# K013430: Ace Bio Win Tibial Nailing System

- Pathway: 510(k) (Traditional)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Dec 17, 2001 after 62 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: 1 generation back to K914453 (1992). 3 ancestors in all.
48 later devices descend from it; 1 cites it directly.
0 of 52 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972183: Depuy Ace a.I.M. Titanium Tibial Nail, Ace Medical Co. (1997) Summary page 1.
- K914453: Universal Tibial Nail and Unreamed Tibial Nail, Synthes (Usa) (1992) Summary page 1.
- K001581: Lactosorb 5.0 MM Washer, Biomet, Inc. (2001) Summary page 1.

## Most influential descendants
- K032097: Depuy Ace Versanail Tibial Nail (2003), 47 descendants of its own
- K082770: Zimmer Natural Nail System Tibial Nail (2008), 35 descendants of its own
- K180436: T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System (2018), 16 descendants of its own
- K191271: T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws System, IMN Instruments System (2019), 15 descendants of its own
- K080706: Connexx Locking Tibia Nail (2008), 11 descendants of its own

## Indications for use
The ACE BioWin Tibial Nailing System is indicated in reamed and unreamed applications for internal fixation of tibial fractures including transverse fractures, oblique fractures, spiral fractures, segmental fractures, comminuted fractures, fractures with bone loss, bone transport, open fractures, corrective osteotomies, pathologic fractures, pseudoarthrosis of the tibial shaft, nonunions, malunions, metaphyseal fractures and epiphyseal fractures.

Source page: https://510kreport.com/device/K013430
Methodology: https://510kreport.com/methodology