TMC Compression Implant System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K242415 FDA 510(k)
- FDA Product Code
- JDR FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3030 FDA 510(k)
- Regulation Number
- 888.3030 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The TMC Compression Implant System is a spinal fixation device designed for orthopedic applications, providing dynamic compression across fusion sites. Constructed from titanium alloy implants (ASTM F136 compliant), it includes locking screws and modular components in varying bridge lengths, leg lengths, and cross-sections to match anatomical requirements.
This system is intended for surgical use in controlled environments and is supplied sterile for single-use. It is classified under FDA 510(k) clearance (K242415) as substantially equivalent to a predicate device, with no third-party review. Implants are available in multiple configurations to accommodate specific procedural needs, adhering to orthopedic fixation standards.
Frequently asked questions
What types of spinal procedures is the TMC Compression Implant System designed to support, and how does its modularity help in surgery?
The TMC Compression Implant System is designed for spinal fixation in orthopedic applications, specifically to provide dynamic compression across fusion sites. Its modularity—offering varying bridge lengths, leg lengths, and cross-sections—allows surgeons to customize the implant to match the patient’s anatomy, ensuring a precise fit and stable fixation during procedures like spinal arthrodesis or decompression surgeries.
Is the TMC Compression Implant System intended for reuse, or is it meant to be used once and then discarded?
The TMC Compression Implant System is supplied sterile and explicitly labeled for single-use only. This ensures patient safety and reduces the risk of infection or contamination from repeated sterilization processes, aligning with best practices for orthopedic implants.
What materials are used in the construction of the TMC Compression Implant System, and why does this matter for spinal surgery?
The system is constructed from titanium alloy implants compliant with ASTM F136, a standard for orthopedic devices. Titanium is favored in spinal surgery for its biocompatibility, corrosion resistance, and strength-to-weight ratio, which minimize the risk of adverse reactions and ensure long-term stability in the body.
How should the TMC Compression Implant System be stored before use, and what precautions should be taken?
Since the system is supplied sterile for single-use, it should be stored in its original, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures. The packaging must remain intact until immediately before use to preserve sterility and prevent contamination, as required for surgical implants.
What distinguishes the regulatory pathway for the TMC Compression Implant System, and how does this affect its availability?
The TMC Compression Implant System received FDA 510(k) clearance (K242415) under a *Special* clearance type, determined to be substantially equivalent to a predicate device without third-party review. This means it has met FDA requirements for safety and effectiveness as an orthopedic spinal fixation device, allowing it to be legally marketed and used in the U.S. without additional regulatory hurdles beyond standard compliance.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Products - Treace Medical Concepts, PDF Treace Medical Concepts Implant Fixation System - Compression Implant ..., PDF Treace Medical Concepts Compression Implant System - Lapiplasty
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K242415 | Class II | Active |
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Manufacturer
- Manufacturer
- Treace Medical Concepts
Sources (1)
- FDA 510(k) K242415 24 fields · synced Sep 19, 2026