# K041591: Scorpio-Flex Posterior Stabilized Tibial Insert Components

- Pathway: 510(k) (Special)
- Applicant: Howmedica Osteonics Corp.
- Decided: Sep 23, 2004 after 101 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 3 cite it directly.
0 of 6 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) Scorpio® Total Knee System: named in the summary without a submission number

## Most influential descendants
- K243817: Scorpio Universal Dome Patella; Scorpio Total Stabilizer Insert; Scorpio-Flex Posterior Stabilized Tibial Insert; Scorpio-Flex Cruciate Retaining Tibial Insert; Scorpio NRG Tibial Bearing Insert – Cruciate Retaining Insert; Scorpio NRG Tibial Bearing Insert – Posteriorly Stabilized Insert (2025), 2 descendants of its own
- K234044: ACS® LD FB Knee System (2024), 1 descendant of its own
- K261898: Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee System (2026), 0 descendants of its own
- K260037: implantcast Packaging System Update (2026), 0 descendants of its own
- K252898: Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella; Triathlon® Symmetric Patella; Triathlon® Asymmetric Patella; Scorpio® Universal Dome Patella; Triathlon® Hinge Bumper (2025), 0 descendants of its own

## Recalls of this device
- Dec 1, 2023 · Class II · Z-0883-2024: 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
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/K041591
Methodology: https://510kreport.com/methodology