# K994128: Scorpio Total Stablizer (TS) Total Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: Mar 6, 2000 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: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K915192 (1992). 6 ancestors in all.
139 later devices descend from it; 6 cite it directly.
0 of 146 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962152: Osteonics Scorpio Posteriorly Stabilized Total Knee System, Osteonics Corp. (1996) Summary page 1.
- K972967: Osteonics Scorpio Total Knee Universal Dome Patellar Component;Osteonics Scorpio Total Knee Recessed Patellar Component, Osteonics Corp. (1998) Summary page 1.
- K915192: 7000 Series Modular Tibial Components, Osteonics Corp. (1992) Summary page 1.
- K925372: Osteonics (R) 700 Series Total Knee Mod Femor Comp, Osteonics Corp. (1993) Summary page 1.
- K920524: Osteonics 7000 Series Total Knee Bone Augmentation, Osteonics Corp. (1992) Summary page 1.
- K960279: Nexgen Compl. Knee Sol. Legacy Posterior Stabilized/Constrained Condylar Knee Femoral Components/Articular Surfaces, Zimmer, Inc. (1996) Summary page 1.

## Cited in the summary but kept off the family tree
- K974596: Dimertest Latex Assay, Agen Biomedical, Ltd. (1998). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## 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
- Dec 1, 2023 · Class II · Z-0879-2024: 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-0876-2024: 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-0882-2024: 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-0878-2024: 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-0875-2024: 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-0877-2024: 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-0880-2024: 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-0881-2024: 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 Scorpio® TS Total Knee System components are intended for single-use, and for cemented use only in the United States. The components feature a posterior cruciate ligament (PCL) substituting design. This system is intended for use when the cruciate ligaments are absent, inadequate, or cannot be preserved during the operative procedure, especially when anterior-posterior stability is impaired due to the absence of the posterior cruciate ligament and/or patella. The collateral ligaments may or may not be intact. The system is also designed to allow compensation for bone loss through the use of blocks and wedges. General TKR 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. Additional Indications for Posterior Stabilized (PS) or Total Stabilized (TS) Components: . Ligamentous instability requiring implant bearing surface geometries with increased constraint. . Absent or non-functioning posterior cruciate ligament. . Severe anteroposterior instability of the knee joint. . For Total Stabilizer (TS) Components Only: Severe instability of the knee secondary to compromised collateral ligament integrity or function. Indications for Bone Augmentation Wedges: . Painful, disabling joint disease of the knee secondary to: degenerative arthritis, rheumatoid arthritis, or post-traumatic arthritis, complicated by the presence of bone loss. . Salvage of previous unsuccessful total knee replacement or other surgical procedure, accompanied by bone loss.

Source page: https://510kreport.com/device/K994128
Methodology: https://510kreport.com/methodology