# K023115: Ace Versanail

- Pathway: 510(k) (Traditional)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Dec 18, 2002 after 90 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 K974781 (1998). 5 ancestors in all.
41 later devices descend from it; 7 cite it directly.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974781: Depuy Ace Aim (R) Titanium Supracondylar Nail, Depuy, Inc. (1998) Summary page 1.
- K003797: Ace Aim TTC Fusion Nail, DePuy Orthopaedics, Inc. (2000)
- K982953: Titanium Intramedullary Nails-Various Styles, Biomet, Inc. (1998) Summary page 1.
- K991790: Ultimax Ankle Fusion Rod System, Encore Orthopedics, Inc. (1999) Summary page 1.
- K983942: Intramedullary Nail System, Locking Screw, Nail Cap, Smith & Nephew, Inc. (1998) Summary page 1.

## Most influential descendants
- K101934: Dynnail, 12MM, Locking Screw, 4.6 MM, Deployment Frame, Dynnail, Models 1200-01-1222, 1200-02-46XX, 2200-01-0000 (2011), 25 descendants of its own
- K113828: Dynanail Ankle Arthrodesis Nail (2012), 24 descendants of its own
- K171376: DynaNail TTC Fusion System (2017), 22 descendants of its own
- K050882: Newdeal Ankle Nail (2005), 15 descendants of its own
- K091788: Panta Nail (Dia. 10MM), Panta Nail XL (2009), 14 descendants of its own

## Indications for use
The VersaNail is intended for use in tibiotalocalcaneal fusions and treatment of trauma to the hindfoot and distal tibia. Indications include: revision after failed ankle arthrodesis with subtalar involvement; absent talus (tibiocalcaneal arthrodesis); post traumatic or primary arthrosis involving both ankle and subtalar joints; rheumatoid hindfoot; avascular necrosis of the talus; previously infected arthrosis, second degree; failed total ankle arthroplasty. Indications also include non-union ankle arthrodesis; osteoarthritis; post-traumatic and degenerative arthritis; neuroarthropathy or neuropathic ankle deformity; neuromuscular disease with severe deformity and Charcot foot.

Source page: https://510kreport.com/device/K023115
Methodology: https://510kreport.com/methodology