# K970202: Depuy Ace Aim Titanium Tibial Nail

- Pathway: 510(k) (Traditional)
- Applicant: Depuy Ace Medical Co.
- Decided: Mar 21, 1997 after 59 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.
No later device cites it as a predicate yet.
0 of 1 device 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) DePuy ACE AIM® Titanium Tibial Nail: named in the summary without a submission number

## Indications for use
The DePuy ACE AIM® Titanium Tibial Nail is indicated for internal fixation of tibial fractures including transverse fractures, oblique and spiral 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/K970202
Methodology: https://510kreport.com/methodology