The Treace Medical Concepts (TMC) Compression Implant System consists of implants and related instrumentation for implantation. The implant is offered in multiple combinations of bridge lengths, leg lengths, cross sections and cannulated versions to accommodate various anatomies. The system is intended to be used for fracture fixation, osteotomy fixation, and joint arthrodesis of the foot and ankle.

AI/ML Overview

This document describes a 510(k) premarket notification for the Treace Medical Concepts (TMC) Compression Implant System, a metallic bone fixation appliance. The information herein pertains to an administrative change to the trade name of the product and its substantial equivalence to predicate devices, rather than an AI/ML-driven medical device. Therefore, much of the requested information regarding acceptance criteria, study methodologies for AI/ML devices, and ground truth establishment (such as those involving expert consensus, MRMC studies, or training/test set sample sizes for AI) is not applicable or cannot be extracted from the provided text.

However, I can extract information related to the device's performance testing and its comparison to a predicate device, which serves as the basis for its substantial equivalence claim.

Here's the relevant information based on the provided text:

1. Table of Acceptance Criteria & Reported Device Performance

Acceptance Criteria	Reported Device Performance
Device must meet the requirements of ASTM F564 for Bone Metallic Staples.	The testing demonstrated that the subject device met all acceptance criteria per ASTM F564.

2. Sample Size & Data Provenance

The document does not specify a "sample size used for the test set" in the context of an AI/ML model or a clinical study with patients. The performance testing mentioned is mechanical testing. Therefore, the concept of data provenance (country of origin, retrospective/prospective) is not applicable in this context. The testing was conducted on the device itself.

3. Number of Experts and Qualifications

Not applicable. The performance testing described is mechanical testing of the implant, not a study requiring human expert evaluation (e.g., radiologists interpreting images).

4. Adjudication Method

Not applicable. This is not a study requiring adjudication of human readings or AI outputs.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is not an AI/ML device whose performance is being compared to human readers.

6. Standalone Performance

The document states, "The testing demonstrated that the subject device met all acceptance criteria" per ASTM F564. This implies a standalone evaluation of the device's mechanical properties against a predefined standard. However, this is for a physical implant, not a software algorithm.

7. Type of Ground Truth Used

The "ground truth" in this context is the mechanical performance standards defined by ASTM F564 for Bone Metallic Staples. The device's performance was compared directly to these established engineering standards.

8. Sample Size for Training Set

Not applicable. This is not an AI/ML device.

9. How Ground Truth for Training Set was Established

Not applicable. This is not an AI/ML device.

Summary of Device and Evidence:

The Treace Medical Concepts (TMC) Compression Implant System is a metallic bone fixation appliance. Its clearance is based on demonstrating substantial equivalence to predicate devices (Z-Medical Z-Staple and Wright Medical FuseForce™ Flex Dynamic Compression System). The primary evidence for this equivalence, specifically regarding performance, is the mechanical testing of the device against the ASTM F564 standard for Bone Metallic Staples. The manufacturer states that the device successfully met all acceptance criteria defined by this standard, indicating similar mechanical properties and safety/effectiveness as the predicate device.

Summary

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February 8, 2023

Treace Medical Concepts Brittany Grochala Sr. Regulatory Affairs Specialist 203 Fort Wade Road, Suite 150 Ponte Vedra, Florida 32081

Re: K222645

Trade/Device Name: Treace Medical Concepts (TMC) Compression Implant System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: JDR

Dear Brittany Grochala:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated November 21, 2022. Specifically, FDA is updating this SE Letter as an administrative correction to the Trade/Device Name from "Treace Medical Concepts (TMC) Implant Fixation System" to "Treace Medical Concepts (TMC) Compression Implant System".

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Limin Sun, Ph.D., OHT6: Office of Orthopedic Devices, 301-796-7056, Limin.Sun(@fda.hhs.gov.

Sincerely,

Image /page/0/Picture/9 description: The image shows the text "Limin Sun -S" in a large, sans-serif font. The text is black and the background is white. The words are arranged horizontally, with "Limin" and "Sun" being the most prominent words. The "-S" is smaller and slightly offset to the right.

Limin Sun, Ph.D. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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November 21, 2022

Treace Medical Concepts Brittany Grochala Sr. Regulatory Affairs Specialist 203 Fort Wade Road, Suite 150 Ponte Vedra, Florida 32081

Re: K222645

Trade/Device Name: Treace Medical Concepts (TMC) Implant Fixation System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: JDR Dated: August 31, 2022 Received: September 1, 2022

Dear Brittany Grochala:

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 (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 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.

Limin Sun -S

Limin Sun, Ph.D. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic 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) K222645

Device Name

Treace Medical Concepts (TMC) Compression Implant System

Indications for Use (Describe)

The system is intended to be used for fracture fixation, and joint arthrodesis of the foot and ankle.

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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Image /page/4/Picture/0 description: The image is a logo for Treace Medical Concepts, Inc. The logo features the word "TREACE" in gray, with a red swoosh above the "A". Below the word "TREACE" is the text "Medical Concepts, Inc." in gray. Below that is the text "The Leader in Hallux Valgus Surgery" in red.

510(k) Summary Treace Medical Concepts (TMC) Compression Implant System August 31st, 2022

Company:	Treace Medical Concepts, Inc.203 Fort Wade Road, Suite 150Ponte Vedra, FL 32081
Establishment Registration:	3011623994
Primary Contact:	Brittany Grochala, Sr. Regulatory Affairs Specialist
	Phone: 515-865-0494
	Fax: 904-834-7169
	Email: bgrochala@treace.net
Secondary Contact:	Kristina Hall, Director, Regulatory Affairs
	Phone: 904-373-5940 ext. 1321
	Fax: 904-834-7169
	Email: khall@treace.net
Trade Name:	Treace Medical Concepts (TMC) Compression Implant
	System
Common Name:	Staple, Fixation, Bone
Classification:	Class II
Regulation Number:	21 CFR 888.3030 Single/multiple component metallic bone
	fixation appliances and accessories.
Panel:	87- Orthopedic
Product Code(s):	JDR Staple, Fixation, Bone

Predicate Device(s):

Primary Predicate:

Z-Medical Z-Staple (K121277, S.E. 11/07/2012) .
Additional Predicate:
Wright Medical FuseForce™ Flex Dynamic Compression System (K203832, S.E. . 05/07/2021)
Reference Device:
Treace Medical Concepts (TMC) Plating System (K220136, S.E. 02/16/2022) .

Device Description:

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Image /page/5/Picture/0 description: The image shows the logo for TREACE Medical Concepts, Inc. The logo is in gray, except for a red swoosh above the letter A. Below the company name is the tagline "The Leader in Hallux Valgus Surgery" in red.

The purpose of this traditional 510(k) submission is for the introduction of the Treace Medical Concepts (TMC) Compression Implant System.

All implantable components are manufactured from implant grade titanium alloy (Ti-6AI-4V-ELI) per ASTM F136 and are provided sterile by gamma irradiation.

Indications for Use:

The system is intended to be used for fracture fixation, osteotomy fixation, and joint arthrodesis of the foot and ankle.

Substantial Equivalence:

The subject TMC Compression Implant System is substantially equivalent to the following predicate and reference devices:

Primary Predicate:

Z-Medical Z-Staple (K121277, S.E. 11/07/2012) .
Additional Predicate:
Wright Medical FuseForce™ Flex Dynamic Compression System (K203832, S.E. . 05/07/2021)
Reference Device:
Treace Medical Concepts (TMC) Plating System (K220136, S.E. 02/16/2022) .
The subject compression implants are intended to be used for fracture fixation, osteotomy fixation, and joint arthrodesis of the foot and ankle, equivalent to the predicate devices. The subject compression implants are manufactured from implant grade titanium alloy (Ti-6AI-4V-ELI) per ASTM F136 and also share similar materials, geometry, construction, packaging, and overall design with the predicate and reference devices (Z-Staple and TMC Plating System). Thus, it can be concluded that the subject devices do not raise new questions about safety and effectiveness and are substantially equivalent to the predicate and reference devices.

Performance Testing:

The subject device was compared to the primary predicate device. Z-Staples, per ASTM F564 for Bone Metallic Staples. The testing demonstrated that the subject device met all acceptance criteria. Therefore, the subject device is substantially equivalent to the predicate device.

Conclusion:

The TMC Compression Implant System has similar intended use, overall design, materials, and mechanical properties to that of the predicate and reference devices. Therefore, it can be concluded that the subject device is at least as safe and substantially equivalent to the predicate and reference devices.

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.