# K012776: Duracon Constrained Posterior Stabilized (PS) Tibial Insert

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: Nov 16, 2001 after 88 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 K973164 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973164: Howmedica Total Stabilizer Knee Components, Howmedica Corp. (1997) Summary page 1.

## Indications for use
The Duracon® Constrained Posterior Stablhzer (PS) Tibial Inserts are intended to be used with legally marketed Duracon® tibial baseplates and wedges, Duracon® PS and TS femoral components, and patellar components as part of a total knee system in primary or revision cemented total knee arthroplasty. These inserts are intended to be used in cases where there is destruction of the joint surfaces with or without bone deformity, where 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 collateral ligaments may or may not be present. More specific indications/contraindications are listed below: Indications » Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis or avascular necrosis, Rheumatoid arthritis, Correction of functional deformity, Revision procedures where other treatments or devices have failed, Post-traumatic loss of joint anatomy, particularly when there is patello-femoral erosion, dysfunction or prior patellectomy; and, * |rreparable fracture of the knee

Source page: https://510kreport.com/device/K012776
Methodology: https://510kreport.com/methodology