510(k) · Cleared
ClearedACTIFY™ Unicondylar Knee System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Globus Medical, Inc. · HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Cleared on Dec 6, 2024 as substantially equivalent to K032824 (Stelkast Company, 2003) and 4 other predicates after a 214-day review. Its family tree reaches back 13 generations to 1981.
- Decided
- Dec 6, 2024
- Review
- 214 days
- Class
- Class II
- Product code
- HSX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 13 generations to K810258 (1981). 241 ancestors in all, the oldest K760245 (1976). No later device cites it as a predicate yet.
- Root · 13 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 9 generations between
- 3 generations backK160738 ZUK Select Knee SystemSmith & Nephew, Inc. · 2016
- 2 generations backK190085 Journey II Unicompartmental Knee SystemSmith & Nephew, Inc. · 2019 · Recalled
- 1 generation backK230653 Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee…Smith & Nephew, Inc. · 2023 · Recalled
- This deviceK241260 ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc. · 2024
Show all 13 generations
- Root · 13 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 12 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- 11 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- 10 generations backK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
- 9 generations backK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
- 8 generations backK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
- 7 generations backK073102 Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular LinersBiomet Manufacturing Corp · 2007
- 6 generations backK100048 E1 Antioxidant Infused TechnologyBiomet Manufacturing Corp · 2010
- 5 generations backK120370 Vivacit-E Vitamin E Highly Crosslinked Polyethylene LinersZimmer, Inc. · 2012
- 4 generations backK122529 Zimmer Unicompartmental Knee System Vivacit-E Articular SurfaceZimmer, Inc. · 2012
- 3 generations backK160738 ZUK Select Knee SystemSmith & Nephew, Inc. · 2016
- 2 generations backK190085 Journey II Unicompartmental Knee SystemSmith & Nephew, Inc. · 2019 · Recalled
- 1 generation backK230653 Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee…Smith & Nephew, Inc. · 2023 · Recalled
- This deviceK241260 ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −12 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| −11 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| −10 | K042051 | Arcomxl Polyethylene Liners | Biomet, Inc. | 2005 | 1 |
| −9 | K051411 | Arcomxl Polyethylene Liners and Biolox Delta Heads | Biomet, Inc. | 2005 | 1 |
| −8 | K061312 | 36MM Biolox Delta Ceramic Heads | Biomet, Inc. | 2006 | — |
| −7 | K073102 | Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular Liners | Biomet Manufacturing Corp | 2007 | — |
| −6 | K100048 | E1 Antioxidant Infused Technology | Biomet Manufacturing Corp | 2010 | — |
| −5 | K120370 | Vivacit-E Vitamin E Highly Crosslinked Polyethylene Liners | Zimmer, Inc. | 2012 | — |
| −4 | K122529 | Zimmer Unicompartmental Knee System Vivacit-E Articular Surface | Zimmer, Inc. | 2012 | — |
| −3 | K160738 | ZUK Select Knee System | Smith & Nephew, Inc. | 2016 | — |
| −2 | K190085 | Journey II Unicompartmental Knee System | Smith & Nephew, Inc. | 2019 | 3 |
| −1 | K230653 | Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System… | Smith & Nephew, Inc. | 2023 | 1 |
| 0 (this device) | K241260 | ACTIFY™ Unicondylar Knee System | Globus Medical, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1976 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 5 | 0 |
| 1992 | 3 | 0 |
| 1993 | 3 | 0 |
| 1994 | 11 | 0 |
| 1995 | 10 | 0 |
| 1996 | 12 | 0 |
| 1997 | 10 | 0 |
| 1998 | 5 | 0 |
| 1999 | 4 | 0 |
| 2000 | 5 | 0 |
| 2001 | 9 | 0 |
| 2002 | 12 | 0 |
| 2003 | 16 | 0 |
| 2004 | 15 | 0 |
| 2005 | 18 | 0 |
| 2006 | 12 | 0 |
| 2007 | 15 | 0 |
| 2008 | 10 | 0 |
| 2009 | 6 | 0 |
| 2010 | 7 | 0 |
| 2011 | 4 | 0 |
| 2012 | 3 | 0 |
| 2013 | 4 | 0 |
| 2014 | 5 | 0 |
| 2015 | 5 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 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 HSX? 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 HSX device
- #1 K261609 Freedom Partial Knee Systemscore 15.1 · 12 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 |
|---|---|---|---|
| * | K032824 | Stelkast Unicondylar Knee SystemSummary page 5…mented prosthesis Product Codes: HSX Regulatory Class: II, Panel Code: 87 Primary Predicate: StelKast Unicondylar Knee System (K032824) Additional Predicates: Smith & Nephew ZUK Unicompartmental Knee System (K033363, K230653)… | 2003 |
| * | K033363 | Zimmer Unicompartmental Knee SystemSummary page 5…Code: 87 Primary Predicate: StelKast Unicondylar Knee System (K032824) Additional Predicates: Smith & Nephew ZUK Unicompartmental Knee System (K033363, K230653) Stryker Triathlon PKR System (K071881, K203099) Reference Device: GENflex2® Total Knee System (K12288… | 2004 |
| * | K230653 | Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Summary page 5…Primary Predicate: StelKast Unicondylar Knee System (K032824) Additional Predicates: Smith & Nephew ZUK Unicompartmental Knee System (K033363, K230653) Stryker Triathlon PKR System (K071881, K203099) Reference Device: GENflex2® Total Knee System (K122883, K16222… | 2023 |
| * | K071881 | Triathlon PKR SystemSummary page 5…32824) Additional Predicates: Smith & Nephew ZUK Unicompartmental Knee System (K033363, K230653) Stryker Triathlon PKR System (K071881, K203099) Reference Device: GENflex2® Total Knee System (K122883, K162222) Purpose: The purpose of this submission is to request… | 2007 |
| * | K203099 | Triathlon PKR SystemSummary page 5…dditional Predicates: Smith & Nephew ZUK Unicompartmental Knee System (K033363, K230653) Stryker Triathlon PKR System (K071881, K203099) Reference Device: GENflex2® Total Knee System (K122883, K162222) Purpose: The purpose of this submission is to request clearanc… | 2020 |
| † | K122883 | Exp Tibial Inserts and Patellar Components for the Proven Gen-Flex Total Knee System | 2013 |
| † | K162222 | GENflex2 Total Knee System | 2016 |
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 43 years and passes through 5 companies; a new generation was cleared every 2.2 years on median.
- 98 of the 240 ancestors have a recall of any class.
- 2 other devices also cite its predicate K032824.
How does its category compare?
All HSX devicesHSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, 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 · HSX
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HSX
59in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HSX
2in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HSX
175in 2025
MAUDE reports naming product code HSX, 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 | 6 | 33 | 0 | 6 |
| 2008 | 4 | 102 | 0 | 4 |
| 2009 | 2 | — | 49 | 21 |
| 2010 | 3 | 74 | 0 | 58 |
| 2011 | 1 | — | 0 | 114 |
| 2012 | 5 | 88 | 0 | 83 |
| 2013 | 2 | — | 1 | 79 |
| 2014 | 0 | — | 0 | 66 |
| 2015 | 1 | — | 0 | 57 |
| 2016 | 3 | 147 | 1 | 107 |
| 2017 | 5 | 160 | 4 | 113 |
| 2018 | 2 | — | 0 | 159 |
| 2019 | 7 | 90 | 0 | 177 |
| 2020 | 4 | 40 | 2 | 273 |
| 2021 | 7 | 81 | 0 | 240 |
| 2022 | 2 | — | 0 | 257 |
| 2023 | 1 | — | 0 | 231 |
| 2024 | 4 | 133 | 0 | 172 |
| 2025 | 4 | 59 | 0 | 175 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The ACTIFY™ Unicondylar Knee System is indicated for unicompartmental knee replacement due to the following conditions:
1. Moderately disabling joint disease of the knee resulting from painful osteo- and/or post-traumatic arthritis, or avascular necrosis.
2. Revision of previous unsuccessful unicompartmental knee replacement or other procedure.
3. Alternative to tibial osteotomy in patients with unicompartmental osteoarthritis.
4. Previous tibial condyle or plateau fractures with loss of anatomy or function.
5. Varus or valgus deformities.
These devices are indicated for cemented use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241260 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241260: ACTIFY™ Unicondylar 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/K241260
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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