510(k) · Cleared
Recalled · Class II · 2023Scorpio NRG Knee System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Osteonics Corp. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Nov 20, 2003 after a 237-day review. The FDA summary names its predicate without a number. 45 later devices descend from it. It has been recalled 11 times.
- Decided
- Nov 20, 2003
- Review
- 237 days
- Class
- Class II
- Product code
- JWH
- Recalls
- 11
- Predicates
- 0
45 later devices descend from it, 8 citing it directly.
- This deviceK030978 Scorpio NRG Knee SystemHowmedica Osteonics Corp. · 2003
- Descendant · cites it directly · 29 of its ownK071991 Modification to Scorpio NRG Knee SystemHowmedica Osteonics Corp. · 2007
- Descendant · cites it directly · 15 of its ownK082019 Freedom Total Knee SystemMaxx Orthopedics, Inc. · 2009
- Descendant · cites it directly · 14 of its ownK110404 Eaum Total Knee SystemCorentec Co., Ltd. · 2012 · Recalled
- Descendant · cites it directly · 10 of its ownK121037 Lospa Tibial Base PlateCorentec Co., Ltd. · 2012
- Descendant · cites it directly · 9 of its ownK130673 Lospa Total Knee Replacement SystemCorentec Co., Ltd. · 2013 · Recalled
Showing 5 of 45 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 45 · See all- K071991Modification to Scorpio NRG Knee SystemHowmedica Osteonics Corp. · 2007 · cites it directly29descendants
- K082019Freedom Total Knee SystemMaxx Orthopedics, Inc. · 2009 · cites it directly15descendants
- K110404Eaum Total Knee SystemCorentec Co., Ltd. · 2012 · cites it directly14descendants
- K121037Lospa Tibial Base PlateCorentec Co., Ltd. · 2012 · cites it directly10descendants
- K130673Lospa Total Knee Replacement SystemCorentec Co., Ltd. · 2013 · cites it directly9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K030978 | Scorpio NRG Knee System | Howmedica Osteonics Corp. | 2003 | — |
| +1 | K071991 | Modification to Scorpio NRG Knee System | Howmedica Osteonics Corp. | 2007 | — |
| +1 | K082019 | Freedom Total Knee System | Maxx Orthopedics, Inc. | 2009 | — |
| +1 | K110404 | Eaum Total Knee System | Corentec Co., Ltd. | 2012 | 2 |
| +1 | K121037 | Lospa Tibial Base Plate | Corentec Co., Ltd. | 2012 | — |
| +1 | K130673 | Lospa Total Knee Replacement System | Corentec Co., Ltd. | 2013 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 4 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 3 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 6 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JWH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JWH device
- #1 K221479 Persona Personalized Knee Systemscore 22.4 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Scorpio Total Knee Named without a submission number | |
| * | — | Scorpio-flex Tibial Inserts Named without a submission number |
What descends from it? (45)
See all 458 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071991 | Modification to Scorpio NRG Knee System | 2007 | 29 |
| K082019 | Freedom Total Knee System | 2009 | 15 |
| K110404 | Eaum Total Knee System | 2012 | 14 |
| K121037 | Lospa Tibial Base Plate | 2012 | 10 |
| K130673 | Lospa Total Knee Replacement System | 2013 | 9 |
| K243817 | Scorpio Universal Dome Patella; Scorpio Total Stabilizer Insert; Scorpio-Flex Posterior… | 2025 | 2 |
| K161414 | Anatomic Total Knee System | 2017 | 1 |
| K261898 | Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee System | 2026 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 1, 2023 | Class II | Z-0899-2024 | Nonconforming Material/Component | 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 | Under Investigation by firm | 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 | Other | 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 barrier system. |
| Oct 2, 2009 | Not classified | Z-0474-2010 | Other | 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 barrier system. |
| Oct 2, 2009 | Not classified | Z-0476-2010 | Other | 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 barrier system. |
| Oct 2, 2009 | Not classified | Z-0477-2010 | Other | 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 barrier system. |
| Oct 2, 2009 | Not classified | Z-0470-2010 | Other | 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 barrier system. |
| Oct 2, 2009 | Not classified | Z-0472-2010 | Other | 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 barrier system. |
| Oct 2, 2009 | Not classified | Z-0473-2010 | Other | 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 barrier system. |
| Oct 2, 2009 | Not classified | Z-0475-2010 | Other | 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 barrier system. |
| Aug 20, 2007 | Not classified | Z-1141-2010 | Process design | A box labeled as a Scorpio NRG Femoral Size 7 Right, may actually contain a Scorpio PS Femoral Size 5 Right. |
The 5 latest of 11 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K071991 (Howmedica Osteonics Corp., 2007) has gone furthest, with 29 descendants of its own.
How does its category compare?
All JWH devicesJWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JWH
20in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JWH
55in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JWH
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JWH
9,306in 2025
MAUDE reports naming product code JWH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 18 | 74 | 14 | 1,305 |
| 2008 | 17 | 81 | 10 | 1,483 |
| 2009 | 11 | 168 | 109 | 1,870 |
| 2010 | 19 | 85 | 32 | 3,286 |
| 2011 | 25 | 87 | 27 | 5,133 |
| 2012 | 33 | 85 | 85 | 5,203 |
| 2013 | 31 | 128 | 31 | 6,135 |
| 2014 | 33 | 98 | 13 | 6,722 |
| 2015 | 27 | 87 | 11 | 6,881 |
| 2016 | 18 | 88 | 17 | 7,586 |
| 2017 | 25 | 118 | 61 | 12,263 |
| 2018 | 25 | 90 | 14 | 14,071 |
| 2019 | 28 | 133 | 5 | 14,987 |
| 2020 | 22 | 59 | 2 | 12,592 |
| 2021 | 24 | 61 | 8 | 9,408 |
| 2022 | 17 | 56 | 12 | 8,364 |
| 2023 | 20 | 57 | 67 | 8,947 |
| 2024 | 19 | 89 | 7 | 10,828 |
| 2025 | 20 | 55 | 2 | 9,306 |
| 2026 | 12 | 63 | 4 | — |
What is it indicated for?
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…
Read the full statement (92 words)
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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030978 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030978: Scorpio NRG Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030978
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026