# K960976: Kinematic II Replacement  Tibial Inserts

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Corp.
- Decided: Aug 7, 1996 after 149 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: 1 generation back to K823420 (1983). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K823420: Kinematic II Knee System, Howmedica Corp. (1983) Summary page 1.
- K936008: Duracon Baseplates, Howmedica Corp. (1995) Summary page 1.
- K940861: Pca (R) Modular Total Knee Tib Insert Durocon Baseplate, Howmedica Corp. (1995) Summary page 1.

## Indications for use
The Kinematic® II Replacement Tibial Inserts are intended to be used in the revision of an existing Kinematic® II tibial component assembly. These inserts are intended to be used when the Vitallium baseplate portion of the tibial assembly is well fixed by cement, but the polyethylene bearing portion of the tibial assembly needs revision due to wear or ligament laxity.

Source page: https://510kreport.com/device/K960976
Methodology: https://510kreport.com/methodology