510(k) · Cleared
Recalled · Class II · 2023Osteonics Scorpio Posteriorly Stabilized 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 Aug 14, 1996 after a 71-day review. The FDA summary names its predicate without a number. 283 later devices descend from it. It has been recalled 13 times.
- Decided
- Aug 14, 1996
- Review
- 71 days
- Class
- Class II
- Product code
- JWH
- Recalls
- 13
- Predicates
- 0
283 later devices descend from it, 10 citing it directly.
- This deviceK962152 Osteonics Scorpio Posteriorly Stabilized Total Knee SystemOsteonics Corp. · 1996
- Descendant · cites it directly · 139 of its ownK994128 Scorpio Total Stablizer (TS) Total Knee SystemHowmedica Osteonics Corp. · 2000 · Recalled
- Descendant · cites it directly · 121 of its ownK033769 Eius Unicompartmental Knee SystemHowmedica Osteonics Corp. · 2004
- Descendant · cites it directly · 120 of its ownK021313 Search Evolution Total Knee SystemAesculap, Inc. · 2002
- Descendant · 2 generations on · 96 of its ownK022672 Columbus Total Knee System (CR)Aesculap, Inc. · 2002 · Recalled
- Descendant · 2 generations on · 80 of its ownK032108 Search Evolution (LC) Total Knee System (Porous Coated)Aesculap, Inc. · 2004
Showing 5 of 283 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 283 · See all- K994128Scorpio Total Stablizer (TS) Total Knee SystemHowmedica Osteonics Corp. · 2000 · cites it directly139descendants
- K033769Eius Unicompartmental Knee SystemHowmedica Osteonics Corp. · 2004 · cites it directly121descendants
- K021313Search Evolution Total Knee SystemAesculap, Inc. · 2002 · cites it directly120descendants
- K022672Columbus Total Knee System (CR)Aesculap, Inc. · 2002 · 2 generations on96descendants
- K032108Search Evolution (LC) Total Knee System (Porous Coated)Aesculap, Inc. · 2004 · 2 generations on80descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K962152 | Osteonics Scorpio Posteriorly Stabilized Total Knee System | Osteonics Corp. | 1996 | — |
| +1 | K994128 | Scorpio Total Stablizer (TS) Total Knee System | Howmedica Osteonics Corp. | 2000 | 8 |
| +1 | K033769 | Eius Unicompartmental Knee System | Howmedica Osteonics Corp. | 2004 | — |
| +1 | K021313 | Search Evolution Total Knee System | Aesculap, Inc. | 2002 | — |
| +2 | K022672 | Columbus Total Knee System (CR) | Aesculap, Inc. | 2002 | 1 |
| +2 | K032108 | Search Evolution (LC) Total Knee System (Porous Coated) | Aesculap, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 4 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 6 | 0 |
| 2007 | 8 | 0 |
| 2008 | 8 | 0 |
| 2009 | 7 | 0 |
| 2010 | 5 | 0 |
| 2011 | 8 | 0 |
| 2012 | 18 | 0 |
| 2013 | 17 | 0 |
| 2014 | 15 | 0 |
| 2015 | 11 | 0 |
| 2016 | 11 | 0 |
| 2017 | 8 | 0 |
| 2018 | 8 | 0 |
| 2019 | 14 | 0 |
| 2020 | 18 | 0 |
| 2021 | 23 | 0 |
| 2022 | 13 | 0 |
| 2023 | 17 | 0 |
| 2024 | 19 | 0 |
| 2025 | 22 | 0 |
| 2026 | 15 | 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® Series 7000 Total Knee Primary Posteriorly Stabilized Femoral Components Named without a submission number | |
| * | — | Osteonics® Series 7000 Total Knee Primary Posteriorly Stabilized All-Polyethylene Tibial… Named without a submission number | |
| * | — | Osteonics® Series 7000 Total Knee Tibial Bearing Insert - P/S I Series Named without a submission number | |
| * | — | Osteonics® Series 7000 Total Knee Resurfacing Patellar Components Named without a submission number |
What descends from it? (283)
See all 28310 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K994128 | Scorpio Total Stablizer (TS) Total Knee System | 2000 | 139 |
| K033769 | Eius Unicompartmental Knee System | 2004 | 121 |
| K021313 | Search Evolution Total Knee System | 2002 | 120 |
| K123166 | Triathlon All-Polyethylene Condylar Stabilizing (CS) Tibial Implants Triathlon… | 2013 | 33 |
| K081127 | Accin Total Knee System | 2008 | 25 |
| K030367 | Columbus (PS) | 2003 | 17 |
| K113060 | Unity Toatal Knee System | 2012 | 8 |
| K152430 | All Poly Tibial Component | 2016 | 0 |
| K020703 | Scorpio CR and PS CO CR Femoral Components with Titanium Plasma Spray Coating | 2002 | 0 |
| K991461 | Osteonics Scorpio Total Knee Relaxed Back P/S Tibial Bearing Insert | 1999 | 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-0886-2024 | 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. |
| Dec 1, 2023 | Class II | Z-0887-2024 | 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. |
| Dec 1, 2023 | Class II | Z-0888-2024 | 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. |
| Dec 1, 2023 | Class II | Z-0889-2024 | 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. |
| Dec 1, 2023 | Class II | Z-0890-2024 | 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. |
| Dec 1, 2023 | Class II | Z-0891-2024 | 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. |
| Dec 1, 2023 | Class II | Z-0892-2024 | 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-0469-2010 | 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. |
| Jul 30, 2007 | Not classified | Z-0795-2010 | Labeling mix-ups | Stryker Orthopaedics became aware that a box packaged and labeled as a Scorpio PS Femoral Waffle (No Post) with LFIT, may actually contain a Scorpio Femoral Waffle (With Post) and LFIT. |
| Nov 8, 2005 | Not classified | Z-1814-2008 | Employee error | Mislabeled boxes -- Scorpio PS Right Femoral Component No Posts contained a Scorpio PS Left Femoral Component with Posts and vice versa. |
| Mar 17, 2005 | Not classified | Z-2079-2008 | Process control | Scorpio Posterior Stabilized Femoral Component labeled and laser marked as a Left, was in fact a Right component. |
| Feb 8, 2005 | Not classified | Z-1382-2008 | Labeling mix-ups | Mislabeled: The labeling indicates a Scorpio PS Femoral Component, however, the device inside the package is actually a Scorpio CR Femoral Component. |
The 5 latest of 13 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K994128 (Howmedica Osteonics Corp., 2000) has gone furthest, with 139 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?
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.
Ligamentous instability requiring implant bearing surface geometries with increased constraint.
Absent or non-functioning posterior cruciate ligament.
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/K962152 · printed Nov 6, 2026
Cite this page
510(k) Report. “K962152: Osteonics Scorpio Posteriorly Stabilized 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/K962152
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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