510(k) · Cleared
Recalled · 2006Scorpio Knee System Tibial Inserts and Patellar 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 Oct 12, 2005 after an 83-day review. The FDA summary names its predicate without a number. 72 later devices descend from it. It has been recalled once.
- Decided
- Oct 12, 2005
- Review
- 83 days
- Class
- Class II
- Product code
- JWH
- Recalls
- 1
- Predicates
- 0
72 later devices descend from it, 4 citing it directly.
- This deviceK051977 Scorpio Knee System Tibial Inserts and Patellar ComponentsHowmedica Osteonics Corp. · 2005
- Descendant · cites it directly · 38 of its ownK132624 Triathlon Tritanium Metal-Backed PatellaStryker Orthopaedics · 2013 · Recalled
- Descendant · 2 generations on · 24 of its ownK172326 Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee…Stryker Orthopaedics · 2017 · Recalled
- Descendant · cites it directly · 15 of its ownK082019 Freedom Total Knee SystemMaxx Orthopedics, Inc. · 2009
- Descendant · 3 generations on · 14 of its ownK173849 Triathlon Total Knee SystemStryker Orthopaedics · 2018 · Recalled
- Descendant · 3 generations on · 11 of its ownK190402 Triathlon Total Knee System-Additional ComponentsStryker Orthopaedics (Aka Howmedica Osteonics Corp.) · 2019
Showing 5 of 72 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 72 · See all- K132624Triathlon Tritanium Metal-Backed PatellaStryker Orthopaedics · 2013 · cites it directly38descendants
- K172326Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee SystemStryker Orthopaedics · 2017 · 2 generations on24descendants
- K082019Freedom Total Knee SystemMaxx Orthopedics, Inc. · 2009 · cites it directly15descendants
- K173849Triathlon Total Knee SystemStryker Orthopaedics · 2018 · 3 generations on14descendants
- K190402Triathlon Total Knee System-Additional ComponentsStryker Orthopaedics (Aka Howmedica Osteonics Corp.) · 2019 · 3 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K051977 | Scorpio Knee System Tibial Inserts and Patellar Components | Howmedica Osteonics Corp. | 2005 | — |
| +1 | K132624 | Triathlon Tritanium Metal-Backed Patella | Stryker Orthopaedics | 2013 | 1 |
| +2 | K172326 | Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System | Stryker Orthopaedics | 2017 | 1 |
| +1 | K082019 | Freedom Total Knee System | Maxx Orthopedics, Inc. | 2009 | — |
| +3 | K173849 | Triathlon Total Knee System | Stryker Orthopaedics | 2018 | 3 |
| +3 | K190402 | Triathlon Total Knee System-Additional Components | Stryker Orthopaedics (Aka Howmedica Osteonics Corp.) | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2011 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 4 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 6 | 0 |
| 2018 | 3 | 0 |
| 2019 | 3 | 0 |
| 2020 | 7 | 0 |
| 2021 | 6 | 0 |
| 2022 | 7 | 0 |
| 2023 | 6 | 0 |
| 2024 | 6 | 0 |
| 2025 | 7 | 0 |
| 2026 | 8 | 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 Polyethylene Tibial Inserts and Scorpio Polyethylene Patellar Components Named without a submission number |
What descends from it? (72)
See all 724 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 |
|---|---|---|---|---|
| Feb 17, 2006 | Not classified | Z-0911-2010 | Process design | Stryker Orthopaedics became aware of a potential anomaly related to the packaging process of referenced lots of X# polyethylene used on Scorpio, Triathlon and Trident inserts. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K132624 (Stryker Orthopaedics, 2013) has gone furthest, with 38 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 Scorpio® X3™ UHMWPE Cruciate Retaining and Posterior Stabilized tibial inserts and the Scorpio® X3™ UHMWPE all polyethylene patellar components are intended to be used with cemented or cementless Scorpio femoral components, cemented or cementless Series 7000 tibial tray components and cemented Scorpio® tibial tray components in primary or revision total knee arthroplasty. The all polyethylene Scorpio® X3™ UHMWPE patellar components are intended for…
Read the full statement (217 words)
The Scorpio® X3™ UHMWPE Cruciate Retaining and Posterior Stabilized tibial inserts and the Scorpio® X3™ UHMWPE all polyethylene patellar components are intended to be used with cemented or cementless Scorpio femoral components, cemented or cementless Series 7000 tibial tray components and cemented Scorpio® tibial tray components in primary or revision total knee arthroplasty. The all polyethylene Scorpio® X3™ UHMWPE patellar components are intended for implantation with bone cement only.
The Scorpio® X3™ Total Stabilizer tibial inserts are intended to be used with the cemented Scorpio® TS femoral components and the cemented Scorpio® or Series 7000 tibial trays in primary or revision total knee arthroplasty.
The Scorpio® 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 ligamentous structures can be returned to adequate function and stability.
* Revision of previous unsuccessful knee replacement or other procedure.
Additional indications for Posterior Stabilized Components:
* Ligamentous instability requiring implant bearing surface geometries with increased constraint.
* Absent or non-functioning posterior cruciate ligament.
Additional indications for Total Stabilized (TS) Components:
* Severe anteroposterior and medial/lateral instability of the knee joint.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051977 · printed Nov 4, 2026
Cite this page
510(k) Report. “K051977: Scorpio Knee System Tibial Inserts and Patellar Components.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K051977
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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