# K124045: Fuseforce Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Solana Surgical, LLC
- Decided: Jul 10, 2013 after 191 days
- Product code: JDR (Staple, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K902307 (1990). 4 ancestors in all.
29 later devices descend from it; 6 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070031: Memometal Memory Staples, Memometal Technologies (2007) Summary page 1.

## Most influential descendants
- K203832: FuseForce™ Flex Dynamic Compression System (2021), 8 descendants of its own
- K142727: CrossCLIP Implant System (2014), 8 descendants of its own
- K222645: Treace Medical Concepts (TMC) Implant Fixation System (2022), 6 descendants of its own
- K181410: MotoCLIP/HiMAX Implant System (2018), 6 descendants of its own
- K232387: Treace Medical Concepts (TMC) Compression Implant System (2023), 4 descendants of its own

## Indications for use
The Solana Surgical, LLC FuseForce Implant System is intended to provide fixation for fractures, fusions or osteotomies of the bones of the hand and foot such as: LisFrane arthradesis, Akin Osteotomy, Scarf and Chevron osteotomies

Source page: https://510kreport.com/device/K124045
Methodology: https://510kreport.com/methodology