Class Class II
TMC Compression Implant System (K243658)
Description
TMC Compression Implant System by Treace Medical Concepts, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243658
Clearance Date2024-12-26
Clearance TypeSpecial
Product CodeJDR
Regulation Number888.3030
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243658
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. TMC Compression Implant System (K243658) cites 2 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K242415 | TMC Compression Implant System | Treace Medical Concepts | 2024 |
| K122113 | MEMORY METAL STAPLES, EASYCLIP | Stryker Corp. | 2013 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K251135 | Treace Medical Concepts (TMC) Implant Fixation System | Treace Medical Concepts | 2025 |
Trace the full predicate network for K243658
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.