# K032097: Depuy Ace Versanail Tibial Nail

- Pathway: 510(k) (Special)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Aug 8, 2003 after 31 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: 2 generations back to K914453 (1992). 4 ancestors in all.
47 later devices descend from it; 6 cite 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)
- K013430: Ace Bio Win Tibial Nailing System, DePuy Orthopaedics, Inc. (2001)

## Most influential descendants
- 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
- K132945: CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral Nail (2014), 10 descendants of its own

## Indications for use
The Tibial Nail is intended for bone fixation in the management of fractures and reconstructive surgeries. Non-weight bearing bone fixation is indicated in the following conditions: Transverse, oblique, spiral, segmental and comminuted fractures; Fractures with bone loss and bone transport; Open fractures, pathologic fractures; Corrective osteotomies; Pseudarthrosis of the tibial shaft; Nonunions, malunions, metaphyseal and epiphyseal fractures.

Source page: https://510kreport.com/device/K032097
Methodology: https://510kreport.com/methodology