510(k) · Cleared
ClearedAnatomic Modular Knee (Amk) System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy, Inc. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Feb 6, 1987 after a 66-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 9 later devices descend from it.
- Decided
- Feb 6, 1987
- Review
- 66 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 3 citing it directly.
- This deviceK864671 Anatomic Modular Knee (Amk) SystemDepuy, Inc. · 1987
- Descendant · cites it directly · 3 of its ownK100981 United Stem, Psa TypeUnited Orthopedic Corp. · 2010
- Descendant · cites it directly · 3 of its ownK991106 P.F.C. Sigma Porous Modular Keel Tibial TrayDePuy Orthopaedics, Inc. · 1999
- Descendant · 2 generations on · 2 of its ownK190100 USTAR II SystemUnited Orthopedic Corporation · 2019 · Recalled
- Descendant · 2 generations on · 1 of its ownK182301 PFC SIGMA Knee SystemDePuy Orthopaedics, Inc. · 2019
- Descendant · 3 generations on · 0 of its ownK252303 Stem Extension Line (USTAR II System)United Orthopedic Corporation · 2025
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K100981United Stem, Psa TypeUnited Orthopedic Corp. · 2010 · cites it directly3descendants
- K991106P.F.C. Sigma Porous Modular Keel Tibial TrayDePuy Orthopaedics, Inc. · 1999 · cites it directly3descendants
- K190100USTAR II SystemUnited Orthopedic Corporation · 2019 · 2 generations on2descendants
- K182301PFC SIGMA Knee SystemDePuy Orthopaedics, Inc. · 2019 · 2 generations on1descendant
- K252303Stem Extension Line (USTAR II System)United Orthopedic Corporation · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K864671 | Anatomic Modular Knee (Amk) System | Depuy, Inc. | 1987 | — |
| +1 | K100981 | United Stem, Psa Type | United Orthopedic Corp. | 2010 | — |
| +1 | K991106 | P.F.C. Sigma Porous Modular Keel Tibial Tray | DePuy Orthopaedics, Inc. | 1999 | — |
| +2 | K190100 | USTAR II System | United Orthopedic Corporation | 2019 | 5 |
| +2 | K182301 | PFC SIGMA Knee System | DePuy Orthopaedics, Inc. | 2019 | — |
| +3 | K252303 | Stem Extension Line (USTAR II System) | United Orthopedic Corporation | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2010 | 1 | 0 |
| 2019 | 2 | 0 |
| 2021 | 1 | 0 |
| 2025 | 2 | 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? (9)
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, K100981 (United Orthopedic Corp., 2010) 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/K864671 · printed Nov 6, 2026
Cite this page
510(k) Report. “K864671: Anatomic Modular Knee (Amk) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K864671
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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