# K261275: Unity Total Knee System, Unity Knee Cementless CR Femur

- Pathway: 510(k) (Traditional)
- Applicant: Corin, Ltd.
- Decided: Sep 17, 2026 after 153 days
- Product code: MBH (Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3565
- 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 K943462 (1994). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073602: Modification to: Apex Knee System, Omnlife Science (2008) Summary page 5.
- K113060: Unity Toatal Knee System, Corin USA (2012) Summary page 5.

## Indications for use
The Unity Total Knee System is intended for use in total knee arthroplasty in skeletally mature patients, to provide increased mobility and reduce pain by replacing the damaged knee joint articulation where there is evidence of sufficient sound bone to seat and support the components. 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 porous coated CR femoral component may be used for cementless (biological fixation) or cemented use. All other femoral components, tibial trays, patellar components, stem extensions and augmentation blocks are indicated for cemented use only. The Unity Total Knee System is intended for single use only.

Source page: https://510kreport.com/device/K261275
Methodology: https://510kreport.com/methodology