510(k) · Cleared
ClearedAdvance Total Knee System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wrightmedicaltechnologyinc · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Jan 30, 1998 after a 73-day review. The FDA summary names its predicate without a number. 65 later devices descend from it.
- Decided
- Jan 30, 1998
- Review
- 73 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 0
65 later devices descend from it, 2 citing it directly.
- This deviceK974328 Advance Total Knee SystemWrightmedicaltechnologyinc · 1998
- Descendant · cites it directly · 43 of its ownK052687 Conformis, Inc. Total Knee Repair SystemConformis, Inc. · 2006
- Descendant · 2 generations on · 41 of its ownK094050 Itotal CR Knee Replacement SystemConformis, Inc. · 2010
- Descendant · 3 generations on · 40 of its ownK103117 Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2011 · Recalled
- Descendant · 3 generations on · 38 of its ownK112780 Conformis Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2011
- Descendant · 3 generations on · 36 of its ownK120316 Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2012
Showing 5 of 65 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 65 · See all- K052687Conformis, Inc. Total Knee Repair SystemConformis, Inc. · 2006 · cites it directly43descendants
- K094050Itotal CR Knee Replacement SystemConformis, Inc. · 2010 · 2 generations on41descendants
- K103117Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2011 · 3 generations on40descendants
- K112780Conformis Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2011 · 3 generations on38descendants
- K120316Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2012 · 3 generations on36descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K974328 | Advance Total Knee System | Wrightmedicaltechnologyinc | 1998 | — |
| +1 | K052687 | Conformis, Inc. Total Knee Repair System | Conformis, Inc. | 2006 | — |
| +2 | K094050 | Itotal CR Knee Replacement System | Conformis, Inc. | 2010 | — |
| +3 | K103117 | Itotal Cruciate Retaining (CR) Knee Replacement System | Conformis, Inc. | 2011 | 1 |
| +3 | K112780 | Conformis Itotal Cruciate Retaining (CR) Knee Replacement System | Conformis, Inc. | 2011 | — |
| +3 | K120316 | Itotal Cruciate Retaining (CR) Knee Replacement System | Conformis, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 6 | 0 |
| 2013 | 5 | 0 |
| 2014 | 8 | 0 |
| 2015 | 1 | 0 |
| 2016 | 5 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 6 | 0 |
| 2021 | 9 | 0 |
| 2022 | 3 | 0 |
| 2023 | 6 | 0 |
| 2025 | 2 | 0 |
| 2026 | 4 | 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 |
|---|---|---|---|
| * | — | ADVANCE® Total Knee System All Polyethylene Tibial Components Named without a submission number |
What descends from it? (65)
See all 652 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?
- Of its descendants, K052687 (Conformis, Inc., 2006) has gone furthest, with 43 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?
Indicated for use in total knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions:
1) noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
2) inflammatory degenerative joint disease including rheumatoid arthritis:
3) correction of functional deformity;
4) revision procedures where other treatments or devices have failed: and
5) treatment of fractures that are unmanageable using other techniques.
This device is intended for use with 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/K974328 · printed Nov 6, 2026
Cite this page
510(k) Report. “K974328: Advance 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/K974328
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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