510(k) · Cleared
ClearedProven Knee System High Flexion Tibial Insert
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stelkast Company · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Jan 18, 2007 after an 87-day review. The FDA summary names no predicate by number. 5 later devices descend from it.
- Decided
- Jan 18, 2007
- Review
- 87 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 4 citing it directly.
- This deviceK063211 Proven Knee System High Flexion Tibial InsertStelkast Company · 2007
- Descendant · cites it directly · 4 of its ownK122883 Exp Tibial Inserts and Patellar Components for the Proven Gen-Flex…Stelkast Company · 2013 · Recalled
- Descendant · cites it directly · 3 of its ownK162222 GENflex2 Total Knee SystemStelkast, Inc. · 2016
- Descendant · cites it directly · 2 of its ownK173875 GENFlex2 Total Knee System - Ultra-Congruent CR Tibial InsertStelkast, Inc. · 2018
- Descendant · 2 generations on · 1 of its ownK240669 ACTIFY™ 3D Total Knee System, ACTIFY™ Total Knee SystemGlobus Medical, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK262251 ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC…Globus Medical, Inc. · 2026
Most influential descendants
Showing 5 of 5 · See all- K122883Exp Tibial Inserts and Patellar Components for the Proven Gen-Flex Total Knee SystemStelkast Company · 2013 · cites it directly4descendants
- K162222GENflex2 Total Knee SystemStelkast, Inc. · 2016 · cites it directly3descendants
- K173875GENFlex2 Total Knee System - Ultra-Congruent CR Tibial InsertStelkast, Inc. · 2018 · cites it directly2descendants
- K240669ACTIFY™ 3D Total Knee System, ACTIFY™ Total Knee SystemGlobus Medical, Inc. · 2024 · 2 generations on1descendant
- K262251ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)Globus Medical, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K063211 | Proven Knee System High Flexion Tibial Insert | Stelkast Company | 2007 | — |
| +1 | K122883 | Exp Tibial Inserts and Patellar Components for the Proven Gen-Flex Total Knee… | Stelkast Company | 2013 | 1 |
| +1 | K162222 | GENflex2 Total Knee System | Stelkast, Inc. | 2016 | — |
| +1 | K173875 | GENFlex2 Total Knee System - Ultra-Congruent CR Tibial Insert | Stelkast, Inc. | 2018 | — |
| +2 | K240669 | ACTIFY™ 3D Total Knee System, ACTIFY™ Total Knee System | Globus Medical, Inc. | 2024 | — |
| +1 | K262251 | ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial… | Globus Medical, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 1 | 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?
The FDA summary names no predicate by number.
What descends from it? (5)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K122883 | Exp Tibial Inserts and Patellar Components for the Proven Gen-Flex Total Knee System | 2013 | 4 |
| K162222 | GENflex2 Total Knee System | 2016 | 3 |
| K173875 | GENFlex2 Total Knee System - Ultra-Congruent CR Tibial Insert | 2018 | 2 |
| K262251 | ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert) | 2026 | 0 |
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, K122883 (Stelkast Company, 2013) has gone furthest, with 4 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. 2007, this device’s year, is highlighted.
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?
1. Total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid
arthritis, and/or post-traumatic degenerative problems.
2. Revision of failed previous reconstructions where sufficient bone stock and
soft tissue integrity are present.
3. For cemented use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063211 · printed Nov 5, 2026
Cite this page
510(k) Report. “K063211: Proven Knee System High Flexion Tibial Insert.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K063211
Report an extraction error
Are you the manufacturer?
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