# K150867: Affixus Tibial Nailing System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Jun 10, 2015 after 70 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: 4 generations back to K951740 (1995). 17 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063570: Biomet Tibial Locking Nail System, Biomet Manufacturing Corp (2007) Summary page 4.
- K032097: Depuy Ace Versanail Tibial Nail, DePuy Orthopaedics, Inc. (2003) Summary page 4.
- K061019: Trigen Meta-Nail Retrograde Femoral and Tibial Nails, Smith & Nephew, Inc. (2006) Summary page 4.

## Most influential descendants
- K231266: Pediatric Nailing Platform  Tibia (2023), 2 descendants of its own
- K250623: Pediatric Nailing Platform  Tibia Pediatric Nailing Platform  Femur (2025), 1 descendant of its own
- K261345: Pediatric Nailing Platform  Femur (2026), 0 descendants of its own

## Indications for use
Indicated for alignment, stabilization, and fixation of fractures caused by trauma or disease, and the fixation of long bones that have been surgically prepared (osteotomy) for correction of deformity and for arthrodesis. This includes transverse fractures, oblique fractures, spiral fractures, segmental fractures, comminuted fractures, open fractures, pathologic fractures, metaphyseal fractures and fractures with bone loss, prophylactic fixation of impending fractures, pseudoarthrosis of the tibial shaft, bone transport, nonunions, malunions, and corrective osteotomies.

Source page: https://510kreport.com/device/K150867
Methodology: https://510kreport.com/methodology