# K030978: Scorpio NRG Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: Nov 20, 2003 after 237 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: 11 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
45 later devices descend from it; 8 cite it directly.
0 of 46 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-flex 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
- K110404: Eaum Total Knee System (2012), 14 descendants of its own
- K121037: Lospa Tibial Base Plate (2012), 10 descendants of its own
- K130673: Lospa Total Knee Replacement System (2013), 9 descendants of its own

## Recalls of this device
- Dec 1, 2023 · Class II · Z-0899-2024: 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.
- 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.
- Oct 2, 2009 · Not classified · Z-0471-2010: It was determined that a change made in the dimensions of the collar component of the packaging resulted in the inner blister material being overstretched causing a potential hole in the sterile barri
- Oct 2, 2009 · Not classified · Z-0474-2010: It was determined that a change made in the dimensions of the collar component of the packaging resulted in the inner blister material being overstretched causing a potential hole in the sterile barri
- Oct 2, 2009 · Not classified · Z-0476-2010: It was determined that a change made in the dimensions of the collar component of the packaging resulted in the inner blister material being overstretched causing a potential hole in the sterile barri
- Oct 2, 2009 · Not classified · Z-0477-2010: It was determined that a change made in the dimensions of the collar component of the packaging resulted in the inner blister material being overstretched causing a potential hole in the sterile barri
- Oct 2, 2009 · Not classified · Z-0470-2010: It was determined that a change made in the dimensions of the collar component of the packaging resulted in the inner blister material being overstretched causing a potential hole in the sterile barri
- Oct 2, 2009 · Not classified · Z-0472-2010: It was determined that a change made in the dimensions of the collar component of the packaging resulted in the inner blister material being overstretched causing a potential hole in the sterile barri
- Oct 2, 2009 · Not classified · Z-0473-2010: It was determined that a change made in the dimensions of the collar component of the packaging resulted in the inner blister material being overstretched causing a potential hole in the sterile barri
- Oct 2, 2009 · Not classified · Z-0475-2010: It was determined that a change made in the dimensions of the collar component of the packaging resulted in the inner blister material being overstretched causing a potential hole in the sterile barri
- Aug 20, 2007 · Not classified · Z-1141-2010: A box labeled as a Scorpio NRG Femoral Size 7 Right, may actually contain a Scorpio PS Femoral Size 5 Right.

## Indications for use
The Scorpio' NRGT"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 the posterior stabilized components include: Ligamentous instability requiring implant bearing surface geometries with increased constraint Absent or non-functioning posterior cruciate ligament

Source page: https://510kreport.com/device/K030978
Methodology: https://510kreport.com/methodology