510(k) · Cleared
ClearedACTIFY™ 3D Total Knee System, ACTIFY™ Total Knee System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Globus Medical, Inc. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Jun 20, 2024 as substantially equivalent to K173849 (Stryker Orthopaedics, 2018) and 4 other predicates after a 101-day review. Its family tree reaches back 11 generations to 1994. 1 later device descends from it.
- Decided
- Jun 20, 2024
- Review
- 101 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 11 generations to K943462 (1994). 134 ancestors in all, the oldest K810258 (1981). 1 later device descends from it, 1 citing it directly.
- Root · 11 generations backK943462 Darwin Knee SystemJohnson & Johnson Professionals, Inc. · 1994 · Recalled
- 7 generations between
- 3 generations backK150307 RESTORIS Multicompartmental Knee SystemMako Surgical Corp. · 2015
- 2 generations backK172326 Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee…Stryker Orthopaedics · 2017 · Recalled
- 1 generation backK173849 Triathlon Total Knee SystemStryker Orthopaedics · 2018 · Recalled
- This deviceK240669 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
Show all 11 generations
- Root · 11 generations backK943462 Darwin Knee SystemJohnson & Johnson Professionals, Inc. · 1994 · Recalled
- 10 generations backK033272 Depuy Sigma Tibial InsertsDePuy Orthopaedics, Inc. · 2004 · Recalled
- 9 generations backK040166 Depuy Sigma XLK Tibial InsertsDePuy Orthopaedics, Inc. · 2004
- 8 generations backK061648 Depuy Graduated Compartmental Knee (GCK)DePuy Orthopaedics, Inc. · 2006 · Recalled
- 7 generations backK070849 Depuy GCK Femoral and Tibial ComponentsDePuy Orthopaedics, Inc. · 2007
- 6 generations backK082172 Mako Modular Knee Compartmental Implant SystemMako Surgical Corporation · 2008 · Recalled
- 5 generations backK090763 Restoris Multicompartmental Knee (MCK) SystemMako Surgical Corporation · 2009 · Recalled
- 4 generations backK133039 Restoris Multicompartmental Knee SystemMako Surgical Corporation · 2013
- 3 generations backK150307 RESTORIS Multicompartmental Knee SystemMako Surgical Corp. · 2015
- 2 generations backK172326 Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee…Stryker Orthopaedics · 2017 · Recalled
- 1 generation backK173849 Triathlon Total Knee SystemStryker Orthopaedics · 2018 · Recalled
- This deviceK240669 ACTIFY™ 3D Total Knee System, ACTIFY™ Total Knee SystemGlobus Medical, Inc. · 2024
Most influential descendants
Showing 1 of 1 · See all- 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 |
|---|---|---|---|---|---|
| −11 | K943462 | Darwin Knee System | Johnson & Johnson Professionals, Inc. | 1994 | 8 |
| −10 | K033272 | Depuy Sigma Tibial Inserts | DePuy Orthopaedics, Inc. | 2004 | 51 |
| −9 | K040166 | Depuy Sigma XLK Tibial Inserts | DePuy Orthopaedics, Inc. | 2004 | — |
| −8 | K061648 | Depuy Graduated Compartmental Knee (GCK) | DePuy Orthopaedics, Inc. | 2006 | 1 |
| −7 | K070849 | Depuy GCK Femoral and Tibial Components | DePuy Orthopaedics, Inc. | 2007 | — |
| −6 | K082172 | Mako Modular Knee Compartmental Implant System | Mako Surgical Corporation | 2008 | 2 |
| −5 | K090763 | Restoris Multicompartmental Knee (MCK) System | Mako Surgical Corporation | 2009 | 5 |
| −4 | K133039 | Restoris Multicompartmental Knee System | Mako Surgical Corporation | 2013 | — |
| −3 | K150307 | RESTORIS Multicompartmental Knee System | Mako Surgical Corp. | 2015 | — |
| −2 | K172326 | Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System | Stryker Orthopaedics | 2017 | 1 |
| −1 | K173849 | Triathlon Total Knee System | Stryker Orthopaedics | 2018 | 3 |
| 0 (this device) | 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 |
|---|---|---|
| 1981 | 1 | 0 |
| 1984 | 1 | 0 |
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 3 | 0 |
| 1993 | 3 | 0 |
| 1994 | 3 | 0 |
| 1995 | 9 | 0 |
| 1996 | 5 | 0 |
| 1997 | 5 | 0 |
| 1998 | 6 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 4 | 0 |
| 2002 | 6 | 0 |
| 2003 | 12 | 0 |
| 2004 | 12 | 0 |
| 2005 | 10 | 0 |
| 2006 | 8 | 0 |
| 2007 | 8 | 0 |
| 2008 | 4 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 4 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (5)
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 |
|---|---|---|---|
| * | K173849 | Triathlon Total Knee SystemSummary page 5…osthesis Product Codes: JWH, MBH, OIY Regulatory Class: II, Panel Code: 87 Primary Predicate: Stryker Triathlon Total Knee System (K173849) Secondary Predicates: GENflex2® Total Knee System (K162222) GENflex2® Total Knee System - Ultra-Congr… | 2018 |
| * | K162222 | GENflex2 Total Knee SystemSummary page 5…Regulatory Class: II, Panel Code: 87 Primary Predicate: Stryker Triathlon Total Knee System (K173849) Secondary Predicates: GENflex2® Total Knee System (K162222) GENflex2® Total Knee System - Ultra-Congruent CR Tibial Insert (K173875)… | 2016 |
| * | K173875 | GENFlex2 Total Knee System - Ultra-Congruent CR Tibial InsertSummary page 5…Secondary Predicates: GENflex2® Total Knee System (K162222) GENflex2® Total Knee System - Ultra-Congruent CR Tibial Insert (K173875) Proven Cemented Semi-Constrained Total Knee System (K122883, K980276) Reference Devices:… | 2018 |
| * | K122883 | Exp Tibial Inserts and Patellar Components for the Proven Gen-Flex Total Knee SystemSummary page 5…tal Knee System - Ultra-Congruent CR Tibial Insert (K173875) Proven Cemented Semi-Constrained Total Knee System (K122883, K980276) Reference Devices: HEDRON® Cervical & Lumbar Spacers, SABLE® Expandable Spacer (K222270)… | 2013 |
| * | K980276 | Stelkast Proven Cemented, Semi-Constrained Total Knee SystemSummary page 5…System - Ultra-Congruent CR Tibial Insert (K173875) Proven Cemented Semi-Constrained Total Knee System (K122883, K980276) Reference Devices: HEDRON® Cervical & Lumbar Spacers, SABLE® Expandable Spacer (K222270)… | 1998 |
| † | K222270 | HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS… | 2022 |
| † | K094035 | Exp Acetabular Liner, Models SC3342 Non-Hooded 28MM, SC3343 Hooded 28MM | 2011 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| 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?
- The line of descent spans 30 years and passes through 6 companies; a new generation was cleared every 1.4 years on median.
- 63 of the 134 ancestors have a recall of any class.
- Of its descendants, K262251 (Globus Medical, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K173849.
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. 2024, 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?
ACTIFY™ Total Knee System and ACTIFY™ 3D Total Knee System are indicated for single use only in skeletally mature individuals undergoing reconstruction of severely disabled and/or very painful joints. ACTIFY™ Total Knee System and ACTIFY™ 3D Total Knee System are indicated for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis, and/or post-traumatic degenerative problems, and revision of failed previous reconstructions…
Read the full statement (108 words)
ACTIFY™ Total Knee System and ACTIFY™ 3D Total Knee System are indicated for single use only in skeletally mature individuals undergoing reconstruction of severely disabled and/or very painful joints.
ACTIFY™ Total Knee System and ACTIFY™ 3D Total Knee System are indicated for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis, and/or post-traumatic degenerative problems, and revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.
ACTIFY™ Total Knee System is indicated for cemented use only, except for the porous femoral component which is indicated for both cemented and uncemented use.
ACTIFY™ 3D Total Knee System is indicated for cemented and uncemented use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240669 · printed Nov 6, 2026
Cite this page
510(k) Report. “K240669: ACTIFY™ 3D Total Knee System, ACTIFY™ Total 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/K240669
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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