# K042343: Scorpio NRG Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: Feb 9, 2005 after 163 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.
42 later devices descend from it; 8 cite it directly.
0 of 43 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: named in the summary without a submission number
- (no number) Scorpio® Scorpio-flex Tibial Inserts: named in the summary without a submission number
- (no number) Duracon A/P Lipped Tibial Inserts: named in the summary without a submission number

## Most influential descendants
- K071991: Modification to Scorpio NRG Knee System (2007), 29 descendants of its own
- K082019: Freedom Total Knee System (2009), 15 descendants of its own
- K113060: Unity Toatal Knee System (2012), 8 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

## Recalls of this device
- Aug 15, 2014 · Class II · Z-1634-2015: The peel strength of the inner blister may have been below internal validated requirements. The strength of the seal is directly related to long term shelf life of the sterile barrier.

## Indications for use
The Scorpio® NRG TM 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 Devices: * 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/K042343
Methodology: https://510kreport.com/methodology