510(k) · Cleared
ClearedGem Knee System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kinamed, Inc. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Jul 19, 2000 after a 218-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 121 later devices descend from it.
- Decided
- Jul 19, 2000
- Review
- 218 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 0
121 later devices descend from it, 5 citing it directly.
- This deviceK994214 Gem Knee SystemKinamed, Inc. · 2000
- Descendant · cites it directly · 120 of its ownK021313 Search Evolution Total Knee SystemAesculap, Inc. · 2002
- Descendant · cites it directly · 96 of its ownK022672 Columbus Total Knee System (CR)Aesculap, Inc. · 2002 · Recalled
- Descendant · cites it directly · 80 of its ownK032108 Search Evolution (LC) Total Knee System (Porous Coated)Aesculap, Inc. · 2004
- Descendant · 2 generations on · 79 of its ownK070981 Search Evolution (LC) Total Knee System (Plasmapore)Aesculap Implant Systems, Inc. · 2007
- Descendant · 3 generations on · 78 of its ownK081023 Evolis Total Knee SystemMedacta International S.A. · 2008 · Recalled
Showing 5 of 121 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 121 · See all- K021313Search Evolution Total Knee SystemAesculap, Inc. · 2002 · cites it directly120descendants
- K022672Columbus Total Knee System (CR)Aesculap, Inc. · 2002 · cites it directly96descendants
- K032108Search Evolution (LC) Total Knee System (Porous Coated)Aesculap, Inc. · 2004 · cites it directly80descendants
- K070981Search Evolution (LC) Total Knee System (Plasmapore)Aesculap Implant Systems, Inc. · 2007 · 2 generations on79descendants
- K081023Evolis Total Knee SystemMedacta International S.A. · 2008 · 3 generations on78descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K994214 | Gem Knee System | Kinamed, Inc. | 2000 | — |
| +1 | K021313 | Search Evolution Total Knee System | Aesculap, Inc. | 2002 | — |
| +1 | K022672 | Columbus Total Knee System (CR) | Aesculap, Inc. | 2002 | 1 |
| +1 | K032108 | Search Evolution (LC) Total Knee System (Porous Coated) | Aesculap, Inc. | 2004 | — |
| +2 | K070981 | Search Evolution (LC) Total Knee System (Plasmapore) | Aesculap Implant Systems, Inc. | 2007 | — |
| +3 | K081023 | Evolis Total Knee System | Medacta International S.A. | 2008 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 3 | 0 |
| 2010 | 3 | 0 |
| 2011 | 5 | 0 |
| 2012 | 10 | 0 |
| 2013 | 8 | 0 |
| 2014 | 4 | 0 |
| 2015 | 5 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 3 | 0 |
| 2019 | 3 | 0 |
| 2020 | 7 | 0 |
| 2021 | 13 | 0 |
| 2022 | 6 | 0 |
| 2023 | 7 | 0 |
| 2024 | 4 | 0 |
| 2025 | 13 | 0 |
| 2026 | 10 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (121)
See all 1215 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, K021313 (Aesculap, Inc., 2002) has gone furthest, with 120 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 Kinamed Inc. Gem Knee System is indicated for use in reconstruction of the diseased knee joint caused by osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, the need to revise failed arthroplasties or osteotomies where pain, deformity or dysfunction persist, and for patients suffering from correctable valgus or varus deformity and moderate flexion contracture.
The Gem Knee System is designed for use with bone cement.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K994214 · printed Nov 6, 2026
Cite this page
510(k) Report. “K994214: Gem Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K994214
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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