# K203832: FuseForce™ Flex Dynamic Compression System

- Pathway: 510(k) (Traditional)
- Applicant: Wright Medical
- Decided: May 7, 2021 after 128 days
- Product code: JDR (Staple, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K902307 (1990). 5 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K124045: Fuseforce Implant System, Solana Surgical, LLC (2013) Summary page 4.

## Most influential descendants
- K222645: Treace Medical Concepts (TMC) Implant Fixation System (2022), 6 descendants of its own
- K232387: Treace Medical Concepts (TMC) Compression Implant System (2023), 4 descendants of its own
- K242415: TMC Compression Implant System (2024), 3 descendants of its own
- K243658: TMC Compression Implant System (2024), 2 descendants of its own
- K251135: Treace Medical Concepts (TMC) Implant Fixation System (2025), 1 descendant of its own

## Recalls of this device
- Mar 10, 2022 · Class II · Z-0853-2022: The drill and adjustable drill guide can jam/bind intraoperatively resulting in the drill guide breaking.

## Indications for use
The FuseForce™ Flex Dynamic Compression System is intended to be used for fracture fixation, osteotomy fixation, and joint arthrodesis of the foot and ankle.

Source page: https://510kreport.com/device/K203832
Methodology: https://510kreport.com/methodology