# K974781: Depuy Ace Aim (R) Titanium Supracondylar Nail

- Pathway: 510(k) (Traditional)
- Applicant: Depuy, Inc.
- Decided: Mar 10, 1998 after 78 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
No predicates in its family tree.
43 later devices descend from it; 2 cite it directly.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) ACE Medical AIM® Titanium Supracondylar Nail: named in the summary without a submission number
- (no number) Smith & Nephew Orthopaedics Richards Supracondylar Nail System: named in the summary without a submission number

## Most influential descendants
- K023115: Ace Versanail (2002), 41 descendants of its own
- 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

## Indications for use
The AIM® Titanium Supracondylar Nail is intended for use in intramedullary fixation of supracondylar fractures of the femur, including those with severe comminution and intra-articular involvement, osteoporosis, nonunions, malunions, pathologic, and fractures proximal to total knee arthroplasty or prosthesis. In addition, the AIM® Titanium Supracondylar Nail is indicated 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 (Tibio Calcaneal Arthrodesis); Post traumatic/primary arthrosis involving both ankle and subtalar joints; A rheumatoid hindfoot; Avascular necrosis of the talus; Previously infected arthrosis, second degree; Failed total arthroplasty.

Source page: https://510kreport.com/device/K974781
Methodology: https://510kreport.com/methodology