# K972183: Depuy Ace a.I.M. Titanium Tibial Nail

- Pathway: 510(k) (Traditional)
- Applicant: Ace Medical Co.
- Decided: Aug 26, 1997 after 77 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
49 later devices descend from it; 1 cites it directly.
0 of 50 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) DePuy ACE A.I.M.® Titanium Tibial Nail: named in the summary without a submission number
- (no number) Synthes Reamed Titanium Tibial Nail: named in the summary without a submission number
- (no number) Synthes Unreamed Titanium Tibial Nail: named in the summary without a submission number

## Most influential descendants
- K013430: Ace Bio Win Tibial Nailing System (2001), 48 descendants of its own
- 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

## Recalls of this device
- Feb 6, 2018 · Class II · Z-1197-2018: The AIM Tibial Nails failed a clinical analysis where the surgical revision rate exceeded the acceptance criteria in the Device Performance Review protocol for the implant system.
- Feb 6, 2018 · Class II · Z-1196-2018: The AIM Tibial Nails failed a clinical analysis where the surgical revision rate exceeded the acceptance criteria in the Device Performance Review protocol for the implant system.

## Indications for use
The DePuy ACE A.I.M.® Titanium Tibial Nail is indicated 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/K972183
Methodology: https://510kreport.com/methodology