# K183533: Unity Total Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Corin U.S.A. Limited
- Decided: Jun 4, 2019 after 167 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: 3 generations back to K040267 (2004). 19 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113060: Unity Toatal Knee System, Corin USA (2012) Summary page 4.
- K063423: Triathlon CS (Condylar Stabilizing) Lipped Insert, Howmedica Osteonics (2007) Summary page 4.

## Most influential descendants
- K241570: Unity Total Knee System (2024), 0 descendants of its own

## Indications for use
General total knee arthroplasty indications include: Painful, disabling joint disease of the knee resulting from: degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis Post-traumatic loss of knee joint configuration and function Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function Revision of previous unsuccessful knee replacement or other procedure, where soft tissue stability is adequate Fracture of the distal femur and/or proximal tibia that cannot be stabilized by standard fracture management techniques The posterior stabilized variant is also indicated for PCL instability requiring implant bearing surface geometries with increased anterior-posterior constraint and absent or non-functioning posterior cruciate ligament The Unity Knee™ is intended for cemented use, single use only.

Source page: https://510kreport.com/device/K183533
Methodology: https://510kreport.com/methodology