# K993692: Duracon Inset Patella, 25MM

- Pathway: 510(k) (Special)
- Applicant: Howmedica Osteonics Corp.
- Decided: Dec 2, 1999 after 30 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 K961482 (1996). 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)
- K961482: Duracon Inset Patella with Central Peg, Howmedica Corp. (1996) Summary page 1.
- K965173: Duration Stabilized Uhmwpe Knee Components, Howmedica Corp. (1997) Summary page 1.

## Indications for use
The subject devices are single use components, intended for cemented use only. They are intended for use in conjunction with associated Duracon femoral components as part of cemented total knee replacement surgery. Indications for use, in keeping with those of other commercially-available, Class II total knee devices, are as follows: Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis or avascular necrosis. Rheumatoid arthritis. Correction of functional deformity. Revision procedures where other treatments have failed. Post-traumatic loss of knee joint anatomy, particularly when there is patello-femoral erosion, dysfunction or prior patellectomy. Irreparable fracture of the knee.

Source page: https://510kreport.com/device/K993692
Methodology: https://510kreport.com/methodology