# K113060: Unity Toatal Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Corin USA
- Decided: Sep 10, 2012 after 332 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: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K915192 (1992). 13 ancestors in all.
8 later devices descend from it; 6 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031729: Triathlon Posteriorly Stabilized (PS) Total Knee System, Howmedica Osteonics Corp. (2003) Summary page 1.
- K040267: Triathlon Cruciate Retaining (CR) Total Knee, Howmedica Osteonics Corp. (2004) Summary page 1.
- K042883: Size 1 Triathlon Cruciate Retaining (CR) Tibial Insert, Howmedica Osteonics Corp. (2004) Summary page 1.
- K050539: Size 1 Triathlon Posterior Stabilized (PS) Tibial Insert, Howmedica Osteonics Corp. (2005) Summary page 1.
- K974556: Osteonics Scorpio Posterior Cruciate Retaining Total Knee System, Osteonics Corp. (1998) Summary page 1.
- K962152: Osteonics Scorpio Posteriorly Stabilized Total Knee System, Osteonics Corp. (1996) Summary page 1.
- K042343: Scorpio NRG Knee System, Howmedica Osteonics Corp. (2005) Summary page 1.
- K994128: Scorpio Total Stablizer (TS) Total Knee System, Howmedica Osteonics Corp. (2000) Summary page 1.

## Most influential descendants
- K173884: Unity Total Knee System (2018), 2 descendants of its own
- K234044: ACS® LD FB Knee System (2024), 1 descendant of its own
- K183533: Unity Total Knee System (2019), 1 descendant of its own
- K261275: Unity Total Knee System, Unity Knee Cementless CR Femur (2026), 0 descendants of its own
- K260037: implantcast Packaging System Update (2026), 0 descendants of its own

## Recalls of this device
- Oct 13, 2023 · Class II · Z-0213-2024: Potential for Unity CR Inserts Right size 6 from batch 529803 to be incorrectly labelled as Unity CR Inserts Right size 7 from batch 532405 and visa versa.
- Oct 13, 2023 · Class II · Z-0214-2024: Potential for Unity CR Inserts Right size 6 from batch 529803 to be incorrectly labelled as Unity CR Inserts Right size 7 from batch 532405 and visa versa.
- Oct 31, 2022 · Class II · Z-0273-2023: The internal packaging system for devices may have damage to the blisters potentially damaging the device or compromising the sterility of the packaging.

## 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-postetior constraint and absent or non-functioning posterior cruciate ligament The Unity Total Knee System is indicated for cemented, single use only.

Source page: https://510kreport.com/device/K113060
Methodology: https://510kreport.com/methodology