510(k) · Cleared
ClearedAgc and Maxim Knee Components with NTS
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 Aug 13, 1992 after a 90-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.
- Decided
- Aug 13, 1992
- Review
- 90 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 3 citing it directly.
- This deviceK922285 Agc and Maxim Knee Components with NTSBiomet, Inc. · 1992
- Descendant · cites it directly · 3 of its ownK984331 Odi Ultimate Compression Hip ScrewOrthopedic Designs, Inc. · 1999
- Descendant · 2 generations on · 2 of its ownK033286 Odi Talon Long Proximal Femoral Nail SystemOrthopedic Designs, Inc. (Odi) · 2004
- Descendant · 3 generations on · 1 of its ownK111352 Talon Distalfix Proximal Femoral NailOrthopedic Designs North America, Inc. · 2011
- Descendant · 4 generations on · 0 of its ownK223933 Exactech Equinoxe PHx Fracture System; Exactech EPIC ScrewsExactech, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK102367 Optigen Total Knee SystemU&I Corp. · 2010
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K984331Odi Ultimate Compression Hip ScrewOrthopedic Designs, Inc. · 1999 · cites it directly3descendants
- K033286Odi Talon Long Proximal Femoral Nail SystemOrthopedic Designs, Inc. (Odi) · 2004 · 2 generations on2descendants
- K111352Talon Distalfix Proximal Femoral NailOrthopedic Designs North America, Inc. · 2011 · 3 generations on1descendant
- K223933Exactech Equinoxe PHx Fracture System; Exactech EPIC ScrewsExactech, Inc. · 2023 · 4 generations on0descendants
- K102367Optigen Total Knee SystemU&I Corp. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K922285 | Agc and Maxim Knee Components with NTS | Biomet, Inc. | 1992 | — |
| +1 | K984331 | Odi Ultimate Compression Hip Screw | Orthopedic Designs, Inc. | 1999 | — |
| +2 | K033286 | Odi Talon Long Proximal Femoral Nail System | Orthopedic Designs, Inc. (Odi) | 2004 | — |
| +3 | K111352 | Talon Distalfix Proximal Femoral Nail | Orthopedic Designs North America, Inc. | 2011 | — |
| +4 | K223933 | Exactech Equinoxe PHx Fracture System; Exactech EPIC Screws | Exactech, Inc. | 2023 | — |
| +1 | K102367 | Optigen Total Knee System | U&I Corp. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2004 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (6)
3 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, K984331 (Orthopedic Designs, Inc., 1999) has gone furthest, with 3 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 | — |
https://510kreport.com/device/K922285 · printed Nov 6, 2026
Cite this page
510(k) Report. “K922285: Agc and Maxim Knee Components with NTS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K922285
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026