# K983141: Capitello-Condylar Total Elbow Prosthesis

- Pathway: 510(k) (Traditional)
- Applicant: Johnson & Johnson Professionals, Inc.
- Decided: Nov 6, 1998 after 59 days
- Product code: JDB (Prosthesis, Elbow, Semi-Constrained, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3160
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 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) Pre-Amendment Capitello-Condylar Elbow System: named in the summary without a submission number

## Most influential descendants
- K992656: Depuy Total Elbow System (1999), 2 descendants of its own
- K060696: Acclaim Total Elbow System (2006), 0 descendants of its own
- K042664: LPS Upper Extremity (2004), 0 descendants of its own

## Indications for use
The Capitello-Condylar Total Elbow Prosthesis is indicated for arthroplasty of the elbow in patients suffering from rheumatoid arthritis with intractable elbow pain, limited motion, and radiographically identifiable destruction, with relative preservation of bony stock. It is also indicated for use in certain older post-traumatic or osteoarthritic patients where a relatively low activity level is anticipated. This device is intended for cemented use.

Source page: https://510kreport.com/device/K983141
Methodology: https://510kreport.com/methodology