510(k) · Cleared
Recalled · Class II · 2012Advance 913 Medial Pivot Tibial Insert, Advance 913 Medial Pivot Tibial Base
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 Aug 20, 2009 after a 29-day review. The FDA summary names no predicate by number. It has been recalled 3 times.
- Decided
- Aug 20, 2009
- Review
- 29 days
- Class
- Class II
- Product code
- JWH
- Recalls
- 3
- Predicates
- 0
The FDA summary names no predicate by number.
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?
The FDA summary names no predicate by 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 5, 2012 | Class II | Z-0183-2013 | Packaging process control | There may be inaccuracies on the labeled shelf life on all products packaged at the Toulon, France facility. |
| Sep 5, 2012 | Class II | Z-0184-2013 | Packaging process control | There may be inaccuracies on the labeled shelf life on all products packaged at the Toulon, France facility. |
| Sep 5, 2012 | Class II | Z-0185-2013 | Packaging process control | There may be inaccuracies on the labeled shelf life on all products packaged at the Toulon, France facility. |
No ancestor or descendant has a Class I recall.
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. 2009, this device’s year, is highlighted.
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 ADVANCE® 913 Medial Pivot Tibial Insert and the ADVANCE® 913 Medial Pivot Tibial Base are indicated for use in 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)…
Read the full statement (101 words)
The ADVANCE® 913 Medial Pivot Tibial Insert and the ADVANCE® 913 Medial Pivot Tibial Base are indicated for use in 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.
ADVANCE® 913 Medial Pivot Tibial Base and Insert Components are for use with bone cement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092201 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092201: Advance 913 Medial Pivot Tibial Insert, Advance 913 Medial Pivot Tibial Base.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092201
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026