Treace Medical Concepts (TMC) Implant Fixation System (K251135)
Description
Treace Medical Concepts (TMC) Implant Fixation System by Treace Medical Concepts, an FDA 510(k) cleared orthopedic device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K251135
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Treace Medical Concepts (TMC) Implant Fixation System (K251135) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K243658 | TMC Compression Implant System | Treace Medical Concepts | 2024 |
| K240173 | Treace Medical Systems (TMC) Plating System | Treace Medical Concepts, Inc. | 2024 |
Trace the full predicate network for K251135
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.