510(k) · Cleared
Recalled · Class II · 2023Scorpio CR Superflex Tibial Insert
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 Jun 28, 2001 as substantially equivalent to K974556 (Osteonics Corp., 1998) after a 30-day review. Its family tree reaches back 1 generation to 1998. 5 later devices descend from it. It has been recalled 2 times.
- Decided
- Jun 28, 2001
- Review
- 30 days
- Class
- Class II
- Product code
- JWH
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K974556 (1998). 5 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK974556 Osteonics Scorpio Posterior Cruciate Retaining Total Knee SystemOsteonics Corp. · 1998 · Recalled
- This deviceK011643 Scorpio CR Superflex Tibial InsertHowmedica Osteonics Corp. · 2001
- 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 |
|---|---|---|---|---|---|
| −1 | K974556 | Osteonics Scorpio Posterior Cruciate Retaining Total Knee System | Osteonics Corp. | 1998 | 7 |
| 0 (this device) | K011643 | Scorpio CR Superflex Tibial Insert | Howmedica Osteonics Corp. | 2001 | — |
| +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 |
|---|---|---|---|
| * | K974556 | Osteonics Scorpio Posterior Cruciate Retaining Total Knee SystemSummary page 1…60 Predicate Device Identification The Scorpio® CR Superflex™ Tibial Bearing Inserts are substantially equivalent to the Scorpio® CR Tibial Bearing Inserts cleared via K974556. Device Description The Scorpio® CR Superflex™ tibial inserts share the same critical design features as the predicate Scorpio®… | 1998 |
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-0884-2024 | 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-0885-2024 | 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?
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® CR Superflex™ Tibial Bearing Inserts are single use devices. They are intended for mating with commercially available Howmedica Osteonics tibial trays and patellas and Scorpio® Total Knee CR femoral components, which are intended for cemented fixation. The indications for the modified Scorpio® CR Superflex™ tibial inserts will remain the same as the indications for the current Scorpio® CR inserts. These are: Painful, disabling joint disease…
Read the full statement (115 words)
The Scorpio® CR Superflex™ Tibial Bearing Inserts are single use devices. They are
intended for mating with commercially available Howmedica Osteonics tibial trays and
patellas and Scorpio® Total Knee CR femoral components, which are intended for
cemented fixation.
The indications for the modified Scorpio® CR Superflex™ tibial inserts will remain the same
as the indications for the current Scorpio® CR inserts. These are:
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/K011643 · printed Nov 5, 2026
Cite this page
510(k) Report. “K011643: Scorpio CR Superflex Tibial Insert.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K011643
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026