510(k) · Cleared
ClearedScorpio Low Profile Tibial Tray
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 Dec 10, 2003 as substantially equivalent to K910990 (Osteonics Corp., 1991) and 2 other predicates after a 90-day review. Its family tree reaches back 1 generation to 1991. 23 later devices descend from it.
- Decided
- Dec 10, 2003
- Review
- 90 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. 23 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK910990 Osteonics 7000 Series Total Knee Tibial ComponentsOsteonics Corp. · 1991
- This deviceK032829 Scorpio Low Profile Tibial TrayHowmedica Osteonics Corp. · 2003
- Descendant · cites it directly · 15 of its ownK082019 Freedom Total Knee SystemMaxx Orthopedics, Inc. · 2009
- Descendant · 2 generations on · 7 of its ownK091280 Freedom Total Knee Cruciate Retaining (CR) Femoral ComponentMaxx Orthopedics, Inc. · 2009
- Descendant · 2 generations on · 6 of its ownK131481 Freedom PCK ComponentsMaxx Orthopedics, Inc. · 2014
- Descendant · cites it directly · 6 of its ownK071499 Columbus Total Knee System Mios CR/PS Tibial TrayAesculap Implant Systems, Inc. · 2007
- Descendant · 2 generations on · 3 of its ownK160771 Destiknee Total Knee SystemMeril Healthcare Private Limited · 2016
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K082019Freedom Total Knee SystemMaxx Orthopedics, Inc. · 2009 · cites it directly15descendants
- K091280Freedom Total Knee Cruciate Retaining (CR) Femoral ComponentMaxx Orthopedics, Inc. · 2009 · 2 generations on7descendants
- K131481Freedom PCK ComponentsMaxx Orthopedics, Inc. · 2014 · 2 generations on6descendants
- K071499Columbus Total Knee System Mios CR/PS Tibial TrayAesculap Implant Systems, Inc. · 2007 · cites it directly6descendants
- K160771Destiknee Total Knee SystemMeril Healthcare Private Limited · 2016 · 2 generations on3descendants
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) | K032829 | Scorpio Low Profile Tibial Tray | Howmedica Osteonics Corp. | 2003 | — |
| +1 | K082019 | Freedom Total Knee System | Maxx Orthopedics, Inc. | 2009 | — |
| +2 | K091280 | Freedom Total Knee Cruciate Retaining (CR) Femoral Component | Maxx Orthopedics, Inc. | 2009 | — |
| +2 | K131481 | Freedom PCK Components | Maxx Orthopedics, Inc. | 2014 | — |
| +1 | K071499 | Columbus Total Knee System Mios CR/PS Tibial Tray | Aesculap Implant Systems, Inc. | 2007 | — |
| +2 | K160771 | Destiknee Total Knee System | Meril Healthcare Private Limited | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 4 | 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? (3)
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 |
|---|---|---|---|
| * | K910990 | Osteonics 7000 Series Total Knee Tibial ComponentsSummary page 2…rpio® Low Profile Tibial Tray is identical in design to the previously cleared Series 7000 Standard Tibial Tray (found substantially equivalent in premarket notification K 910990) with the following exception: the length of the keel has been decreased to 0.50 inches to allow the implant to be inserted throu… | 1991 |
| * | K926228 | Duracon Cruciform Tibial BaseplateSummary page 3…lizations) to provide rotational stability and enhance cement fixation. Equivalent products include: Series 7000 Tibial Tray (K910990); Duracon® Cruciform Tibial Tray (K926228); and Interax Modular Tibial Tray (K973121). Finite element analysis was presented to support substantial equivalence to a pred… | 1994 |
| * | K973121 | Interax Total Knee SystemSummary page 3…and enhance cement fixation. Equivalent products include: Series 7000 Tibial Tray (K910990); Duracon® Cruciform Tibial Tray (K926228); and Interax Modular Tibial Tray (K973121). Finite element analysis was presented to support substantial equivalence to a predicate device.… | 1997 |
What descends from it? (23)
See all 232 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)
No FDA recall names this device.
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® Low Profile Tibial Tray is intended to be used with commercially available Scorpio® Cruciate Retaining femoral components and associated patellar components, and Scorpio® CR and ScorpioFlex CR tibial bearing inserts in primary cemented total knee arthroplasty. The indications/contraindications for the Scorpio® Low Profile Tibial Tray are outlined below: Indications · Painful, disabling joint disease of the knee resulting from: degenerative…
Read the full statement (220 words)
The Scorpio® Low Profile Tibial Tray is intended to be used with commercially available Scorpio® Cruciate Retaining femoral components and associated patellar components, and Scorpio® CR and ScorpioFlex CR tibial bearing inserts in primary cemented total knee arthroplasty. The indications/contraindications for the Scorpio® Low Profile Tibial Tray are outlined below:
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.
Contraindications
· 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 itself.
: The use of bone augmentations is contraindicated with the Scorpio® Low Profile Tibial Tray
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032829 · printed Nov 3, 2026
Cite this page
510(k) Report. “K032829: Scorpio Low Profile Tibial Tray.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K032829
Report an extraction error
Are you the manufacturer?
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