(96 days)
No
The document describes various bone fixation systems consisting of plates, screws, and distractors made of titanium or titanium alloy. There is no mention of software, algorithms, image processing, or any other components typically associated with AI/ML in medical devices. The performance studies mentioned are related to MRI compatibility, not algorithmic performance.
Yes
The device, described as systems of plates and screws, distractors, and fixation systems, is indicated for the treatment of fractures and osteotomies, reconstructive surgery, and the correction of dentofacial deformities, all of which are therapeutic interventions.
No
The provided text describes various plate and screw systems, distractors, and fixation systems intended for surgical procedures like trauma repair, reconstructive surgery, and orthognathic surgery. These devices are used for treatment and stabilization, not for diagnosing medical conditions.
No
The device description explicitly details various physical components made of titanium and titanium alloy, such as plates, screws, meshes, and distractors, which are implanted in the body. This indicates it is a hardware-based medical device, not software-only.
Based on the provided information, none of the listed DePuy Synthes devices are In Vitro Diagnostic (IVD) devices.
Here's why:
- Intended Use/Indications for Use: All the listed devices are intended for surgical procedures involving the fixation, reconstruction, or distraction of bones in the maxillofacial region. This is a direct surgical intervention on the patient's body.
- Device Description: The descriptions detail implants like plates, screws, and distractors made of materials like titanium. These are physical devices implanted into the body.
- Definition of IVD: An IVD device is defined as a medical device intended for use in vitro for the examination of specimens, including blood, tissue, and urine, from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
The DePuy Synthes devices described here are surgical implants used in vivo (within the living body) for structural support and fixation, not for analyzing biological specimens in vitro.
N/A
Intended Use / Indications for Use
DePuy Synthes MatrixWAVE MMF System (originally cleared per K141165): The DePuy Synthes MatrixWAVE MMF System is indicated for the temporary treatment of mandibular and maxillary fractures and osteotomies in adults and adolescents (age 12 and higher) in whom permanent teeth have erupted.
DePuy Synthes MatrixMANDIBLE Plate and Screw System (originally cleared per K121574, K113567, K082335, K063790): The DePuy Synthes MatrixMANDIBLE Plate and Screw System is intended for oral, maxillofacial surgery: Trauma, Reconstructive surgery, Orthognathic surgery (surgical correction of dentofacial deformities).
DePuy Synthes Dentoalveolar Bone Fixation System (originally cleared per K102656): The DePuy Synthes Dentoalveolar Bone Fixation System is intended for use in non-load bearing applications for maintaining the relative position of and/or containing bony fragments, bone grafts (autograft or allograft), or bone graft substitutes in reconstruction of maxillary and/or mandibular areas, including the dentoalveolar ridge.
DePuy Synthes MatrixMANDIBLE Subcondylar Plates (originally cleared per K091233): The DePuy Synthes MatrixMANDIBLE Subcondylar Plates are intended for oral, maxillofacial surgery; trauma and reconstructive surgery, specifically for fractures of the subcondylar region of the mandible and fractures of the condylar basis region of the mandible.
DePuy Synthes MatrixMANDIBLE Preformed Reconstruction Plates (originally cleared per K091144): The DePuy Synthes MatrixMANDIBLE Preformed Reconstruction Plates are intended for use in oral and maxillofacial surgery, trauma and reconstructive surgery. This includes primary mandibular reconstruction, comminuted fractures and temporary bridging pending delayed secondary reconstruction, including fractures of edentulous and/or atrophic mandibles, as well as unstable fractures.
DePuy Synthes MatrixORTHOGNATHIC Plating System (originally cleared per K083388): The DePuy Synthes MatrixORTHOGNATHIC Plating System is intended for use in selective trauma of the midface and maxillofacial skeleton; maxillofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla, mandible and chin in adolescents (greater than 12 to 21 years of age) and adults. Specific Indications for Use: Fractures of the midface and maxillofacial skeleton, LeFort I osteotomies, sagittal split osteotomies and genioplasties, Orthognathic surgery including reconstructive procedures.
DePuy Synthes Craniofacial Plate and Screw System (originally cleared per K080331, K050608): The DePuy Synthes Craniofacial Plate and Screw System 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 Neuro Plate and Screw System (originally cleared per K042365): The DePuy Synthes Neuro Plate and Screw System 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 1.3 & 1.5 mm Contourable Titanium (Ti.) Mesh Plates (originally cleared per K033121): The DePuy Synthes 1.3 & 1.5 mm Contourable Titanium (Ti.) Mesh Plates are 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 Orbital Plates (originally cleared per K031761): The DePuy Synthes Orbital Plates are 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 Low Profile Neuro System (originally cleared per K022012): The DePuy Synthes Low Profile Neuro System is intended for use in selective trauma of the midfacial skeleton; maxillofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.
DePuy Synthes Midface Distractor (Originally cleared per K022005, K010499): The DePuy Synthes Midface Distractor is intended for use in adult and pediatic populations for the treatment of midface conditions for which reconstructive osteotomy and segment are indicated. This includes conditions such as midfacial retrusion. The device is intended to provide temporary stabilization and gradual lengthening of the midfacial bones.
DePuy Synthes Translating Maxillary Distractor (Originally cleared per K020505): The DePuy Synthes Translating Maxillary 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 in adult and pediatric populations.
DePuy Synthes Maxillary Distractor (Originally cleared per K003393): The DePuy Synthes Maxillary 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 in adult and pediatric populations.
DePuy Synthes Orbital Mesh Plates (Originally cleared per K001311): The DePuy Synthes Orbital Mesh Plates for the Midfacial System are indicated for selective trauma of the midface and maxillofacial skeleton; maxillofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.
DePuy Synthes 2.0 mm Locking Plate System (2.0 LPS) (originally cleared per K974555): The DePuy Synthes 2.0 LPS is intended for oral, maxillofacial surgery: trauma; reconstructive surgery; and orthognathic surgery (surgical correction of dentofacial deformities).
DePuy Synthes 2.4 mm Universal Locking Plate System (originally cleared per K961421): The DePuy Synthes 2.4 mm Universal Locking Plate and screw system, that is intended for mandible trauma and reconstruction procedures.
DePuy Synthes Mandibular Modular Fixation System (originally cleared per K954385): The DePuy Synthes Mandibular Modular Fixation System is a plate and screw system, manufactured from commercially pure titanium, and is intended for use in: Oral, maxillofacial surgery: trauma; surgical correction of dentofacial deformities; reconstructive surgery; and maxillofacial surgery.
DePuy Synthes Maxillofacial Titanium Micro Set (originally cleared per K912932): General indications: Maxillofacial surgery.
Product codes
JEY
Device Description
DePuy Synthes MatrixWAVE MMF System: The DePuy Synthes MatrixWAVE MMF is a bone-borne maxillomandibular fixation (MMF) system that consists of wave shaped plates (made from commercially pure Titanium) that are attached to the dental arches with self-drilling locking screws (made from Titanium alloy, Ti-6Al-7Nb). The system is intended for temporary stabilization of mandibular and maxillary fractures and osteotomies to maintain proper occlusion during intraoperative bone fixation and postoperative bone healing (approximately 6-8 weeks). The dental arches are brought into occlusion by wiring around the plate hooks and/or accessible screw heads.
DePuy Synthes MatrixMANDIBLE Plate and Screw System (K121574, K082335, K063790): The DePuy Synthes MatrixMANDIBLE Plate and Screw System consists of a variety of plates offered in multiple shapes and a variety of screws offered in multiple diameters and lengths to meet the anatomical needs of the patient. System implants are manufactured in either titanium or titanium alloy and are intended for single use only. The DePuy Synthes MatrixMANDIBLE screws that are the subject of this premarket notification are made from titanium alloy (Ti-6A1-7Nb) and are available in a diameter of 2.0 mm and lengths ranging from 4 mm to 8 mm, and have a thread pitch of 0.5 mm. These screws work with all plates within the DePuy Synthes MatrixMANDIBLE Plate and Screw System. These devices are offered, non-sterile and must be sterilized prior to use. DePuy Synthes MatrixMANDLBLE screws are intended for single use. (K082335): The DePuy Synthes MatrixMANDIBLE Plate and Screw System incorporates small, medium and large plates designed so all plates accept all system screws. The plates are available in various shapes and thicknesses and accept self-tapping and self-drilling cortex and locking screws. The implants are manufactured from titanium. (K063790): The DePuy Synthes MatrixMANDIBLE Plate and Screw System is the next generation of Synthes (USA) fixation systems for the mandible. The system incorporates small, medium, and large plates designed so that all plates accept all system screws. The plates are available in various shapes and thicknesses, and accept self-tapping cortex and locking screws. The implants are manufactured from CP titanium and titanium alloy.
DePuy Synthes MatrixMANDIBLE Plate and Screw System (K113567): The DePuy Synthes MatrixMANDIBLE Plate and Screw System consists of a variety of plates offered in multiple shapes and a variety of screws offered in multiple diameters and lengths to meet the anatomical needs of the patient. This submission pertains to 1.5 mm thick MatrixMANDIBLE Reconstruction Plates, which are available as left and right single angle reconstruction plates and in three sizes of double angle reconstruction plates. These plates are made from pure titanium and may be offered sterile or non-sterile (non-sterile implants must be sterilized prior to use). DePuy Synthes MatrixMANDIBLE 1.5 mm thick reconstruction plates are intended for single use only.
DePuy Synthes Dentoalveolar Bone Fixation System: The DePuy Synthes Dentoalveolar Bone Fixation System is a plate, mesh, and screw system intended to be implanted intraorally for use in non-load bearing applications for maintaining the relative position of and/or containing bony fragments, bone grafts (autograft or allograft), or bone graft substitutes in reconstruction of maxillary and/or mandibular areas, including the dentoalveolar ridge. Screws: The System includes 1.3 mm, 1.5 mm, and 2.0 mm diameter cortex screws in lengths from 3 mm to 20 mm. Screws are offered with both self-tapping and self drilling tips. Screws are manufactured from titanium alloy (Ti-6A1-7Nb). Plates and Meshes: The System includes plates and meshes that come in a variety of configurations to accommodate various dentoalveolar defect sites. The plates attach to bone via titanium cortex screws. Plates and meshes are manufactured from commercially pure titanium.
DePuy Synthes MatrixMANDIBLE Subcondylar Plates: The DePuy Synthes MatrixMANDIBLE Subcondylar Plates are designed specifically to match the anatomy of the subcondylar region of the mandible. These plates are designed for use with DePuy Synthes MatrixMANDIBLE screws that come in multiple diameters and lengths to meet the anatomical needs of the patient. System components are manufactured in either titanium or titanium alloy and are intended for single use only.
DePuy Synthes MatrixMANDIBLE Preformed Reconstruction Plates: The DePuy Synthes MatrixMANDIBLE Preformed Reconstruction Plates are anatomically contoured to match the body and angle regions of the mandible in most patients. These plates are designed for use with DePuy Synthes MatrixMANDIBLE screws that come in multiple diameters and lengths to meet the anatomical needs of the patient. System components are manufactured in either titanium alloy and are intended for single use only.
DePuy Synthes MatrixORTHOGNATHIC Plating System: The DePuy Synthes MatrixORTHOGNATHIC Plating System consists of a variety of plates that come in a variety of shapes and sizes to meet the anatomical needs of the patient. This system is designed for use with DePuy Synthes Matrix screws. System components are manufactured in either titanium or titanium alloy and are intended for single use only.
DePuy Synthes Craniofacial Plate and Screw System (K080331, K050608): The DePuy Synthes Orbital Plates, components of the Synthes Craniofacial Plate and Screw System, consist of anatomically shaped orbital plates that come in various sizes and configurations to fit the patient anatomy. These devices are designed for use with DePuy Synthes craniofacial bone screws commercially available in the U.S. System components are manufactured in titanium and are intended for single use only. (K050608): The DePuy Synthes Craniofacial Plate and Screw System consist of plates and meshes that come in a variety of shapes and sizes to meet the anatomical needs of the patient. This system is designed for use with 1.8 mm screws and 2.1 mm emergency screws. The screws will be used with Synthes 1.8 mm hexagonal screwdriver blades. System components are manufactured in either titanium or titanium alloy and are intended for single use only.
DePuy Synthes Neuro Plate and Screw System: DePuy Synthes Neuro Plate and Screw System consists of plates, burr hole covers, and meshes that come in a variety of shapes and sizes to meet the anatomical needs of the patient. This system is designed for use with 1.8 mm screws and 2.1 mm emergency screws. The screws will be used with Synthes 1.8 mm hexagonal screwdriver blades. System components are manufactured in either titanium or titanium alloy and are intended for single use only.
DePuy Synthes 1.3 & 1.5 mm Contourable Titanium (Ti.) Mesh Plates: The DePuy Synthes 1.3 & 1.5 mm Contourable Ti. Mesh Plates come in a variety of shapes and sizes to meet the anatomical need of the patient. The plates are sterile and for single use only.
DePuy Synthes Orbital Plates: The DePuy Synthes Orbital Plates come in a variety of shapes and sizes to meet the anatomical need of the patient. The plates are sterile/non-sterile and for single use only.
DePuy Synthes Low Profile Neuro System: The DePuy Synthes Low Profile Neuro System consists of titaniurn plates, meshes, and screws in a variety of shapes and sizes designed for various maxillofacial procedures.
DePuy Synthes Midface Distractor (K022005, K010499): The DePuy Synthes Midface Distractor is a maxillofacial distraction device consisting of two telescoping components with attached footplates. The device is intended to be placed subcutaneously with an anterior footplate fastened to the lateral orbital rim, extending down to the maxilla and spanning the zygomaticomaxillary suture; and a posterior footplate fastened to the temporal region of the cranium. The plates are fixed to the bone through unthreaded screw holes using 1.5 mm or 2.0 mm Cortex screws.
DePuy Synthes Translating Maxillary Distractor: The DePuy Synthes Translating Maxillary Distractor is an intra-oral distraction device. It features a distractor body with two adjustable footplate components, each with contourable legs having screw holes that are fixed to the bone via 2.0 mm or 2.4 mm cortex screws.
DePuy Synthes Maxillary Distractor: The DePuy Synthes Maxillary Distractor is an intra-oral distraction device. It features two telescoping components, with contourable legs having screw holes, that are fixed to the bone via 2.0 mm or 2.4 mm cortex screws.
DePuy Synthes Orbital Mesh Plates: The DePuy Synthes Orbital Mesh Plates have a semi-circular shape with a radially designed mesh pattern. Orbital Mesh Plates are available in 0.2, 0.3 and 0.4 mm profile thickness. Standard 1.0 mm screw holes positioned along the outer arc of the Orbital Mesh Plate accept 1.0 mm selftapping bone screws and 1.2 mm emergency screws. Synthes Orbital Mesh Plates for the Midfacial System are provided nonsterile.
DePuy Synthes 2.0 MM Locking Plate System (2.0 LPS): The DePuy Synthes 2.0 Locking Plate System consists of five different types of plates and two screws, as follows: 2.0 Straight Locking Plates, 2.0 Crescent Locking Plates, 2.0 Atrophic Locking Plates, 2.0 Reconstruction Locking Plates, 2.0 Specialty Plates (Y- and 1.5 mm and 2.0 mm Self-drilling Locking Screws. The plates feature a threaded screw hole which accepts a locking screw with a mating external thread on the screw head. Engaging these screw threads fixes the screw to the plate thereby reducing the likelihood of screw loosening and improving the screw to plate stability of the implant system.
DePuy Synthes 2.4 MM Universal Locking Plate System: The DePuy Synthes 2.4 mm Universal Locking Plate System plates are designed to accept the 2.4 mm – 3.0 mm diameter locking/non-locking screws.
DePuy Synthes Mandibular Modular Fixation System: The DePuy Synthes Mandibular Fixation System is a plate and screw system manufactured from titanium. The plates are available in a variety of shapes and sizes, and attach to bone via 2.0 mm, 2.4 mm or 2.7 mm screws.
DePuy Synthes Maxillofacial Titanium Micro Set: The DePuy Synthes Maxillofacial Titanium Micro set consists of titanium bone plates (shapes include L,Y,H,T, Double-Y, Mesh and Straight) and self-tapping screws.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Mandibular, Maxillary, Midface, Chin, Mandibular dentoalveolar ridge, Maxillary dentoalveolar ridge, Subcondylar region of the mandible, Condylar basis region of the mandible, Midfacial Skeleton, Cranium, Maxillofacial skeleton.
Indicated Patient Age Range
Adults and adolescents (age 12 and higher) for MatrixWAVE MMF System.
Adolescents (greater than 12 to 21 years of age) and adults for MatrixORTHOGNATHIC Plating System.
Adult and pediatric populations for Midface Distractor, Translating Maxillary Distractor, and Maxillary Distractor.
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 all listed DePuy Synthes Maxillofacial Portfolio devices (MatrixWAVE MMF System, MatrixMANDIBLE Plate and Screw System, Dentoalveolar Bone Fixation System, MatrixMANDIBLE Subcondylar Plates, MatrixMANDIBLE Preformed Reconstruction Plates, MatrixORTHOGNATHIC Plating System, Craniofacial Plate and Screw System, Neuro Plate and Screw System, 1.3 & 1.5 mm Contourable Titanium (Ti.) Mesh Plates, Orbital Plates, Low Profile Neuro System, Midface Distractor, Translating Maxillary Distractor, Maxillary Distractor, Orbital Mesh Plates, 2.0 MM Locking Plate System (2.0 LPS), 2.4 MM Universal Locking Plate System, Mandibular Modular Fixation System, Maxillofacial Titanium Micro Set) 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 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)
K141165, K121574, K113567, K102656, K091233, K091144, K083388, K082335, K080331, K063790, K050608, K042365, K033121, K031761, K022012, K022005, K020505, K010499, K003393, K001311, K974555, K961421, K954385, K912932
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 30, 2019
Synthes (USA) Products LLC Satapa Dhamankar Regulatory Affairs Specialist II 1301 Goshen Parkway West Chester, Pennsylvania 19380
Re: K192655
Trade/Device Name: DePuy Synthes Maxillofacial Portfolio - MR Conditional Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: Class II Product Code: JEY Dated: December 23, 2019 Received: December 26, 2019
Dear Satapa Dhamankar:
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for Srinivas Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known) K192655
Device Name
DePuy Synthes Maxillofacial Portfolio - MR Conditional
Indications for Use (Describe) DePuy Synthes MatrixWAVE MMF System (originally cleared per K141165)
The DePuy Synthes MatrixWAVE MMF System is indicated for the temporary treatment of mandibular and maxillary fractures and osteotomies in adults and adolescents (age 12 and higher) in whom permanent teeth have erupted.
| 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) K192655
Device Name
DePuy Synthes Maxillofacial Portfolio - MR Conditional
Indications for Use (Describe) DePuy Synthes MatrixMANDIBLE Plate and Screw System (originally cleared per K121574)
The DePuy Synthes MatrixMANDIBLE Plate and Screw System is intended for oral, maxillofacial surgery:
- Trauma
· Reconstructive surgery
· Orthognathic surgery (surgical correction of dentofacial deformities)
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) K192655
Device Name
DePuy Synthes Maxillofacial Portfolio - MR Conditional
Indications for Use (Describe) DePuy Synthes MatrixMANDIBLE Plate and Screw System (originally cleared per K113567)
The DePuy Synthes MatrixMANDIBLE Plate and Screw System is intended for oral, maxillofacial surgery:
- Trauma
· Reconstructive surgery
· Orthognathic surgery (surgical correction of dentofacial deformities)
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) K192655
Device Name
DePuy Synthes Maxillofacial Portfolio - MR Conditional
Indications for Use (Describe)
DePuy Synthes Dentoalveolar Bone Fixation System (originally cleared per K102656)
The DePuy Synthes Dentoalveolar Bone Fixation System is intended for use in non-load bearing applications for maintaining the relative position of and/or containing bony fragments, bone grafts (autograft or allograft), or bone graft substitutes in reconstruction of maxillary and/or mandibular areas, including the dentoalveolar ridge.
| 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) K192655
Device Name DePuy Synthes Maxillofacial Portfolio - MR Conditional
Indications for Use (Describe) DePuy Synthes MatrixMANDIBLE Subcondylar Plates (originally cleared per K091233)
The DePuy Synthes MatrixMANDIBLE Subcondylar Plates are intended for oral, maxillofacial surgery; trauma and reconstructive surgery, specifically for fractures of the subcondylar region of the mandible and fractures of the condylar basis region of the mandible.
| 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
7
510(k) Number (if known) K192655
Device Name
DePuy Synthes Maxillofacial Portfolio - MR Conditional
Indications for Use (Describe) DePuy Synthes MatrixMANDIBLE Preformed Reconstruction Plates (originally cleared per K091144)
The DePuy Synthes MatrixMANDIBLE Preformed Reconstruction Plates are intended for use in oral and maxillofacial surgery, trauma and reconstructive surgery. This includes primary mandibular reconstruction, comminuted fractures and temporary bridging pending delayed secondary reconstruction, including fractures of edentulous and/or atrophic mandibles, as well as unstable fractures.
| 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
8
510(k) Number (if known) K192655
Device Name
DePuy Synthes Maxillofacial Portfolio – MR Conditional
Indications for Use (Describe) DePuy Synthes MatrixORTHOGNATHIC Plating System (originally cleared per K083388)
The DePuy Synthes MatrixORTHOGNATHIC Plating System consists of a variety of plates that come in a variety of shapes and sizes to meet the anatomical needs of the patient. This system is designed for use with Synthes Matrix screws. System components are manufactured in either titanium alloy and are intended for single use only.
The Synthes MatrixORTHOGNATHIC Plating System is intended for use in selective trauma of the midface and maxillofacial skeleton; maxillofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla, mandible and chin in adolescents (greater than 12 to 21 years of age) and adults. Specific Indications for Use:
· Fractures of the midface and maxillofacial skeleton
- · LeFort I osteotomies, sagittal split osteotomies and genioplasties
- · Orthognathic surgery including reconstructive procedures
| 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) K192655
Device Name
DePuy Synthes Maxillofacial Portfolio - MR Conditional
Indications for Use (Describe) DePuy Synthes MatrixMANDIBLE Plate and Screw System (originally cleared per K082335)
The DePuy Synthes MatrixMANDIBLE Plate and Screw System is intended for oral, maxillofacial surgery; trauma; reconstructive surgery; and orthognathic surgery (surgical correction of dentofacial deformities).
| 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) K192655
Device Name
DePuy Synthes Maxillofacial Portfolio - MR Conditional
Indications for Use (Describe)
DePuy Synthes Craniofacial Plate and Screw System (originally cleared per K080331)
The DePuy Synthes Craniofacial Plate and Screw System 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
11
510(k) Number (if known) K192655
Device Name
DePuy Synthes Maxillofacial Portfolio - MR Conditional
Indications for Use (Describe) DePuy Synthes MatrixMANDIBLE Plate and Screw System (originally cleared per K063790)
The DePuy Synthes MatrixMANDIBLE Plate and Screw System is intended for oral, maxillofacial surgery; trauma; reconstructive surgery; and orthognathic surgery (surgical correction of dentofacial deformities).
| 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) K192655
Device Name
DePuy Synthes Maxillofacial Portfolio - MR Conditional
Indications for Use (Describe)
DePuy Synthes Craniofacial Plate and Screw System (originally cleared per K050608)
The DePuy Synthes Craniofacial Plate and Screw System 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
13
510(k) Number (if known) K192655
Device Name
DePuy Synthes Maxillofacial Portfolio - MR Conditional
Indications for Use (Describe) DePuy Synthes Neuro Plate and Screw System (originally cleared per K042365)
The DePuy Synthes Neuro Plate and Screw System 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
14
510(k) Number (if known) K192655
Device Name DePuy Synthes Maxillofacial Portfolio - MR Conditional
Indications for Use (Describe) DePuy Synthes 1.3 & 1.5 mm Contourable Titanium (Ti.) Mesh Plates (originally cleared per K033121)
The DePuy Synthes 1.3 & 1.5 mm Contourable Titanium (Ti.) Mesh Plates are 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
15
510(k) Number (if known) K192655
Device Name
DePuy Synthes Maxillofacial Portfolio - MR Conditional
Indications for Use (Describe) DePuy Synthes Orbital Plates (originally cleared per K031761)
The DePuy Synthes Orbital Plates are 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
16
510(k) Number (if known) K192655
Device Name
DePuy Synthes Maxillofacial Portfolio - MR Conditional
Indications for Use (Describe) DePuy Synthes Low Profile Neuro System (originally cleared per K022012)
The DePuy Synthes Low Profile Neuro System is intended for use in selective trauma of the midfacial 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
17
510(k) Number (if known) K192655
Device Name DePuy Synthes Maxillofacial Portfolio - MR Conditional
Indications for Use (Describe) DePuy Synthes Midface Distractor (Originally cleared per K022005)
The DePuy Synthes Midface Distractor is intended for use in adult and pediatic populations for the treatment of midface conditions for which reconstructive osteotomy and segment are indicated. This includes conditions such as midfacial retrusion. The device is intended to provide temporary stabilization and gradual lengthening of the midfacial bones.
| 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) K192655
Device Name
DePuy Synthes Maxillofacial Portfolio - MR Conditional
Indications for Use (Describe) DePuy Synthes Translating Maxillary Distractor (Originally cleared per K020505)
The DePuy Synthes Translating Maxillary 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 in adult and pediatric populations.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 807 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
19
510(k) Number (if known) K192655
Device Name DePuy Synthes Maxillofacial Portfolio - MR Conditional
Indications for Use (Describe) DePuy Synthes Midface Distractor (Originally cleared per K010499)
The DePuy Synthes Midface Distractor is intended for use in adult and pediatic populations for the treatment of midface conditions for which reconstructive osteotomy and segment are indicated. This includes conditions such as midfacial retrusion. The device is intended to provide temporary stabilization and gradual lengthening of the midfacial bones.
| 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) K192655
Device Name DePuy Synthes Maxillofacial Portfolio - MR Conditional
Indications for Use (Describe) DePuy Synthes Maxillary Distractor (Originally cleared per K003393)
The DePuy Synthes Maxillary 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 in adult and pediatric populations.
| 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
510(k) Number (if known) K192655
Device Name
DePuy Synthes Maxillofacial Portfolio - MR Conditional
Indications for Use (Describe) DePuy Synthes Orbital Mesh Plates (Originally cleared per K001311)
The DePuy Synthes Orbital Mesh Plates for the Midfacial System are indicated for 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) | |
|---|---|
| ------------------------------------------------- | -- |
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
22
510(k) Number (if known) K192655
Device Name
DePuy Synthes Maxillofacial Portfolio - MR Conditional
Indications for Use (Describe) DePuy Synthes 2.0 mm Locking Plate System (2.0 LPS) (originally cleared per K974555)
The DePuy Synthes 2.0 LPS is intended for oral, maxillofacial surgery: trauma; reconstructive surgery; and orthognathic surgery (surgical correction of dentofacial deformities).
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
23
510(k) Number (if known) K192655
Device Name DePuy Synthes Maxillofacial Portfolio - MR Conditional
Indications for Use (Describe) DePuy Synthes 2.4 mm Universal Locking Plate System (originally cleared per K961421)
The DePuy Synthes 2.4 mm Universal Locking Plate and screw system, that is intended for mandible trauma and reconstruction procedures.
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
24
510(k) Number (if known) K192655
Device Name
DePuy Synthes Maxillofacial Portfolio - MR Conditional
Indications for Use (Describe) DePuy Synthes Mandibular Modular Fixation System (originally cleared per K954385)
The DePuy Synthes Mandibular Modular Fixation System is a plate and screw system, manufactured from commercially pure titanium, and is intended for use in:
· Oral, maxillofacial surgery: trauma; surgical correction of dentofacial deformities; reconstructive surgery; and maxillofacial surgery
| 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
25
510(k) Number (if known) K192655
Device Name DePuy Synthes Maxillofacial Portfolio - MR Conditional
Indications for Use (Describe) DePuy Synthes Maxillofacial Titanium Micro Set (originally cleared per K912932)
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)
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
26
510(k) Summary 1.
Date Prepared: December 23, 2019
Submitter 1.1.
Primary Contact:
Satapa Dhamankar Regulatory Affairs Specialist II DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: 610-719-6574 Email: sdhamank@its.jnj.com
Alternate Contact:
Jeffrey Krawiec, PhD Senior Regulatory Affairs Specialist DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5356 Email: jkrawiec@its.jnj.com
1.2. Device
Trade Name: DePuy Synthes Maxillofacial Portfolio – MR Conditional
Name of Device: DePuy Synthes MatrixWAVE MMF System
Classification Name(s): Plate, Bone
Regulatory Class: Class II; 872.4760
Product Code(s): JEY
1.3. Predicate Device
K141165 MatrixWAVE MMF System
Device Description 1.4.
The DePuy Synthes MatrixWAVE MMF is a bone-borne maxillomandibular fixation (MMF) system that consists of wave shaped plates (made from commercially pure Titanium) that are attached to the dental arches with self-drilling locking screws (made from Titanium alloy, Ti-6Al-7Nb). The system is intended for temporary stabilization of mandibular and maxillary fractures and osteotomies to maintain proper occlusion during intraoperative bone fixation and postoperative bone healing (approximately 6-8 weeks). The dental arches are brought into occlusion by wiring around the plate hooks and/or accessible screw heads.
27
The DePuy Synthes MatrixWAVE MMF System is indicated for the temporary treatment of mandibular and maxillary fractures and osteotomies in adults and adolescents (age 12 and higher) in whom permanent teeth have erupted.
Substantial Equivalence 1.6.
The purpose of this submission is to add MR Conditional information to the device labeling for the DePuy Synthes MatrixWAVE MMF 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, and indicate MR Conditional use by adding " - MR Conditional" to the name of each subject system.
| K192655 | K141165 |
|---|---|
| For the temporary treatment of mandibular | For the temporary treatment of mandibular |
| and maxillary fractures and osteotomies in | and maxillary fractures and osteotomies in |
| adults and adolescents (age 12 and higher) in | adults and adolescents (age 12 and higher) in |
| whom permanent teeth have erupted. | whom permanent teeth have erupted. |
Performance Testing 1.7.
Non-clinical testing is provided to support the conditional safety of the DePuy Synthes MatrixWAVE MMF 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 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.
Conclusion 1.8.
28
Date Prepared: December 23, 2019
1.1. Submitter
Primary Contact: Satapa Dhamankar Regulatory Affairs Specialist II DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: 610-719-6574 Email: sdhamank@its.jnj.com Alternate Contact: Jeffrey Krawiec, PhD Senior Regulatory Affairs Specialist DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5356 Email: jkrawiec@its.jnj.com
1.2. Device
Trade Name: DePuy Synthes Maxillofacial Portfolio – MR Conditional
Name of Device: DePuy Synthes MatrixMANDIBLE Plate and Screw System
Classification Name(s): Plate, Bone
Regulatory Class: Class II; 872.4760
Product Code(s): JEY
- 1.3. Predicate Device
K121574 MatrixMANDIBLE Plate and Screw System
Device Description 1.4.
The DePuy Synthes MatrixMANDIBLE Plate and Screw System consists of a variety of plates offered in multiple shapes and a variety of screws offered in multiple diameters and lengths to meet the anatomical needs of the patient. System implants are manufactured in either titanium or titanium alloy and are intended for single use only.
The DePuy Synthes MatrixMANDIBLE screws that are the subject of this premarket notification are made from titanium alloy (Ti-6A1-7Nb) and are available in a diameter of 2.0 mm and lengths ranging from 4 mm to 8 mm, and have a thread pitch of 0.5 mm. These screws work with all plates within the DePuy Synthes MatrixMANDIBLE Plate and Screw System.
29
These devices are offered, non-sterile and must be sterilized prior to use. DePuy Synthes MatrixMANDLBLE screws are intended for single use.
1.5. Indications for Use
The DePuy Synthes MatrixMANDIBLE Plate and Screw System is intended for oral, maxillofacial surgery:
- Trauma
- · Reconstructive surgery
- Orthognathic surgery (surgical correction of dentofacial deformities)
Substantial Equivalence 1.6.
The purpose of this submission is to add MR Conditional information to the device labeling for the DePuy Synthes MatrixMANDIBLE Plate and Screw 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, and indicate MR Conditional use by adding "- MR Conditional" to the name of each subject system.
| K192655 | K121574 |
|---|---|
| For oral, maxillofacial surgery: | For oral, maxillofacial surgery: |
| • Trauma | • Trauma |
| • Reconstructive surgery | • Reconstructive surgery |
| • Orthognathic surgery (surgical correction | • Orthognathic surgery (surgical correction of |
| of dentofacial deformities) | dentofacial deformities) |
1.7. Performance Testing
Non-clinical testing is provided to support the conditional safety of the DePuy Synthes MatrixMANDIBLE Plate and Screw 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 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.
1.8. Conclusion
30
Date Prepared: December 23, 2019
1.1. Submitter
Primary Contact: Satapa Dhamankar Regulatory Affairs Specialist II DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: 610-719-6574 Email: sdhamank@its.jnj.com Alternate Contact: Jeffrey Krawiec, PhD Senior Regulatory Affairs Specialist DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5356 Email: jkrawiec@its.jnj.com
1.2. Device
Trade Name: DePuy Synthes Maxillofacial Portfolio – MR Conditional
Name of Device: DePuy Synthes MatrixMANDIBLE Plate and Screw System
Classification Name(s): Plate, Bone
Regulatory Class: Class II; 872.4760
Product Code(s): JEY
- 1.3. Predicate Device
K113567 MatrixMANDIBLE Plate and Screw System
Device Description 1.4.
The DePuy Synthes MatrixMANDIBLE Plate and Screw System consists of a variety of plates offered in multiple shapes and a variety of screws offered in multiple diameters and lengths to meet the anatomical needs of the patient.
This submission pertains to 1.5 mm thick MatrixMANDIBLE Reconstruction Plates, which are available as left and right single angle reconstruction plates and in three sizes of double angle reconstruction plates. These plates are made from pure titanium and may be offered sterile or non-sterile (non-sterile implants must be sterilized prior to use).
31
DePuy Synthes MatrixMANDIBLE 1.5 mm thick reconstruction plates are intended for single use only.
1.5. Indications for Use
The DePuy Synthes MatrixMANDIBLE Plate and Screw System is intended for oral, maxillofacial surgery:
- Trauma
- · Reconstructive surgery
- Orthognathic surgery (surgical correction of dentofacial deformities)
Substantial Equivalence 1.6.
The purpose of this submission is to add MR Conditional information to the device labeling for the DePuy Synthes MatrixMANDIBLE Plate and Screw 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, and indicate MR Conditional use by adding "- MR Conditional" to the name of each subject system.
| K192655 | K113567 |
|---|---|
| For oral, maxillofacial surgery: | For oral, maxillofacial surgery: |
| • Trauma | • Trauma |
| • Reconstructive surgery | • Reconstructive surgery |
| • Orthognathic surgery (surgical correction | • Orthognathic surgery (surgical correction of |
| of dentofacial deformities) | dentofacial deformities) |
1.7. Performance Testing
Non-clinical testing is provided to support the conditional safety of the DePuy Synthes MatrixMANDIBLE Plate and Screw 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 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.
1.8. Conclusion
32
Date Prepared: December 23, 2019
1.1. Submitter
Primary Contact: Satapa Dhamankar Regulatory Affairs Specialist II DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: 610-719-6574 Email: sdhamank@its.jnj.com Alternate Contact: Jeffrey Krawiec, PhD Senior Regulatory Affairs Specialist DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5356 Email: jkrawiec@its.jnj.com
1.2. Device
Trade Name: DePuy Synthes Maxillofacial Portfolio – MR Conditional
Name of Device: DePuy Synthes Dentoalveolar Bone Fixation System
Classification Name(s): Plate, Bone
Regulatory Class: Class II; 872.4760
Product Code(s): JEY
1.3. Predicate Device
K102656 Synthes Dentoalveolar Bone Fixation System
Device Description 1.4.
The DePuy Synthes Dentoalveolar Bone Fixation System is a plate, mesh, and screw system intended to be implanted intraorally for use in non-load bearing applications for maintaining the relative position of and/or containing bony fragments, bone grafts (autograft or allograft), or bone graft substitutes in reconstruction of maxillary and/or mandibular areas, including the dentoalveolar ridge.
Screws
The System includes 1.3 mm, 1.5 mm, and 2.0 mm diameter cortex screws in lengths from 3 mm to 20 mm. Screws are offered with both self-tapping and self drilling tips. Screws are manufactured from titanium alloy (Ti-6A1-7Nb).
33
Plates and Meshes
The System includes plates and meshes that come in a variety of configurations to accommodate various dentoalveolar defect sites. The plates attach to bone via titanium cortex screws. Plates and meshes are manufactured from commercially pure titanium.
1.5. Indications for Use
The DePuy Synthes Dentoalveolar Bone Fixation System is intended for use in non-load bearing applications for maintaining the relative position of and/or containing bony fragments, bone grafts (autograft or allograft), or bone graft substitutes in reconstruction of maxillary and/or mandibular areas, including the dentoalveolar ridge.
Substantial Equivalence 1.6.
The purpose of this submission is to add MR Conditional information to the device labeling for the DePuy Synthes Dentoalveolar Bone Fixation 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, and indicate MR Conditional use by adding "- MR Conditional" to the name of each subject system.
| K192655 | K102656 |
|---|---|
| For use in non-load bearing applications for | For use in non-load bearing applications for |
| maintaining the relative position of and/or | maintaining the relative position of and/or |
| containing bony fragments, bone grafts | containing bony fragments, bone grafts |
| (autograft or allograft), or bone graft | (autograft or allograft), or bone graft |
| substitutes in reconstruction of maxillary | substitutes in reconstruction of maxillary |
| and/or mandibular areas, including the | and/or mandibular areas, including the |
| dentoalveolar ridge. | dentoalveolar ridge. |
Performance Testing 1.7.
Non-clinical testing is provided to support the conditional safety of the DePuy Synthes Dentoalveolar Bone Fixation 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 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.
1.8. Conclusion
34
Date Prepared: December 23, 2019
Submitter 1.1.
Primary Contact: Satapa Dhamankar Regulatory Affairs Specialist II DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: 610-719-6574 Email: sdhamank@its.jnj.com Alternate Contact: Jeffrey Krawiec, PhD Senior Regulatory Affairs Specialist DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5356 Email: jkrawiec@its.jnj.com
1.2. Device
Trade Name: DePuy Synthes Maxillofacial Portfolio – MR Conditional
Name of Device: DePuy Synthes MatrixMANDIBLE Subcondylar Plates
Classification Name(s): Plate, Bone
Regulatory Class: Class II; 872.4760
Product Code(s): JEY
- 1.3. Predicate Device
K091233 Synthes MatrixMANDIBLE Subcondylar Plates
Device Description 1.4.
The DePuy Synthes MatrixMANDIBLE Subcondylar Plates are designed specifically to match the anatomy of the subcondylar region of the mandible. These plates are designed for use with DePuy Synthes MatrixMANDIBLE screws that come in multiple diameters and lengths to meet the anatomical needs of the patient. System components are manufactured in either titanium or titanium alloy and are intended for single use only.
35
The DePuy Synthes MatrixMANDIBLE Subcondylar Plates are intended for oral, maxillofacial surgery; trauma and reconstructive surgery, specifically for fractures of the subcondylar region of the mandible and fractures of the condylar basis region of the mandible.
Substantial Equivalence 1.6.
The purpose of this submission is to add MR Conditional information to the device labeling for the DePuy Synthes MatrixMANDIBLE Subcondylar Plates. 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, and indicate MR Conditional use by adding "- MR Conditional" to the name of each subject system.
| K192655 | K091233 |
|---|---|
| For oral, maxillofacial surgery; trauma and | For oral, maxillofacial surgery; trauma and |
| reconstructive surgery, specifically for | reconstructive surgery, specifically for |
| fractures of the subcondylar region of the | fractures of the subcondylar region of the |
| mandible and fractures of the condylar | mandible and fractures of the condylar basis |
| basis region of the mandible. | region of the mandible. |
Performance Testing 1.7.
Non-clinical testing is provided to support the conditional safety of the DePuy Synthes MatrixMANDIBLE Subcondylar Plates 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 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.
1.8. Conclusion
36
Date Prepared: December 23, 2019
1.1. Submitter
Primary Contact: Satapa Dhamankar Regulatory Affairs Specialist II DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: 610-719-6574 Email: sdhamank@its.jnj.com Alternate Contact: Jeffrey Krawiec, PhD Senior Regulatory Affairs Specialist DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5356 Email: jkrawiec@its.jnj.com
1.2. Device
Trade Name: DePuy Synthes Maxillofacial Portfolio – MR Conditional
Name of Device: DePuy Synthes MatrixMANDIBLE Preformed Reconstruction Plates
Classification Name(s): Plate, Bone
Regulatory Class: Class II; 872.4760
Product Code(s): JEY
1.3. Predicate Device
K091144 Synthes MatrixMANDIBLE Performed Reconstruction Plates
Device Description 1.4.
The DePuy Synthes MatrixMANDIBLE Preformed Reconstruction Plates are anatomically contoured to match the body and angle regions of the mandible in most patients. These plates are designed for use with DePuy Synthes MatrixMANDIBLE screws that come in multiple diameters and lengths to meet the anatomical needs of the patient. System components are manufactured in either titanium alloy and are intended for single use only.
Indications for Use 1.5.
The DePuy Synthes MatrixMANDIBLE Preformed Reconstruction Plates are intended for use in oral and maxillofacial surgery, trauma and reconstructive surgery. This includes primary
37
mandibular reconstruction, comminuted fractures and temporary bridging pending delayed secondary reconstruction, including fractures of edentulous and/or atrophic mandibles, as well as unstable fractures.
Substantial Equivalence 1.6.
The purpose of this submission is to add MR Conditional information to the device labeling for the DePuy Synthes MatrixMANDIBLE Preformed Reconstruction Plates. 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, and indicate MR Conditional use by adding "- MR Conditional" to the name of each subject system.
| K192655 | K091144 |
|---|---|
| For use in oral and maxillofacial surgery, | For use in oral and maxillofacial surgery, |
| trauma and reconstructive surgery. This | trauma and reconstructive surgery. This |
| includes primary mandibular reconstruction, | includes primary mandibular reconstruction, |
| comminuted fractures and temporary | comminuted fractures and temporary |
| bridging pending delayed secondary | bridging pending delayed |
| secondary | |
| reconstruction, including fractures of | reconstruction, including fractures of |
| edentulous and/or atrophic mandibles, as | edentulous and/or atrophic mandibles, as |
| well as unstable fractures. | well as unstable fractures. |
Performance Testing 1.7.
Non-clinical testing is provided to support the conditional safety of the DePuy Synthes MatrixMANDIBLE Preformed Reconstruction Plates 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 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.
Conclusion 1.8.
38
Date Prepared: December 23, 2019
1.1. Submitter
Primary Contact: Satapa Dhamankar Regulatory Affairs Specialist II DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: 610-719-6574 Email: sdhamank@its.jnj.com Alternate Contact: Jeffrey Krawiec, PhD Senior Regulatory Affairs Specialist DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5356 Email: jkrawiec@its.jnj.com
1.2. Device
Trade Name: DePuy Synthes Maxillofacial Portfolio – MR Conditional
Name of Device: DePuy Synthes MatrixORTHOGNATHIC Plating System
Classification Name(s): Plate, Bone
Regulatory Class: Class II; 872.4760
Product Code(s): JEY
1.3. Predicate Device
K083388 Synthes MatrixORTHOGNATHIC Plating System
Device Description 1.4.
The DePuy Synthes MatrixORTHOGNATHIC Plating System consists of a variety of plates that come in a variety of shapes and sizes to meet the anatomical needs of the patient. This system is designed for use with DePuy Synthes Matrix screws. System components are manufactured in either titanium or titanium alloy and are intended for single use only.
Indications for Use 1.5.
The DePuy Synthes MatrixORTHOGNATHIC Plating System is intended for use in selective trauma of the midface and maxillofacial skeleton; maxillofacial surgery; reconstructive procedures; and
39
selective orthognathic surgery of the maxilla, mandible and chin in adolescents (greater than 12 to 21 years of age) and adults.
Specific Indications for Use:
- . Fractures of the midface and maxillofacial skeleton
- . LeFort I osteotomies, sagittal split osteotomies and genioplasties
- Orthognathic surgery including reconstructive procedures ●
1.6. Substantial Equivalence
The purpose of this submission is to add MR Conditional information to the device labeling for the DePuy Synthes MatrixORTHOGNATHIC Plating 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, and indicate MR Conditional use by adding " - MR Conditional" to the name of each subject system.
| K192655 | K083388 |
|---|---|
| For use in selective trauma of the midface | |
| and maxillofacial skeleton; maxillofacial | |
| surgery; reconstructive procedures; and | |
| selective orthognathic surgery of the maxilla, | |
| mandible and chin in adolescents (greater | |
| than 12 to 21 years of age) and adults. | For use in selective trauma of the midface and |
| craniofacial skeleton; craniofacial surgery; | |
| reconstructive procedures; and selective | |
| orthognathic surgery of the maxilla, mandible | |
| and chin in adolescents (greater than 12 to 21 | |
| years of age) and adults. | |
| Specific Indications for Use: | Specific Indications for Use: |
| • Fractures of the midface and | |
| maxillofacial skeleton | • Fractures of the midface and |
| craniofacial skeleton | |
| • LeFort I osteotomies, sagittal split | |
| osteotomies and genioplasties | • LeFort I osteotomies, sagittal split |
| osteotomies and genioplasties | |
| • Orthognathic surgery including | |
| reconstructive procedures | • Orthognathic surgery including |
| reconstructive procedures |
Performance Testing 1.7.
Non-clinical testing is provided to support the conditional safety of the DePuy Synthes MatrixORTHOGNATHIC Plating 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 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.
40
1.8. Conclusion
41
510(k) Summary 1.
Date Prepared: December 23, 2019
1.1. Submitter
Primary Contact: Satapa Dhamankar Regulatory Affairs Specialist II DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: 610-719-6574 Email: sdhamank@its.jnj.com Alternate Contact: Jeffrey Krawiec, PhD Senior Regulatory Affairs Specialist DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5356 Email: jkrawiec@its.jnj.com
1.2. Device
Trade Name: DePuy Synthes Maxillofacial Portfolio – MR Conditional
Name of Device: DePuy Synthes MatrixMANDIBLE Plate and Screw System
Classification Name(s): Plate, Bone
Regulatory Class: Class II; 872.4760
Product Code(s): JEY
1.3. Predicate Device
K082335 Synthes MatrixMANDIBLE Plate and Screw System
Device Description 1.4.
The DePuy Synthes MatrixMANDIBLE Plate and Screw System incorporates small, medium and large plates designed so all plates accept all system screws. The plates are available in various shapes and thicknesses and accept self-tapping and self-drilling cortex and locking screws. The implants are manufactured from titanium.
Indications for Use 1.5.
The DePuy Synthes MatrixMANDIBLE Plate and Screw System is intended for oral, maxillofacial surgery; trauma; reconstructive surgery; and orthognathic surgery (surgical correction of dentofacial deformities).
42
Substantial Equivalence 1.6.
The purpose of this submission is to add MR Conditional information to the device labeling for the DePuy Synthes MatrixMANDIBLE Plate and Screw 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, and indicate MR Conditional use by adding "- MR Conditional" to the name of each subject system.
| K192655 | K082335 |
|---|---|
| For oral, maxillofacial surgery; trauma; | |
| reconstructive surgery; and orthognathic | |
| surgery (surgical correction of dentofacial | |
| deformities). | For oral, maxillofacial surgery; trauma; |
| reconstructive surgery; and orthognathic | |
| surgery (surgical correction of dentofacial | |
| deformities). |
Performance Testing 1.7.
Non-clinical testing is provided to support the conditional safety of the DePuy Synthes MatrixMANDIBLE Plate and Screw 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 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.
1.8. Conclusion
43
Date Prepared: December 23, 2019
Submitter 1.1.
Primary Contact: Satapa Dhamankar Regulatory Affairs Specialist II DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: 610-719-6574 Email: sdhamank@its.jnj.com Alternate Contact: Jeffrey Krawiec, PhD Senior Regulatory Affairs Specialist DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5356 Email: jkrawiec@its.jnj.com
1.2. Device
Trade Name: DePuy Synthes Maxillofacial Portfolio – MR Conditional
Name of Device: DePuy Synthes Craniofacial Plate and Screw System
Classification Name(s): Plate, Bone
Regulatory Class: Class II; 872.4760
Product Code(s): JEY
1.3. Predicate Device
K080331 Synthes Craniofacial Plate and Screw System
Device Description 1.4.
The DePuy Synthes Orbital Plates, components of the Synthes Craniofacial Plate and Screw System, consist of anatomically shaped orbital plates that come in various sizes and configurations to fit the patient anatomy. These devices are designed for use with DePuy Synthes craniofacial bone screws commercially available in the U.S. System components are manufactured in titanium and are intended for single use only.
44
The DePuy Synthes Craniofacial Plate and Screw System 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 Craniofacial Plate and Screw 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, and indicate MR Conditional use by adding "- MR Conditional" to the name of each subject system.
| K192655 | K080331 |
|---|---|
| For use in selective trauma of the midface | |
| and maxillofacial skeleton, maxillofacial | |
| surgery, reconstructive procedures and | |
| selective orthognathic surgery of the maxilla | |
| and chin. | For use in selective trauma of the midface and |
| craniofacial skeleton, craniofacial surgery, | |
| reconstructive procedures and selective | |
| orthognathic surgery of the maxilla and chin. |
Performance Testing 1.7.
Non-clinical testing is provided to support the conditional safety of the DePuy Synthes Craniofacial Plate and Screw 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 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.
1.8. Conclusion
45
Date Prepared: December 23, 2019
Submitter 1.1.
Primary Contact: Satapa Dhamankar Regulatory Affairs Specialist II DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: 610-719-6574 Email: sdhamank@its.jnj.com Alternate Contact: Jeffrey Krawiec, PhD Senior Regulatory Affairs Specialist DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5356 Email: jkrawiec@its.jnj.com
1.2. Device
Trade Name: DePuy Synthes Maxillofacial Portfolio – MR Conditional
Name of Device: The DePuy Synthes MatrixMANDIBLE Plate and Screw System
Classification Name(s): Plate, Bone
Regulatory Class: Class II; 872.4760
Product Code(s): JEY
1.3. Predicate Device
K063790 The Synthes MatrixMANDIBLE Plate and Screw System
Device Description 1.4.
The DePuy Synthes MatrixMANDIBLE Plate and Screw System is the next generation of Synthes (USA) fixation systems for the mandible. The system incorporates small, medium, and large plates designed so that all plates accept all system screws. The plates are available in various shapes and thicknesses, and accept self-tapping cortex and locking screws. The implants are manufactured from CP titanium and titanium alloy.
46
The DePuy Synthes MatrixMANDIBLE Plate and Screw System is intended for oral, maxillofacial surgery; trauma; reconstructive surgery; and orthognathic surgery (surgical correction of dentofacial deformities).
Substantial Equivalence 1.6.
The purpose of this submission is to add MR Conditional information to the device labeling for the The DePuy Synthes MatrixMANDIBLE Plate and Screw 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, and indicate MR Conditional use by adding "- MR Conditional" to the name of each subject system.
| K192655 | K063790 |
|---|---|
| For oral, maxillofacial surgery; trauma; | |
| reconstructive surgery; and orthognathic | |
| surgery (surgical correction of dentofacial | |
| deformities). | For oral, maxillofacial surgery; trauma; |
| reconstructive surgery; and orthognathic | |
| surgery (surgical correction of dentofacial | |
| deformities). |
Performance Testing 1.7.
Non-clinical testing is provided to support the conditional safety of the The DePuy Synthes MatrixMANDIBLE Plate and Screw 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 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.
1.8. Conclusion
47
Date Prepared: December 23, 2019
Submitter 1.1.
Primary Contact: Satapa Dhamankar Regulatory Affairs Specialist II DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: 610-719-6574 Email: sdhamank@its.jnj.com Alternate Contact: Jeffrey Krawiec, PhD Senior Regulatory Affairs Specialist DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5356 Email: jkrawiec@its.jnj.com
1.2. Device
Trade Name: DePuy Synthes Maxillofacial Portfolio – MR Conditional
Name of Device: DePuy Synthes Craniofacial Plate and Screw System
Classification Name(s): Plate, Bone
Regulatory Class: Class II; 872.4760
Product Code(s): JEY
1.3. Predicate Device
K050608 Synthes (USA) Craniofacial Plate and Screw System
Device Description 1.4.
The DePuy Synthes Craniofacial Plate and Screw System consist of plates and meshes that come in a variety of shapes and sizes to meet the anatomical needs of the patient. This system is designed for use with 1.8 mm screws and 2.1 mm emergency screws. The screws will be used with Synthes 1.8 mm hexagonal screwdriver blades. System components are manufactured in either titanium or titanium alloy and are intended for single use only.
48
The DePuy Synthes Craniofacial Plate and Screw System 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 Craniofacial Plate and Screw 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, and indicate MR Conditional use by adding "- MR Conditional" to the name of each subject system.
| K192655 | K050608 |
|---|---|
| For use in selective trauma of the midface | For use in selective trauma of the midface and |
| and maxillofacial skeleton; maxillofacial | craniofacial skeleton; craniofacial surgery; |
| surgery; reconstructive procedures; and | reconstructive procedures; and selective |
| selective orthognathic surgery of the maxilla | orthognathic surgery of the maxilla and chin. |
| and chin. |
Performance Testing 1.7.
Non-clinical testing is provided to support the conditional safety of the DePuy Synthes Craniofacial Plate and Screw 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 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.
1.8. Conclusion
49
Date Prepared: December 23, 2019
Submitter 1.1.
Primary Contact: Satapa Dhamankar Regulatory Affairs Specialist II DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: 610-719-6574 Email: sdhamank@its.jnj.com Alternate Contact: Jeffrey Krawiec, PhD Senior Regulatory Affairs Specialist DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5356 Email: jkrawiec@its.jnj.com
1.2. Device
Trade Name: DePuy Synthes Maxillofacial Portfolio – MR Conditional
Name of Device: DePuy Synthes Neuro Plate and Screw System
Classification Name(s): Plate, Bone
Regulatory Class: Class II; 872.4760
Product Code(s): JEY
1.3. Predicate Device
K042365 Synthes (USA) Neuro Plate and Screw System
Device Description 1.4.
DePuy Synthes Neuro Plate and Screw System consists of plates, burr hole covers, and meshes that come in a variety of shapes and sizes to meet the anatomical needs of the patient. This system is designed for use with 1.8 mm screws and 2.1 mm emergency screws. The screws will be used with Synthes 1.8 mm hexagonal screwdriver blades. System components are manufactured in either titanium or titanium alloy and are intended for single use only.
50
DePuy Synthes Neuro Plate and Screw System 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 Neuro Plate and Screw 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, and indicate MR Conditional use by adding "- MR Conditional" to the name of each subject system.
| K192655 | K042365 |
|---|---|
| For use in selective trauma of the midface | |
| and maxillofacial skeleton; maxillofacial | For use in selective trauma of the midface and |
| craniofacial skeleton; craniofacial surgery; | |
| surgery; reconstructive procedures; and | reconstructive procedures; and selective |
| selective orthognathic surgery of the maxilla | orthognathic surgery of the maxilla and chin. |
| and chin. |
Performance Testing 1.7.
Non-clinical testing is provided to support the conditional safety of the DePuy Synthes Neuro Plate and Screw 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 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.
1.8. Conclusion
51
Date Prepared: December 23, 2019
1.1. Submitter
Primary Contact: Satapa Dhamankar Regulatory Affairs Specialist II DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: 610-719-6574 Email: sdhamank@its.jnj.com Alternate Contact: Jeffrey Krawiec, PhD Senior Regulatory Affairs Specialist DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5356 Email: jkrawiec@its.jnj.com
1.2. Device
Trade Name: DePuy Synthes Maxillofacial Portfolio – MR Conditional
Name of Device: DePuy Synthes 1.3 & 1.5 mm Contourable Titanium (Ti.) Mesh Plates
Classification Name(s): Plate, Bone
Regulatory Class: Class II; 872.4760
Product Code(s): JEY
1.3. Predicate Device
K033121 Synthes (USA) 1.3 & 1.5 mm Contourable Titanium (Ti.) Mesh Plates
Device Description 1.4.
The DePuy Synthes 1.3 & 1.5 mm Contourable Ti. Mesh Plates come in a variety of shapes and sizes to meet the anatomical need of the patient. The plates are sterile and for single use only.
Indications for Use 1.5.
The DePuy Synthes 1.3 & 1.5 mm Contourable Titanium (Ti.) Mesh Plates are 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.
52
Substantial Equivalence 1.6.
The purpose of this submission is to add MR Conditional information to the device labeling for the DePuy Synthes 1.3 & 1.5 mm Contourable Titanium (Ti.) Mesh Plates. 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, and indicate MR Conditional use by adding "- MR Conditional" to the name of each subject system.
| K192655 | K033121 |
|---|---|
| For use in selective trauma of the midface | For use in selective trauma of the midface and |
| and maxillofacial skeleton; maxillofacial | craniofacial skeleton; craniofacial surgery; |
| surgery; reconstructive procedures; and | reconstructive procedures; and selective |
| selective orthognathic surgery of the maxilla | orthognathic surgery of the maxilla and chin. |
| and chin. |
Performance Testing 1.7.
Non-clinical testing is provided to support the conditional safety of the DePuy Synthes 1.3 & 1.5 mm Contourable Titanium (Ti.) Mesh Plates 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 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.
Conclusion 1.8.
53
Date Prepared: December 23, 2019
Submitter 1.1.
Primary Contact: Satapa Dhamankar Regulatory Affairs Specialist II DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: 610-719-6574 Email: sdhamank@its.jnj.com Alternate Contact: Jeffrey Krawiec, PhD Senior Regulatory Affairs Specialist DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5356 Email: jkrawiec@its.jnj.com
1.2. Device
Trade Name: DePuy Synthes Maxillofacial Portfolio – MR Conditional
Name of Device: DePuy Synthes Orbital Plates
Classification Name(s): Plate, Bone
Regulatory Class: Class II; 872.4760
Product Code(s): JEY
- 1.3. Predicate Device
K031761 Synthes (USA) New/Sterial Orbital Plates
Device Description 1.4.
The DePuy Synthes Orbital Plates come in a variety of shapes and sizes to meet the anatomical need of the patient. The plates are sterile/non-sterile and for single use only.
Indications for Use 1.5.
The DePuy Synthes Craniofacial Plates are 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.
54
Substantial Equivalence 1.6.
The purpose of this submission is to add MR Conditional information to the device labeling for the DePuy Synthes Orbital Plates. 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, and indicate MR Conditional use by adding "- MR Conditional" to the name of each subject system.
| K192655 | K031761 |
|---|---|
| For use in selective trauma of the midface and | For use in selective trauma of the midface and |
| and maxillofacial skeleton; maxillofacial | craniofacial skeleton; craniofacial surgery; |
| surgery; reconstructive procedures; and | reconstructive procedures; and selective |
| selective orthognathic surgery of the maxilla | orthognathic surgery of the maxilla and chin. |
| and chin. |
Performance Testing 1.7.
Non-clinical testing is provided to support the conditional safety of the DePuy Synthes Orbital Plates 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 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.
1.8. Conclusion
55
Date Prepared: December 23, 2019
Submitter 1.1.
Primary Contact: Satapa Dhamankar Regulatory Affairs Specialist II DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: 610-719-6574 Email: sdhamank@its.jnj.com Alternate Contact: Jeffrey Krawiec, PhD Senior Regulatory Affairs Specialist DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5356 Email: jkrawiec@its.jnj.com
1.2. Device
Trade Name: DePuy Synthes Maxillofacial Portfolio – MR Conditional
Name of Device: DePuy Synthes Low Profile Neuro System
Classification Name(s): Plate, Bone
Regulatory Class: Class II; 872.4760
Product Code(s): JEY
1.3. Predicate Device
K022012 Synthes Low Profile Neuro System
Device Description 1.4.
The DePuy Synthes Low Profile Neuro System consists of titaniurn plates, meshes, and screws in a variety of shapes and sizes designed for various maxillofacial procedures.
1.5. Indications for Use
The DePuy Synthes Low Profile Neuro System 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.
56
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. 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, and indicate MR Conditional use by adding "- MR Conditional" to the name of each subject system.
| K192655 | K022012 |
|---|---|
| For use in selective trauma of the midface | For use in selective trauma of the midface and |
| and maxillofacial skeleton; maxillofacial | craniofacial skeleton; craniofacial surgery; |
| surgery; reconstructive procedures; and | reconstructive procedures; and selective |
| selective orthognathic surgery of the maxilla | orthognathic surgery of the maxilla and chin. |
| and chin. |
Performance Testing 1.7.
Non-clinical testing is provided to support the conditional safety of the DePuy Synthes Low Profile Neuro 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 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.
1.8. Conclusion
57
Date Prepared: December 23, 2019
Submitter 1.1.
Primary Contact: Satapa Dhamankar Regulatory Affairs Specialist II DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: 610-719-6574 Email: sdhamank@its.jnj.com Alternate Contact: Jeffrey Krawiec, PhD Senior Regulatory Affairs Specialist DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5356 Email: jkrawiec@its.jnj.com
1.2. Device
Trade Name: DePuy Synthes Maxillofacial Portfolio – MR Conditional
Name of Device: DePuy Synthes Midface Distractor
Classification Name(s): Plate, Bone
Regulatory Class: Class II; 872.4760
Product Code(s): JEY
1.3. Predicate Device
K022005 Synthes Midface Distractor
Device Description 1.4.
The DePuy Synthes Midface Distractor is a maxillofacial distraction device consisting of two telescoping components with attached footplates. The device is intended to be placed subcutaneously with an anterior footplate fastened to the lateral orbital rim, extending down to the maxilla and spanning the zygomaticomaxillary suture; and a posterior footplate fastened to the temporal region of the cranium. The plates are fixed to the bone through unthreaded screw holes using 1.5 mm or 2.0 mm Cortex screws.
58
The DePuy Synthes Midface Distractor is intended for use in adult and pediatric populations for the treatment of midface conditions for which reconstructive osteotomy and segment advancement are indicated. This includes conditions such as midfacial retrusion. The device is intended to provide temporary stabilization and gradual lengthening of the midfacial bones.
Substantial Equivalence 1.6.
The purpose of this submission is to add MR Conditional information to the device labeling for the DePuy Synthes Midface 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, and indicate MR Conditional use by adding "- MR Conditional" to the name of each subject system.
| K192655 | K022005 |
|---|---|
| For use in adult and pediatric populations for | For use in adult and pediatric populations for |
| the treatment of midface conditions for | the treatment of cranial or midface conditions |
| which reconstructive osteotomy and | for which reconstructive osteotomy and |
| segment advancement are indicated. This | segment advancement are indicated. This |
| includes conditions such as midfacial | includes conditions such as syndromic |
| retrusion. The device is intended to provide | craniosynostosis and midfacial retrusion. The |
| temporary stabilization and gradual | device is intended to provide temporary |
| lengthening of the midfacial bones. | stabilization and gradual lengthening of the |
| cranial or midfacial bones. |
1.7. Performance Testing
Non-clinical testing is provided to support the conditional safety of the DePuy Synthes 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 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.
Conclusion 1.8.
59
510(k) Summary 1.
Date Prepared: December 23, 2019
1.1. Submitter
Primary Contact: Satapa Dhamankar Regulatory Affairs Specialist II DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: 610-719-6574 Email: sdhamank@its.jnj.com Alternate Contact: Jeffrey Krawiec, PhD Senior Regulatory Affairs Specialist DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5356 Email: jkrawiec@its.jnj.com
1.2. Device
Trade Name: DePuy Synthes Maxillofacial Portfolio – MR Conditional
Name of Device: DePuy Synthes Translating Maxillary Distractor
Classification Name(s): Plate, Bone
Regulatory Class: Class II; 872.4760
Product Code(s): JEY
1.3. Predicate Device
K020505 Synthes (USA) Translating Maxillary Distractor
Device Description 1.4.
The DePuy Synthes Translating Maxillary Distractor is an intra-oral distraction device. It features a distractor body with two adjustable footplate components, each with contourable legs having screw holes that are fixed to the bone via 2.0 mm or 2.4 mm cortex screws.
1.5. Indications for Use
The DePuy Synthes Translating Maxillary 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 in adult and pediatric populations.
60
Substantial Equivalence 1.6.
The purpose of this submission is to add MR Conditional information to the device labeling for the DePuy Synthes Translating Maxillary 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, and indicate MR Conditional use by adding "- MR Conditional" to the name of each subject system.
| K192655 | K020505 |
|---|---|
| For use in maxillofacial surgery, | For use in craniofacial surgery, reconstructive |
| reconstructive procedures, and selective | procedures, and selective orthognathic |
| orthognathic surgery of the maxilla. | surgery of the maxilla. Specifically it is |
| Specifically it is intended for distraction of | intended for distraction of the maxilla utilizing |
| the maxilla utilizing a LeFort I osteotomy in | a LeFort I osteotomy in adult and pediatric |
| adult and pediatric populations. | populations. |
Performance Testing 1.7.
Non-clinical testing is provided to support the conditional safety of the DePuy Synthes Translating Maxillary 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 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.
Conclusion 1.8.
61
Date Prepared: December 23, 2019
Submitter 1.1.
Primary Contact: Satapa Dhamankar Regulatory Affairs Specialist II DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: 610-719-6574 Email: sdhamank@its.jnj.com Alternate Contact: Jeffrey Krawiec, PhD Senior Regulatory Affairs Specialist DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5356 Email: jkrawiec@its.jnj.com
1.2. Device
Trade Name: DePuy Synthes Maxillofacial Portfolio – MR Conditional
Name of Device: DePuy Synthes Midface Distractor
Classification Name(s): Plate, Bone
Regulatory Class: Class II; 872.4760
Product Code(s): JEY
1.3. Predicate Device
K010499 Synthes (USA) Midface Distractor
Device Description 1.4.
The DePuy Synthes Midface Distractor is a maxillofacial distraction device consisting of two telescoping components with attached footplates. The device is intended to be placed subcutaneously with an anterior footplate fastened to the lateral orbital rim, extending down to the maxilla and spanning the zygomaticomaxillary suture; and a posterior footplate fastened to the temporal region of the cranium. The plates are fixed to the bone through unthreaded screw holes using 1.5 mm or 2.0 mm Cortex screws.
62
The DePuy Synthes Midface Distractor is intended for use in adult and pediatric populations for the treatment of midface conditions for which reconstructive osteotomy and segment advancement are indicated. This includes conditions such as midfacial retrusion. The device is intended to provide temporary stabilization and gradual lengthening of the midfacial bones.
Substantial Equivalence 1.6.
The purpose of this submission is to add MR Conditional information to the device labeling for the DePuy Synthes Midface 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, and indicate MR Conditional use by adding "- MR Conditional" to the name of each subject system.
| K192655 | K010499 |
|---|---|
| For use in adult and pediatric populations for | For use in adult and pediatric populations for |
| the treatment of midface conditions for | the treatment of cranial or midface conditions |
| which reconstructive osteotomy and | for which reconstructive osteotomy and |
| segment advancement are indicated. This | segment advancement are indicated. This |
| includes conditions such as midfacial | includes conditions such as syndromic |
| retrusion. The device is intended to provide | craniosynostosis and midfacial retrusion. The |
| temporary stabilization and gradual | device is intended to provide temporary |
| lengthening of the midfacial bones. | stabilization and gradual lengthening of the |
| cranial or midfacial bones. |
1.7. Performance Testing
Non-clinical testing is provided to support the conditional safety of the DePuy Synthes 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 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.
Conclusion 1.8.
63
Date Prepared: December 23, 2019
1.1. Submitter
Primary Contact: Satapa Dhamankar Regulatory Affairs Specialist II DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: 610-719-6574 Email: sdhamank@its.jnj.com Alternate Contact: Jeffrey Krawiec, PhD Senior Regulatory Affairs Specialist DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5356 Email: jkrawiec@its.jnj.com
1.2. Device
Trade Name: DePuy Synthes Maxillofacial Portfolio – MR Conditional
Name of Device: DePuy Synthes Maxillary Distractor
Classification Name(s): Plate, Bone
Regulatory Class: Class II; 872.4760
Product Code(s): JEY
1.3. Predicate Device
K003393 Synthes Maxillary Distractor
Device Description 1.4.
The DePuy Synthes Maxillary Distractor is an intra-oral distraction device. It features two telescoping components, with contourable legs having screw holes, that are fixed to the bone via 2.0 mm or 2.4 mm cortex screws.
1.5. Indications for Use
The DePuy Synthes Maxillary 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 in adult and pediatric populations.
64
Substantial Equivalence 1.6.
The purpose of this submission is to add MR Conditional information to the device labeling for the DePuy Synthes Maxillary 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, and indicate MR Conditional use by adding "- MR Conditional" to the name of each subject system.
| K192655 | K003393 |
|---|---|
| for use in maxillofacial surgery, | For use in craniofacial surgery, reconstructive |
| reconstructive procedures, and selective | procedures, and selective orthognathic |
| orthognathic surgery of the maxilla. | surgery of the maxilla. Specifically it is |
| Specifically it is intended for distraction of | intended for distraction of the maxilla utilizing |
| the maxilla utilizing a LeFort I osteotomy in | a LeFort I osteotomy in adult and pediatric |
| adult and pediatric populations. | populations. |
Performance Testing 1.7.
Non-clinical testing is provided to support the conditional safety of the DePuy Synthes Maxillary 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 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.
Conclusion 1.8.
65
Date Prepared: December 23, 2019
Submitter 1.1.
Primary Contact: Satapa Dhamankar Regulatory Affairs Specialist II DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: 610-719-6574 Email: sdhamank@its.jnj.com Alternate Contact: Jeffrey Krawiec, PhD Senior Regulatory Affairs Specialist DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5356 Email: jkrawiec@its.jnj.com
1.2. Device
Trade Name: DePuy Synthes Maxillofacial Portfolio – MR Conditional
Name of Device: DePuy Synthes Orbital Mesh Plates
Classification Name(s): Plate, Bone
Regulatory Class: Class II; 872.4760
Product Code(s): JEY
1.3. Predicate Device
K001311 Synthes (USA) Orbital Mesh Plates
Device Description 1.4.
The DePuy Synthes Orbital Mesh Plates have a semi-circular shape with a radially designed mesh pattern. Orbital Mesh Plates are available in 0.2, 0.3 and 0.4 mm profile thickness. Standard 1.0 mm screw holes positioned along the outer arc of the Orbital Mesh Plate accept 1.0 mm selftapping bone screws and 1.2 mm emergency screws. Synthes Orbital Mesh Plates for the Midfacial System are provided nonsterile.
66
The DePuy Synthes Orbital Mesh Plates for the Midfacial System are indicated 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 Orbital Mesh Plates. 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, and indicate MR Conditional use by adding "- MR Conditional" to the name of each subject system.
| K192655 | K001311 |
|---|---|
| For the Midfacial System are indicated for | |
| selective trauma of the midface and | |
| maxillofacial skeleton; maxillofacial surgery; | |
| reconstructive procedures; and selective | |
| orthognathic surgery of the maxilla and chin. | For selective trauma of the midface and |
| craniofacial skeleton; craniofacial surgery; | |
| reconstructive procedures; and selective | |
| orthognathic surgery of the maxilla and chin. |
Performance Testing 1.7.
Non-clinical testing is provided to support the conditional safety of the DePuy Synthes Orbital Mesh Plates 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 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.
1.8. Conclusion
67
Date Prepared: December 23, 2019
1.1. Submitter
Primary Contact: Satapa Dhamankar Regulatory Affairs Specialist II DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: 610-719-6574 Email: sdhamank@its.jnj.com Alternate Contact: Jeffrey Krawiec, PhD Senior Regulatory Affairs Specialist DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5356 Email: jkrawiec@its.jnj.com
1.2. Device
Trade Name: DePuy Synthes Maxillofacial Portfolio – MR Conditional
Name of Device: DePuy Synthes 2.0 MM Locking Plate System (2.0 LPS)
Classification Name(s): Plate, Bone
Regulatory Class: Class II; 872.4760
Product Code(s): JEY
1.3. Predicate Device
K974555 Synthes 2.0 MM Locking Plate System (2.0 LPS)
Device Description 1.4.
The DePuy Synthes 2.0 Locking Plate System consists of five different types of plates and two screws, as follows: 2.0 Straight Locking Plates, 2.0 Crescent Locking Plates, 2.0 Atrophic Locking Plates, 2.0 Reconstruction Locking Plates, 2.0 Specialty Plates (Y- and 1.5 mm and 2.0 mm Self-drilling Locking Screws.
The plates feature a threaded screw hole which accepts a locking screw with a mating external thread on the screw head. Engaging these screw threads fixes the screw to the plate thereby reducing the likelihood of screw loosening and improving the screw to plate stability of the implant system.
68
The Depuy Synthes 2.0 LPS is intended for oral, maxillofacial surgery: trauma; reconstructive surgery; and orthognathic surgery (surgical correction of dentofacial deformities).
Substantial Equivalence 1.6.
The purpose of this submission is to add MR Conditional information to the device labeling for the DePuy Synthes 2.0 MM Locking Plate System (2.0 LPS). 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, and indicate MR Conditional use by adding "- MR Conditional" to the name of each subject system.
| K192655 | K974555 |
|---|---|
| For oral, maxillofacial surgery: trauma; | |
| reconstructive surgery; and orthognathic | |
| surgery (surgical correction of dentofacial | |
| deformities). | For oral, maxillofacial surgery: trauma; |
| reconstructive surgery; and orthognathic | |
| surgery (surgical correction of dentofacial | |
| deformities). |
1.7. Performance Testing
Non-clinical testing is provided to support the conditional safety of the DePuy Synthes 2.0 MM Locking Plate System (2.0 LPS) 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 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.
Conclusion 1.8.
69
Date Prepared: December 23, 2019
Submitter 1.1.
Primary Contact: Satapa Dhamankar Regulatory Affairs Specialist II DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: 610-719-6574 Email: sdhamank@its.jnj.com Alternate Contact: Jeffrey Krawiec, PhD Senior Regulatory Affairs Specialist DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5356 Email: jkrawiec@its.jnj.com
1.2. Device
Trade Name: DePuy Synthes Maxillofacial Portfolio – MR Conditional
Name of Device: DePuy Synthes 2.4 MM Universal Locking Plate System
Classification Name(s): Plate, Bone
Regulatory Class: Class II; 872.4760
Product Code(s): JEY
Predicate Device 1.3.
K961421 Synthes 2.4 MM Universal Locking Plate System
Device Description 1.4.
The DePuy Synthes 2.4 mm Universal Locking Plate System plates are designed to accept the 2.4 mm – 3.0 mm diameter locking/non-locking screws.
Indications for Use 1.5.
The DePuy Synthes 2.4 mm Universal Locking Plate System is a plate and screw system, that is intended for mandible trauma and reconstruction procedures.
70
Substantial Equivalence 1.6.
The purpose of this submission is to add MR Conditional information to the device labeling for the DePuy Synthes 2.4 MM Universal Locking Plate 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, and indicate MR Conditional use by adding "- MR Conditional" to the name of each subject system.
| K192655 | K961421 |
|---|---|
| For mandible | For mandible trauma and reconstruction |
| trauma and reconstruction procedures. | procedures. |
1.7. Performance Testing
Non-clinical testing is provided to support the conditional safety of the DePuy Synthes 2.4 MM Universal Locking Plate 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 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.
1.8. Conclusion
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Date Prepared: December 23, 2019
1.1. Submitter
Primary Contact: Satapa Dhamankar Regulatory Affairs Specialist II DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: 610-719-6574 Email: sdhamank@its.jnj.com Alternate Contact: Jeffrey Krawiec, PhD Senior Regulatory Affairs Specialist DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5356 Email: jkrawiec@its.jnj.com
1.2. Device
Trade Name: DePuy Synthes Maxillofacial Portfolio – MR Conditional
Name of Device: DePuy Synthes Mandibular Modular Fixation System
Classification Name(s): Plate, Bone
Regulatory Class: Class II; 872.4760
Product Code(s): JEY
1.3. Predicate Device
K954385 Synthes Mandibular Modular Fixation System
Device Description 1.4.
The DePuy Synthes Mandibular Fixation System is a plate and screw system manufactured from titanium. The plates are available in a variety of shapes and sizes, and attach to bone via 2.0 mm, 2.4 mm or 2.7 mm screws.
1.5. Indications for Use
The DePuy Synthes Mandibular Fixation System is a plate and screw system, manufactured from commercially pure titanium, and is intended for use in:
- Oral, maxillofacial surgery: trauma; surgical correction of dentofacial deformities; . reconstructive surgery; and maxillofacial surgery
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1.6. Substantial Equivalence
The purpose of this submission is to add MR Conditional information to the device labeling for the DePuy Synthes Mandibular Modular Fixation 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, and indicate MR Conditional use by adding "- MR Conditional" to the name of each subject system.
| K192655 | K954385 |
|---|---|
| For use in: | |
| • Oral, maxillofacial surgery: trauma; | |
| surgical correction of dentofacial | For use in: |
| • Oral, maxillofacial surgery: trauma; | |
| surgical correction of dentofacial | |
| deformities; reconstructive surgery; | |
| and maxillofacial surgery | deformities; reconstructive surgery; and |
| craniofacial surgery | |
| • ENT: trauma of the nasal bones | |
| • Neurosurgery: osteosynthesis of the cranial | |
| bones. |
1.7. Performance Testing
Non-clinical testing is provided to support the conditional safety of the DePuy Synthes Mandibular Modular Fixation 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 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.
1.8. Conclusion
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510(k) Summary 1.
Date Prepared: December 23, 2019
1.1. Submitter
Primary Contact: Satapa Dhamankar Regulatory Affairs Specialist II DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: 610-719-6574 Email: sdhamank@its.jnj.com Alternate Contact: Jeffrey Krawiec, PhD Senior Regulatory Affairs Specialist DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5356 Email: jkrawiec@its.jnj.com
1.2. Device
Trade Name: DePuy Synthes Maxillofacial Portfolio – MR Conditional
Name of Device: DePuy Synthes Maxillofacial Titanium Micro Set
Classification Name(s): Plate, Bone
Regulatory Class: Class II; 872.4760
Product Code(s): JEY
1.3. Predicate Device
K912932 Synthes Maxillofacial Titanium Micro Set
Device Description 1.4.
The DePuy Synthes Maxillofacial Titanium Micro set consists of titanium bone plates (shapes include L,Y,H,T, Double-Y, Mesh and Straight) and self-tapping screws.
1.5. Indications for Use
General indications:
- Maxillofacial surgery
1.6. Substantial Equivalence
The purpose of this submission is to add MR Conditional information to the device labeling for the DePuy Synthes Maxillofacial Titanium Micro Set. The intended use and technological
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characteristics of the devices remains unchanged. The device name has been updated to reflect the current company name, DePuy Synthes, and indicate MR Conditional use by adding " - MR Conditional" to the name of each subject system.
| K192655 | K912932 |
|---|---|
| General indications: | Specific Indications: |
| • Maxillofacial surgery | • Nasoethmoidal fractures |
| • Infraorbital area fractures | |
| • Frontal sinus wall Fractures | |
| • Infant craniofacial surgery | |
| General indications: | |
| • Maxillofacial surgery | |
| • Neurosurgery | |
| • Hand surgery |
Performance Testing 1.7.
Non-clinical testing is provided to support the conditional safety of the DePuy Synthes Maxillofacial Titanium Micro Setin 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 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.