510(k) · Cleared
ClearedAscent System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet, Inc. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Sep 22, 1998 after a 39-day review. The FDA summary names its predicate without a number. 79 later devices descend from it.
- Decided
- Sep 22, 1998
- Review
- 39 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 0
79 later devices descend from it, 4 citing it directly.
- This deviceK982869 Ascent SystemBiomet, Inc. · 1998
- Descendant · cites it directly · 60 of its ownK033489 Agc Total Knee System Knee, Ascent Total Knee System, Maxim Complete…Biomet, Inc. · 2004
- Descendant · 2 generations on · 47 of its ownK060303 Vanguard PS Open Box Porous Femoral ComponentsBiomet Manufacturing Corp · 2006
- Descendant · 2 generations on · 46 of its ownK113550 Vanguard Complete Knee SystemBiomet Manufacturing Corp · 2012 · Recalled
- Descendant · cites it directly · 15 of its ownK082019 Freedom Total Knee SystemMaxx Orthopedics, Inc. · 2009
- Descendant · 2 generations on · 13 of its ownK080361 Regenerex Tibial ComponentsBiomet, Inc. · 2008 · Recalled
Showing 5 of 79 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 79 · See all- K033489Agc Total Knee System Knee, Ascent Total Knee System, Maxim Complete Knee System, Maxim…Biomet, Inc. · 2004 · cites it directly60descendants
- K060303Vanguard PS Open Box Porous Femoral ComponentsBiomet Manufacturing Corp · 2006 · 2 generations on47descendants
- K113550Vanguard Complete Knee SystemBiomet Manufacturing Corp · 2012 · 2 generations on46descendants
- K082019Freedom Total Knee SystemMaxx Orthopedics, Inc. · 2009 · cites it directly15descendants
- K080361Regenerex Tibial ComponentsBiomet, Inc. · 2008 · 2 generations on13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K982869 | Ascent System | Biomet, Inc. | 1998 | — |
| +1 | K033489 | Agc Total Knee System Knee, Ascent Total Knee System, Maxim Complete Knee… | Biomet, Inc. | 2004 | — |
| +2 | K060303 | Vanguard PS Open Box Porous Femoral Components | Biomet Manufacturing Corp | 2006 | — |
| +2 | K113550 | Vanguard Complete Knee System | Biomet Manufacturing Corp | 2012 | 7 |
| +1 | K082019 | Freedom Total Knee System | Maxx Orthopedics, Inc. | 2009 | — |
| +2 | K080361 | Regenerex Tibial Components | Biomet, Inc. | 2008 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2004 | 2 | 0 |
| 2006 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 4 | 0 |
| 2014 | 4 | 0 |
| 2015 | 5 | 0 |
| 2016 | 3 | 0 |
| 2017 | 4 | 0 |
| 2018 | 3 | 0 |
| 2019 | 5 | 0 |
| 2020 | 3 | 0 |
| 2021 | 7 | 0 |
| 2022 | 3 | 0 |
| 2023 | 3 | 0 |
| 2024 | 8 | 0 |
| 2025 | 8 | 0 |
| 2026 | 7 | 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 |
|---|---|---|---|
| * | — | AGC 2000 Total Knee Prosthesis Named without a submission number | |
| * | — | Maxim Knee System Named without a submission number | |
| * | — | Performance Knee System Named without a submission number |
What descends from it? (79)
See all 794 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, K033489 (Biomet, Inc., 2004) has gone furthest, with 60 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 indications for use of the Ascent Knee are the same as for other conventional knee prostheses. These include the relief of pain and restoration of motion due to non-inflammatory degenerative joint diseases, rheumatoid arthritis, deformities of the knee and revisions of previously failed knee replacements.
Standard surgical and rehabilitative procedures are indicted with this device.
This device is 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/K982869 · printed Nov 4, 2026
Cite this page
510(k) Report. “K982869: Ascent System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982869
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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