# K961482: Duracon Inset Patella with Central Peg

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Corp.
- Decided: Jul 5, 1996 after 78 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
No predicates in its family tree.
3 later devices descend from it; 2 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. The FDA summary names its predicate without a number.
- (no number) Duracon® Recessed Patella: named in the summary without a submission number
- (no number) Duracon® All-Poly Patella: named in the summary without a submission number
- (no number) Genesis Biconvex Patella: named in the summary without a submission number
- (no number) Oomnifit All-Polyethylene Patella: named in the summary without a submission number
- (no number) Miller-Galante II All-Polyethylene Patella: named in the summary without a submission number
- (no number) Kinematic® II All-Polyethylene Patella: named in the summary without a submission number

## Most influential descendants
- K971789: Implex Continuum Porous Patellar (1997), 1 descendant of its own
- K993692: Duracon Inset Patella, 25MM (1999), 0 descendants of its own
- K983835: Implex Continuum Patella-Revision Hedrocel Patella (1999), 0 descendants of its own

## Indications for use
This device, an all-polyethylene concentric dome patella, is intended to be used with the femoral and tibial components of the Duracon® and P.C.A.® MTK II components as a total knee system. This component is intended to be used in the primary and/or revision replacement of the articular surface of the patella.

Source page: https://510kreport.com/device/K961482
Methodology: https://510kreport.com/methodology