# K963242: Duracon Posterior Femoral Spacer

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Corp.
- Decided: Nov 14, 1996 after 87 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 K904208 (1991). 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)
- K915512: Duracon Total Knee System Tibial Components, Pfizer Hospital Products Group, Inc. (1992) Summary page 1.
- K904208: Kinemax Superstabilizer Total Knee System, Howmedica Corp. (1991) Summary page 1.
- (no number) Series 7000 Total Knee System Femoral Posterior Spacers: named in the summary without a submission number
- (no number) Genesis Total Knee System Femoral Posterior Spacers: named in the summary without a submission number
- (no number) Coordinate Total Knee System Femoral Posterior Spacers: named in the summary without a submission number

## Indications for use
The Duracon® Femoral Posterior Spacer is intended to be used with the femoral components of the Duracon® Total Knee System (reference premarket notifications K910235, K920034, K932070, and K954138) to augment bone loss in the area of the posterior condyle of the femur. Posterior bone loss that requires augmentation by spacers may be noted in primary or revision total knee arthroplasty cases.

Source page: https://510kreport.com/device/K963242
Methodology: https://510kreport.com/methodology