# K972629: Depuy AE TK2 Hip Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Depuy, Inc.
- Decided: Oct 9, 1997 after 87 days
- Product code: KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K791619 (1979). 2 ancestors in all.
42 later devices descend from it; 4 cite it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K791619: Dynamic Hip Screw, Synthes (Usa) (1979) Summary page 1.
- K861178: Depuy Compression Hip Screw System, Depuy, Inc. (1986) Summary page 1.

## Most influential descendants
- K031401: Fixion Dynamic Hip Screw System (Fixion DHS) (2003), 32 descendants of its own
- K091425: Quantum M Composite Nailing System (2010), 31 descendants of its own
- K100497: Quantum IM Composite Nailing System (Quantum Nailing System) (2010), 29 descendants of its own
- K102369: Piccolo Composite Nailing System (2011), 16 descendants of its own
- K111056: Piccolo Composite Nailing System (2011), 15 descendants of its own

## Recalls of this device
- Oct 30, 2007 · Not classified · Z-0434-2008: Mis-etched/labeled as to barrel length: the lot with the short barrel was etched and labeled as a standard barrel and the lot with the standard barrel was etched and labeled as a short barrel.
- Oct 30, 2007 · Not classified · Z-0435-2008: Mis-etched/labeled as to barrel length: the lot with the short barrel was etched and labeled as a standard barrel and the lot with the standard barrel was etched and labeled as a short barrel.

## Indications for use
The DePuy ACE TK2 Hip Screw System is indicated for fractures of the proximal femur extending from the subcapital area to the level of the lesser trochanter, as well as proximal femoral osteotomies. Appropriate utilization of this device ultimately depends on the surgical judgement surrounding each patient’s particular situation.

Source page: https://510kreport.com/device/K972629
Methodology: https://510kreport.com/methodology