510(k) · Cleared
Recalled · Class II · 2026Scorpio Universal Dome Patella; Scorpio Total Stabilizer Insert; Scorpio-Flex Posterior Stabilized Tibial Insert; Scorpio-Flex Cruciate Retaining Tibial Insert; Scorpio NRG Tibial Bearing Insert – Cruciate Retaining Insert; Scorpio NRG Tibial Bearing Insert – Posteriorly Stabilized Insert
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Osteonics Corp., Dba Stryker Orthopaedics · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Feb 6, 2025 as substantially equivalent to K994128 (Howmedica Osteonics Corp., 2000) and 5 other predicates after a 56-day review. Its family tree reaches back 2 generations to 1992. 2 later devices descend from it. It has been recalled 2 times.
- Decided
- Feb 6, 2025
- Review
- 56 days
- Class
- Class II
- Product code
- JWH
- Recalls
- 2
- Predicates
- 6
Its longest line of descent runs back 2 generations to K915192 (1992). 12 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK915192 7000 Series Modular Tibial ComponentsOsteonics Corp. · 1992
- 1 generation backK994128 Scorpio Total Stablizer (TS) Total Knee SystemHowmedica Osteonics Corp. · 2000 · Recalled
- This deviceK243817 Scorpio Universal Dome Patella; Scorpio Total Stabilizer Insert…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2025
- 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 · cites it directly · 0 of its ownK252898 Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium®…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2025 · Recalled
Most influential descendants
Showing 2 of 2 · See all- K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemHowmedica Osteonics Corp. dba Stryker Orthopaedics · 2026 · cites it directly0descendants
- K252898Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K915192 | 7000 Series Modular Tibial Components | Osteonics Corp. | 1992 | — |
| −1 | K994128 | Scorpio Total Stablizer (TS) Total Knee System | Howmedica Osteonics Corp. | 2000 | 8 |
| 0 (this device) | K243817 | Scorpio Universal Dome Patella; Scorpio Total Stabilizer Insert; Scorpio-Flex… | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2025 | — |
| +1 | K261898 | Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee System | Howmedica Osteonics Corp. dba Stryker Orthopaedics | 2026 | — |
| +1 | K252898 | Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric… | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2025 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 2 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
| 2026 | 1 | 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? (6)
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 |
|---|---|---|---|
| * | K994128 | Scorpio Total Stablizer (TS) Total Knee SystemSummary page 6…strained cemented prosthesis. (21 CFR § 888.3560) Product Codes: JWH Primary Predicate Device to Which Substantial Equivalence is Claimed: Submission Number: K994128 Device Name: Scorpio Total Stabilizer (TS) Total Knee System Product Codes: JWH… | 2000 |
| * | K041591 | Scorpio-Flex Posterior Stabilized Tibial Insert ComponentsSummary page 7…f 5 Additional Predicate Devices Used to Support Substantial Equivalence: Submission Number Device Name Product Codes K041591 Scorpio-flex Posterior Stabilized Tibial JWH Insert Components K011643… | 2004 |
| * | K011643 | Scorpio CR Superflex Tibial InsertSummary page 7…Product Codes K041591 Scorpio-flex Posterior Stabilized Tibial JWH Insert Components K011643 Scorpio Cr Superflex Tibial Insert JWH K030978 Scorpio NRG Knee System… | 2001 |
| * | K030978 | Scorpio NRG Knee SystemSummary page 7…Posterior Stabilized Tibial JWH Insert Components K011643 Scorpio Cr Superflex Tibial Insert JWH K030978 Scorpio NRG Knee System JWH K042343 Scorpio NRG Knee System… | 2003 |
| * | K042343 | Scorpio NRG Knee SystemSummary page 7…nts K011643 Scorpio Cr Superflex Tibial Insert JWH K030978 Scorpio NRG Knee System JWH K042343 Scorpio NRG Knee System JWH K972967 Osteonics Scorpio Total K… | 2005 |
| * | K972967 | Osteonics Scorpio Total Knee Universal Dome Patellar Component;Osteonics Scorpio Total…Summary page 7…JWH K030978 Scorpio NRG Knee System JWH K042343 Scorpio NRG Knee System JWH K972967 Osteonics Scorpio Total Knee Universal JWH Dome Patellar Component; Os… | 1998 |
What descends from it? (2)
2 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 |
|---|---|---|---|---|
| Jul 30, 2026 | Class II | Z-3206-2026 | Process change control | Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading… |
| Jul 30, 2026 | Class II | Z-3197-2026 | Process change control | Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 33 years and passes through 3 companies; a new generation was cleared every 24.9 years on median.
- 9 of the 12 ancestors have a recall of any class.
- Of its descendants, K261898 (Howmedica Osteonics Corp. dba Stryker Orthopaedics, 2026) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K994128.
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. 2025, this device’s year, is highlighted.
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?
Indications for the Scorpio-Flex Cruciate Retaining Tibial Insert: • 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 ligaments structures can be returned to adequate function and stability • Revision of previous unsuccessful knee replacement or…
Read the full statement (597 words)
Indications for the Scorpio-Flex Cruciate Retaining Tibial Insert:
• 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 ligaments structures can be returned to adequate function and stability
• Revision of previous unsuccessful knee replacement or other procedure
Indications for the Scorpio NRG Tibial Bearing Insert – Posteriorly Stabilized Insert:
The Scorpio NRG 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 ligaments 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 the Scorpio-Flex Posterior Stabilized Tibial Insert:
• 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 ligaments 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 the Scorpio NRG Tibial Bearing Insert – Cruciate Retaining Insert:
The Scorpio NRG 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 ligaments structures can be returned to adequate function and stability
• Revision of previous unsuccessful knee replacement or other procedure
Additional Indications for Posterior Stabilized Devices:
• Ligamentous instability requiring implant bearing surface geometries with increased constraint
• Absent or non-functioning posterior cruciate ligament.
Indications for the Osteonics Scorpio Universal Dome Patella:
• 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 ligaments structures can be returned to adequate function and stability
• Revision of previous unsuccessful knee replacement or other procedure
Indications for the Scorpio Total Stabilizer Insert:
General TKR 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 ligaments structures can be returned to adequate function and stability
• Revision of previous unsuccessful knee replacement or other procedure
Additional Indications for Posterior Stabilized (PS) or Total Stabilized (TS) Components:
• Ligamentous instability requiring implant bearing surface geometries with increased constraint
• Absent or non-functioning posterior cruciate ligament
• Severe anteroposterior instability of the knee joint
• For Total Stabilizer (TS) Components Only: Severe instability of the knee secondary to compromised collateral ligament integrity or function
Indications for Bone Augmentation Wedges:
• Painful, disabling joint disease of the knee secondary to: degenerative arthritis, rheumatoid arthritis, or post-traumatic arthritis, complicated by the presence of bone loss
• Salvage of previous unsuccessful total knee replacement or other surgical procedure, accompanied by bone loss
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243817 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243817: Scorpio Universal Dome Patella; Scorpio Total Stabilizer Insert; Scorpio-Flex Posterior Stabilized Tibial Insert; Scorpio-Flex Cruciate Retaining Tibial Insert; Scorpio NRG Tibial Bearing Insert – Cruciate Retaining Insert; Scorpio NRG Tibial Bearing Insert – Posteriorly Stabilized Insert.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243817
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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