510(k) · Cleared
Recalled · Class II · 2014Osteonics Scorpio Posterior Cruciate Retaining Total Knee System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osteonics Corp. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Feb 27, 1998 after an 84-day review. The FDA summary names its predicate without a number. 192 later devices descend from it. It has been recalled 7 times.
- Decided
- Feb 27, 1998
- Review
- 84 days
- Class
- Class II
- Product code
- JWH
- Recalls
- 7
- Predicates
- 0
192 later devices descend from it, 12 citing it directly.
- This deviceK974556 Osteonics Scorpio Posterior Cruciate Retaining Total Knee SystemOsteonics Corp. · 1998
- Descendant · cites it directly · 120 of its ownK021313 Search Evolution Total Knee SystemAesculap, Inc. · 2002
- Descendant · cites it directly · 96 of its ownK022672 Columbus Total Knee System (CR)Aesculap, Inc. · 2002 · Recalled
- Descendant · cites it directly · 80 of its ownK032108 Search Evolution (LC) Total Knee System (Porous Coated)Aesculap, Inc. · 2004
- Descendant · 2 generations on · 79 of its ownK070981 Search Evolution (LC) Total Knee System (Plasmapore)Aesculap Implant Systems, Inc. · 2007
- Descendant · 3 generations on · 78 of its ownK081023 Evolis Total Knee SystemMedacta International S.A. · 2008 · Recalled
Showing 5 of 192 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 192 · See all- K021313Search Evolution Total Knee SystemAesculap, Inc. · 2002 · cites it directly120descendants
- K022672Columbus Total Knee System (CR)Aesculap, Inc. · 2002 · cites it directly96descendants
- K032108Search Evolution (LC) Total Knee System (Porous Coated)Aesculap, Inc. · 2004 · cites it directly80descendants
- K070981Search Evolution (LC) Total Knee System (Plasmapore)Aesculap Implant Systems, Inc. · 2007 · 2 generations on79descendants
- K081023Evolis Total Knee SystemMedacta International S.A. · 2008 · 3 generations on78descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K974556 | Osteonics Scorpio Posterior Cruciate Retaining Total Knee System | Osteonics Corp. | 1998 | — |
| +1 | K021313 | Search Evolution Total Knee System | Aesculap, Inc. | 2002 | — |
| +1 | K022672 | Columbus Total Knee System (CR) | Aesculap, Inc. | 2002 | 1 |
| +1 | K032108 | Search Evolution (LC) Total Knee System (Porous Coated) | Aesculap, Inc. | 2004 | — |
| +2 | K070981 | Search Evolution (LC) Total Knee System (Plasmapore) | Aesculap Implant Systems, Inc. | 2007 | — |
| +3 | K081023 | Evolis Total Knee System | Medacta International S.A. | 2008 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 4 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 3 | 0 |
| 2009 | 5 | 0 |
| 2010 | 4 | 0 |
| 2011 | 5 | 0 |
| 2012 | 11 | 0 |
| 2013 | 10 | 0 |
| 2014 | 8 | 0 |
| 2015 | 9 | 0 |
| 2016 | 4 | 0 |
| 2017 | 7 | 0 |
| 2018 | 7 | 0 |
| 2019 | 7 | 0 |
| 2020 | 15 | 0 |
| 2021 | 15 | 0 |
| 2022 | 10 | 0 |
| 2023 | 12 | 0 |
| 2024 | 14 | 0 |
| 2025 | 20 | 0 |
| 2026 | 13 | 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? (4)
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 |
|---|---|---|---|
| * | — | Osteonics® Scorpio™ Total Knee Posteriorly Stabilized Femoral Components Named without a submission number | |
| * | — | Osteonics® Series 7000 Total Knee Femoral Components Named without a submission number | |
| * | — | Osteonics® Series 7000 Total Knee All-Polyethylene Tibial Components Named without a submission number | |
| * | — | Osteonics® Tibial Bearing Inserts Named without a submission number |
What descends from it? (192)
See all 19212 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K021313 | Search Evolution Total Knee System | 2002 | 120 |
| K022672 | Columbus Total Knee System (CR) | 2002 | 96 |
| K032108 | Search Evolution (LC) Total Knee System (Porous Coated) | 2004 | 80 |
| K123166 | Triathlon All-Polyethylene Condylar Stabilizing (CS) Tibial Implants Triathlon… | 2013 | 33 |
| K081127 | Accin Total Knee System | 2008 | 25 |
| K023788 | Columbus (CR) Total Knee System | 2002 | 25 |
| K151266 | Physica CR Knee System | 2015 | 8 |
| K113060 | Unity Toatal Knee System | 2012 | 8 |
| K091280 | Freedom Total Knee Cruciate Retaining (CR) Femoral Component | 2009 | 7 |
| K011643 | Scorpio CR Superflex Tibial Insert | 2001 | 5 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| 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-0466-2010 | 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-0467-2010 | 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-0468-2010 | 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 11, 2005 | Not classified | Z-0058-06 | Other | The Left Scorpio Total Knee Cruciate Retaining Waffle Femoral Component #7 packaged and labeled as left may contain a Right and vice versa. |
| Aug 11, 2005 | Not classified | Z-0059-06 | Other | The Left Scorpio Total Knee Cruciate Retaining Waffle Femoral Component #7 packaged and labeled as left may contain a Right and vice versa. |
| Feb 8, 2005 | Not classified | Z-1381-2008 | Labeling mix-ups | Mislabeled: The labeling indicates a Scorpio CR Femoral Component, however, the device inside the package is actually a Scorpio PS Femoral Component. |
The 5 latest of 7 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K021313 (Aesculap, Inc., 2002) has gone furthest, with 120 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 Osteonics® Scorpio™ Posterior Cruciate Retaining (CR) Total Knee System consists of posterior cruciate retaining total knee replacement femoral components, with corresponding cruciate retaining tibial bearing components, specifically designed to articulate together. These devices are single use components, intended for cemented fixation, and indicated for use in total knee replacement when the posterior cruciate ligament is functional. The Osteonics®…
Read the full statement (216 words)
The Osteonics® Scorpio™ Posterior Cruciate Retaining (CR) Total Knee System consists of posterior cruciate retaining total knee replacement femoral components, with corresponding cruciate retaining tibial bearing components, specifically designed to articulate together. These devices are single use components, intended for cemented fixation, and indicated for use in total knee replacement when the posterior cruciate ligament is functional.
The Osteonics® Scorpio™ Total Knee CR Femoral Components are compatible for femoro-tibial articulation with the Osteonics® Scorpio™ Total Knee CR Tibial Bearing Inserts and the Osteonics® Scorpio™ Total Knee CR All-Polyethylene Tibial Components. The Osteonics® Scorpio™ Total Knee CR Tibial Bearing Inserts are intended for use with the legally marketed Osteonics® Series 7000 Total Knee Tibial Trays and Osteonics® Omnifit® Total Knee Tibial Trays.
The Osteonics® Scorpio™ Total Knee CR Femoral Components are intended for patello-femoral articulation with the Osteonics® Scorpio™ Total Knee Patellar Components. In addition, the Osteonics® Series 7000 Femoral Bone Augmentation Components are compatible with the Osteonics® Scorpio™ Total Knee CR Femoral Components.
Indications:
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K974556 · printed Nov 6, 2026
Cite this page
510(k) Report. “K974556: Osteonics Scorpio Posterior Cruciate Retaining Total 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/K974556
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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