510(k) Report

510(k) · Cleared

Cleared

ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)

K262251510(k) SpecialCleared Jul 31, 202630-day reviewClass II21 CFR 888.3560

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Globus Medical, Inc. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Cleared on Jul 31, 2026 as substantially equivalent to K240669 (Globus Medical, Inc., 2024) and 5 other predicates after a 30-day review. Its family tree reaches back 12 generations to 1981.

Decided
Jul 31, 2026
Review
30 days
Class
Class II
Product code
JWH
Recalls
None
Predicates
6

Its longest line of descent runs back 12 generations to K810258 (1981). 179 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2024: 1 other ancestor2018: 2 other ancestors2016: 1 other ancestor2013: 5 other ancestors2007: 12 other ancestors2012: 2 other ancestors2011: 2 other ancestors2010: 4 other ancestors1998: 5 other ancestors2017: 2 other ancestors2014: 1 other ancestor2008: 7 other ancestors2006: 10 other ancestors2005: 11 other ancestors2004: 14 other ancestors2003: 13 other ancestors1997: 6 other ancestors1996: 6 other ancestors1995: 11 other ancestors1994: 7 other ancestors1992: 4 other ancestors2015: 2 other ancestors2009: 3 other ancestors2002: 8 other ancestors2000: 5 other ancestors1993: 3 other ancestors1991: 4 other ancestors1984: 1 other ancestor1999: 3 other ancestors1990: 1 other ancestor1989: 1 other ancestor1986: 1 other ancestor2001: 8 other ancestors1988: 1 other ancestorK810258 · Proximal Fermoral Hip Replacement · Biomet, Inc. · 1981K974558 · Salvage/Onocology Hip and Total Femur System · Biomet, Inc. · 1998K032396 · Ringloc 36MM Line and Modular Femoral Heads · Biomet, Inc. · 2003 · recalled×2: 2 generations cleared close together, K042051 (2005), K051411 (2005) K061312 · 36MM Biolox Delta Ceramic Heads · Biomet, Inc. · 2006K073102 · Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular Liners · Biomet Manufacturing Corp · 2007K100048 · E1 Antioxidant Infused Technology · Biomet Manufacturing Corp · 2010×2: 2 generations cleared close together, K120370 (2012), K121771 (2012) K150090 · Zimmer Persona Personalized Knee System · Zimmer, Inc. · 2015K211609 · ATTUNE Medial Stabilized (MS) Fixed Bearing (FB) Insert · Depuy Ireland UC · 202119801990200020102020
Other ancestors, by generation 1 generation back: 5 other ancestors2 generations back: 5 other ancestors3 generations back: 26 other ancestors4 generations back: 36 other ancestors5 generations back: 38 other ancestors6 generations back: 24 other ancestors7 generations back: 27 other ancestors8 generations back: 6 other ancestors K211609 · ATTUNE Medial Stabilized (MS) Fixed Bearing (FB) Insert · Depuy Ireland UC · 2021K150090 · Zimmer Persona Personalized Knee System · Zimmer, Inc. · 2015K121771 · Zimmer Persona the Personalized Knee System · Zimmer, Inc. · 2012 · recalledK120370 · Vivacit-E Vitamin E Highly Crosslinked Polyethylene Liners · Zimmer, Inc. · 2012K100048 · E1 Antioxidant Infused Technology · Biomet Manufacturing Corp · 2010K073102 · Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular Liners · Biomet Manufacturing Corp · 2007K061312 · 36MM Biolox Delta Ceramic Heads · Biomet, Inc. · 2006K051411 · Arcomxl Polyethylene Liners and Biolox Delta Heads · Biomet, Inc. · 2005 · recalledK042051 · Arcomxl Polyethylene Liners · Biomet, Inc. · 2005 · recalledK032396 · Ringloc 36MM Line and Modular Femoral Heads · Biomet, Inc. · 2003 · recalledK974558 · Salvage/Onocology Hip and Total Femur System · Biomet, Inc. · 1998K810258 · Proximal Fermoral Hip Replacement · Biomet, Inc. · 1981−10−50
  1. Root · 12 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
  2. 8 generations between
  3. 3 generations backK121771 Zimmer Persona the Personalized Knee SystemZimmer, Inc. · 2012 · Recalled
  4. 2 generations backK150090 Zimmer Persona Personalized Knee SystemZimmer, Inc. · 2015
  5. 1 generation backK211609 ATTUNE Medial Stabilized (MS) Fixed Bearing (FB) InsertDepuy Ireland UC · 2021
  6. This deviceK262251 ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC…Globus Medical, Inc. · 2026
Show all 12 generations
  1. Root · 12 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
  2. 11 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
  3. 10 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
  4. 9 generations backK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
  5. 8 generations backK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
  6. 7 generations backK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
  7. 6 generations backK073102 Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular LinersBiomet Manufacturing Corp · 2007
  8. 5 generations backK100048 E1 Antioxidant Infused TechnologyBiomet Manufacturing Corp · 2010
  9. 4 generations backK120370 Vivacit-E Vitamin E Highly Crosslinked Polyethylene LinersZimmer, Inc. · 2012
  10. 3 generations backK121771 Zimmer Persona the Personalized Knee SystemZimmer, Inc. · 2012 · Recalled
  11. 2 generations backK150090 Zimmer Persona Personalized Knee SystemZimmer, Inc. · 2015
  12. 1 generation backK211609 ATTUNE Medial Stabilized (MS) Fixed Bearing (FB) InsertDepuy Ireland UC · 2021
  13. This deviceK262251 ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC…Globus Medical, Inc. · 2026
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−12K810258Proximal Fermoral Hip ReplacementBiomet, Inc.1981—
−11K974558Salvage/Onocology Hip and Total Femur SystemBiomet, Inc.1998—
−10K032396Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc.20033
−9K042051Arcomxl Polyethylene LinersBiomet, Inc.20051
−8K051411Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc.20051
−7K06131236MM Biolox Delta Ceramic HeadsBiomet, Inc.2006—
−6K073102Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular LinersBiomet Manufacturing Corp2007—
−5K100048E1 Antioxidant Infused TechnologyBiomet Manufacturing Corp2010—
−4K120370Vivacit-E Vitamin E Highly Crosslinked Polyethylene LinersZimmer, Inc.2012—
−3K121771Zimmer Persona the Personalized Knee SystemZimmer, Inc.20122
−2K150090Zimmer Persona Personalized Knee SystemZimmer, Inc.2015—
−1K211609ATTUNE Medial Stabilized (MS) Fixed Bearing (FB) InsertDepuy Ireland UC2021—
0 (this device)K262251ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial…Globus Medical, Inc.2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198410
198610
198810
198910
199010
199140
199240
199330
199470
1995110
199660
199760
199850
199930
200050
200180
200280
2003130
2004140
2005110
2006100
2007120
200870
200930
201040
201120
201220
201350
201410
201520
201610
201720
201820
202410
FIG. 1 — Lineage of K262251, 1981–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K221479 Persona Personalized Knee Systemscore 22.4 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (6)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K240669ACTIFY™ 3D Total Knee System, ACTIFY™ Total Knee System
Summary page 5
…ct Code(s): JWH, MBH, OIY Regulatory Class: II Primary Predicate: ACTIFY 3D Total Knee System, ACTIFY Total Knee System (K240669) Additional Predicates: Proven Knee CR-HF Tibial Insert (K063211, K122883) ACTIFY Total Knee System (…
Globus Medical, Inc.2024—
*K063211Proven Knee System High Flexion Tibial Insert
Summary page 5
…y Predicate: ACTIFY 3D Total Knee System, ACTIFY Total Knee System (K240669) Additional Predicates: Proven Knee CR-HF Tibial Insert (K063211, K122883) ACTIFY Total Knee System (K162222, K173875) J&J MedTech ATTUNE Medial Stabilize…
Stelkast Company2007—
*K122883Exp Tibial Inserts and Patellar Components for the Proven Gen-Flex Total Knee System
Summary page 5
…te: ACTIFY 3D Total Knee System, ACTIFY Total Knee System (K240669) Additional Predicates: Proven Knee CR-HF Tibial Insert (K063211, K122883) ACTIFY Total Knee System (K162222, K173875) J&J MedTech ATTUNE Medial Stabilized Fixed B…
Stelkast Company20131
*K162222GENflex2 Total Knee System
Summary page 5
…Knee System (K240669) Additional Predicates: Proven Knee CR-HF Tibial Insert (K063211, K122883) ACTIFY Total Knee System (K162222, K173875) J&J MedTech ATTUNE Medial Stabilized Fixed Bearing Insert (K211609) Purpose: Th…
Stelkast, Inc.2016—
*K173875GENFlex2 Total Knee System - Ultra-Congruent CR Tibial Insert
Summary page 5
…em (K240669) Additional Predicates: Proven Knee CR-HF Tibial Insert (K063211, K122883) ACTIFY Total Knee System (K162222, K173875) J&J MedTech ATTUNE Medial Stabilized Fixed Bearing Insert (K211609) Purpose: The purpose…
Stelkast, Inc.2018—
*K211609ATTUNE Medial Stabilized (MS) Fixed Bearing (FB) Insert
Summary page 5
…22883) ACTIFY Total Knee System (K162222, K173875) J&J MedTech ATTUNE Medial Stabilized Fixed Bearing Insert (K211609) Purpose: The purpose of this submission is to request clearance of ACTIFY MC (Medial Conforming) tibial inserts for use with pr…
Depuy Ireland UC2021—

What descends from it?

No later submission names this one as a predicate yet.

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 45 years and passes through 5 companies; a new generation was cleared every 2.3 years on median.
  • 80 of the 179 ancestors have a recall of any class.

How does its category compare?

All JWH devices

JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.

FDA decisions per year · JWH

20in 2025

2007: 182008: 172009: 112010: 192011: 252012: 332013: 312014: 332015: 272016: 182017: 252018: 252019: 282020: 222021: 242022: 172023: 202024: 192025: 202026 (partial year): 12
2007high 33 (2012) · low 11 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JWH

55in 2025

2007: 74 days median2008: 81 days median2009: 168 days median2010: 85 days median2011: 87 days median2012: 85 days median2013: 128 days median2014: 98 days median2015: 87 days median2016: 88 days median2017: 118 days median2018: 90 days median2019: 133 days median2020: 59 days median2021: 61 days median2022: 56 days median2023: 57 days median2024: 89 days median2025: 55 days median2026 (partial year): 63 days median
2007high 168 (2009) · low 55 (2025)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JWH

2in 2025

2007: 142008: 102009: 1092010: 322011: 272012: 852013: 312014: 132015: 112016: 172017: 612018: 142019: 52020: 22021: 82022: 122023: 672024: 72025: 22026 (partial year): 4
2007high 109 (2009) · low 2 (2020)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JWH

9,306in 2025

2007: 1,3052008: 1,4832009: 1,8702010: 3,2862011: 5,1332012: 5,2032013: 6,1352014: 6,7222015: 6,8812016: 7,5862017: 12,2632018: 14,0712019: 14,9872020: 12,5922021: 9,4082022: 8,3642023: 8,9472024: 10,8282025: 9,306
2007high 14,987 (2019) · low 1,305 (2007)2025

MAUDE reports naming product code JWH, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071874141,305
20081781101,483
2009111681091,870
20101985323,286
20112587275,133
20123385855,203
201331128316,135
20143398136,722
20152787116,881
20161888177,586
2017251186112,263
201825901414,071
201928133514,987
20202259212,592
2021246189,408
20221756128,364
20232057678,947
20241989710,828
2025205529,306
202612634—

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 posttraumatic degenerative problems, and revision of failed previous reconstructions where…

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 posttraumatic 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.

More from Globus Medical, Inc.

184 FDA decisions under this applicant name. See the company

  • K262779ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2026
  • K254043TRIVANCE™ Hip StemGlobus Medical, Inc. · 2026
  • K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System…Globus Medical, Inc. · 2026
  • K253401SCRIPT™ Implant SystemGlobus Medical, Inc. · 2026
  • K261043AUTOBAHN™ Nailing SystemGlobus Medical, Inc. · 2026

Recent decisions in JWH

The JWH category page

  • K262057GMK ExtensionMedacta International SA · 2026
  • K260063GSPE SpacerThe General Hospital Corporation, d/b/a Massachusetts · 2026
  • K262293EVOLUTION MPX™ Total Knee SystemSuzhou Microport Orthorecon Co., Ltd. · 2026
  • K262341b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem…B-One Ortho, Corp. · 2026
  • K262130ATTUNE Revision Knee SystemDepuy Orthopaedics, Inc. · 2026

https://510kreport.com/device/K262251 · printed Nov 6, 2026

Cite this page

510(k) Report. “K262251: ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K262251

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Record history
  • FDA decision record loaded Oct 30, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026