DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm)

K201944 · Synthes (USA) Products, LLC · JEY · Sep 10, 2020 · Dental

Device Facts

• Record ID: K201944
• Device Name: DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm)
• Applicant: Synthes (USA) Products, LLC
• Product Code: JEY · Dental
• Decision Date: Sep 10, 2020
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.4760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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).

Device Story

The DePuy Synthes MatrixMANDIBLE system consists of titanium alloy (Ti-6Al-7Nb) bone plates and self-tapping screws used for fracture fixation in oral and maxillofacial surgery. The subject device adds 26-40mm length screws to the existing system. These implants are provided non-sterile and require sterilization by the healthcare provider before use. The screws are designed to be used with existing MatrixMANDIBLE plates to stabilize bone segments. The device is intended for single use only. By providing mechanical fixation, the system supports bone healing and structural reconstruction in patients undergoing maxillofacial procedures.

Clinical Evidence

No clinical data was necessary for the determination of substantial equivalence. Evidence provided includes bench testing per ASTM F543, sterilization validation, packaging validation, and biocompatibility evaluation per ISO 10993-1.

Technological Characteristics

Material: Titanium Alloy (Ti-6Al-7Nb). Design: 2.4mm diameter self-tapping screws, 1.0mm thread pitch, 26-40mm lengths. Sterilization: Moist heat (non-sterile packaging). Compliance: ASTM F543 (mechanical testing), ISO 10993-1 (biocompatibility).

Indications for Use

Indicated for patients requiring oral, maxillofacial, trauma, reconstructive, or orthognathic surgery. Contraindicated in patients with acute/chronic local or systemic infections, allergy to implant material, or insufficient bone quality to secure the implant.

Regulatory Classification

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.

Predicate Devices

• Synthes MatrixMANDIBLE Plate and Screw System (K063790)

Reference Devices

• Synthes Mandibular Modular Fixation System (K954385)
• Synthes MatrixMANDIBLE Plate and Screw System (K121574)

Submission Summary (Full Text)

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September 10, 2020

Prem Pisupati Senior Regulatory Affairs Specialist DePuy Synthes 1301 Goshen Parkway West Chester, Pennsylvania 19380

Re: K201944

Trade/Device Name: DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm) Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: Class II Product Code: JEY Dated: August 10, 2020 Received: August 11, 2020

Dear Prem Pisupati:

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 ([e-mail]) or phone [phone] 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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## Indications for Use

510(k) Number (if known) K201944

Device Name

DePuy Synthes 2.4 mm Ti Self-Tapping MatrixMANDIBLE Screws (26 - 40mm)

Indications for Use (Describe)

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) |
|-------------------------------------------------|
|-------------------------------------------------|

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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| Sponsor | DePuy Synthes<br>Prem Pisupati<br>1301 Goshen Parkway<br>West Chester, PA USA<br>Phone: [phone] |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared | September 10, 2020 |
| Proprietary<br>Name | DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE screws (26-40mm) |
| Common Name | Bone Plate |
| Classification | Class II<br>Regulation Number: 21 CFR 872.4760<br>Product Code: JEY |
| Predicate Device | Synthes MatrixMANDIBLE Plate and Screw System (K063790) |
| Reference<br>Device | Synthes Mandibular Modular Fixation System (K954385)<br>Synthes MatrixMANDIBLE Plate and Screw System (K121574) |
| Reason for<br>Submission | To introduce a non-sterile packaged version of the 2.4mm Ti Self-Tapping<br>MatrixMANDIBLE screws additional lengths (26mm - 40mm). |
| Device<br>Description | The Synthes MatrixMANDIBLE Plate and Screw System consists of a variety<br>of plates offered in multiple shapes and sizes and a variety of screws offered in<br>multiple diameters and lengths to meet the anatomical needs of the patient.<br>System implants are manufactured in either titanium or titanium alloy and are<br>intended for single use only. |
| | The Synthes MatrixMANDIBLE screws that are the subject of this submission<br>are made from titanium alloy (Ti-6Al-7Nb) and are available in a diameter of<br>2.4 mm and lengths ranging from 26-40mm, and have a thread pitch of 1.0 mm.<br>These screws work with all plates within the MatrixMANDIBLE Plate and<br>Screw system. |
| | These devices are offered non-sterile and must be sterilized before use.<br>MatrixMANDIBLE screws are intended for single use only. |
| Indications for<br>use | The DePuy Synthes MatrixMANDIBLE Plate and Screw System is intended for<br>oral, maxillofacial surgery; trauma; reconstructive surgery; and orthognathic<br>surgery (surgical correction of dentofacial deformities) |
| Contraindications | - Acute or chronic, local or systemic infections<br>- Allergy to implant material<br>- Insufficient bone quality to secure the implant |
| Comparison to<br>Predicate | The subject device has the same intended use as the predicate device. The<br>intended use of the subject system is a subset of the intended use of the reference<br>device. |
| | The subject devices, predicate device and the reference device are metallic plates<br>with a low-profile design intended for bone fracture fixation. Both subject,<br>predicate and reference devices are compatible with the same screw types. |
| | The subject and predicate devices are made from Titanium Alloy (TAN). |
| | The subject devices present the following features that are not similar in the<br>reference device: |
| | • Reference devices have a slightly larger screw head diameter and thread<br>diameter than the subject devices |
| | • Reference devices core diameter is lower than the subject devices |
| | • Reference devices are manufactured from commercially pure Titanium,<br>while the subject devices are manufactured from Titanium Alloy (TAN) |
| | |
| Non-clinical<br>Performance<br>Testing | Testing was performed per ASTM F543 to compare the proposed DePuy Synthes<br>2.4mm Ti Self-Tapping MatrixMANDIBLE screws to the reference device. This<br>information supports that the mechanical performance of the subject devices is at<br>least non-inferior to that of the reference device. |
| | Sterilization adoption evaluated the subject device design and materials and<br>confirmed that the subject device does not present a new worst case and can<br>therefore be adopted under existing Moist Heat sterilization validation. |
| | Packaging validation demonstrates that the bag LDPE on roll or PE tubing for the<br>non-sterile version of the subject device can protect the non-sterile device during<br>distribution and ensure product integrity. |
| | Biocompatibility evaluation confirms that the non-sterile packaged version of the<br>subject device meets the requirements of ISO 10993-1 and that the proposed<br>devices intended for direct contact with the human body present no toxicological<br>risk. |
| Clinical<br>Performance<br>Data | Clinical data was not necessary for the determination of substantial equivalence. |
| Substantial | The subject device has the same indications for use, design, and material of<br>manufacture as the predicate device. The subject devices will be available in |
| Equivalence | longer lengths than the predicate devices.<br><br>The summary of verification and validation activities included in this submission support that the addition of a non-sterile version of the 2.4mm Ti Self-Tapping MatrixMANDIBLE screws do not raise any issues regarding safety and effectiveness.<br><br>It is concluded that the information provided in this submission supports substantial equivalence. |

## 510(k) Summary

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