# K110837: Revision Prothesis

- Pathway: 510(k) (Special)
- Applicant: Smith & Nephew, Inc.
- Decided: Apr 22, 2011 after 28 days
- Product code: JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3560
- 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 K951987 (1995). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042515: Smith & Nephew, Inc. High Performance Knee, Smith & Nephew, Inc. (2005) Summary page 1.

## Indications for use
Total knee components are indicated for: 1. Rheumatoid arthritis 2. Post-traumatic arthritis, ost~oarhritis, or degenerative arthritis in older patients whose age, weight, and activity levels are compatible with an adequate long-term result. 3. Failed osteotomies, unicomparimental replacement, or total knee replacement. 4. The posterior-stabilized knee system is designed for use in patients in primary and revision-surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain Intact. The Journey BCS STID Inserts are indicated for use without bone cement, and are single use devices.

Source page: https://510kreport.com/device/K110837
Methodology: https://510kreport.com/methodology