# K984458: Depuy Ace Spider Plate

- Pathway: 510(k) (Traditional)
- Applicant: Depuy Ace Medical Co.
- Decided: Dec 31, 1998 after 16 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- 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 K965028 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K965028: Acumed Suture Washer, Acu Med, Inc. (1997) Summary page 1.
- (no number) DePuy ACE Orthopaedic Washer: named in the summary without a submission number

## Indications for use
Fixation of Metaphyseal Fractures of the Distal Tibia Proximal Metaphyseal Tibial Fractures Calcaneus Body Fractures Proximal Humeral Head/Shaft Fractures Distal Femur Fracture — Comminuted Shaft Fractures

Source page: https://510kreport.com/device/K984458
Methodology: https://510kreport.com/methodology