# K033342: Scorpio Knee System - Tibial Inserts

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: Jan 15, 2004 after 90 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.
No later device cites it as a predicate yet.
0 of 1 device 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) Scorpio® Knee System - Tibial Inserts: named in the summary without a submission number

## Indications for use
The Scorpio® Knee System components are for use in total knee arthroplasty as a result of: · Painful, disabling joint disease of the knee resulting from degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis · Post-traumatic loss of knee joint configuration and function · Moderate varus, valgus or flexion deformity in.which the ligamentous structures can be returned to adequate function and stability; · Revision of previous unsuccessful knee replacement or other procedure; · Ligamentous instability requiring implant bearing surface geometries with increased constraint; · Absent or non-functioning posterior cruciate ligament. These components are single use only and are intended for implantation with bone cement.

Source page: https://510kreport.com/device/K033342
Methodology: https://510kreport.com/methodology