# K974843: Duracon (R) Small Stabilizer Tibial Insert

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Corp.
- Decided: Jun 18, 1998 after 176 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 small Duracon® Stabilizer Tibial Insert is intended to be used with Howmedica Universal tibial baseplates in cemented primary or revision total knee arthroplasty. This insert is intended to be used specifically when the cruciate ligaments are inadequate, not present, or cannot be preserved during the operative procedure, especially when anterior-posterior stability is impaired due to absence of the patella. The intercondylar post of the insert is intended to limit anterior-posterior motion, as does the posterior cruciate ligament in the intact knee. This design is not intended to provide an absolute substitution for either collateral ligament. Therefore, the collateral ligaments should be intact, or there should be adequate overall capsular ligamentous stability.

Source page: https://510kreport.com/device/K974843
Methodology: https://510kreport.com/methodology