# K243907: Affixus Tibial Nailing System - 4mm screws

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Feb 12, 2025 after 55 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)
- K241651: Affixus Tibial and Antegrade Femoral Nailing System, Zimmer, Inc. (2024) Summary page 5.
- K142281: Zimmer M/DN Intramedullary Fixation System, Zimmer, Inc. (2014) Summary page 5.
- K082770: Zimmer Natural Nail System Tibial Nail, Zimmer, Inc. (2008) Summary page 5.
- K063570: Biomet Tibial Locking Nail System, Biomet Manufacturing Corp (2007) Summary page 5.

## Indications for use
The Affixus® Tibial Nailing System is indicated for temporary stabilization and fixation of tibial fractures and osteotomies including proximal, metaphyseal, and distal shaft fractures, closed fractures, open fractures, pathologic fractures, non-unions, malunions and deformity corrections.

Source page: https://510kreport.com/device/K243907
Methodology: https://510kreport.com/methodology