# K992656: Depuy Total Elbow System

- Pathway: 510(k) (Traditional)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Nov 5, 1999 after 88 days
- Product code: JDC (Prosthesis, Elbow, Constrained, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3150
- 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 K872084 (1987). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K872084: Porocoat Mark II Total Elbow, Depuy, Inc. (1987) Summary page 2.
- K983141: Capitello-Condylar Total Elbow Prosthesis, Johnson & Johnson Professionals, Inc. (1998) Summary page 2.

## Most influential descendants
- K060696: Acclaim Total Elbow System (2006), 0 descendants of its own
- K042664: LPS Upper Extremity (2004), 0 descendants of its own

## Recalls of this device
- Nov 8, 2005 · Not classified · Z-0531-06: The ulnar bearing may damage the implant's polyethylene sleeve such that revision surgery is necessary.
- Nov 8, 2005 · Not classified · Z-0530-06: The ulnar bearing may damage the implant's polyethylene sleeve such that revision surgery is necessary.

## Indications for use
The DePuy Total Elbow System is indicated to reduce pain and improve the function and mobility of the affected joint in patients with a painful arthritic joint due to osteoarthritis, rheumatoid arthritis, or post traumatic arthritis and pathological fractures of the distal humerus in which adequate bone stock exists for the fixation of prosthetic components. Total Elbow replacement may be considered for younger patients, if, in the opinion of the surgeon, an unequivocal indication for elbow replacement outweighs the risks associated with the age of the patient , and if limited demands regarding activity and elbow joint loading can be assured. This included patients for whom an immediate gain of elbow mobility may lead to an expectation of significant improvement in the quality of their lives. The DePuy Total Elbow System is intended for cemented use only.

Source page: https://510kreport.com/device/K992656
Methodology: https://510kreport.com/methodology