The TMC Implant Fixation System is intended for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of the feet. The system can be used in both pediatric (aged > 12-21) and adult (aged 22 and over) patients. In the foot, the system can be used for the following specific examples:

• Osteotomy of the 1st metatarsal for the treatment of deformity (e.g., hallux valgus) such as:

Opening base wedge osteotomy
Closing base wedge osteotomy
Crescentic osteotomy
Proximal Chevron osteotomy
Distal Chevron osteotomy (Austin)
Transverse osteotomy

• Arthrodesis of the tarsometatarsal (TMT) joints or the 1st metatarsophalangeal (MTP) joint for the treatment of deformity (e.g., hallux valgus, hallux rigidus, metatarsus adductus) and/or arthritis

• First metatarsal fracture fixation

• Flatfoot Osteotomies

Lateral Column Lengthening (Evans Osteotomy)
Plantar Flexion Opening Wedge Osteotomy of the Medial Cuneiform (Cotton Osteotomy)

• Mid / Flatfoot Fusions

LisFranc Arthrodesis and/or Stabilization
Intercuneiform Fusions
Navicular-Cuneiform (NC) Fusion
Talo-Navicular (TN) Fusion
Calcaneo-Cuboid (CC) Fusion

• Medial Column Fusion

Device Description

The TMC Implant Fixation System is comprised of straight, L-shaped, H-shaped, anatomically curved plates, intramedullary plates, cannulated and non-cannulated compression implants, and associated instruments. It includes 2.5 mm, 2.7 mm, 3.0 mm, and 3.3 mm diameter cannulated and non-cannulated, locking, and non-locking screws in lengths ranging from 10-36 mm. The plates, screws, and compression implants are intended for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of the feet. All implantable components are manufactured from implant grade titanium alloy (Ti-6Al-4V-ELI) per ASTM F136 and are provided sterile by gamma irradiation.

AI/ML Overview

This document describes the regulatory clearance of a medical device, the "TMC Implant Fixation System," not an AI diagnostic device. Therefore, many of the requested categories for AI-specific studies are not applicable. I will extract the information that is relevant to the provided text.

Here's an analysis of the provided FDA 510(k) clearance letter:

1. Table of acceptance criteria and the reported device performance:

Acceptance Criteria Category	Specific Acceptance Criteria (if stated)	Reported Device Performance
Mechanical Performance	Static 4-point bend testing (ASTM F382)	Met acceptance criteria
	Dynamic 4-point bend testing (ASTM F382)	Met acceptance criteria
	Axial pullout testing	Met modified acceptance criteria derived from FDA Guidance for Orthopedic Non-Spinal Metallic Bone Screws and Washers

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

Sample Size (Test Set): Not explicitly stated. The document refers to "testing and analysis" between the subject and predicate devices for mechanical properties. This typically involves a defined number of test specimens (e.g., plates, screws) for each test type, but the exact quantity is not detailed in this summary.
Data Provenance: Not applicable in the context of clinical data for an AI device. The testing described is mechanical, performed on physical device samples.

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

Not applicable. This device is a metallic bone fixation system, and the "ground truth" for mechanical testing is established by recognized engineering standards (like ASTM F382) and FDA guidance, not by expert interpretation of images or clinical outcomes in the same way an AI diagnostic device would.

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

Not applicable. Mechanical testing results are objective measurements (e.g., force, displacement, cycles to failure) against predefined pass/fail criteria, not subjective human assessments requiring adjudication.

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:

No. This is a medical device for bone fixation, not an AI diagnostic tool. MRMC studies are used for evaluating diagnostic performance with and without AI assistance.

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

No. This is a physical implant system, not a software algorithm.

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

For mechanical performance: The ground truth refers to established engineering standards (ASTM F382) and FDA guidance for orthopedic implants. Performance is measured against physical properties like strength, fatigue resistance, and screw pullout force.

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable.

Summary of the Study Proving Device Meets Acceptance Criteria:

The study proving the TMC Implant Fixation System meets acceptance criteria was a series of mechanical performance tests. The primary testing included:

Static 4-point bend testing
Dynamic 4-point bend testing
Axial pullout testing

These tests were conducted in accordance with established standards:

ASTM F382 Standard Specification and Test Method for Metallic Bone Plates was used for the 4-point bend testing.
Modified acceptance criteria derived from the FDA Guidance for Orthopedic Non-Spinal Metallic Bone Screws and Washers – Performance Criteria for Safety and Performance Based Pathway (issued November 22, 2024) were used for the axial pullout testing.

The document states that "The testing and analysis demonstrated that the subject devices met all acceptance criteria and therefore are substantially equivalent to the predicate devices." This substantial equivalence determination suggests that the new device's mechanical performance is comparable to or better than that of the legally marketed predicate devices, thereby assuring its safety and effectiveness for its intended use.

Summary

FDA 510(k) Clearance Letter - TMC Implant Fixation System

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.08.00

August 21, 2025

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

Re: K251135
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: HRS, JDR, HWC
Dated: April 11, 2025
Received: April 14, 2025

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 (the 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 available 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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K251135 - Brittany Grochala Page 2

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-

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K251135 - Brittany Grochala Page 3

assistance/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,

CHRISTOPHER FERREIRA -S

Christopher Ferreira, M.S.
Assistant Director
DHT6C: Division of Restorative, Repair and Trauma Devices
OHT6: Office of Orthopedic Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

Page 4

Indications for Use

Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions.

K251135

Please provide the device trade name(s).

Treace Medical Concepts (TMC) Implant Fixation System

Please provide your Indications for Use below.

• Osteotomy of the 1st metatarsal for the treatment of deformity (e.g., hallux valgus) such as:

Opening base wedge osteotomy
Closing base wedge osteotomy
Crescentic osteotomy
Proximal Chevron osteotomy
Distal Chevron osteotomy (Austin)
Transverse osteotomy

• First metatarsal fracture fixation

• Flatfoot Osteotomies

Lateral Column Lengthening (Evans Osteotomy)
Plantar Flexion Opening Wedge Osteotomy of the Medial Cuneiform (Cotton Osteotomy)

• Mid / Flatfoot Fusions

LisFranc Arthrodesis and/or Stabilization
Intercuneiform Fusions
Navicular-Cuneiform (NC) Fusion
Talo-Navicular (TN) Fusion
Calcaneo-Cuboid (CC) Fusion

• Medial Column Fusion

Please select the types of uses (select one or both, as applicable).

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

TMC Implant Fixation System
Page 9 of 25
K251135

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TMC Implant Fixation System

Special 510(k) Premarket Notification

K251135

510(k) Summary

Treace Medical Concepts (TMC) Implant Fixation System

August 20, 2025

Company: Treace Medical Concepts, Inc.
100 Palmetto Park Place
Ponte Vedra, FL 32081
Establishment Registration: 3011623994

Primary Contact: Brittany Grochala, Senior Regulatory Affairs Specialist II
Phone: 515-865-0494
Fax: 904-834-7169
Email: bgrochala@treace.net

Secondary Contact: Kristina Hall, Sr. Director, Regulatory Affairs
Phone: 904-373-5940 ext. 1321
Fax: 904-834-7169
Email: khall@treace.net

Trade Name: Treace Medical Concepts (TMC) Implant Fixation System
Common Name: Primary: Plate, fixation, bone
Subsequent: Staple, fixation, bone; Screw, fixation, bone
Classification: Class II
Regulation Number: 21 CFR 888.3030
21 CFR 888.3040
Panel: 87- Orthopedic
Product Code(s): Primary: HRS
Subsequent: JDR, HWC

Predicate Device(s):
• Primary Predicate: TMC Plating System (S.E. K240173 02/22/2024)
• Additional Predicate: TMC Compression Implant System (S.E. K243658 S.E. 12/26/2024)

Device Description:

Page 1 of 3

Page 6

TMC Implant Fixation System

Special 510(k) Premarket Notification

K251135

The changes described in this submission do not impact reprocessing, sterility, shelf-life, and biocompatibility considerations in comparison to the predicate device. The software, cybersecurity, EMC, and wireless technology sections are not applicable to the subject device.

Indications for Use:

The TMC Implant Fixation System is intended for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of the feet. The system can be used in both pediatric (aged >12-21) and adult (aged 22 and over) patients. In the foot, the system can be used for the following specific examples:

• Osteotomy of the 1st metatarsal for the treatment of deformity (e.g., hallux valgus) such as:

Opening base wedge osteotomy
Closing base wedge osteotomy
Crescentic osteotomy
Proximal Chevron osteotomy
Distal Chevron osteotomy (Austin)
Transverse osteotomy

• First metatarsal fracture fixation

• Flatfoot Osteotomies

Lateral Column Lengthening (Evans Osteotomy)
Plantar Flexion Opening Wedge Osteotomy of the Medial Cuneiform (Cotton Osteotomy)

• Mid / Flatfoot Fusions

LisFranc Arthrodesis and/or Stabilization
Intercuneiform Fusions
Navicular-Cuneiform (NC) Fusion
Talo-Navicular (TN) Fusion
Calcaneo-Cuboid (CC) Fusion

• Medial Column Fusion

Substantial Equivalence:

The subject TMC Implant Fixation System is substantially equivalent to the following predicate devices:
• Primary Predicate: TMC Plating System (S.E. K240173 02/22/2024)
• Additional Predicate: TMC Compression Implant System (S.E. K243658 S.E. 12/26/2024)

The TMC Implant Fixation System is substantially equivalent to the primary predicate TMC Plating System (S.E. K240173 02/22/2024) based on similar intended use, materials, packaging, sterilization, and mechanical performance.

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.

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TMC Implant Fixation System

Special 510(k) Premarket Notification

K251135

Performance Testing:

Mechanical testing including static and dynamic 4-point bend testing based on ASTM F382 Standard Specification and Test Method for Metallic Bone Plates was completed between the subject and predicate device. Further, axial pullout testing was performed and was assessed with modified acceptance criteria derived from the FDA Guidance for Orthopedic Non-Spinal Metallic Bone Screws and Washers – Performance Criteria for Safety and Performance Based Pathway, issued November 22, 2024. The testing and analysis demonstrated that the subject devices met all acceptance criteria and therefore are substantially equivalent to the predicate devices.

Conclusion:

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

Page 3 of 3

Regulation Number and Section

N/A