# K060696: Acclaim Total Elbow System

- Pathway: 510(k) (Special)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Apr 14, 2006 after 29 days
- Product code: JDC (Prosthesis, Elbow, Constrained, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K872084 (1987). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992656: Depuy Total Elbow System, DePuy Orthopaedics, Inc. (1999) Summary page 1.
- K872084: Porocoat Mark II Total Elbow, Depuy, Inc. (1987) Summary page 1.

## Indications for use
The AcclaimTM Total Elbow System is indicated to reduce pain and improve the function and mobility of the afficted 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 AcclaimM Total Elbow System is intended for cemented use only.

Source page: https://510kreport.com/device/K060696
Methodology: https://510kreport.com/methodology