# K972864: Duration Stabilized Uhmwpe Knee Comp., Wear Claims

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Corp.
- Decided: Oct 29, 1997 after 86 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
The PCA® Primary Inserts for Duracon® Baseplates (K936008), PCA® Modular Inserts for Duracon® Baseplates (K940861), PCA® Modular Primary/Revision Patella (K940713), Duracon® Recessed Patella (K951655), Duracon® Inset Patella with Central Peg (K961482), Duracon® All Poly Patella Il (K961483), Duracon® Extra Small Tibial Stabilizer Insert (K370758), Kinematic® All Poly Patella with Three Pegs (K971550); and the Kinematic® Il Replacement Tibial Inserts (K960976) are intended to be used with the PCA®, Duracon®, or Kinemax® family of femoral components, tibial baseplates, and patellar components in primary or revision cemented total knee arthroplasty.

Source page: https://510kreport.com/device/K972864
Methodology: https://510kreport.com/methodology