# K032829: Scorpio Low Profile Tibial Tray

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: Dec 10, 2003 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
Longest line of descent: 1 generation back to K910990 (1991). 3 ancestors in all.
23 later devices descend from it; 2 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K910990: Osteonics 7000 Series Total Knee Tibial Components, Osteonics Corp. (1991) Summary page 2.
- K926228: Duracon Cruciform Tibial Baseplate, Howmedica Corp. (1994) Summary page 3.
- K973121: Interax Total Knee System, Howmedica Corp. (1997) Summary page 3.

## Most influential descendants
- K082019: Freedom Total Knee System (2009), 15 descendants of its own
- K091280: Freedom Total Knee Cruciate Retaining (CR) Femoral Component (2009), 7 descendants of its own
- K131481: Freedom PCK Components (2014), 6 descendants of its own
- K071499: Columbus Total Knee System Mios CR/PS Tibial Tray (2007), 6 descendants of its own
- K160771: Destiknee Total Knee System (2016), 3 descendants of its own

## Indications for use
The Scorpio® Low Profile Tibial Tray is intended to be used with commercially available Scorpio® Cruciate Retaining femoral components and associated patellar components, and Scorpio® CR and ScorpioFlex CR tibial bearing inserts in primary cemented total knee arthroplasty. The indications/contraindications for the Scorpio® Low Profile Tibial Tray are outlined below: 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. Contraindications · 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 itself. : The use of bone augmentations is contraindicated with the Scorpio® Low Profile Tibial Tray

Source page: https://510kreport.com/device/K032829
Methodology: https://510kreport.com/methodology