Class Class II
Treace Medical Concepts (TMC) Plating System (K221181)
Description
Treace Medical Concepts (TMC) Plating System by Treace Medical Concepts, Inc., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK221181
Clearance Date2023-01-05
Clearance TypeTraditional
Product CodeHRS
Regulation Number888.3030
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K221181
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) Plating System (K221181) cites 3 predicate devices and is itself cited by 2 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K220136 | Treace Medical Concepts (TMC) Plating System | Treace Medical Concepts, Inc. | 2022 |
| K181872 | MIS Bunion System | Crossroads Extremity Systems, LLC | 2019 |
| K101962 | MINI MAXLOCK EXTREME PLATING SYSTEM | Orthohelix Surgical Designs, Inc. | 2010 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K240173 | Treace Medical Systems (TMC) Plating System | Treace Medical Concepts, Inc. | 2024 |
| K233154 | SkyOPS™ Orthopedic Plate System | Sky Surgical, LLC | 2023 |
Trace the full predicate network for K221181
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.