# K020703: Scorpio CR and PS CO CR Femoral Components with Titanium Plasma Spray Coating

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: Nov 13, 2002 after 254 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 K910990 (1991). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974556: Osteonics Scorpio Posterior Cruciate Retaining Total Knee System, Osteonics Corp. (1998) Summary page 1.
- K962152: Osteonics Scorpio Posteriorly Stabilized Total Knee System, Osteonics Corp. (1996) Summary page 1.
- K910990: Osteonics 7000 Series Total Knee Tibial Components, Osteonics Corp. (1991) Summary page 1.
- (no number) MCK Total Knee System: named in the summary without a submission number

## Indications for use
The Scorpio CR and PS Femoral Components with Titanium Plasma Spray Coating and the Scorpio Tibial Tray with Titanium Plasma Spray Coating are intended for single-use, and are intended to be marketed for cemented fixation only. These femoral components and tibial tray are intended to be used with Osteonics tibial inserts and patellar components in total knee arthroplasty. The following are the specific indications/contraindications for the Scorpio CR and PS femoral components with Titanium Plasma Sprayed Coating, and the Scorpio Tibial Tray with Titanium Plasma Sprayed Coating: Indications 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 Additional Indications for Posterior Stabilized Components Ligamentous instability requiring implant bearing surface geometries with increased constraint Absent or non-functioning posterior cruciate ligament Contraindications The contraindications for the subject devices include Any active or suspected latent infection in or about the knee joint Any mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure or complications in postoperative care Bone stock compromised by disease, infection or prior implantation which cannot provide adequate support and/or fixation to the prosthesis Skeletal immaturity Severe instability of the knee joint secondary to the absence of collateral ligament integrity and function Obesity An overweight or obese patient can produce loads on the prosthesis which can lead to failure of the fixation of the device or to failure of the device

Source page: https://510kreport.com/device/K020703
Methodology: https://510kreport.com/methodology