510(k) · Cleared
Recalled · Class II · 2023Scorpio-Flex Posterior Stabilized Tibial Insert Components
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 Sep 23, 2004 after a 101-day review. The FDA summary names its predicate without a number. 5 later devices descend from it. It has been recalled once.
- Decided
- Sep 23, 2004
- Review
- 101 days
- Class
- Class II
- Product code
- JWH
- Recalls
- 1
- Predicates
- 0
5 later devices descend from it, 3 citing it directly.
- This deviceK041591 Scorpio-Flex Posterior Stabilized Tibial Insert ComponentsHowmedica Osteonics Corp. · 2004
- Descendant · cites it directly · 2 of its ownK243817 Scorpio Universal Dome Patella; Scorpio Total Stabilizer Insert…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2025 · Recalled
- Descendant · cites it directly · 1 of its ownK234044 ACS® LD FB Knee SystemImplantcast GmbH · 2024
- Descendant · cites it directly · 0 of its ownK261898 Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total…Howmedica Osteonics Corp. dba Stryker Orthopaedics · 2026
- Descendant · 2 generations on · 0 of its ownK260037 implantcast Packaging System UpdateImplantcast GmbH · 2026
- Descendant · 2 generations on · 0 of its ownK252898 Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium®…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2025 · Recalled
Most influential descendants
Showing 5 of 5 · See all- K243817Scorpio Universal Dome Patella; Scorpio Total Stabilizer Insert; Scorpio-Flex Posterior…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2025 · cites it directly2descendants
- K234044ACS® LD FB Knee SystemImplantcast GmbH · 2024 · cites it directly1descendant
- K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemHowmedica Osteonics Corp. dba Stryker Orthopaedics · 2026 · cites it directly0descendants
- K260037implantcast Packaging System UpdateImplantcast GmbH · 2026 · 2 generations on0descendants
- K252898Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K041591 | Scorpio-Flex Posterior Stabilized Tibial Insert Components | Howmedica Osteonics Corp. | 2004 | — |
| +1 | K243817 | Scorpio Universal Dome Patella; Scorpio Total Stabilizer Insert; Scorpio-Flex… | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2025 | 2 |
| +1 | K234044 | ACS® LD FB Knee System | Implantcast GmbH | 2024 | — |
| +1 | K261898 | Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee System | Howmedica Osteonics Corp. dba Stryker Orthopaedics | 2026 | — |
| +2 | K260037 | implantcast Packaging System Update | Implantcast GmbH | 2026 | — |
| +2 | K252898 | Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric… | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2025 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 2 | 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? (1)
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 System Named without a submission number |
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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-0883-2024 | 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. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K243817 (Howmedica Osteonics Corp., Dba Stryker Orthopaedics, 2025) has gone furthest, with 2 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 as stated in the FDA summary.
https://510kreport.com/device/K041591 · printed Nov 4, 2026
Cite this page
510(k) Report. “K041591: Scorpio-Flex Posterior Stabilized Tibial Insert Components.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K041591
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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