FDA 510(k)

Treace Medical Concepts (TMC) Implant Fixation System

K-Number: K251135 · 2025-08-21

Decision Date2025-08-21

Product CodeHRS

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Treace Medical Concepts (TMC) Implant Fixation System is a medical device manufactured by Treace Medical Concepts. It received FDA 510(k) clearance on 2025-08-21 under approval number K251135. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Treace Medical Concepts (TMC) Implant Fixation System?

Treace Medical Concepts (TMC) Implant Fixation System is a medical device that received FDA 510(k) clearance on 2025-08-21. It is manufactured by Treace Medical Concepts. The 510(k) number is K251135.

When was Treace Medical Concepts (TMC) Implant Fixation System approved by the FDA?

Treace Medical Concepts (TMC) Implant Fixation System received FDA 510(k) clearance on 2025-08-21, under approval number K251135.

What company makes Treace Medical Concepts (TMC) Implant Fixation System?

Treace Medical Concepts (TMC) Implant Fixation System is manufactured by Treace Medical Concepts.

What is the FDA product code for Treace Medical Concepts (TMC) Implant Fixation System?

The FDA product code for Treace Medical Concepts (TMC) Implant Fixation System is HRS.

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Related PubMed Literature

PMID: 42181028 Systematic biocompatibility assessment of 4-µm surface silicone implants. Biomaterials and biosystems (2026) PMID: 42175114 Make Open Source Compliant: Validation in Non-Interventional Clinical Studies. Studies in health technology and informatics (2026) PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 42056377 Signal detection of adverse events in medical devices using natural language processing: a case study in pelvic mesh. Scientific reports (2026)

Other Devices by Treace Medical Concepts

K222645Treace Medical Concepts (TMC) Implant Fixation System K232387Treace Medical Concepts (TMC) Compression Implant System K243658TMC Compression Implant System K242415TMC Compression Implant System

Related Devices (Code: HRS)

K163086VLP MINI-MOD 2.0mm Column PlatesSmith & Nephew, Inc. K162829Medline UNITE® Ankle Fracture Plating SystemMedline Industries, Inc. K162974Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation K163007Biomet Microfixation SternaLock 360 Sternal Closure SystemBiomet Microfixation K161696aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5Aap Implantate AG K161747LOQTEQ® VA Distal Tibia Plate System: LOQTEQ® VA Distal Medial Tibia Plate 3.5; LOQTEQ® VA Distal Anterolateral Tibia Plate 3.5; LOQTEQ® VA Distal Fibula Plate 2.7/3.5Aap Implantate AG

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.