# K965173: Duration Stabilized Uhmwpe Knee Components

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Corp.
- Decided: Jun 11, 1997 after 169 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K993692: Duracon Inset Patella, 25MM (1999), 0 descendants of its own

## Indications for use
The Duracon®, P.CA® and Kinemax® Plus Tibial Inserts, All Plastic Tibial Components and Patellar Components (previously cleared in K915512, K923573, K916235, K922048, K932070, K913188, K872735, K871772 and K921640) are intended to be used with Duracon®, P.C.A.® or Kinemax® femoral components, tibial baseplates and patellar components in primary or revision cemented total knee arthroplasty.

Source page: https://510kreport.com/device/K965173
Methodology: https://510kreport.com/methodology