510(k) · Cleared
ClearedGMK Extension
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medacta International SA · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Sep 15, 2026 as substantially equivalent to K131310 (Medacta International, 2013) and 5 other predicates after an 89-day review. Its family tree reaches back 17 generations to 1994.
- Decided
- Sep 15, 2026
- Review
- 89 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 17 generations to K941847 (1994). 149 ancestors in all, the oldest K810258 (1981). No later device cites it as a predicate yet.
- Root · 17 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 13 generations between
- 3 generations backK162035 GMK SphereMedacta International S.A. · 2017
- 2 generations backK181635 GMK Sphere CR Tibial InsertsMedacta International S.A. · 2018
- 1 generation backK202022 GMK-SPHERE Tibial inserts FLEX Tibial Insert CR and Resurfacing…Medacta International S.A. · 2020
- This deviceK262057 GMK ExtensionMedacta International SA · 2026
Show all 17 generations
- Root · 17 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 16 generations backK964650 TCP-Coated Porocoat Aml Femoral Hip ProsthesisDepuy, Inc. · 1997
- 15 generations backK980711 Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic…Zimmer, Inc. · 1998 · Recalled
- 14 generations backK001277 Triflange Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2000
- 13 generations backK031495 Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc. · 2003
- 12 generations backK042344 Excia Total Hip SystemAesculap, Inc. · 2005 · Recalled
- 11 generations backK070981 Search Evolution (LC) Total Knee System (Plasmapore)Aesculap Implant Systems, Inc. · 2007
- 10 generations backK081023 Evolis Total Knee SystemMedacta International S.A. · 2008 · Recalled
- 9 generations backK090988 GMK Total Knee SystemMedacta International S.A. · 2009 · Recalled
- 8 generations backK102437 GMK Revision Knee SystemMedacta International S.A. · 2010
- 7 generations backK103170 GMK Revision Knee SC LinersMedacta International S.A. · 2011
- 6 generations backK113571 GMK Resufacing Patella Size 4Medacta International · 2012
- 5 generations backK121416 GMK SphereMedacta International · 2012
- 4 generations backK140826 GMK Sphere ExtensionMedacta International · 2014
- 3 generations backK162035 GMK SphereMedacta International S.A. · 2017
- 2 generations backK181635 GMK Sphere CR Tibial InsertsMedacta International S.A. · 2018
- 1 generation backK202022 GMK-SPHERE Tibial inserts FLEX Tibial Insert CR and Resurfacing…Medacta International S.A. · 2020
- This deviceK262057 GMK ExtensionMedacta International SA · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K941847 | 5/8 Porocoat Aml Hip Porocoat Porous Coating | Depuy, Inc. | 1994 | — |
| −16 | K964650 | TCP-Coated Porocoat Aml Femoral Hip Prosthesis | Depuy, Inc. | 1997 | — |
| −15 | K980711 | Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic Coating | Zimmer, Inc. | 1998 | 1 |
| −14 | K001277 | Triflange Acetabular Cup System | DePuy Orthopaedics, Inc. | 2000 | — |
| −13 | K031495 | Pinnacle Duofix HA Acetabular Cup Prosthesis | DePuy Orthopaedics, Inc. | 2003 | — |
| −12 | K042344 | Excia Total Hip System | Aesculap, Inc. | 2005 | 10 |
| −11 | K070981 | Search Evolution (LC) Total Knee System (Plasmapore) | Aesculap Implant Systems, Inc. | 2007 | — |
| −10 | K081023 | Evolis Total Knee System | Medacta International S.A. | 2008 | 1 |
| −9 | K090988 | GMK Total Knee System | Medacta International S.A. | 2009 | 1 |
| −8 | K102437 | GMK Revision Knee System | Medacta International S.A. | 2010 | — |
| −7 | K103170 | GMK Revision Knee SC Liners | Medacta International S.A. | 2011 | — |
| −6 | K113571 | GMK Resufacing Patella Size 4 | Medacta International | 2012 | — |
| −5 | K121416 | GMK Sphere | Medacta International | 2012 | — |
| −4 | K140826 | GMK Sphere Extension | Medacta International | 2014 | — |
| −3 | K162035 | GMK Sphere | Medacta International S.A. | 2017 | — |
| −2 | K181635 | GMK Sphere CR Tibial Inserts | Medacta International S.A. | 2018 | — |
| −1 | K202022 | GMK-SPHERE Tibial inserts FLEX Tibial Insert CR and Resurfacing Patella made… | Medacta International S.A. | 2020 | — |
| 0 (this device) | K262057 | GMK Extension | Medacta International SA | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1984 | 2 | 0 |
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 5 | 0 |
| 1993 | 5 | 0 |
| 1994 | 7 | 0 |
| 1995 | 11 | 0 |
| 1996 | 10 | 0 |
| 1997 | 9 | 0 |
| 1998 | 8 | 0 |
| 1999 | 4 | 0 |
| 2000 | 7 | 0 |
| 2001 | 7 | 0 |
| 2002 | 9 | 0 |
| 2003 | 9 | 0 |
| 2004 | 7 | 0 |
| 2005 | 3 | 0 |
| 2006 | 4 | 0 |
| 2007 | 6 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2021 | 1 | 0 |
| 2023 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K131310 | GMK Full PE Tibial ComponentsSummary page 5…III. Predicate Device Substantial equivalence is claimed to the following predicate devices. Primary Predicate device: • GMK Full PE Tibial Components, K131310, Medacta International SA Additional Predicate devices: • GMK Sphere E-CROSS CR Tibial Inserts, GMK Sphere E-CRO… | 2013 |
| * | K202022 | GMK-SPHERE Tibial inserts FLEX Tibial Insert CR and Resurfacing Patella made of E-CROSS…Summary page 5…ional Predicate devices: • GMK Sphere E-CROSS CR Tibial Inserts, GMK Sphere E-CROSS Flex Tibial Inserts and GMK Sphere E-CROSS Resurfacing Patella, K202022, Medacta International SA • GMK® Total Knee System, K090988, Medacta International SA • GMK Spherika Femurs and… | 2020 |
| * | K090988 | GMK Total Knee SystemSummary page 5…rts, GMK Sphere E-CROSS Flex Tibial Inserts and GMK Sphere E-CROSS Resurfacing Patella, K202022, Medacta International SA • GMK® Total Knee System, K090988, Medacta International SA • GMK Spherika Femurs and Fixed Tibial Trays Plus, K211004, Medacta International SA… | 2009 |
| * | K211004 | GMK Spherika Femurs and Fixed Tibial Trays PlusSummary page 5…tella, K202022, Medacta International SA • GMK® Total Knee System, K090988, Medacta International SA • GMK Spherika Femurs and Fixed Tibial Trays Plus, K211004, Medacta International SA • GMK Short Stem, K133630, Medacta International SA • GMK Sphere & GMK SpheriKA Cemen… | 2021 |
| * | K133630 | GMK Short StemSummary page 5…l Knee System, K090988, Medacta International SA • GMK Spherika Femurs and Fixed Tibial Trays Plus, K211004, Medacta International SA • GMK Short Stem, K133630, Medacta International SA • GMK Sphere & GMK SpheriKA Cementless, K223548, Medacta International SA IV. Device Des… | 2013 |
| * | K223548 | GMK Sphere & GMK SpheriKA CementlessSummary page 5…Fixed Tibial Trays Plus, K211004, Medacta International SA • GMK Short Stem, K133630, Medacta International SA • GMK Sphere & GMK SpheriKA Cementless, K223548, Medacta International SA IV. Device Description The GMK Sphere FULL PE FLEX and FLEX E-CROSS Tibias and the GMK Primary O… | 2023 |
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 32 years and passes through 8 companies; a new generation was cleared every 1.6 years on median.
- 54 of the 148 ancestors have a recall of any class.
- 1 other device also cites its predicate K131310.
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. 2026, 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 GMK knee cemented prosthesis is designed for cemented application in total knee arthroplasty if there is evidence of sufficient sound bone to seat and support the components. The use of the cementless GMK femur is limited to cases in which the surgeon considers the bone quality to be sufficient for cementless applications. The GMK 3D Metal Tibial Baseplate is indicated for cementless or cemented application if there is evidence of sufficient sound…
Read the full statement (279 words)
The GMK knee cemented prosthesis is designed for cemented application in total knee arthroplasty if there is evidence of sufficient sound bone to seat and support the components.
The use of the cementless GMK femur is limited to cases in which the surgeon considers the bone quality to be sufficient for cementless applications.
The GMK 3D Metal Tibial Baseplate is indicated for cementless or cemented application if there is evidence of sufficient sound bone to seat and support the components.
This knee replacement system is indicated in the following cases:
• Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid arthritis or polyarthritis
• Collagen disorders, and avascular necrosis of the femoral condyle
• Post traumatic loss of joint configuration
• Primary implantation failure
Tibial augments cemented are to be attached to the tibial baseplate with both the fixing cylinders and bone cement. The screw-fixed tibial augments are for screwed fixation to the tibial baseplate. In case a semi-constrained liner is used, an extension stem must be implanted both on the tibial and on the femoral components. In case a GMK Revision or GMK Sphere Revision tibial tray is used, an extension stem must be implanted. It is not possible to implant tibial augments, offsets, and extension stems with the GMK 3D Metal Tibial Baseplate and Full PE tibial components.
GMK Sphere and GMK SpheriKA can be implanted in kinematic alignment. In this case, this knee replacement system is indicated for:
• Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid arthritis or polyarthritis
• Collagen disorders, and/or avascular necrosis of the femoral condyle
• Moderate valgus, varus, or flexion deformities
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K262057 · printed Nov 6, 2026
Cite this page
510(k) Report. “K262057: GMK Extension.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K262057
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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