# K253566: Affixus Retrograde Femoral Nailing System

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Mar 12, 2026 after 115 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: 9 generations back to K970097 (1997). 42 ancestors in all.
No later device cites it as a predicate yet.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072161: Biomet Femoral Locking Nail System, Biomet Manufacturing Corp (2007) Summary page 5.
- K101622: Zimmer Natural Nail System Retrograde Femoral Nails, Zimmer, Inc. (2010) Summary page 5.
- K241651: Affixus Tibial and Antegrade Femoral Nailing System, Zimmer, Inc. (2024) Summary page 5.

## Indications for use
The Affixus Retrograde Femoral Nailing System is indicated for: • Compound and simple shaft fractures • Proximal, metaphyseal and distal shaft fractures • Segmental fractures • Closed supracondylar fractures • Severely comminuted supracondylar fractures with articular involvement • Fractures involving femoral condyles • Comminuted fractures • Fractures involving osteopenic and osteoporotic bone • Pathological fractures • Fractures with bone loss • Pseudoarthrosis, non union, and mal union • Periprosthetic fractures • Poly trauma patients

Source page: https://510kreport.com/device/K253566
Methodology: https://510kreport.com/methodology