The TMC Hammertoe Fixation System is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe. Cannulated implants in the TMC Hammertoe Fixation System can be used with K-wires for the delivery of implants or the temporary stabilization of outlying joints (e.g. MTP Joint).

The Implantable K-Wires are indicated for use in fixation of bone reconstructions, and as guide pins for insertion of other implants. Additionally, Implantable K-Wires are indicated for the fixation of osteotomies and reconstruction of the lesser toe following correction procedures for hammertoe, claw toe, and metatarsophalangeal joint instability.

Device Description

The Treace Medical Concepts (TMC) Hammertoe Fixation System is for the fixation of osteotomies and reconstruction of the lesser toes. The cannulated implant is made of PEEK (Polyetheretherketone) according to ASTM F2026 and is available in different sizes. The implants are delivered sterile packaged and for single use only.

The Implantable K-wire is made from stainless steel according to ASTM F138 and available in different sizes. The k-wire is delivered sterile packaged and for single use only.

All implantable components are provided sterile by gamma irradiation.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the Treace Medical Concepts (TMC) Hammertoe Fixation System. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting new clinical studies to prove safety and effectiveness. Therefore, the information typically requested in your prompt regarding acceptance criteria and a study to prove the device meets these criteria is not directly applicable in the context of this 510(k) summary.

Instead, the submission focuses on performance testing to demonstrate that the new device is as safe and effective as the predicate devices. The "acceptance criteria" here implicitly refer to the mechanical properties required to be substantially equivalent to the predicate devices and conform to relevant ASTM standards.

Here's an attempt to structure the information based on your request, understanding that it's framed for a different type of submission (e.g., a de novo or PMA where new clinical data might be generated):

1. Table of Acceptance Criteria and Reported Device Performance

Performance Test (based on ASTM Standard)	Acceptance Criteria (Implicit: Substantial Equivalence to Predicate & Standard Conformance)	Reported Device Performance
Static and Dynamic Four-Point Bending (ASTM F382-17, Annex A1 and A2)	Device performance must be comparable to predicate devices and meet the specifications for bone fixation fasteners.	Evaluated to confirm substantial equivalence to predicate devices. (Specific values not provided in this summary)
Axial Pullout (ASTM F543-17, Annex A3)	Device performance must be comparable to predicate devices and meet the specifications for bone fixation fasteners.	Evaluated to confirm substantial equivalence to predicate devices. (Specific values not provided in this summary)
Static Torsion (ASTM F543-17, Annex A1)	Device performance must be comparable to predicate devices and meet the specifications for bone fixation fasteners.	Evaluated to confirm substantial equivalence to predicate devices. (Specific values not provided in this summary)
Driving Insertion and Removal Torque (ASTM F543-17, Annex A2)	Device performance must be comparable to predicate devices and meet the specifications for bone fixation fasteners.	Evaluated to confirm substantial equivalence to predicate devices. (Specific values not provided in this summary)
Material Conformance (PEEK implant)	ASTM F2026 for Polyetheretherketone (PEEK)	Manufactured according to ASTM F2026.
Material Conformance (Implantable K-wire)	ASTM F138 for Stainless Steel	Made from stainless steel according to ASTM F138.

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

Sample Size: Not explicitly stated. The performance testing for substantial equivalence typically involves a predetermined number of physical units subjected to mechanical tests, as per the ASTM standards referenced. This is not a patient-based "test set" in the sense of clinical data.
Data Provenance: The data provenance is from the mechanical testing performed by the manufacturer, Treace Medical Concepts, Inc. This is not clinical data (e.g., country of origin, retrospective/prospective).

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not Applicable: For a 510(k) submission based on mechanical testing for substantial equivalence, "ground truth" established by human experts in the clinical diagnostic sense is not involved. The "ground truth" for mechanical performance is defined by the relevant ASTM standards and the performance characteristics of the predicate devices.

4. Adjudication Method for the Test Set

Not Applicable: There is no clinical "test set" in need of adjudication. Mechanical testing results are compared against predefined criteria and predicate device performance.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No: An MRMC comparative effectiveness study is designed to assess the impact of a device on human reader performance, typically in the context of imaging or diagnostics. This is a surgical fixation device, and the submission is based on mechanical equivalence, not clinical diagnostic performance.

6. Standalone (Algorithm Only) Performance Study

No: This is a physical medical device (implants and K-wires), not an algorithm or AI-based system. Therefore, standalone algorithm performance is not relevant.

7. Type of Ground Truth Used

Mechanical Standards and Predicate Device Performance: The "ground truth" for this submission is adherence to established ASTM mechanical testing standards (e.g., F382-17, F543-17) and demonstrating performance comparable to the legally marketed predicate devices (In2Bones SAS, Duafit® interphalangeal implant (K132912) and Wright Medical Technology Inc., PRO-TOE® Hammertoe Fixation System (K140148)).

8. Sample Size for the Training Set

Not Applicable: There is no "training set" in the context of a 510(k) submission for a physical device. This terminology relates to machine learning models, which are not involved here.

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

Not Applicable: As there is no training set or machine learning involved, this question is not relevant.

Summary

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November 15, 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 & Human Services logo. To the right of that 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. % Danielle Besal Principal Consultant MRC Global 9085 E. Mineral Circle, Suite 110 Centennial, Colorado 80112

Re: K222564

Trade/Device Name: Treace Medical Concepts (TMC) Hammertoe 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: August 24, 2022 Received: August 24, 2022

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.

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,

Colin O'neill -S

Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal 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) K222564

Device Name Treace Medical Concepts (TMC) Hammertoe Fixation System

Indications for Use (Describe)

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 August 24, 2022

Company: Treace Medical Concepts, Inc. 203 Fort Wade Rd., Suite 150 Ponte Vedra, FL 32081
Primary Contact: Danielle Besal Principal Consultant, MRC Global Phone: 901-827-8670 Danielle.Besal@askmrcglobal.com

Company/Secondary Kristina Hall Contact: Director, Regulatory Affairs Treace Medical Concepts, LLC Phone: 904-373-5940 khall@treace.net

Trade Name: Treace Medical Concepts (TMC) Hammertoe Fixation System
Common Name: Screw, Fixation, Bone
- Classification: Class II
21 CFR 888.3040 Smooth or Threaded Metallic Bone Fixation Regulation Number: Fastener
- Panel: Orthopedic
- Product Code: HWC
- Primary Predicate: K132912 In2Bones SAS, Duafit® interphalangeal implant
Additional Predicate: K140148, Wright Medical Technology Inc., PRO-TOE® Hammertoe Fixation System

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Device Description:

The Implantable K-wire is made from stainless steel according to ASTM F138 and available in different sizes. The k-wire is delivered sterile packaged and for single use only.

All implantable components are provided sterile by gamma irradiation.

Indications for Use:

The TMC Hammertoe Fixation System is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe. Cannulated implants in the TMC Hammertoe Fixation System can be used with Kwires for the delivery of implants or the temporary stabilization of outlying joints (e.g., MTP Joint).

The Implantable K-Wires are indicated for use in fixation of bone fractures, for bone reconstructions, and as guide pins for insertion of other implants. Additionally, Implantable K-Wires are indicated for the fixation of osteotomies and reconstruction of the lesser toe following correction procedures for hammertoe, claw toe, mallet toe, and metatarsophalangeal ioint instability.

Substantial Equivalence:

The subject TMC Hammertoe Fixation System is substantially equivalent to the predicate In2Bones SAS, Duafit® interphalangeal implant (K132912) and Wright Medical Technology Inc., PRO-TOE® Hammertoe Fixation System (K140148).

The subject device, TMC Hammertoe Fixation System, is comprised of polyetheretherketone (PEEK) implant, stainless steel k-wires for implantation, and stainless steel bone preparation instruments. The system is provided sterile by gamma irradiation. The PEEK implant is manufactured according to the surgical specification requirements of ASTM F2026. The implantable k-wires are made from stainless steel according to ASTM F138.

The components are equivalent in intended use, indication for use, geometry, design, materials, and mechanical performance. Thus, it can be concluded that the subject does not raise new questions about safety and effectiveness.

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Performance Testing:

The TMC Hammertoe Fixation System geometry, materials, and mechanical properties (Static and Dynamic Four-Point Bending per ASTM F382-17, Annex A1 and A2, Axial Pullout per ASTM F543-17, Annex A3, Static Torsion per ASTM F543-17, Annex A1, and Driving Insertion and Removal Torque per ASTM F543-17, Annex A2,) have been evaluated to confirm substantial equivalence to the predicate devices.

Conclusion:

The subject TMC Plating System is substantially equivalent to the predicates, In2Bones SAS, Duafit® interphalangeal implant (K132912) and Wright Medical Technology Inc., PRO-TOE® Hammertoe Fixation System (K140148).

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.