# K972967: Osteonics Scorpio Total Knee Universal Dome Patellar Component;Osteonics Scorpio Total Knee Recessed Patellar Component

- Pathway: 510(k) (Traditional)
- Applicant: Osteonics Corp.
- Decided: Jan 16, 1998 after 158 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: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
140 later devices descend from it; 3 cite it directly.
0 of 141 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 All-Polyethylene Patellar Components - concentric dome design: named in the summary without a submission number
- (no number) Johnson and Johnson® P.F.C.® Cruciate Sacrificing Patellar Component: 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
- 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

## Recalls of this device
- Dec 1, 2023 · Class II · Z-0893-2024: 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-0895-2024: 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-0896-2024: 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-0897-2024: 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-0900-2024: 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-0894-2024: 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.

## Indications for use
The Osteonics® Scorpio™ Total Knee Universal Dome and Recessed Patellar Components are intended to articulate with any commercially available Osteonics® Scorpio™ Total Knee Femoral Component, any commercially available Osteonics® Series 7000 Total Knee Femoral Component, and any commercially available Osteonics® Omnifit® Total Knee Femoral Component. The subject patellar components are single use devices, intended for cemented application onto the surgically prepared posterior patella. These components replace the patellar articulating surface of the knee joint and simulate the natural function of the knee. The indications for the use of the Osteonics® Scorpio™ Total Knee Universal Dome and Recessed Patellar Components in conjunction with a total knee replacement, in keeping with those of other legally marketed Class II patellar components, are as follows: 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/K972967
Methodology: https://510kreport.com/methodology