510(k) · Cleared
ClearedSecond Generation Knee System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthomet, Inc. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Oct 6, 1989 after an 84-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
- Oct 6, 1989
- Review
- 84 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 4 citing it directly.
- This deviceK894334 Second Generation Knee SystemOrthomet, Inc. · 1989
- Descendant · cites it directly · 7 of its ownK113325 Evolution MP Adaptive CS InsertWrightmedicaltechnologyinc · 2011
- Descendant · 2 generations on · 6 of its ownK131679 Evolution MP Adaptive PS Tibial InsertWrightmedicaltechnologyinc · 2013
- Descendant · 2 generations on · 5 of its ownK140735 Evolution MP CS/CR Porous Femur/Evolution Adaptive CS and PS InsertsMicroport Orthopedics, Inc. · 2014 · Recalled
- Descendant · cites it directly · 2 of its ownK122218 Advance Total Knee System-PatellaWrightmedicaltechnologyinc · 2013
- Descendant · 3 generations on · 1 of its ownK243574 Evolution® Total Knee Systems - Kinematic Alignment Instrumentation…Microport Orthopedics, Inc. · 2025
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K113325Evolution MP Adaptive CS InsertWrightmedicaltechnologyinc · 2011 · cites it directly7descendants
- K131679Evolution MP Adaptive PS Tibial InsertWrightmedicaltechnologyinc · 2013 · 2 generations on6descendants
- K140735Evolution MP CS/CR Porous Femur/Evolution Adaptive CS and PS InsertsMicroport Orthopedics, Inc. · 2014 · 2 generations on5descendants
- K122218Advance Total Knee System-PatellaWrightmedicaltechnologyinc · 2013 · cites it directly2descendants
- K243574Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and TechniqueMicroport Orthopedics, Inc. · 2025 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K894334 | Second Generation Knee System | Orthomet, Inc. | 1989 | — |
| +1 | K113325 | Evolution MP Adaptive CS Insert | Wrightmedicaltechnologyinc | 2011 | — |
| +2 | K131679 | Evolution MP Adaptive PS Tibial Insert | Wrightmedicaltechnologyinc | 2013 | — |
| +2 | K140735 | Evolution MP CS/CR Porous Femur/Evolution Adaptive CS and PS Inserts | Microport Orthopedics, Inc. | 2014 | 1 |
| +1 | K122218 | Advance Total Knee System-Patella | Wrightmedicaltechnologyinc | 2013 | — |
| +3 | K243574 | Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and… | Microport Orthopedics, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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? (9)
4 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, K113325 (Wrightmedicaltechnologyinc, 2011) has gone furthest, with 7 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/K894334 · printed Nov 6, 2026
Cite this page
510(k) Report. “K894334: Second Generation 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/K894334
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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