# K071991: Modification to Scorpio NRG Knee System

- Pathway: 510(k) (Special)
- Applicant: Howmedica Osteonics Corp.
- Decided: Aug 15, 2007 after 26 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K030978 (2003). 2 ancestors in all.
29 later devices descend from it; 5 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042343: Scorpio NRG Knee System, Howmedica Osteonics Corp. (2005) Summary page 2.
- K030978: Scorpio NRG Knee System, Howmedica Osteonics Corp. (2003) Summary page 2.

## Most influential descendants
- K082019: Freedom Total Knee System (2009), 15 descendants of its own
- K103733: United U2 Xpe Total Knee System (2011), 8 descendants of its own
- K091280: Freedom Total Knee Cruciate Retaining (CR) Femoral Component (2009), 7 descendants of its own
- K131481: Freedom PCK Components (2014), 6 descendants of its own
- K132752: Ultracongruent Insert (2014), 5 descendants of its own

## Indications for use
The Scorpio® NRG® 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 These components are single use only and are intended for implantation with bone cement.

Source page: https://510kreport.com/device/K071991
Methodology: https://510kreport.com/methodology