# K051977: Scorpio Knee System Tibial Inserts and Patellar Components

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: Oct 12, 2005 after 83 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.
72 later devices descend from it; 4 cite it directly.
0 of 73 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 Polyethylene Tibial Inserts and Scorpio Polyethylene Patellar Components: named in the summary without a submission number

## Most influential descendants
- K132624: Triathlon Tritanium Metal-Backed Patella (2013), 38 descendants of its own
- K172326: Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System (2017), 24 descendants of its own
- K082019: Freedom Total Knee System (2009), 15 descendants of its own
- K173849: Triathlon Total Knee System (2018), 14 descendants of its own
- K190402: Triathlon Total Knee System-Additional Components (2019), 11 descendants of its own

## Recalls of this device
- Feb 17, 2006 · Not classified · Z-0911-2010: Stryker Orthopaedics became aware of a potential anomaly related to the packaging process of referenced lots of X# polyethylene used on Scorpio, Triathlon and Trident inserts.

## Indications for use
The Scorpio® X3™ UHMWPE Cruciate Retaining and Posterior Stabilized tibial inserts and the Scorpio® X3™ UHMWPE all polyethylene patellar components are intended to be used with cemented or cementless Scorpio femoral components, cemented or cementless Series 7000 tibial tray components and cemented Scorpio® tibial tray components in primary or revision total knee arthroplasty. The all polyethylene Scorpio® X3™ UHMWPE patellar components are intended for implantation with bone cement only. The Scorpio® X3™ Total Stabilizer tibial inserts are intended to be used with the cemented Scorpio® TS femoral components and the cemented Scorpio® or Series 7000 tibial trays in primary or revision total knee arthroplasty. The Scorpio® Knee System components are for use in total knee arthroplasty as a result of: * 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 Components: * Ligamentous instability requiring implant bearing surface geometries with increased constraint. * Absent or non-functioning posterior cruciate ligament. Additional indications for Total Stabilized (TS) Components: * Severe anteroposterior and medial/lateral instability of the knee joint.

Source page: https://510kreport.com/device/K051977
Methodology: https://510kreport.com/methodology