# K955916: Townley Total Elbow System

- Pathway: 510(k) (Traditional)
- Applicant: Biologically Oriented Prostheses
- Decided: Aug 8, 1996 after 223 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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) Capitello-Condylar Total Elbow: named in the summary without a submission number

## Most influential descendants
- K983036: Single Axle Total Elbow (1999), 0 descendants of its own

## Indications for use
The Townley Elbow System contains three components which are intended for single use. Cement fixation of the components is required. Osteoarthritis, Rheumatoid arthritis with severe elbow pain and limited joint motion.

Source page: https://510kreport.com/device/K955916
Methodology: https://510kreport.com/methodology