# K970758: Duracon Extra-Small Stabilizer Tibial Insert & Baseplate

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Corp.
- Decided: May 22, 1997 after 80 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 K915512 (1992). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K932070: Duracon Stabilizer Femoral Component and Insert, Howmedica Corp. (1995) Summary page 1.
- K915512: Duracon Total Knee System Tibial Components, Pfizer Hospital Products Group, Inc. (1992) Summary page 1.

## Indications for use
The Duracon® Extra-Small Stabilizer Tibial insert and Baseplate are intended to be used with previously released Duracon femoral and patellar components as a total knee system in primary or revision cemented total knee arthroplasty. These components are specificaily intended to be used in situations where the posterior cruciate ligament.is not intact, not present, or cannot be repaired. The collateral ligaments should be intact, or repaired so that adequate mediolateral stability is present. These components are intended to be implanted using bone cement in small boned, skeletally mature individuals.

Source page: https://510kreport.com/device/K970758
Methodology: https://510kreport.com/methodology