# K102577: Force Medical IM Nail System

- Pathway: 510(k) (Traditional)
- Applicant: Force Medical, Inc.
- Decided: May 3, 2012 after 603 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- 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 K982953 (1998). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051590: T2 Ankle Arthrodesis Nail, Howmedica Osteonics Corp. (2005) Summary page 1.
- K020384: T2 Arthrodesis Nail System, Howmedica Osteonics Corp. (2002) Summary page 1.
- K091976: Biomet Phoenix Ankle Nail and Ankle Arthrodesis Nail, Biomet Trauma (2009) Summary page 1.
- K081243: Biomet Phoenix Ankle Nail System, Biomet Trauma (2008) Summary page 1.
- K110552: Valor (R) Ankle Fusion Nail System Screw, Wrightmedicaltechnologyinc (2011). Cleared while this submission was under review Summary page 1.

## Indications for use
The Force Medical IM Nail is intended for tibiotalocalcaneal (TTC) arthrodesis (fusion) and to provide stabilization of the hindfoot and ankle including the transverse tarsal joints coupling the mid-foot to the hindfoot. Indications for use include: > Posttraumatic and primary Arthrosis > Neuromuscular deformity > Revision of Failed Ankle Arthrodesis > Failed Total Ankle Replacement > Avascular Necrosis of the Talus (requiring tibiocalcaneal arthrodesis) > Neuroarthropathy (Charcot) > Rheumatoid Arthritis with severe deformity > Osteoarthritis > Pseudarthrosis

Source page: https://510kreport.com/device/K102577
Methodology: https://510kreport.com/methodology