510(k) · Cleared
ClearedScorpio CR and PS CO CR Femoral Components with Titanium Plasma Spray Coating
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 Nov 13, 2002 as substantially equivalent to K974556 (Osteonics Corp., 1998) and 2 other predicates after a 254-day review. Its family tree reaches back 1 generation to 1991.
- Decided
- Nov 13, 2002
- Review
- 254 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K910990 (1991). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK910990 Osteonics 7000 Series Total Knee Tibial ComponentsOsteonics Corp. · 1991
- This deviceK020703 Scorpio CR and PS CO CR Femoral Components with Titanium Plasma…Howmedica Osteonics Corp. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K910990 | Osteonics 7000 Series Total Knee Tibial Components | Osteonics Corp. | 1991 | — |
| 0 (this device) | K020703 | Scorpio CR and PS CO CR Femoral Components with Titanium Plasma Spray Coating | Howmedica Osteonics Corp. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 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? (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 |
|---|---|---|---|
| * | K974556 | Osteonics Scorpio Posterior Cruciate Retaining Total Knee SystemSummary page 1…ibial Tray with Titanium Plasma Spray Coating, are substantially equivalent to the predicate Cobalt Chromium alloy (CoCr) MicroStructured@Scorpio@ CR (#K974556) and PS (#K962152) femoral components, and the MicroStructured@ standard tibial trays of the Osteonics@Series 7000 Total… | 1998 |
| * | K962152 | Osteonics Scorpio Posteriorly Stabilized Total Knee SystemSummary page 1…tanium Plasma Spray Coating, are substantially equivalent to the predicate Cobalt Chromium alloy (CoCr) MicroStructured@Scorpio@ CR (#K974556) and PS (#K962152) femoral components, and the MicroStructured@ standard tibial trays of the Osteonics@Series 7000 Total Knee System (#K91… | 1996 |
| * | K910990 | Osteonics 7000 Series Total Knee Tibial ComponentsSummary page 1…io@ CR (#K974556) and PS (#K962152) femoral components, and the MicroStructured@ standard tibial trays of the Osteonics@Series 7000 Total Knee System (#K910990) in all material and design aspects. The following reflect the new characteristics of the subject components:… | 1991 |
| * | — | MCK Total Knee System Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 2 of the 3 ancestors have a recall of any class.
- 11 other devices also cite its predicate K974556.
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 and PS Femoral Components with Titanium Plasma Spray Coating and the Scorpio Tibial Tray with Titanium Plasma Spray Coating are intended for single-use, and are intended to be marketed for cemented fixation only. These femoral components and tibial tray are intended to be used with Osteonics tibial inserts and patellar components in total knee arthroplasty. The following are the specific indications/contraindications for the Scorpio CR and…
Read the full statement (270 words)
The Scorpio CR and PS Femoral Components with Titanium Plasma Spray Coating and the Scorpio Tibial Tray with Titanium Plasma Spray Coating are intended for single-use, and are intended to be marketed for cemented fixation only. These femoral components and tibial tray are intended to be used with Osteonics tibial inserts and patellar components in total knee arthroplasty.
The following are the specific indications/contraindications for the Scorpio CR and PS femoral components with Titanium Plasma Sprayed Coating, and the Scorpio Tibial Tray with Titanium Plasma Sprayed Coating:
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 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
Contraindications
The contraindications for the subject devices include
Any active or suspected latent infection in or about the knee joint
Any mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure or complications in postoperative care
Bone stock compromised by disease, infection or prior implantation which cannot provide adequate support and/or fixation to the prosthesis
Skeletal immaturity
Severe instability of the knee joint secondary to the absence of collateral ligament integrity and function
Obesity An overweight or obese patient can produce loads on the prosthesis which can lead to failure of the fixation of the device or to failure of the device
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K020703 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020703: Scorpio CR and PS CO CR Femoral Components with Titanium Plasma Spray Coating.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020703
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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