The Treace Medical Concepts (TMC) Screw Fixation System is intended for use for adult and pediatric patients aged >12 years, and indicated for small or long bones requiring fixation of fracture repair, revision procedures, joint fusions (arthrodesis), bone reconstructions, osteotomy, ligament fixation, and pseudoarthrosis (non-unions) of bones, including scaphoid and other carpal bones, metacarpals, tarsals, phalanges, patella, ulnar styloid, capitellum, radial head and radial styloid.

In the foot, the following specific examples are indicated with screws appropriate for the size of the device:

· mono or bicortical osteotomies
· distal or proximal metatarsal osteotomies
· weil osteotomy
· fusion of the metatarsalphalangeal joint
· fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.)
· Akin type osteotomy
· talonavicular fusions
cuboid fusions

Not for spinal use.

Device Description

Treace Medical Concepts (TMC) Screw Fixation System includes headed and headless cannulated screws. The TMC Screw Fixation System is intended for use for adult and pediatric patients aged >12 years, and indicated for small or long bones requiring fixation of fractures, fracture repair, revision procedures, joint fusions (arthrodesis), bone reconstructions, osteotomy, ligament fixation, and pseudoarthrosis (non-unions) of bones, including scaphoid and other carpal bones, metacarpals, tarsals, metatarsals, phalanges, patella, ulnar styloid, capitellum, radial head and radial styloid, appropriate for the size of the device.

The purpose of this special 510(k) submission is to add a new non-cannulated screw option known as the Rapid Insertion Implant System.

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

The provided text does not contain information about an AI device or a study proving its acceptance criteria. Instead, it is an FDA 510(k) clearance letter for the Treace Medical Concepts (TMC) Screw Fixation System, which is a traditional medical device (bone fixation fastener).

Therefore, I cannot provide the requested information regarding acceptance criteria and studies for an AI device. The document describes performance testing for a non-AI medical device through bench testing in accordance with ASTM F543.

Here's the information about the acceptance criteria and study as presented in the document for the Treace Medical Concepts (TMC) Screw Fixation System (a non-AI device):

Acceptance Criteria and Device Performance for Treace Medical Concepts (TMC) Screw Fixation System

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance
Torque To Failure and Insertion & Removal Torque	Met all acceptance criteria (specific criteria not detailed in the provided text)	Demonstrated
Axial Pullout - Driver Disengagement	Met all acceptance criteria (specific criteria not detailed in the provided text)	Demonstrated
Axial Pullout - Bone Screw Disengagement	Met all acceptance criteria (specific criteria not detailed in the provided text)	Demonstrated

Note: The specific numerical acceptance criteria and performance results are not detailed in the provided FDA clearance letter. The letter states that "Testing demonstrated that the subject screws met all acceptance criteria" and are "considered substantially equivalent to the predicate screws."

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

Sample Size: Not specified in the provided text.
Data Provenance: The testing was "bench testing," meaning it was conducted in a laboratory setting, not using human or animal clinical data. The data provenance is a controlled laboratory environment.

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

This information is not applicable as the testing was physical bench testing against engineering standards (ASTM F543), not expert-driven evaluation of medical data.

4. Adjudication method for the test set:

Not applicable for bench testing. The evaluation is based on meeting predefined engineering and performance specifications outlined in ASTM F543.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size:

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI devices or diagnostic tools where human interpretation of medical images or data is involved. The TMC Screw Fixation System is a physical implant, and its performance is evaluated through mechanical testing.

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

Not applicable. This device is not an algorithm or an AI product.

7. The type of ground truth used:

The "ground truth" for this device's performance testing was adherence to established industry standards and mechanical properties as defined by ASTM F543. The device's performance was compared against the predicate device to establish substantial equivalence.

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. This is not an AI/machine learning device.

Summary

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October 21, 2021

Treace Medical Concepts, Inc. % Danielle Besal Principal Consultant MRC Global, LLC 9085 E Mineral Circle, Suite 110 Centennial. Colorado 80112

Re: K213036

Trade/Device Name: Treace Medical Concepts (TMC) Screw Fixation System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: September 20, 2021 Received: September 21, 2021

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 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.

Shumaya Ali, MPH 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) K213036

Device Name

Treace Medical Concepts (TMC) Screw Fixation System

Indications for Use (Describe)

In the foot, the following specific examples are indicated with screws appropriate for the size of the device:

· mono or bicortical osteotomies
· distal or proximal metatarsal osteotomies
· weil osteotomy
· fusion of the metatarsalphalangeal joint
· fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.)
· Akin type osteotomy
· talonavicular fusions
cuboid fusions

Not for spinal use.

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) Screw Fixation System
October 21, 2021
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 Contact:	Kristina HallRegulatory Affairs DirectorTreace Medical Concepts, Inc.Phone: 904.373.5940khall@treace.net
Trade Name:	Treace Medical Concepts (TMC) Screw Fixation System
Common Name:	Screw, Fixation, Bone
Classification:	Class II
Regulation Number:	21 CFR 888.3040 (Smooth or threaded metallic bone fixation fastener)
Panel:	87- Orthopedic
Product Code:	HWC
Primary Predicate:	K172617 TMC Compression Screw System

Device Description:

The purpose of this special 510(k) submission is to add a new non-cannulated screw option known as the Rapid Insertion Implant System.

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

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K213036

Indications for Use:

The Treace Medical Concepts (TMC) Screw Fixation System is intended for use for adult and pediatric patients aged >12 years, and indicated for small or long bones requiring fixation of fractures, fracture repair, revision procedures, joint fusions (arthrodesis), bone reconstructions, osteotomy, ligament fixation, and pseudoarthrosis (non-unions) of bones, including scaphoid and other carpal bones, metacarpals, tarsals, phalanges, patella, ulnar styloid, capitellum, radial head and radial styloid.

In the foot, the following specific examples are indicated with screws appropriate for the size of the device:

. mono or bicortical osteotomies
distal or proximal metatarsal osteotomies
. weil osteotomy
fusion of the metatarsalphalangeal joint
fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.)
Akin type osteotomy
talonavicular fusions
. cuboid fusions

Not for spinal use.

Substantial Equivalence:

The subject TMC Screw Fixation System is substantially equivalent to the predicate Treace Medical Concepts (TMC) Compression Screw System (K172617).

The subject screws 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 been slightly modified to very clearly state the age range of the patient population. The patient population has not changed. The subject screws also share similar geometry and construction with the predicate.

Thus, it can be concluded that the subject does not raise new questions about safety and effectiveness.

Performance Testing:

The following performance testing has been completed in accordance with ASTM F543:

Torque To Failure and Insertion & Removal Torque
. Axial Pullout - Driver Disengagement
Axial Pullout - Bone Screw Disengagement

Testing demonstrated that the subject screws met all acceptance criteria and can be considered substantially equivalent to the predicate screws.

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K213036

Conclusion:

The Treace Medical Concepts (TMC) Screw Fixation 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

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.