510(k) · Cleared
Recalled · 2003Interax Total Knee System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Corp. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Nov 18, 1997 after a 90-day review. The FDA summary names its predicate without a number. 25 later devices descend from it. It has been recalled 8 times.
- Decided
- Nov 18, 1997
- Review
- 90 days
- Class
- Class II
- Product code
- JWH
- Recalls
- 8
- Predicates
- 0
25 later devices descend from it, 2 citing it directly.
- This deviceK973121 Interax Total Knee SystemHowmedica Corp. · 1997
- Descendant · cites it directly · 23 of its ownK032829 Scorpio Low Profile Tibial TrayHowmedica Osteonics Corp. · 2003
- Descendant · 2 generations on · 15 of its ownK082019 Freedom Total Knee SystemMaxx Orthopedics, Inc. · 2009
- Descendant · 3 generations on · 7 of its ownK091280 Freedom Total Knee Cruciate Retaining (CR) Femoral ComponentMaxx Orthopedics, Inc. · 2009
- Descendant · 3 generations on · 6 of its ownK131481 Freedom PCK ComponentsMaxx Orthopedics, Inc. · 2014
- Descendant · 2 generations on · 6 of its ownK071499 Columbus Total Knee System Mios CR/PS Tibial TrayAesculap Implant Systems, Inc. · 2007
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K032829Scorpio Low Profile Tibial TrayHowmedica Osteonics Corp. · 2003 · cites it directly23descendants
- K082019Freedom Total Knee SystemMaxx Orthopedics, Inc. · 2009 · 2 generations on15descendants
- K091280Freedom Total Knee Cruciate Retaining (CR) Femoral ComponentMaxx Orthopedics, Inc. · 2009 · 3 generations on7descendants
- K131481Freedom PCK ComponentsMaxx Orthopedics, Inc. · 2014 · 3 generations on6descendants
- K071499Columbus Total Knee System Mios CR/PS Tibial TrayAesculap Implant Systems, Inc. · 2007 · 2 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K973121 | Interax Total Knee System | Howmedica Corp. | 1997 | — |
| +1 | K032829 | Scorpio Low Profile Tibial Tray | Howmedica Osteonics Corp. | 2003 | — |
| +2 | K082019 | Freedom Total Knee System | Maxx Orthopedics, Inc. | 2009 | — |
| +3 | K091280 | Freedom Total Knee Cruciate Retaining (CR) Femoral Component | Maxx Orthopedics, Inc. | 2009 | — |
| +3 | K131481 | Freedom PCK Components | Maxx Orthopedics, Inc. | 2014 | — |
| +2 | K071499 | Columbus Total Knee System Mios CR/PS Tibial Tray | Aesculap Implant Systems, Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2003 | 1 | 0 |
| 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? (2)
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 |
|---|---|---|---|
| * | — | Duracon® Total Knee System Named without a submission number | |
| * | — | Kinemax® Plus Total Knee System Named without a submission number |
What descends from it? (25)
See all 252 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 |
|---|---|---|---|---|
| Jan 23, 2003 | Not classified | Z-0854-03 | Other | The device is demonstrating early wear and delamination. |
| Jan 23, 2003 | Not classified | Z-0855-03 | Other | The device is demonstrating early wear and delamination. |
| Jan 23, 2003 | Not classified | Z-0856-03 | Other | The device is demonstrating early wear and delamination. |
| Jan 23, 2003 | Not classified | Z-0858-03 | Other | The device is demonstrating early wear and delamination. |
| Jan 23, 2003 | Not classified | Z-0851-03 | Other | The device is demonstrating early wear and delamination. |
| Jan 23, 2003 | Not classified | Z-0857-03 | Other | The device is demonstrating early wear and delamination. |
| Jan 23, 2003 | Not classified | Z-0853-03 | Other | The device is demonstrating early wear and delamination. |
| Jan 23, 2003 | Not classified | Z-0852-03 | Other | The device is demonstrating early wear and delamination. |
The 5 latest of 8 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K032829 (Howmedica Osteonics Corp., 2003) has gone furthest, with 23 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 Interax® Total Knee System is intended to be used in cemented primary and/or revision total knee arthroplasty procedures in patients who require total knee replacement as a result of non-inflammatory joint disease and all of its variants, inflammatory joint disease, trauma, or failed previous prosthesis. The Interax® system is intended to accommodate the posterior cruciate ligament if it is intact. The collateral ligaments should be intact, or reparable, or there must be adequate capsular support to provide medio-lateral stability. The Interax® Total Knee System is intended to be implanted using bone cement.
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/K973121 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973121: Interax Total Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973121
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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