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
Neurosurgery: osteosynthesis of the cranial bones.

Dental: The DePuy Synthes Single Vector Distractor with Detachable Feet is intended for use as a bone stabilizer and lengthener for conditions such as mandibular hypoplasia or posttraumatic defects of the mandible, where gradual bone distraction is required. The device is ideal for treating fonns of clefts of the lip and palate, and congenital mandbular hypoplasia, such as Hemifacial Microsomia, Treacher Collins Syndrome, Pierre Robin Syndrome, Goldenhar Syndrome, Apert Syndrome, and Crouzon Syndrome.
The DePuy Synthes Single Vector Distractor with Detachable Feet is also ideal for treating hypoplasias of an acquired origin such as from post-traumatic growth disorders associated with injury to the temporomandibular joint, temporomandibular ankylosis, and segmental loss of bone.
Neuro: The DePuy Synthes Single Vector Distractor with Detachable Feet can be used for stabilization and advancement of the mid-face, in which a deficiency of mid-facial bone requires gradual bone distraction. Such deficiencies include, but are not limited to Plagiocephaly, Trigonocephaly, Scaphocephaly, and Brachycephaly.

The DePuy Synthes Cranial Tube Clamp is intended to reattach a cranial bone flap to the surrounding cranium after a craniotomy procedure.

Dental: 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.
Neuro: The DePuy Synthes Low Profile Neuro System is intended for cranial closure and/or bone fixation, craniotomies, cranial trauma repair and reconstruction.

Dental: 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.
Neuro: The DePuy Synthes 1.3 & 1.5 mm Contourable Titanium (Ti.) Mesh Plates are intended for use in selective trauma of the craniofacial skeleton and craniofacial surgery.

Dental: The DePuy Synthes External Midface Distractor is intended for use in maxillofacial surgery, reconstructive procedures, and selective orthognathic surgery of the maxilla. Specifically, it is intended for distraction of the maxilla utilizing a LeFort I osteotomy, the midface utilizing a LeFort II or III osteotomy in adult and pediations where gradual bone distraction is required.
Neuro: The DePuy Synthes External Midface Distractor is intended for use in craniofacial surgery and reconstructive procedures. Specifically, it is intended for distraction of the cranium utilizing a monobloc osteotomy in adult and pediativ populations where gradual bone distration is required.

The DePuy Synthes 1.0/1.2 mm Craniofacial Screws are intended for use as follows: Neuro:
• Nasoethmoidal fractures

Infraorbital area fractures
Frontal sinus wall fractures ●
Infant craniofacial surgery
Dental:
Maxillofacial surgery

Dental: 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.
Neuro: DePuy Synthes Neuro Plate and Screw System is intended for use in fixation of the cranial bones in procedures such as reconstruction, fracture repair, craniotomies, and osteotomies.

Dental: 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.
Neuro: The DePuy Synthes Craniofacial Plate and Screw System is intended for use in selective trauma of the craniofacial skeleton and craniofacial surgery.

The DePuy Synthes CMF Distraction System is intended for use as a bone stabilizer and lengthening (and/or transport) device.
The DePuy Synthes CMF Distraction System is indicated for correction of congenital deficiencies or post-traumatic defects of the cranium, where gradual bone distraction is required in adults and pediatric patients.

The DePuy Synthes MatrixNEURO Cranial Plating System is intended for use in fixation of the cranial bones in procedures such as reconstruction, fracture repair, craniotomies, and osteotomies.

The DePuy Synthes MatrixNEURO Preformed Mesh is intended for use in fixation of the cranial bones in procedures such as reconstruction, fracture repair, craniotomies, and osteotomies.

Device Description

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.

The DePuy Synthes Mandibular Modular 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 Single Vector Distractor with Detachable Feet is a subcutaneous bone distractor activated by a drive component. It features two telescoping components activated by a jack screw, fixed to the bone with bone screws. Bone lengthening and distraction are achieved by gradually activating the device. Upon removal, the telescoping components and jack screw are disengaged and removed, leaving the subcutaneous foot plates in the patient.

The DePuy Synthes Cranial Flap Tube Clamp consists of two clamp discs with a clamp shaft in between the discs. The clamp shaft consists of a 1.6 mm tube which is secured to the bottom disc. The top disc has a thickness of 0.4 mm and the plate diameters range from 8.0 to 20. mm.

The DePuy Synthes Low Profile Neuro System consists of titaniurn plates, and screws in a variety of shapes and sizes designed for various cranio-facial procedures.

Synthes ø1.6 mm Low Profile Neuro System self-drilling, self·tapping, and ø1.9 mm emergency self-tapping screws in 3 mm lengths are to be added to the system.

The 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 External Midface Distractor is an external distraction osteogenesis device that attaches to the cranium and midface and is used to gradually lengthen the midface at the LeFort I, II, and III levels (including monobloc). The device consists of an external headframe, a central adjustment mechanism, a veridical central rod, horizontal crosspieces containing distraction screws, and separate footplates assemblies that attach to the zygoma and maxilla.

The DePuy Synthes 1.0/1.2 mm Craniofacial Screws are either self-drilling or self tapping, have a flat head profile with rounded edges with a cruciform recess, and are available in various lengths.

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 alloy and are intended for single use only.

The DePuy Synthes 1.6 mm burr hole covers come in various sizes to accommodate various fracture and osteotomy sites, have a low plate/screw head profile and use existing (previously cleared) 1.6 mm or 1.9 mm emergency self-tapping and self-drilling screws. The DePuy Synthes 1.6 mm Burr Hole Covers have 5 lobes to accommodate a shunt/drain and are available in 12, 15, 17, and 24 mm diameters with a plate thickness of 0.5 mm.

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 Craniomaxillofacial (CMF) Distraction System is a modular distractor system intended for correction and reconstruction of the cranium in adults, adolescents, children, infants, and neonates. The distractor construct consists of the distractor body, footplates, extension arms, and bone screws, all of which are available in multiple configurations to meet patient and surgeon needs. The distractor body is first assembled with the desired footplates, and then the footplates are secured to bone using the bone screws. After implantation the distractor is activated through the rotation of an advancement/lead screw with an activation instrument percutaneously.

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 MatrixNEURO Cranial Plating System consists of bone fixation implants offered in a variety of shapes and sizes to meet the anatomical needs of the patient.
The reconstruction meshes are manufactured from titanium, are designed for use with DePuy Synthes MatrixNEURO Cranial Plating System screws, are offered sterile, and are intended for single use only.
The screws are manufactured from titanium alloy, are designed for use with DePuy Synthes MatrixNEURO plates, burr hole covers, and meshes, maybe be offered sterile or non-sterile, and are intended for single use only.

The DePuy Synthes MatrixNEURO Cranial Plating System consists of bone fixation implants offered in a variety of shapes and sizes to meet the anatomical needs of the patient.
The DePuy Synthes MatrixNEURO Preformed Meshes are precontoured to cover common cranial defects manufactured from grade 2 titanium that are designed for use with MatrixNEURO Cranial Plating System screws. The Preformed Meshes are offered sterile packed and are intended for single use only.

AI/ML Overview

The provided text is a 510(k) Premarket Notification from the U.S. Food & Drug Administration (FDA) regarding several DePuy Synthes Craniomaxillofacial Neuro Devices. It describes changes to the labeling of these devices to indicate "MR Conditional" use.

The document consistently states that the purpose of the submission is to add MR Conditional information to the device labeling. It explicitly mentions that the intended use and technological characteristics of the devices remain unchanged. This implies that the devices are already cleared for their stated indications and the current submission is concerned with demonstrating their safety in an MR environment.

Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the non-clinical performance testing conducted to support the MR Conditional safety of the devices. This is not a study proving clinical effectiveness or diagnostic accuracy of an AI/algorithm-based device, but rather a set of engineering tests to confirm a physical device's compatibility with an MR environment.

Based on the provided text, here's how to address your request:

1. A table of acceptance criteria and the reported device performance:

The document repeatedly cites the ASTM standards as the basis for performance testing, which inherently contain acceptance criteria within them. The document does not provide specific quantitative performance results for each device against these criteria, but rather states that "Non-clinical testing is provided to support the conditional safety." This implies that the devices met the acceptance criteria defined by these ASTM standards.

Acceptance Criteria (ASTM Standards)	Reported Device Performance
Magnetically Induced Displacement Force: ASTM F2052-14	Non-clinical testing provided to support conditional safety. (Implied: Met standard)
Magnetically Induced Torque: ASTM F2213-06	Non-clinical testing provided to support conditional safety. (Implied: Met standard)
Radio Frequency (RF) Heating: ASTM F2182-11a	Non-clinical testing provided to support conditional safety. The DUKE model places devices in the clinically relevant anatomic position. The DUKE results will be used for labeling of RF heating. (Implied: Met standard)
Image Artifacts: ASTM F2119-07	Non-clinical testing provided to support conditional safety. (Implied: Met standard)

2. Sample sized used for the test set and the data provenance:

Sample Size: The document does not specify the number of individual devices or prototypes tested for each type of assessment (displacement, torque, heating, artifacts). These are engineering tests typically performed on representative samples.
Data Provenance: The data provenance is "non-clinical testing" conducted by the manufacturer, DePuy Synthes. The "DUKE model" for RF heating is mentioned, which is a widely accepted phantom model for electromagnetic simulations in medical device testing. There's no information about the country of origin of the data beyond it being part of a US FDA submission. It is a prospective test in the sense that the testing was conducted to support the MR Conditional labeling.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This question is not applicable in the context of this submission. The "ground truth" for MR Conditional safety is established by engineering tests against recognized consensus standards (ASTM), not by human expert review of clinical cases. The tests directly measure physical properties like temperature increase or magnetic force, and these measurements are compared to the limits specified in the standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. This is not a human reader study requiring adjudication. The assessment is based on objective physical measurements and adherence to ASTM standards.

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 for physical medical devices (implants), not an AI/algorithm-based diagnostic or assistive software. No MRMC study was performed because the device is not an AI reading tool.

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

Not applicable. This is not an algorithm, so standalone performance is irrelevant. The tests are for the physical properties of the implants.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

The "ground truth" for these tests is defined by the physical laws and empirically derived thresholds outlined in the ASTM standards for MR compatibility. For example, a certain temperature rise in a standard phantom model is deemed acceptable if it remains below a specified limit.

8. The sample size for the training set:

Not applicable. There is no "training set" as this is not a machine learning or AI model.

9. How the ground truth for the training set was established:

Not applicable, as there is no training set.

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.

September 18, 2020

Synthes (USA) Products LLC Jeffrey Krawiec Senior Regulatory Affairs Specialist 1301 Goshen Parkway West Chester, Pennsylvania 19380

Re: K192702

Trade/Device Name: DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional Regulation Number: 21 CFR 882.5330 Regulation Name: Preformed Nonalterable Cranioplasty Plate Regulatory Class: Class II Product Code: GXN, GXR, GWO, JEY, DZL, MQN Dated: August 19, 2020 Received: August 20, 2020

Dear Jeffrey Krawiec:

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.

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

{1}------------------------------------------------

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 (QS) 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 mediation-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,

Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known)

K192702

Device Name

DePuy Synthes Maxillofacial Titanium Micro Set - MR Conditional

Indications for Use (Describe) Neuro:

· Neurosurgery
Nasoethmoidal fractures
Infraorbital area fractures
Frontal sinus wall Fractures
· Infant craniofacial surgery
Dental:
· Maxillofacial surgery

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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510(k) Number (if known)

K192702

Device Name

DePuy Synthes Mandibular Modular Fixation System - MR Conditional

Indications for Use (Describe)

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

· Neurosurgery: osteosynthesis of the cranial bones.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)		Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)	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.

{4}------------------------------------------------

510(k) Number (if known)

K192702

Device Name

DePuy Synthes Single Vector Distractor with Detachable Feet - MR Conditional

Indications for Use (Describe)

The DePuy Synthes Single Vector Distractor with Detachable Feet is also ideal for treating hypoplasias of an acquired origin such as from post-traumatic growth disorders associated with injury to the temporomandibular joint, temporomandibular ankylosis, and segmental loss of bone.

Neuro: The DePuy Synthes Single Vector Distractor with Detachable Feet can be used for stabilization and advancement of the mid-face, in which a deficiency of mid-facial bone requires gradual bone distraction. Such deficiencies include, but are not limited to Plagiocephaly, Trigonocephaly, Scaphocephaly, and Brachycephaly.

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.

{5}------------------------------------------------

510(k) Number (if known)

K192702

Device Name

DePuy Synthes Cranial Tube Clamp - MR Conditional

Indications for Use (Describe)

The DePuy Synthes Cranial Tube Clamp is intended to reattach a cranial bone flap to the surrounding cranium after a craniotomy procedure.

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.

{6}------------------------------------------------

510(k) Number (if known)

K192702

Device Name

DePuy Synthes Low Profile Neuro System - MR Conditional

Indications for Use (Describe)

Neuro: The DePuy Synthes Low Profile Neuro System is intended for cranial closure and/or bone fixation, craniotomies, cranial trauma repair and reconstruction.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
------------------------------------------------------------	-----------------------------------------------------------

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

{7}------------------------------------------------

510(k) Number (if known)

K192702

Device Name

DePuy Synthes Low Profile Neuro System - 3 mm Screws - MR Conditional

Indications for Use (Describe)

Neuro: The DePuy Synthes Low Profile Neuro System is intended for cranial closure and/or bone fixation, craniotomies, cranial trauma repair and reconstruction.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

{8}------------------------------------------------

510(k) Number (if known)

K192702

Device Name

DePuy Synthes 1.3 & 1.5 mm Contourable Titanium (Ti.) Mesh Plates - MR Conditional

Indications for Use (Describe)

Neuro: The DePuy Synthes 1.3 & 1.5 mm Contourable Titanium (Ti.) Mesh Plates are intended for use in selective trauma of the craniofacial skeleton and craniofacial surgery.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

{9}------------------------------------------------

510(k) Number (if known)

K192702

Device Name

DePuy Synthes External Midface Distractor - MR Conditional

Indications for Use (Describe)

Neuro: The DePuy Synthes External Midface Distractor is intended for use in craniofacial surgery and reconstructive procedures. Specifically, it is intended for distraction of the cranium utilizing a monobloc osteotomy in adult and pediativ populations where gradual bone distration is required.

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.

{10}------------------------------------------------

510(k) Number (if known)

K192702

Device Name

DePuy Synthes 1.0/1.2 mm Craniofacial Screws - MR Conditional

Indications for Use (Describe)

The DePuy Synthes 1.0/1.2 mm Craniofacial Screws are intended for use as follows: Neuro:

• Nasoethmoidal fractures

Infraorbital area fractures
Frontal sinus wall fractures
· Infant craniofacial surgery

Dental:

· 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.

{11}------------------------------------------------

510(k) Number (if known)

K192702

Device Name

DePuy Synthes Neuro Plate and Screw System - MR Conditional

Indications for Use (Describe)

Neuro: DePuy Synthes Neuro Plate and Screw System is intended for use in fixation of the cranial bones in procedures such as reconstruction, fracture repair, craniotomies, and osteotomies.

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)

K192702

Device Name

Modification to DePuy Synthes Low Profile Neuro System - MR Conditional

Indications for Use (Describe)

Neuro: The DePuy Synthes Low Profile Neuro System is intended for cranial closure and/or bone fixation, craniotomies, cranial trauma repair and reconstruction.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

{13}------------------------------------------------

510(k) Number (if known)

K192702

Device Name

DePuy Synthes Craniofacial Plate and Screw System - MR Conditional

Indications for Use (Describe)

Neuro: The DePuy Synthes Craniofacial Plate and Screw System is intended for use in selective trauma of the craniofacial skeleton and craniofacial surgery.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

{14}------------------------------------------------

510(k) Number (if known)

K192702

Device Name

DePuy Synthes Craniomaxillofacial Distraction System (CMF Distraction System) – MR Conditional

Indications for Use (Describe)

The DePuy Synthes CMF Distraction System is intended for use as a bone stabilizer and lengthening (and/or transport) device.

The DePuy Synthes CMF Distraction System is indicated for correction of congenital deficiencies or post-traumatic defects of the cranium, where gradual bone distraction is required in adults and pediatric patients.

Cranium

The 1.5 mm and 2.0 mm mesh and cloverleaf footplates and screws are intended for infants, children, and adults.

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.

{15}------------------------------------------------

510(k) Number (if known)

K192702

Device Name

DePuy Synthes MatrixNEURO Cranial Plating System - MR Conditional

Indications for Use (Describe)

The DePuy Synthes MatrixNEURO Cranial Plating System is intended for use in fixation of the cranial bones in procedures such as reconstruction, fracture repair, craniotomies, and osteotomies.

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.

{16}------------------------------------------------

510(k) Number (if known) K192702

Device Name

DePuy Synthes MatrixNEURO Preformed Mesh (Part of the MatrixNEURO Cranial Plating System) - MR Conditional

Indications for Use (Describe)

The DePuy Synthes MatrixNEURO Preformed Mesh is intended for use in fixation of the cranial bones in procedures such as reconstruction, fracture repair, craniotomies, and osteotomies.

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.

{17}------------------------------------------------

Date Prepared: August 19, 2020

1.1 Submitter

Primary 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

Alternate Contact:

Thomas Shea Manager, Regulatory Affairs DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5679 Email: tshea@its.jnj.com

1.2 Device

Name of Device: DePuy Synthes Maxillofacial Titanium Micro Set – MR Conditional

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

Neuro:

Neurosurgery
Nasoethmoidal fractures
Infraorbital area fractures
Frontal sinus wall Fractures
Infant craniofacial surgery

{18}------------------------------------------------

Dental:

. Maxillofacial surgery

Substantial Equivalence 1.6

The purpose of this submission is to add MR Conditional information to the device labeling for the DePuy Synthes Maxillofacial Titanium Micro Set. 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.

1.7 Performance Testing

Non-clinical testing is provided to support the conditional safety of the DePuy Synthes Maxillofacial Titanium Micro Set in the MR environment including assessment of magnetically induced displacement force (ASTM F2052-14) and torque (ASTM F2213-06), radio frequency (RF) heating (ASTM F2182-11a), and image artifacts (ASTM F2119-07). The DUKE model places devices in the clinically relevant anatomic position. The DUKE results will be used for labeling of RF heating.

1.8 Conclusion

{19}------------------------------------------------

Date Prepared: August 19, 2020

1.1 Submitter

Primary 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

Alternate Contact:

Thomas Shea Manager, Regulatory Affairs DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5679 Email: tshea@its.jnj.com

1.2 Device

Name of Device: DePuy Synthes MAandibular Modular Fixation System – MR Conditional

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

1.4 Device Description

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
Neurosurgery: osteosynthesis of the cranial bones.

{20}------------------------------------------------

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.

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

{21}------------------------------------------------

Date Prepared: August 19, 2020

1.1 Submitter

Primary 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

Alternate Contact:

Thomas Shea Manager, Regulatory Affairs DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5679 Email: tshea@its.jnj.com

1.2 Device

Name of Device: DePuy Synthes Single Vector Distractor with Detachable Feet - MR Conditional

Classification Name(s): External Mandibular Fixator And/Or Distractor

Regulatory Class: Class II; 872.4760

Product Code(s): MQN

1.3 Predicate Device

K981075 Synthes (USA) Single Vector Distractor with Detachable Feet

1.4 Device Description

1.5 Indications for Use

{22}------------------------------------------------

Hemifacial Microsomia, Treacher Collins Syndrome, Pierre Robin Syndrome, Goldenhar Syndrome, Apert Syndrome, and Crouzon Syndrome.

Substantial Equivalence 1.6

The purpose of this submission is to add MR Conditional information to the device labeling for the DePuy Synthes Single Vector Distractor with Detachable Feet. 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.

1.7 Performance Testing

Non-clinical testing is provided to support the conditional safety of the DePuy Synthes Single Vector Distractor with Detachable Feet in the MR environment including assessment of magnetically induced displacement force (ASTM F2052-14) and torque (ASTM F2213-06), radio frequency (RF) heating (ASTM F2182-11a and DUKE model), and image artifacts (ASTM F2119-07). The DUKE model places devices in the clinically relevant anatomic position. The DUKE results will be used for labeling of RF heating.

1.8 Conclusion

{23}------------------------------------------------

510(k) Summary

Date Prepared: August 19, 2020

1.1 Submitter

Primary 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

Alternate Contact: Thomas Shea Manager, Regulatory Affairs DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5679 Email: tshea@its.jnj.com

1.2. Device

Name of Device: DePuy Synthes Cranial Tube Clamp - MR Conditional

Classification Name(s): Plate, Cranioplasty, Preformed, Non-Alterable

Regulatory Class: Class II, §882.5330

Product Code(s): GXN

1.3. Predicate Device

K992000 Synthes Cranial Tube Clamp

1.4. Device Description

1.5. Intended Use

The DePuy Synthes Cranial Tube Clamp is intended to reattach a cranial bone flap to the surrounding Cranium after a craniotomy procedure.

1.6. Substantial Equivalence

{24}------------------------------------------------

The purpose of this submission is to add MR Conditional information to the device labeling for the DePuy Synthes Cranial Tube Clamp. 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.

1.7. Performance Testing

Non-clinical testing is provided to support the conditional safety of the DePuy Synthes Cranial Tube Clamp 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

{25}------------------------------------------------

Date Prepared: August 19, 2020

1.1 Submitter

Primary 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

Alternate Contact:

Thomas Shea Manager, Regulatory Affairs DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5679 Email: tshea@its.jnj.com

1.2 Device

Name of Device: DePuy Synthes Low Profile Neuro System - MR Conditional

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

1.4 Device Description

The DePuy Synthes Low Profile Neuro System consists of titaniurn plates, and screws in a variety of shapes and sizes designed for various cranio-facial procedures.

1.5 Indications for Use

Neuro: The DePuy Synthes Low Profile Neuro System is intended for cranial closure and/or bone fixation, craniotomies, cranial trauma repair and reconstruction.

{26}------------------------------------------------

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.

1.7 Performance Testing

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

{27}------------------------------------------------

Date Prepared: August 19, 2020

Submitter 1.1.

Primary 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

Alternate Contact:

Thomas Shea Manager, Regulatory Affairs DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5679 Email: tshea@its.jnj.com

1.2. Device

Name of Device: DePuy Synthes Low Profile Neuro System - 3 mm Screws - MR Conditional

Classification Name(s): Screw, Fixation, Intraosseous

Regulatory Class: Class II; 872.4880

Product Code(s): DZL

1.3. Predicate Device

K031807 Synthes Low Profile Neuro System - 3 mm Screws

1.4. Device Description

Synthes ø1.6 mm Low Profile Neuro System self-drilling, self·tapping, and ø1.9 mm emergency self-tapping screws in 3 mm lengths are to be added to the system.

1.5. Indications for Use

Neuro: The DePuy Synthes Low Profile Neuro System is intended for cranial closure and/or bone fixation, craniotomies, cranial trauma repair and reconstruction.

{28}------------------------------------------------

Substantial Equivalence 1.6.

The purpose of this submission is to add MR Conditional information to the device labeling for the DePuy Synthes Low Profile Neuro System - 3 mm Screws. 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.

1.7. Performance Testing

Non-clinical testing is provided to support the conditional safety of the DePuy Synthes Low Profile Neuro System - 3 mm Screws in the MR environment including assessment of magnetically induced displacement force (ASTM F2052-14) and torque (ASTM F2213-06), radio frequency (RF) heating (ASTM F2182-11a and DUKE model), and image artifacts (ASTM F2119-07). The DUKE model places devices in the clinically relevant anatomic position. The DUKE results will be used for labeling of RF heating.

1.8. Conclusion

{29}------------------------------------------------

Date Prepared: August 19, 2020

1.1 Submitter

Primary 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

Alternate Contact:

Thomas Shea Manager, Regulatory Affairs DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5679 Email: tshea@its.jnj.com

1.2 Device

Name of Device: DePuy Synthes 1.3 & 1.5mm Contourable Titanium (Ti.) Mesh Plates – MR Conditional

Classification Name(s): Plate, Bone

Regulatory Class: Class II; 872.4760

Product Code(s): JEY

1.3 Predicate Device
K033121 1.3 & 1. 5MM Contourable Titanium (Ti.) Mesh Plates

1.4 Device Description

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.

1.5 Indications for Use

{30}------------------------------------------------

Neuro: The DePuy Synthes 1.3 & 1.5 mm Contourable Titanium (Ti.) Mesh Plates are intended for use in selective trauma of the craniofacial skeleton and craniofacial surgery.

Substantial Equivalence 1.6

The purpose of this submission is to add MR Conditional information to the device labeling for the DePuy Synthes 1.3 & 1.5mm 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.

1.7 Performance Testing

Non-clinical testing is provided to support the conditional safety of the DePuy Synthes 1.3 & 1.5mm 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.

1.8 Conclusion

{31}------------------------------------------------

Date Prepared: August 19, 2020

1.1. Submitter

Primary 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

Alternate Contact:

Thomas Shea Manager, Regulatory Affairs DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5679 Email: tshea@its.jnj.com

1.2. Device

Name of Device: DePuy Synthes External Midface Distractor - MR Conditional

Classification Name(s): External Mandibular Fixator And/Or Distractor

Regulatory Class: Class II; 872.4760

Product Code(s): MQN

1.3. Predicate Device

K040083 Synthes External Midface Distractor

1.4. Device Description

Indications for Use 1.5.

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

utilizing a LeFort II or III osteotomy in adult and pediations where gradual bone distraction is required.

Neuro: The DePuy Synthes External Midface Distractor is intended for use in craniofacial surgery and reconstructive procedures. Specifically, it is intended for distraction of the cranium utilizing a monobloc osteotomy in adult and pediatric populations where gradual bone distration is required.

1.6. Substantial Equivalence

The purpose of this submission is to add MR Conditional information to the device labeling for the DePuy Synthes External 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.

1.7. Performance Testing

Non-clinical testing is provided to support the conditional safety of the DePuy Synthes External Midface Distractor in the MR environment including assessment of magnetically induced displacement force (ASTM F2052-14) and torque (ASTM F2213-06), radio frequency (RF) heating (ASTM F2182-11a and DUKE model), and image artifacts (ASTM F2119-07). The DUKE model places devices in the clinically relevant anatomic position. The DUKE results will be used for labeling of RF heating.

1.8. Conclusion

{33}------------------------------------------------

Date Prepared: August 19, 2020

1.1 Submitter

Primary 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

Alternate Contact:

Thomas Shea Manager, Regulatory Affairs DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5679 Email: tshea@its.jnj.com

1.2 Device

Name of Device: DePuy Synthes 1.0/1.2 mm Craniofacial Screws - MR Conditional

Classification Name(s): Screw, Fixation, Intraosseous

Regulatory Class: Class II; 872.4880

Product Code(s): DZL

1.3 Predicate Device
K041887 Synthes (USA) 1.0/1.2 mm Craniofacial Screws

1.4 Device Description

The DePuy Synthes 1.0/1.2 mm Craniofacial Screws are either self-drilling or self tapping, have a flat head profile with rounded edges with a cruciform recess, and are available in various lengths.

{34}------------------------------------------------

The DePuy Synthes 1.0/1.2 mm Craniofacial Screws are intended for use as follows:

Neuro:

Nasoethmoidal fractures
Infraorbital area fractures
Frontal sinus wall fractures ●
Infant craniofacial surgery

Dental:

Maxillofacial surgery

Substantial Equivalence 1.6

The purpose of this submission is to add MR Conditional information to the device labeling for the DePuy Synthes 1.0/1.2 mm Craniofacial Screws. 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.

1.7 Performance Testing

Non-clinical testing is provided to support the conditional safety of the DePuy Synthes 1.0/1.2 mm Craniofacial Screws in the MR environment including assessment of magnetically induced displacement force (ASTM F2052-14) and torque (ASTM F2213-06), radio frequency (RF) heating (ASTM F2182-11a and DUKE model), and image artifacts (ASTM F2119-07). The DUKE model places devices in the clinically relevant anatomic position. The DUKE results will be used for labeling of RF heating.

1.8. Conclusion

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

Date Prepared: August 19, 2020

1.1 Submitter

Primary 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

Alternate Contact:

Thomas Shea Manager, Regulatory Affairs DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5679 Email: tshea@its.jnj.com

1.2 Device

Name of Device: DePuy Synthes Neuro Plate And Screw System – MR Conditional

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

1.4 Device Description

1.5 Indications for Use

{36}------------------------------------------------

Neuro: DePuy Synthes Neuro Plate and Screw System is intended for use in fixation of the cranial bones in procedures such as reconstruction, fracture repair, craniotomies, and osteotomies.

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.

1.7 Performance Testing

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.

Conclusion 1.8

{37}------------------------------------------------

510(k) Summary

Date Prepared: August 19, 2020

1.1 Submitter

Primary 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

Alternate Contact: Thomas Shea Manager, Regulatory Affairs DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5679 Email: tshea@its.jnj.com

1.2. Device

Name of Device: Modification to DePuy Synthes Low Profile Neuro System - MR Conditional

Classification Name(s): Cover, Burr Hole

Regulatory Class: Class II, §882.5250

Product Code(s): GXR

1.3. Predicate Device

K042986 Modification to Synthes (USA) Low Profile Neuro System

1.4. Device Description

1.5. Intended Use

{38}------------------------------------------------

Neuro: The DePuy Synthes Low Profile Neuro System is intended for cranial closure and/or bone fixation, craniotomies, cranial trauma repair and reconstruction.

1.6. Substantial Equivalence

1.7. Performance Testing

1.8. Conclusion

{39}------------------------------------------------

Date Prepared: August 19, 2020

1.1 Submitter

Primary 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

Alternate Contact:

Thomas Shea Manager, Regulatory Affairs DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5679 Email: tshea@its.jnj.com

1.2 Device

Name of Device: DePuy Synthes Craniofacial Plate And Screw System – MR Conditional

Classification Name(s): Plate, Bone

Regulatory Class: Class II; 872.4760

Product Code(s): JEY

1.3 Predicate Device

K050608 Synthes Craniofacial Plate and Screw System

1.4 Device Description

1.5 Indications for Use

{40}------------------------------------------------

Neuro: The DePuy Synthes Craniofacial Plate and Screw System is intended for use in selective trauma of the craniofacial skeleton and craniofacial surgery.

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.

1.7 Performance Testing

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

{41}------------------------------------------------

Date Prepared: August 19, 2020

1.1 Submitter

Primary 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

Alternate Contact:

Thomas Shea Manager, Regulatory Affairs DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5679 Email: tshea@its.jnj.com

1.2 Device

Name of Device: DePuy Synthes Craniomaxillofacial Distraction System (CMF Distraction System) - MR Conditional

Classification Name(s): External Mandibular Fixator And/Or Distractor

Regulatory Class: Class II; 872.4760

Product Code(s): MQN

1.3 Predicate Device

K060138 Synthes (USA) Craniomaxillofacial Distraction System K170818 DePuy Synthes Craniomaxillofacial Distraction (CMFD) System Cranial Indications

1.4 Device Description

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

The DePuy Synthes CMF Distraction System is intended for use as a bone stabilizer and lengthening (and/or transport) device.

Cranium

The 1.5 mm and 2.0 mm mesh and cloverleaf footplates and screws are intended for infants, children, adolescents, and adults.

Substantial Equivalence 1.6

The purpose of this submission is to add MR Conditional information to the device labeling for the DePuy Synthes Craniomaxillofacial Distraction System. The intended use and technological characteristics of the devices remains unchanged. The device name has been updated to reflect the current company name, DePuy Synthes, and indicate MR Conditional use by adding " - MR Conditional" to the name of each subject system.

1.7 Performance Testing

Non-clinical testing is provided to support the conditional safety of the DePuy Synthes Craniomaxillofacial Distraction System in the MR environment including assessment of magnetically induced displacement force (ASTM F2052-14) and torque (ASTM F2213-06), radio frequency (RF) heating (ASTM F2182-11a), and image artifacts (ASTM F2119-07). The DUKE model places devices in the clinically relevant anatomic position. The DUKE results will be used for labeling of RF heating.

1.8 Conclusion

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

Date Prepared: August 19, 2020

1.1 Submitter

Primary 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

Alternate Contact:

Thomas Shea Manager, Regulatory Affairs DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5679 Email: tshea@its.jnj.com

1.2 Device

Name of Device: DePuy Synthes Craniofacial Plate And Screw System – MR Conditional

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

1.4 Device Description

1.5 Indications for Use

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

Neuro: The DePuy Synthes Craniofacial Plate and Screw System is intended for use in selective trauma of the craniofacial skeleton and craniofacial surgery.

Substantial Equivalence 1.6

1.7 Performance Testing

1.8 Conclusion

{45}------------------------------------------------

510(k) Summary

Date Prepared: August 19, 2020

1.1 Submitter

Primary 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

Alternate Contact: Thomas Shea Manager, Regulatory Affairs DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5679 Email: tshea@its.jnj.com

1.2. Device

Name of Device: DePuy Synthes MatrixNEURO Cranial Plating System - MR Conditional

Classification Name(s): Plate, Cranioplasty, Preformed, Alterable

Regulatory Class: Class II, §882.5320

Product Code(s): GWO

1.3. Predicate Device

K123723 Synthes MatrixNEURO Cranial Plating System

1.4. Device Description

The DePuy Synthes MatrixNEURO Cranial Plating System consists of bone fixation implants offered in a variety of shapes and sizes to meet the anatomical needs of the patient.

The reconstruction meshes are manufactured from titanium, are designed for use with DePuy Synthes MatrixNEURO Cranial Plating System screws, are offered sterile, and are intended for single use only.

The screws are manufactured from titanium alloy, are designed for use with DePuy Synthes MatrixNEURO plates, burr hole covers, and meshes, maybe be offered sterile or non-sterile, and are intended for single use only.

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

1.5. Intended Use

The DePuy Synthes MatrixNEURO Cranial Plating System is intended for use in fixation of the cranial bones in procedures such as reconstruction, fracture repair, craniotomies, and osteotomies.

1.6. Substantial Equivalence

The purpose of this submission is to add MR Conditional information to the device labeling for the DePuy Synthes MatrixNEURO Cranial 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.

1.7. Performance Testing

Non-clinical testing is provided to support the conditional safety of the DePuy Synthes MatrixNEURO Cranial 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.

1.8. Conclusion

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510(k) Summary

Date Prepared: August 19, 2020

1.1 Submitter

Primary 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

Alternate Contact: Thomas Shea Manager, Regulatory Affairs DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5679 Email: tshea@its.jnj.com

1.2. Device

Name of Device: DePuy Synthes MatrixNEURO Preformed Mesh (Part of the MatrixNEURO Cranial Plating System) - MR Conditional

Classification Name(s): Plate, Cranioplasty, Preformed, Alterable

Regulatory Class: Class II, §882.5320

Product Code(s): GWO

1.3. Predicate Device

K140462 MatrixNEURO Preformed Mesh (Part of the MatrixNEURO Cranial Plating System)

1.4. Device Description

The DePuy Synthes MatrixNEURO Cranial Plating System consists of bone fixation implants offered in a variety of shapes and sizes to meet the anatomical needs of the patient.

The DePuy Synthes MatrixNEURO Preformed Meshes are precontoured to cover common cranial defects manufactured from grade 2 titanium that are designed for use with MatrixNEURO Cranial Plating System screws. The Preformed Meshes are offered sterile packed and are intended for single use only.

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1.5. Intended Use

The DePuy Synthes MatrixNEURO Preformed Mesh is intended for use in fixation of the cranial bones in procedures such as reconstruction, fracture repair, craniotomies, and osteotomies.

1.6. Substantial Equivalence

The purpose of this submission is to add MR Conditional information to the device labeling for the DePuy Synthes MatrixNEURO Preformed Mesh. 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.

1.7. Performance Testing

Non-clinical testing is provided to support the conditional safety of the MatrixNEURO Preformed Mesh 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

Regulation Number and Section

§ 882.5330 Preformed nonalterable cranioplasty plate.

(a)
Identification. A preformed nonalterable cranioplasty plate is a device that is implanted in a patient to repair a skull defect and is constructed of a material, e.g., stainless steel or vitallium, that cannot be altered or reshaped at the time of surgery without changing the chemical behavior of the material.(b)
Classification. Class II (performance standards).