# K962152: Osteonics Scorpio Posteriorly Stabilized Total Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Osteonics Corp.
- Decided: Aug 14, 1996 after 71 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: 13 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
283 later devices descend from it; 10 cite it directly.
0 of 284 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® Series 7000 Total Knee Primary Posteriorly Stabilized Femoral Components: named in the summary without a submission number
- (no number) Osteonics® Series 7000 Total Knee Primary Posteriorly Stabilized All-Polyethylene Tibial Component: named in the summary without a submission number
- (no number) Osteonics® Series 7000 Total Knee Tibial Bearing Insert - P/S I Series: named in the summary without a submission number
- (no number) Osteonics® Series 7000 Total Knee Resurfacing Patellar Components: named in the summary without a submission number

## Most influential descendants
- K994128: Scorpio Total Stablizer (TS) Total Knee System (2000), 139 descendants of its own
- K033769: Eius Unicompartmental Knee System (2004), 121 descendants of its own
- 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

## Recalls of this device
- Dec 1, 2023 · Class II · Z-0886-2024: Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
- Dec 1, 2023 · Class II · Z-0887-2024: Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
- Dec 1, 2023 · Class II · Z-0888-2024: Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
- Dec 1, 2023 · Class II · Z-0889-2024: Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
- Dec 1, 2023 · Class II · Z-0890-2024: Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
- Dec 1, 2023 · Class II · Z-0891-2024: Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
- Dec 1, 2023 · Class II · Z-0892-2024: Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
- 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-0469-2010: 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
- Jul 30, 2007 · Not classified · Z-0795-2010: Stryker Orthopaedics became aware that a box packaged and labeled as a Scorpio PS Femoral Waffle (No Post) with LFIT, may actually contain a Scorpio Femoral Waffle (With Post) and LFIT.
- Nov 8, 2005 · Not classified · Z-1814-2008: Mislabeled boxes -- Scorpio PS Right Femoral Component No Posts contained a Scorpio PS Left Femoral Component with Posts and vice versa.
- Mar 17, 2005 · Not classified · Z-2079-2008: Scorpio Posterior Stabilized Femoral Component labeled and laser marked as a Left, was in fact a Right component.
- Feb 8, 2005 · Not classified · Z-1382-2008: Mislabeled: The labeling indicates a Scorpio PS Femoral Component, however, the device inside the package is actually a Scorpio CR Femoral Component.

## Indications for use
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.

Source page: https://510kreport.com/device/K962152
Methodology: https://510kreport.com/methodology