510(k) · Cleared
Recalled · 2009Advance Ultra-Congruent Tibial Insert
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 Oct 21, 1997 after an 89-day review. The FDA summary names its predicate without a number. 30 later devices descend from it. It has been recalled 2 times.
- Decided
- Oct 21, 1997
- Review
- 89 days
- Class
- Class II
- Product code
- JWH
- Recalls
- 2
- Predicates
- 0
30 later devices descend from it, 5 citing it directly.
- This deviceK972770 Advance Ultra-Congruent Tibial InsertWrightmedicaltechnologyinc · 1997
- Descendant · cites it directly · 20 of its ownK121416 GMK SphereMedacta International · 2012
- Descendant · 2 generations on · 17 of its ownK140826 GMK Sphere ExtensionMedacta International · 2014
- Descendant · 2 generations on · 10 of its ownK162035 GMK SphereMedacta International S.A. · 2017
- Descendant · cites it directly · 7 of its ownK113325 Evolution MP Adaptive CS InsertWrightmedicaltechnologyinc · 2011
- Descendant · 2 generations on · 6 of its ownK173890 GMK Sphere - Kinematic AlignmentMedacta International S.A. · 2018
Showing 5 of 30 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 30 · See all- K121416GMK SphereMedacta International · 2012 · cites it directly20descendants
- K140826GMK Sphere ExtensionMedacta International · 2014 · 2 generations on17descendants
- K162035GMK SphereMedacta International S.A. · 2017 · 2 generations on10descendants
- K113325Evolution MP Adaptive CS InsertWrightmedicaltechnologyinc · 2011 · cites it directly7descendants
- K173890GMK Sphere - Kinematic AlignmentMedacta International S.A. · 2018 · 2 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K972770 | Advance Ultra-Congruent Tibial Insert | Wrightmedicaltechnologyinc | 1997 | — |
| +1 | K121416 | GMK Sphere | Medacta International | 2012 | — |
| +2 | K140826 | GMK Sphere Extension | Medacta International | 2014 | — |
| +2 | K162035 | GMK Sphere | Medacta International S.A. | 2017 | — |
| +1 | K113325 | Evolution MP Adaptive CS Insert | Wrightmedicaltechnologyinc | 2011 | — |
| +2 | K173890 | GMK Sphere - Kinematic Alignment | Medacta International S.A. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 4 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 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 |
|---|---|---|---|
| * | — | Intermedics Natural Knee Ultra-Congruent Tibial Insert Named without a submission number |
What descends from it? (30)
See all 305 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 |
|---|---|---|---|---|
| Nov 24, 2009 | Not classified | Z-1637-2010 | Packaging process control | The left medial pivot and right medial pivot inserts were co-mingled |
| Nov 24, 2009 | Not classified | Z-1636-2010 | Packaging process control | The left medial pivot and right medial pivot inserts were co-mingled |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K121416 (Medacta International, 2012) has gone furthest, with 20 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 ADVANCE® Ultra-Congruent Tibial Insert is 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…
Read the full statement (97 words)
The ADVANCE® Ultra-Congruent Tibial Insert is 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
S) treatment of fractures that are unmanageable using other techniques.
The ADVANCE® Ultra-Congruent tibial insert is part of a total system that is
indicated for use only with 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/K972770 · printed Nov 5, 2026
Cite this page
510(k) Report. “K972770: Advance Ultra-Congruent Tibial Insert.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K972770
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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