510(k) · Cleared
ClearedGENflex2 Total Knee System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stelkast, Inc. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Sep 7, 2016 as substantially equivalent to K980276 (Stelkast Company, 1998) and 2 other predicates after a 30-day review. Its family tree reaches back 8 generations to 1981. 3 later devices descend from it.
- Decided
- Sep 7, 2016
- Review
- 30 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K810258 (1981). 47 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- Root · 8 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 7 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- 6 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- 5 generations backK050327 E-Poly (Vitamin E) Acetabular LinersBiomet, Inc. · 2005
- 4 generations backK070364 100KGY E-Poly Maxrom Acetabular LinersBiomet, Inc. · 2007
- 3 generations backK080528 E-Poly Tibial BearingsBiomet Orthopedics, Inc. · 2008
- 2 generations backK113550 Vanguard Complete Knee SystemBiomet Manufacturing Corp · 2012 · Recalled
- 1 generation backK122883 Exp Tibial Inserts and Patellar Components for the Proven Gen-Flex…Stelkast Company · 2013 · Recalled
- This deviceK162222 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 · cites it directly · 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 3 of 3 · See all- 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 · cites it directly1descendant
- 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 |
|---|---|---|---|---|---|
| −8 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −7 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| −6 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| −5 | K050327 | E-Poly (Vitamin E) Acetabular Liners | Biomet, Inc. | 2005 | — |
| −4 | K070364 | 100KGY E-Poly Maxrom Acetabular Liners | Biomet, Inc. | 2007 | — |
| −3 | K080528 | E-Poly Tibial Bearings | Biomet Orthopedics, Inc. | 2008 | — |
| −2 | K113550 | Vanguard Complete Knee System | Biomet Manufacturing Corp | 2012 | 7 |
| −1 | K122883 | Exp Tibial Inserts and Patellar Components for the Proven Gen-Flex Total Knee… | Stelkast Company | 2013 | 1 |
| 0 (this device) | K162222 | GENflex2 Total Knee System | Stelkast, Inc. | 2016 | — |
| +1 | K173875 | GENFlex2 Total Knee System - Ultra-Congruent CR Tibial Insert | Stelkast, Inc. | 2018 | — |
| +1 | 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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1986 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 7 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 4 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K980276 | Stelkast Proven Cemented, Semi-Constrained Total Knee SystemSummary page 5…other. Predicate Devices: The modified GENflex2 Total Knee System is substantially equivalent to the predicate Proven Total Knee System (K980276, K063211, K122883) with respect to intended use, materials, geometry, range of availa… | 1998 |
| * | K063211 | Proven Knee System High Flexion Tibial InsertSummary page 5…s: The modified GENflex2 Total Knee System is substantially equivalent to the predicate Proven Total Knee System (K980276, K063211, K122883) with respect to intended use, materials, geometry, range of available sizes, methods of fixation,… | 2007 |
| * | K122883 | Exp Tibial Inserts and Patellar Components for the Proven Gen-Flex Total Knee SystemSummary page 5…modified GENflex2 Total Knee System is substantially equivalent to the predicate Proven Total Knee System (K980276, K063211, K122883) with respect to intended use, materials, geometry, range of available sizes, methods of fixation, and… | 2013 |
What descends from it? (3)
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?
- The line of descent spans 35 years and passes through 5 companies; a new generation was cleared every 3.1 years on median.
- 16 of the 47 ancestors have a recall of any class.
- Of its descendants, K173875 (Stelkast, Inc., 2018) has gone furthest, with 2 descendants of its own.
- 4 other devices also cite its predicate K980276.
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. 2016, 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?
The GENFlex2 Total Knee System is intended for:
Total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis, and/or post-traumatic degenerative problems.
Revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.
The device is intended for cemented use only.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K162222 · printed Nov 4, 2026
Cite this page
510(k) Report. “K162222: GENflex2 Total Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K162222
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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