The TMC Compression Implant System consists of implants and related instrumentation for implantation. The implants are offered in multiple combinations of bridge lengths, leg lengths, and cross sections to accommodate various anatomies. This includes two (2x2, 4x1) legged implants. The system is intended to be used for fracture fixation, osteotomy fixation, and joint arthrodesis of the foot and ankle.

The purpose of this Special 510(k) submission is to expand the implant and instrument options for the TMC Compression Implant System. The subject implants and instruments are modifications of the previously cleared TMC Compression Implant System (K222645).

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

AI/ML Overview

This document describes the Treace Medical Concepts (TMC) Compression Implant System, a device used for fracture fixation, osteotomy fixation, and joint arthrodesis of the foot and ankle. The FDA has determined it is substantially equivalent to legally marketed predicate devices.

Here's an analysis of the acceptance criteria and study information provided, focusing on what is stated and what is not:

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

The document explicitly states that mechanical testing, including bending and pull-out performance, was conducted according to ASTM F564-17 Standard Specification and Test Methods for Metallic Bone Staples.

Acceptance Criteria	Reported Device Performance
Bending performance per ASTM F564	Met all acceptance criteria
Pull-out performance per ASTM F564	Met all acceptance criteria

Note: The specific quantitative acceptance criteria (e.g., minimum bending strength, minimum pull-out force) are not provided in this document. It only states that the device "met all acceptance criteria" as defined by ASTM F564.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

The document does not specify the sample size used for the mechanical testing (bending and pull-out). It also does not provide information about the data provenance (e.g., country of origin) or whether the tests were prospective or retrospective. Mechanical tests are typically performed in a laboratory setting on new devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

This information is not applicable as the study described is a mechanical performance study of a bone fixation device, not a study evaluating diagnostic imaging or clinical outcomes that would require expert review to establish ground truth. The "ground truth" here is the physical performance of the device under stress, measured quantitatively against established engineering standards (ASTM F564).

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

This information is not applicable for a mechanical performance study. Adjudication methods are relevant for studies where subjective interpretation (e.g., by clinicians, radiologists) is involved in determining outcomes or ground truth.

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:

This information is not applicable. This document describes the mechanical testing of a medical implant, not an AI-assisted diagnostic or treatment device involving human readers.

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

This information is not applicable. This document does not describe an algorithm or AI device.

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

The ground truth used for this study is based on established engineering standards and test methods as defined by ASTM F564 Standard Specification and Test Methods for Metallic Bone Staples. The performance metrics (e.g., bending strength, pull-out force) are quantitative and derived directly from these standardized tests.

8. The sample size for the training set:

This information is not applicable. This document describes mechanical performance testing, not a machine learning or AI model that would require a training set.

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

This information is not applicable as there is no training set for a mechanical performance study.

Summary

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August 28, 2023

Treace Medical Concepts Brittany Grochala Sr. Regulatory Affairs Specialist 100 Palmetto Park Place Ponte Vedra, Florida 32081

Re: K232387

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 Dated: August 8, 2023 Received: August 9, 2023

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.

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

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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 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,

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 Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K232387

Device Name

Treace Medical Concepts (TMC) Compression Implant System

Indications for Use (Describe)

The system is intended to be used for fracture fixation, osteotomy 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/3/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 08, 2023

Company:	Treace Medical Concepts, Inc.100 Palmetto Park PlacePonte Vedra, FL 32081
Establishment Registration:	3011623994
Primary Contact:	Brittany Grochala, Sr. Regulatory Affairs SpecialistPhone: 515-865-0494Fax: 904-834-7169Email: bgrochala@treace.net
Secondary Contact:	Kristina Hall, Director, Regulatory AffairsPhone: 904-373-5940 ext. 1321Fax: 904-834-7169Email: khall@treace.net
Trade Name:	Treace Medical Concepts (TMC) Compression ImplantSystem
Common Name:	Staple, fixation, bone
Classification:	Class II
Regulation Number:	21 CFR 888.3030 Single/multiple component metallic bonefixation appliances and accessories
Panel:	87- Orthopedic
Product Code(s):	Primary: JDR

Predicate Device(s):

Primary Predicate:

TMC Compression Implant System (K222645, S.E. 11/21/2022) .
Additional Predicate:
Z-Medical Z-Staple (K121277, S.E. 11/07/2012) .

Device Description:

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Image /page/4/Picture/0 description: The image is a logo for TREACE Medical Concepts, Inc. The logo is in gray, except for a red swoosh above the letters A and C. Below the company name is the tagline "The Leader in Hallux Valgus Surgery" in red.

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 devices:

Primary Predicate:

TMC Compression Implant System (K222645, S.E. 11/21/2022) .
Additional Predicate:
Z-Medical Z-Staple (K121277, S.E. 11/07/2012) .
The subject compression implants are intended to be used for fracture fixation, osteotomy fixation, and joint arthrodesis of the foot and ankle, identical or equivalent to the predicate devices. The subject compression implants are manufactured from implant grade titanium alloy (Ti-6Al-4V-ELI) per ASTM F136, identical to the predicate devices.

The subject device modifications include updates to the implant bridge geometry, leg diameter, leg length. leg profile, and an anatomic leg location design (4x1 implant only). The subject 2x1 and 4x1 compression implants include thinner bridges and the subject 4x1 implants have shorter legs as compared to the primary predicate. The subject 2x1 implants have larger leg diameters while the leg lengths remain unchanged as compared to the primary predicate.

The subject implants were compared to the additional predicate per ASTM F564-17 Standard Specification and Test Methods for Metallic Bone Staples. Mechanical testing including bending and pull-out performance have been completed to evaluate the subject device against the additional predicate device. These are the same well-established methods utilized in the original, primary predicate TMC Compression Implant System submission (K222645). The testing demonstrated that the subject device met all acceptance criteria.

The subject devices share similar materials, geometry, construction, packaging, overall design, and performance with the predicate devices. 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 devices.

Performance Testing:

The subject devices were compared to the predicate device, Z-Medical Z-Staples, in bending performance and pullout performance testing per ASTM F564 Standard Specification and Test Methods 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.

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Image /page/5/Picture/0 description: The image is a logo for Treace Medical Concepts, Inc. The logo is in gray, except for a red swoosh above the letters 'ACE'. Below the logo is the text 'Medical Concepts, Inc.' in gray. Below that, in red, is the text 'The Leader in Hallux Valgus Surgery'.

TMC Compression Implant System Special 510(k) Premarket Notification K232387 Page 3

Conclusion:

The subject TMC Compression Implant System has similar intended use, overall design, materials, and mechanical properties to that of the predicate devices. Moreover, there is no change in the intended use as compared to the predicate TMC Compression Implant System. Therefore, it can be concluded that the subject device is at least as safe and effective and substantially equivalent to the predicate 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.