# K020830: Scorpio Inset Patellar Component

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: Jun 6, 2002 after 84 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 K863668 (1986). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K863668: Omnifit (TM) Total Knee Prosthesis System, Osteonics Corp. (1986) Summary page 1.

## Indications for use
The Scorpio@Inset Patellar Component is intended to articulate with any commercially available Scorpio@Total Knee Femoral Component, any commercially available Osteonics@Series 7000 Total Knee Femoral component, and any commercially available Osteonics@OmnifitB Total Knee Femoral Component. The subject patellar components are single use devices, intended for cemented applications on the surgically prepared posterior patella as part of primary or revision total knee arthroplasty. This component replaces the patellar articulating surface of the knee joint to simulate the normal function of the knee.

Source page: https://510kreport.com/device/K020830
Methodology: https://510kreport.com/methodology