The TMC Plating System is intended for use in stabilization of fresh fractures, joint fusion and reconstruction of small bones of the feet. The system can be used in both and pediatric patients aged > 12 years. In the foot, the system can be used for the following specific examples:

First metatarsal osteotomies for hallux valgus correction such as:
Opening base wedge osteotomy
· Closing base wedge osteotomy
· Crescentic osteotomy
· Proximal Chevron osteotomy
· Distal Chevron osteotomy (Austin)
First metatarsal fracture fixation
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
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-Cubiod (CC) Fusion
Medial Column Fusion

Device Description

The Treace Medical Concepts (TMC) Plating System includes straight, L-shaped, H- shaped, curved and Python plates and associated screws. The plates and screws are intended for use in stabilization and fixation of fractures, revision procedures, fusions, and reconstructions (osteotomy) of small bones of the foot.
The purpose of this special 510(k) is to clarify the indications for use for the Treace Medical Concepts (TMC) Plating System (K192504 and K200961).
All implantable components are manufactured from medical grade titanium alloy (Ti-6AI-4V-ELI) per ASTM F136 and are provided sterile by gamma irradiation.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the "Treace Medical Concepts (TMC) Plating System." It is a submission to the FDA seeking clearance to market a device that is demonstrably "substantially equivalent" to legally marketed predicate devices.

Crucially, this document focuses on demonstrating substantial equivalence through a clarification of 'indications for use' and states that 'performance testing was not required.' This implies that the device is a modification or re-statement of an existing cleared device, rather than an entirely new device requiring extensive new performance validation studies.

Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, which are typical for de novo device approvals or for devices requiring complex performance validation (e.g., AI/ML-based diagnostic devices), is not present in this document.

Here's an analysis based on the provided text:

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

Not applicable/Provided. The document states: "Performance testing was not required to support the clarification of the indications statement." The basis for clearance is "substantial equivalence" to predicate devices, not performance against specific acceptance criteria developed for a new device study.

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

Not applicable. No performance studies with test sets were conducted or reported in this document, as "Performance testing was not required."

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)

Not applicable. No ground truth establishment for a test set was performed or reported.

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

Not applicable. No test set adjudication was performed or reported.

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 device is a metallic bone fixation system, not an AI/ML-based diagnostic or assistive technology. Therefore, MRMC studies and AI-related effectiveness are irrelevant to this submission.

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

Not applicable. This is not an algorithm or software device.

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

Not applicable. No specific ground truth was established for performance testing as no such testing was required. The "ground truth" for this submission is effectively the established safety and effectiveness of the multiple predicate devices to which the TMC Plating System is demonstrated to be substantially equivalent.

8. The sample size for the training set

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

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

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

Summary of the document's approach to "proving" the device meets acceptance criteria:

The "acceptance criteria" in this context are not quantitative performance metrics from a new study, but rather the qualitative assessment of "substantial equivalence" to existing, legally marketed devices.

The "study that proves the device meets the acceptance criteria" in this case is a comparison to predicate devices and a risk analysis, as stated:

"The subject TMC Plating System is manufactured from titanium (Ti-6Al-4V-ELI) and is intended to be used in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the feet, identical to the predicate devices."
"Indications for use have been clarified and were found through a risk analysis including literature review to be equivalent to the predicate device."
"Thus, it can be concluded that the subject changes to the Indications for Use do not raise new questions about safety and effectiveness."
"The Treace Medical Concepts (TMC) Screw Fixation System has identical design and construction to the predicate devices. A risk analysis found that the Indications for Use statement remain substantially equivalent to those of the system in previous clearances. Therefore, it can be concluded that the subject device is as safe, as effective, and performs as safely and effectively as the predicate device."

In essence, the "proof" is the argument that the refined indications for use and the device's design and materials are so similar to previously cleared devices that no new performance testing is necessary to establish its safety and effectiveness.

Summary

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February 16, 2022

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and 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.

Treace Medical Concepts, Inc. % Dawn Norman Partner MRC Global, LLC 9085 E Mineral Circle, Suite 110 Centennial. Colorado 80112

Re: K220136

Trade/Device Name: Treace Medical Concepts (TMC) Plating 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. HWC Dated: January 14, 2022 Received: January 18, 2022

Dear Dawn Norman:

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

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gencies. You must comply with all the Act's

Page 2

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,

For: Shumaya Ali, M.P.H. 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

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Indications for Use

510(k) Number (if known) K220136

Device Name

Treace Medical Concepts (TMC) Plating System

Indications for Use (Describe)

First metatarsal osteotomies for hallux valgus correction such as:
Opening base wedge osteotomy
· Closing base wedge osteotomy
· Crescentic osteotomy
· Proximal Chevron osteotomy
· Distal Chevron osteotomy (Austin)
First metatarsal fracture fixation
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
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-Cubiod (CC) Fusion
Medial Column Fusion

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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510(k) Summary

Treace Medical Concepts (TMC) Plating System February 15, 2022

Company:	Treace Medical Concepts, Inc.203 Fort Wade Rd., Suite 150Ponte Vedra, FL 32081
Primary Contact:	Dawn NormanPartner, MRC GlobalPhone: 618-604-3064Dawn.Norman@askmrcglobal.com
Company Contact:	Kristina HallRegulatory Affairs DirectorTreace Medical Concepts, Inc.Phone: 904.373.5940khall@treace.net
Trade Name:	Treace Medical Concepts (TMC) Plating System
Common Name:	Plate, Fixation, BoneScrew, Fixation, Bone
Classification:	Class II
Regulation Number:	21 CFR 888.3030 (Single/multiple component metallic bonefixation appliances and accessories) (primary)21 CFR 888.3040 (Smooth or threaded metallic bone fixationfastener)
Panel:	87- Orthopedic
Product Code:	HRS; HWC
Primary Predicate:	K200961 TMC Plating System

Device Description:

The purpose of this special 510(k) is to clarify the indications for use for the Treace Medical Concepts (TMC) Plating System (K192504 and K200961).

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

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Indications for Use:

The TMC Plating System is intended for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the feet. The system can be used in both adult and pediatric patients aged >12 years. In the foot, the system can be used for the following specific examples:

First metatarsal osteotomies for hallux valgus correction such as:
· Opening base wedge osteotomy
Closing base wedge osteotomy
· Crescentic osteotomy
Proximal Chevron osteotomy
Distal Chevron osteotomy (Austin)
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-Cubiod (CC) Fusion
Medial Column Fusion

Substantial Equivalence:

The subject TMC Plating System is substantially equivalent to the predicate TMC Plating System previously cleared in K143717, K153531, K183321, K192504, and K200961.

The subject TMC Plating System is manufactured from titanium (Ti-6Al-4V-ELI) and is intended to be used in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the feet, identical to the predicate devices. Indications for use have been clarified and were found through a risk analysis including literature review to be equivalent to the predicate device. The subject TMC Plating System also shares similar geometry, and construction with the predicate devices.

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Thus, it can be concluded that the subject changes to the Indications for Use do not raise new questions about safety and effectiveness.

Performance Testing:

Performance testing was not required to support the clarification of the indications statement.

Conclusion:

The Treace Medical Concepts (TMC) Screw Fixation System has identical design and construction to the predicate devices. A risk analysis found that the Indications for Use statement remain substantially equivalent to those of the system in previous clearances. Therefore, it can be concluded that the subject device is as safe, as effective, and performs as safely and effectively as the predicate device.

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.