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)
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 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)

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 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).

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.

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).

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.

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)
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 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.

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

Device Description

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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 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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

AI/ML Overview

The provided document, K192655, is a 510(k) Premarket Notification for DePuy Synthes Maxillofacial Portfolio - MR Conditional. This type of submission is a declaration from the manufacturer to the FDA that their device is substantially equivalent to a legally marketed predicate device, and it does not typically involve clinical performance studies with acceptance criteria as one would find for novel AI/ML medical devices.

Instead, the provided document focuses on demonstrating MR Conditional safety for a portfolio of existing maxillofacial bone plates and screw systems that were previously cleared by the FDA. The "acceptance criteria" and "study" described herein relate to non-clinical electromagnetic compatibility (EMC) testing in an MR environment, not clinical performance for diagnostic or therapeutic accuracy of an AI/ML algorithm.

Therefore, the requested information elements related to AI/ML device performance (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this specific submission.

Here's a breakdown of the information that is available and relevant to the document's purpose:

Acceptance Criteria and Study for MR Conditional Safety (Non-Clinical)

The submission aims to add "MR Conditional" labeling to a portfolio of maxillofacial devices. This requires demonstrating that the devices are safe for use in a specified MR environment under defined conditions. The "acceptance criteria" for this type of submission are typically based on recognized international consensus standards for testing the MR compatibility of medical devices.

1. Table of Acceptance Criteria and Reported Device Performance

The document consistently references the following ASTM standards for non-clinical testing to support MR Conditional safety across all listed devices:

Acceptance Criteria (based on ASTM Standards)	Reported Device Performance (Summary)
Magnetically Induced Displacement Force: (ASTM F2052-14)	Non-clinical testing was conducted to assess magnetically induced displacement force.
Magnetically Induced Torque: (ASTM F2213-06)	Non-clinical testing was conducted to assess magnetically induced torque.
Radiofrequency (RF) Heating: (ASTM F2182-11a)	Non-clinical testing was conducted to assess radio frequency (RF) heating. The DUKE model was used for clinically relevant anatomic positioning, and DUKE results will be used for labeling of RF heating.
Image Artifacts: (ASTM F2119-07)	Non-clinical testing was conducted to assess image artifacts.

Note: The document states that "Non-clinical testing is provided to support the conditional safety..." for each of these parameters. While it doesn't provide specific quantitative results (e.g., exact temperature rise in °C, or N/A for displacement/torque if deemed safe), the acceptance of the 510(k) by the FDA implies that the results of these tests met the predefined safety thresholds for an MR Conditional designation as per the referenced ASTM standards. The specific numerical results (e.g., maximum temperature rises, displacement forces, etc.) would be detailed in the full test reports submitted to the FDA, which are not part of this public summary.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: For non-clinical MR compatibility testing, the "sample size" refers to the number of device units tested. The document does not specify the exact number of physical devices or models tested for each parameter. However, standard practice for such assessments involves testing representative samples of each device type (plates, screws, meshes, distractors) and material compositions (titanium, titanium alloy) to ensure the portfolio's MR safety.
Data Provenance: The data is "non-clinical testing" conducted by the manufacturer (Synthes - DePuy Synthes). The country of origin for the testing itself is not explicitly stated in this summary, but it would typically be conducted in a laboratory setting compliant with relevant international standards. This is retrospective in the sense that the studies were performed specifically to characterize the existing devices for MR compatibility.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

Not Applicable. This is a non-clinical evaluation of physical device properties in an MR environment, not a clinical study involving expert interpretation of medical images or patient outcomes. The "ground truth" for MR safety is established by adherence to recognized ASTM testing standards and the physical properties of the materials and device in situ within the MR scanner, not by human expert consensus or annotations on medical data.

4. Adjudication Method for the Test Set

Not Applicable. As this is non-clinical testing of physical device characteristics, there is no "adjudication" in the sense of resolving discrepancies between human readers or AI outputs. The test results are objective measurements against standard-defined thresholds.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable. This submission is not for an AI-powered device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not Applicable. This submission is not for an AI-powered device.

7. The Type of Ground Truth Used

Physical Measurements against ASTM Standard Thresholds: The "ground truth" for MR Conditional safety is determined by rigorous physical measurements (e.g., temperature changes, displacement forces, torque, observable image artifacts) obtained through standardized testing protocols (ASTM F2052-14, F2213-06, F2182-11a, F2119-07) and comparison against acceptance limits defined by these standards or applicable regulatory guidance. It's about validating the device's behavior in an MR field, not diagnosing a condition. The "DUKE model" for RF heating indicates a high-fidelity computational human body model used for simulating temperature distributions due to RF fields.

8. The Sample Size for the Training Set

Not Applicable. This is not an AI/ML device. There is no "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set was Established

Not Applicable. As there is no training set for AI/ML, this question doesn't apply.

Summary

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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.

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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

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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:

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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)

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.

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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)

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.

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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)
-------------------------------------------------

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.

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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.

{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.

{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)
-------------------------------------------------

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.

{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.

{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)
-------------------------------------------------	--

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.

{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)

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.

{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)
-------------------------------------------------	--

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.

{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)
-------------------------------------------------	--

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.

{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.

{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.

{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)
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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.

{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.

{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)
----------------------------------------------	---------------------------------------------

|__ 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.

{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)

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.

{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.

{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.

{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.

{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.

{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.

{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)

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.

{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}------------------------------------------------

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 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

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.

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.

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

1.8. Conclusion

{32}------------------------------------------------

Date Prepared: December 23, 2019

1.1. Submitter

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.

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

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.

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.

{35}------------------------------------------------

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

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.

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 delayedsecondary
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

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.

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 midfaceand maxillofacial skeleton; maxillofacialsurgery; reconstructive procedures; andselective orthognathic surgery of the maxilla,mandible and chin in adolescents (greaterthan 12 to 21 years of age) and adults.	For use in selective trauma of the midface andcraniofacial skeleton; craniofacial surgery;reconstructive procedures; and selectiveorthognathic surgery of the maxilla, mandibleand chin in adolescents (greater than 12 to 21years of age) and adults.
Specific Indications for Use:	Specific Indications for Use:
• Fractures of the midface andmaxillofacial skeleton	• Fractures of the midface andcraniofacial skeleton
• LeFort I osteotomies, sagittal splitosteotomies and genioplasties	• LeFort I osteotomies, sagittal splitosteotomies and genioplasties
• Orthognathic surgery includingreconstructive procedures	• Orthognathic surgery includingreconstructive 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

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.

Indications for Use 1.5.

{42}------------------------------------------------

Substantial Equivalence 1.6.

K192655	K082335
For oral, maxillofacial surgery; trauma;reconstructive surgery; and orthognathicsurgery (surgical correction of dentofacialdeformities).	For oral, maxillofacial surgery; trauma;reconstructive surgery; and orthognathicsurgery (surgical correction of dentofacialdeformities).

Performance Testing 1.7.

1.8. Conclusion

{43}------------------------------------------------

Date Prepared: December 23, 2019

Submitter 1.1.

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.

{44}------------------------------------------------

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 midfaceand maxillofacial skeleton, maxillofacialsurgery, reconstructive procedures andselective orthognathic surgery of the maxillaand chin.	For use in selective trauma of the midface andcraniofacial skeleton, craniofacial surgery,reconstructive procedures and selectiveorthognathic 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.

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.

{46}------------------------------------------------

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 orthognathicsurgery (surgical correction of dentofacialdeformities).	For oral, maxillofacial surgery; trauma;reconstructive surgery; and orthognathicsurgery (surgical correction of dentofacialdeformities).

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.

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.

{48}------------------------------------------------

Substantial Equivalence 1.6.

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.

1.8. Conclusion

{49}------------------------------------------------

Date Prepared: December 23, 2019

Submitter 1.1.

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.

{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 midfaceand maxillofacial skeleton; maxillofacial	For use in selective trauma of the midface andcraniofacial 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

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.

{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.

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.

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.

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.

{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

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.

1.5. Indications for Use

{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.

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.

{62}------------------------------------------------

Substantial Equivalence 1.6.

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

Conclusion 1.8.

{63}------------------------------------------------

Date Prepared: December 23, 2019

1.1. Submitter

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.

1.5. Indications for Use

{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.

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.

{66}------------------------------------------------

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 forselective trauma of the midface andmaxillofacial skeleton; maxillofacial surgery;reconstructive procedures; and selectiveorthognathic surgery of the maxilla and chin.	For selective trauma of the midface andcraniofacial skeleton; craniofacial surgery;reconstructive procedures; and selectiveorthognathic 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

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 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 orthognathicsurgery (surgical correction of dentofacialdeformities).	For oral, maxillofacial surgery: trauma;reconstructive surgery; and orthognathicsurgery (surgical correction of dentofacialdeformities).

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.

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

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.

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; andcraniofacial surgery• ENT: trauma of the nasal bones
	• Neurosurgery: osteosynthesis of the cranialbones.

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

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.

Conclusion 1.8.

Regulation Number and Section

§ 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.