The TMC Plating System is intended for use in stabilization of fresh fractures, joint fusion and reconstruction of small bones of the system can be used in both adult and pediatric patients. 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 first metatarsalcuneiform joint (Lapidus Fusion)
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
- 1st (Lapidus), 2nd, 3rd, 4th, and 5th Tarsometatarsal (TMT) Fusions
- Intercuneiform Fusions
- Navicular-Cuneiform (NC) Fusion
- Talo-Navicular (TN) Fusion
- Calcaneo-Cubiod (CC) Fusion
Medial Column Fusion
Arthrodesis of the first metatarsophalangeal joint (MTP)

Device Description

The previously cleared Treace Medical Concepts (TMC) Plating System includes straight, Lshaped, H- shaped, and Python plates and 2.5mm-3.0mm diameter screws in lengths ranging from 10-32mm. 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) submission is to add the Lapiplasty® Mini-Incision™ Plates to the TMC Plating System. The subject plates are based on the design of the previously cleared Lapiplasty® S1 Plate (K192504). The subject plates are used with the same screws as the predicate plate.

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

AI/ML Overview

This document describes a 510(k) premarket notification for the Treace Medical Concepts (TMC) Plating System, specifically an update to include Lapiplasty® Mini-Incision™ Plates. The submission aims to demonstrate substantial equivalence to a previously cleared predicate device (K192504).

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the traditional sense of a performance target with a specific threshold. Instead, it relies on demonstrating substantial equivalence to a predicate device through bench testing and engineering analysis. The "performance" is reported as the subject device being substantially equivalent to the predicate.

Acceptance Criterion (Implicit)	Reported Device Performance
Dynamic 4-point bend performance (per ASTM F382) equivalent to predicate.	"Dynamic 4-point bend testing has been performed per ASTM F382 on the subject plates. The results have shown subject device to be substantially equivalent to the primary predicate."
Static 4-point bend performance equivalent to predicate.	"Additionally, an engineering analysis of the subject device concluded that its performance with respect to static 4-point bend testing is equivalent to the predicate device. Thus, the addition of these plates does not present a new worst case with respect to static or dynamic 4-point bend testing."

2. Sample Size Used for the Test Set and Data Provenance

The study described is bench testing and engineering analysis of the physical device components.

Sample Size for Test Set: Not explicitly stated as "sample size" in the context of patient data. For bench testing (e.g., dynamic 4-point bend), a certain number of plates would have been tested. This number is not provided, but standard ASTM F382 testing protocols would dictate the number of samples.
Data Provenance: The data originates from laboratory bench testing and engineering analysis, rather than human subjects. Therefore, "country of origin of the data" and "retrospective or prospective" are not applicable in the typical clinical study sense. It's a prospective engineering evaluation of the manufactured device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This is not a study involving human interpretation of medical images or data requiring expert consensus for ground truth. The "ground truth" for material properties and mechanical performance is established by the standardized methods of ASTM F382 and engineering principles.

4. Adjudication Method for the Test Set

Not applicable. There is no ambiguous data requiring adjudication by multiple experts. The tests are mechanical and analytical, yielding objective measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The submission focuses on the mechanical substantial equivalence of a medical device (surgical plates) through bench testing, not on the interpretative performance of human readers with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a physical medical device (surgical plates), not an algorithm or AI software. Therefore, the concept of "standalone performance" for an algorithm is not relevant.

7. The Type of Ground Truth Used

The "ground truth" for the performance claims is based on standardized biomechanical testing methods (ASTM F382) and engineering principles/analysis which predict and measure the mechanical properties of the plates. The "ground truth" is the empirically measured mechanical characteristics and the theoretical predictions from engineering models.

8. The Sample Size for the Training Set

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

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set (for AI/ML) was used or is relevant to this device submission.

Summary

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May 8, 2020

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue and "ADMINISTRATION" in a smaller font size below.

Treace Medical Concepts, Inc. % Danielle Besal Principal Consultant MRC Global 9085 East Mineral Circle, Suite Centennial, Colorado 80112

Re: K200961

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: April 8, 2020 Received: April 10, 2020

Dear Danielle Besal:

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 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.

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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K200961

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 first metatarsalcuneiform joint (Lapidus Fusion)
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
- · 1st (Lapidus), 2nd, 3rd, 4th, and 5th Tarsometatarsal (TMT) Fusions
- · Intercuneiform Fusions
- · Navicular-Cuneiform (NC) Fusion
- · Talo-Navicular (TN) Fusion
- Calcaneo-Cubiod (CC) Fusion
Medial Column Fusion
Arthrodesis of the first metatarsophalangeal joint (MTP)

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 May 7, 2020

Company:	Treace Medical Concepts, Inc.203 Fort Wade Rd., Suite 150Ponte Vedra, FL 32081
Primary Contact:	Danielle BesalPrincipal Consultant, MRC GlobalPhone: 901-827-8670Danielle.Besal@askmrcglobal.com
Company/Secondary Contact:	Rachel OsbeckVP, Quality Assurance & Regulatory AffairsTreace Medical Concepts, LLCPhone: 904.373.5940 Ext. 1304rosbeck@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)21 CFR 888.3040 (Smooth or threaded metallic bone fixationfastener)
Panel:	87- Orthopedic
Product Code:	HRS and HWC
Primary Predicate:	K192504 Treace Medical Concepts (TMC) Plating System

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Device Description:

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

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. 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 first metatarsalcuneiform joint (Lapidus Fusion)
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
- 1st (Lapidus), 2nd, 3rd, 4th, and 5th Tarsometatarsal (TMT) Fusions
- Intercuneiform Fusions
- Navicular-Cuneiform (NC) Fusion
- Talo-Navicular (TN) Fusion
- Calcaneo-Cubiod (CC) Fusion
Medial Column Fusion
Arthrodesis of the first metatarsophalangeal joint (MTP)

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Substantial Equivalence:

The subject TMC Plating System is substantially equivalent to the predicate Treace Medical Concepts (TMC) Plating System (K192504, S.E. 10/30/2019).

The subject plates are manufactured from titanium (Ti-6Al-4V-ELI) and are 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 not changed and are identical to the predicate device. The subject plates also share similar geometry and construction with the predicate plate. Thus, it can be concluded that the subject does not raise different questions about safety and effectiveness.

Performance Testing:

Dynamic 4-point bend testing has been performed per ASTM F382 on the subject plates. The results have shown subject device to be substantially equivalent to the primary predicate. Additionally, an engineering analysis of the subject device concluded that its performance with respect to static 4-point bend testing is equivalent to the predicate device. Thus, the addition of these plates does not present a new worst case with respect to static or dynamic 4-point bend testing.

Conclusion:

The Treace Medical Concepts (TMC) Plating System has identical intended use, similarities in design and construction, and equivalent performance to the predicate device as demonstrated through bench testing and engineering analysis. Therefore, it can be concluded that the subject device is as safe, as effective, and performs at least 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.