1.4
This document is regarding the DePuy Synthes Cerclage Wires, which are a subset of the DePuy Synthes Maxillofacial Portfolio – MR Conditional. The DePuy Synthes Cerclage Wires are used to augment fracture stabilization with or without plates. The wire is available in a variety of diameters. The wires are pre-cut to a usable length or available in coils allowing the surgeon to cut the length to his patient's needs. The devices in scope of K183113 are being reviewed for MR Conditional labeling for maxillofacial indications.
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Image /page/70/Picture/0 description: The image shows the logo for DePuy Synthes. The logo consists of a gold abstract symbol on the left, followed by the company name in blue, and the tagline "People inspired" in gold script. Below the company name is the text "PART OF THE Johnson & Johnson FAMILY OF COMPANIES" in a smaller font size.
The DePuy Synthes Cerclage Wires are indicated for use in the jaws in adults and children to directly wire bony segments together, for the fixation of arch bars or splints to the teeth, for stabilization of bony segments, or for wiring the teeth together maxillomandibular fixation.
Substantial Equivalence 1.6
The purpose of this submission is to add MR Conditional information to the device labeling for the DePuy Synthes Cerclage Wires. The intended use and technological characteristics of the devices remains unchanged. The device name has been updated to reflect the current company name, DePuy Synthes. DePuy Synthes selected K092530 as the predicate device for the Pre-Amendment Cerclage Wires, as the indications for use are similar as well as the device's application. An indications for use comparison table is provided below.
| K183113 | K092530 | Pre-Amendment |
|---|---|---|
| The DePuy Synthes Cerclage | ||
| Wires are indicated for use in | ||
| the jaws in adults and children | ||
| to directly wire bony | ||
| segments together, for the | ||
| fixation of arch bars or splints | ||
| to the teeth, for stabilization | ||
| of bony segments, or for | ||
| wiring the teeth together | ||
| maxillomandibular fixation. | Sprytie wires are indicated for | |
| use in the jaws in adults and | ||
| children to directly wire bony | ||
| segments together, for the | ||
| fixation of arch bars or splints | ||
| to the teeth, for stabilization | ||
| of bony segments, are for | ||
| wiring the teeth together | ||
| (maxillomandibular fixation). | This device is Pre-Amendment | |
| and does not have an | ||
| indications for use statement. |
Non-Clinical Testing Summary 1.7
Non-clinical testing is provided to support the conditional safety of the DePuy Synthes Cerclage Wires in the MR environment including assessment of magnetically induced displacement force (ASTM F2052-14) and torque (ASTM F2213-06), radio frequency (RF) heating (ASTM F2182-11a and DUKE model), and image artifacts (ASTM F2119-07). The DUKE model places devices in the clinically relevant anatomic position. The DUKE results will be used for labeling of RF heating.