# K230555: Cemented Tibia Baseplate no Taper with JRNY Lock

- Pathway: 510(k) (Special)
- Applicant: Smith & Nephew, Inc.
- Decided: Mar 30, 2023 after 30 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: 8 generations back to K951987 (1995). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142807: ANTHEM PS Total Knee System, Smith & Nephew, Inc. (2014) Summary page 4.
- K111711: Journey II BCS Knee System, Smith & Nephew, Inc. (2011) Summary page 4.

## Indications for use
Total Knee components are indicated for: * Rheumatoid arthritis * Post-traumatic arthritis, osteoarthritis, or degenerative arthritis * Failed osteotomies, unicompartmental replacement, or total knee replacement. * Posterior stabilized knee systems are 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 Smith & Nephew Cemented Tibia Baseplate no Taper with JRNY Lock are indicated for use with cement only and are single use devices.

Source page: https://510kreport.com/device/K230555
Methodology: https://510kreport.com/methodology