# K012172: Duracon PS Lipped Tibial Insert

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics
- Decided: Oct 10, 2001 after 90 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: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K932070 (1995). 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.
- K936292: Packaging and Manufacturing Methods Change/Knee Components, Howmedica Corp. (1995) Summary page 1.

## Recalls of this device
- Dec 1, 2023 · Class II · Z-0923-2024: Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
- Dec 1, 2023 · Class II · Z-0924-2024: Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

## Indications for use
The Duracon® Posteriorly Stabilizer éPS) Lipped Tibial Inserts are intended to be used with legally marketed Duracon” tibial baseplates and wedges, 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 used for revision of a failed prosthesis. 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, Irreparable fracture of the knee

Source page: https://510kreport.com/device/K012172
Methodology: https://510kreport.com/methodology