# K974556: Osteonics Scorpio Posterior Cruciate Retaining Total Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Osteonics Corp.
- Decided: Feb 27, 1998 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: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
192 later devices descend from it; 12 cite it directly.
0 of 193 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) Osteonics® Scorpio™ Total Knee Posteriorly Stabilized Femoral Components: named in the summary without a submission number
- (no number) Osteonics® Series 7000 Total Knee Femoral Components: named in the summary without a submission number
- (no number) Osteonics® Series 7000 Total Knee All-Polyethylene Tibial Components: named in the summary without a submission number
- (no number) Osteonics® Tibial Bearing Inserts: named in the summary without a submission number

## Most influential descendants
- K021313: Search Evolution Total Knee System (2002), 120 descendants of its own
- K022672: Columbus Total Knee System (CR) (2002), 96 descendants of its own
- K032108: Search Evolution (LC) Total Knee System (Porous Coated) (2004), 80 descendants of its own
- K070981: Search Evolution (LC) Total Knee System (Plasmapore) (2007), 79 descendants of its own
- K081023: Evolis Total Knee System (2008), 78 descendants of its own

## Recalls of this device
- Aug 15, 2014 · Class II · Z-1634-2015: The peel strength of the inner blister may have been below internal validated requirements. The strength of the seal is directly related to long term shelf life of the sterile barrier.
- Oct 2, 2009 · Not classified · Z-0466-2010: It was determined that a change made in the dimensions of the collar component of the packaging resulted in the inner blister material being overstretched causing a potential hole in the sterile barri
- Oct 2, 2009 · Not classified · Z-0467-2010: It was determined that a change made in the dimensions of the collar component of the packaging resulted in the inner blister material being overstretched causing a potential hole in the sterile barri
- Oct 2, 2009 · Not classified · Z-0468-2010: It was determined that a change made in the dimensions of the collar component of the packaging resulted in the inner blister material being overstretched causing a potential hole in the sterile barri
- Aug 11, 2005 · Not classified · Z-0058-06: The Left Scorpio Total Knee Cruciate Retaining Waffle Femoral Component #7 packaged and labeled as left may contain a Right and vice versa.
- Aug 11, 2005 · Not classified · Z-0059-06: The Left Scorpio Total Knee Cruciate Retaining Waffle Femoral Component #7 packaged and labeled as left may contain a Right and vice versa.
- Feb 8, 2005 · Not classified · Z-1381-2008: Mislabeled: The labeling indicates a Scorpio CR Femoral Component, however, the device inside the package is actually a Scorpio PS Femoral Component.

## Indications for use
The Osteonics® Scorpio™ Posterior Cruciate Retaining (CR) Total Knee System consists of posterior cruciate retaining total knee replacement femoral components, with corresponding cruciate retaining tibial bearing components, specifically designed to articulate together. These devices are single use components, intended for cemented fixation, and indicated for use in total knee replacement when the posterior cruciate ligament is functional. The Osteonics® Scorpio™ Total Knee CR Femoral Components are compatible for femoro-tibial articulation with the Osteonics® Scorpio™ Total Knee CR Tibial Bearing Inserts and the Osteonics® Scorpio™ Total Knee CR All-Polyethylene Tibial Components. The Osteonics® Scorpio™ Total Knee CR Tibial Bearing Inserts are intended for use with the legally marketed Osteonics® Series 7000 Total Knee Tibial Trays and Osteonics® Omnifit® Total Knee Tibial Trays. The Osteonics® Scorpio™ Total Knee CR Femoral Components are intended for patello-femoral articulation with the Osteonics® Scorpio™ Total Knee Patellar Components. In addition, the Osteonics® Series 7000 Femoral Bone Augmentation Components are compatible with the Osteonics® Scorpio™ Total Knee CR Femoral Components. 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.

Source page: https://510kreport.com/device/K974556
Methodology: https://510kreport.com/methodology