# K915512: Duracon Total Knee System Tibial Components

- Pathway: 510(k) (Traditional)
- Applicant: Pfizer Hospital Products Group, Inc.
- Decided: Aug 18, 1992 after 253 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: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 3 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K970758: Duracon Extra-Small Stabilizer Tibial Insert & Baseplate (1997), 0 descendants of its own
- K964951: Kinemax Plus Tibial Spacers (1997), 0 descendants of its own
- K963242: Duracon Posterior Femoral Spacer (1996), 0 descendants of its own

## Recalls of this device
- Dec 1, 2023 · Class II · Z-0917-2024: 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-0918-2024: 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-0916-2024: 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.
- May 5, 2006 · Not classified · Z-1601-2009: A box packaged and labeled as a Duracon Total Knee Duration A-P Lipped Tibial Insert 11MM may actually contain a 9MM insert.

Source page: https://510kreport.com/device/K915512
Methodology: https://510kreport.com/methodology