510(k) · Cleared
ClearedGMK 3D Metal Tibial Tray Extension
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medacta International S.A. · MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Cleared on Feb 26, 2026 as substantially equivalent to K221850 (Medacta International S.A., 2022) after a 149-day review. Its family tree reaches back 18 generations to 1994.
- Decided
- Feb 26, 2026
- Review
- 149 days
- Class
- Class II
- Product code
- MBH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 18 generations to K941847 (1994). 255 ancestors in all, the oldest K810258 (1981). No later device cites it as a predicate yet.
- Root · 18 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 14 generations between
- 3 generations backK173890 GMK Sphere - Kinematic AlignmentMedacta International S.A. · 2018
- 2 generations backK201343 Triathlon Total KneeSystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2020
- 1 generation backK221850 GMK 3D Metal Tibial TrayMedacta International S.A. · 2022
- This deviceK253328 GMK 3D Metal Tibial Tray ExtensionMedacta International S.A. · 2026
Show all 18 generations
- Root · 18 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 17 generations backK964650 TCP-Coated Porocoat Aml Femoral Hip ProsthesisDepuy, Inc. · 1997
- 16 generations backK980711 Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic…Zimmer, Inc. · 1998 · Recalled
- 15 generations backK001277 Triflange Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2000
- 14 generations backK031495 Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc. · 2003
- 13 generations backK042344 Excia Total Hip SystemAesculap, Inc. · 2005 · Recalled
- 12 generations backK070981 Search Evolution (LC) Total Knee System (Plasmapore)Aesculap Implant Systems, Inc. · 2007
- 11 generations backK081023 Evolis Total Knee SystemMedacta International S.A. · 2008 · Recalled
- 10 generations backK090988 GMK Total Knee SystemMedacta International S.A. · 2009 · Recalled
- 9 generations backK102437 GMK Revision Knee SystemMedacta International S.A. · 2010
- 8 generations backK103170 GMK Revision Knee SC LinersMedacta International S.A. · 2011
- 7 generations backK113571 GMK Resufacing Patella Size 4Medacta International · 2012
- 6 generations backK121416 GMK SphereMedacta International · 2012
- 5 generations backK140826 GMK Sphere ExtensionMedacta International · 2014
- 4 generations backK162035 GMK SphereMedacta International S.A. · 2017
- 3 generations backK173890 GMK Sphere - Kinematic AlignmentMedacta International S.A. · 2018
- 2 generations backK201343 Triathlon Total KneeSystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2020
- 1 generation backK221850 GMK 3D Metal Tibial TrayMedacta International S.A. · 2022
- This deviceK253328 GMK 3D Metal Tibial Tray ExtensionMedacta International S.A. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K941847 | 5/8 Porocoat Aml Hip Porocoat Porous Coating | Depuy, Inc. | 1994 | — |
| −17 | K964650 | TCP-Coated Porocoat Aml Femoral Hip Prosthesis | Depuy, Inc. | 1997 | — |
| −16 | K980711 | Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic Coating | Zimmer, Inc. | 1998 | 1 |
| −15 | K001277 | Triflange Acetabular Cup System | DePuy Orthopaedics, Inc. | 2000 | — |
| −14 | K031495 | Pinnacle Duofix HA Acetabular Cup Prosthesis | DePuy Orthopaedics, Inc. | 2003 | — |
| −13 | K042344 | Excia Total Hip System | Aesculap, Inc. | 2005 | 10 |
| −12 | K070981 | Search Evolution (LC) Total Knee System (Plasmapore) | Aesculap Implant Systems, Inc. | 2007 | — |
| −11 | K081023 | Evolis Total Knee System | Medacta International S.A. | 2008 | 1 |
| −10 | K090988 | GMK Total Knee System | Medacta International S.A. | 2009 | 1 |
| −9 | K102437 | GMK Revision Knee System | Medacta International S.A. | 2010 | — |
| −8 | K103170 | GMK Revision Knee SC Liners | Medacta International S.A. | 2011 | — |
| −7 | K113571 | GMK Resufacing Patella Size 4 | Medacta International | 2012 | — |
| −6 | K121416 | GMK Sphere | Medacta International | 2012 | — |
| −5 | K140826 | GMK Sphere Extension | Medacta International | 2014 | — |
| −4 | K162035 | GMK Sphere | Medacta International S.A. | 2017 | — |
| −3 | K173890 | GMK Sphere - Kinematic Alignment | Medacta International S.A. | 2018 | — |
| −2 | K201343 | Triathlon Total KneeSystem | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2020 | — |
| −1 | K221850 | GMK 3D Metal Tibial Tray | Medacta International S.A. | 2022 | — |
| 0 (this device) | K253328 | GMK 3D Metal Tibial Tray Extension | Medacta International S.A. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 4 | 0 |
| 1992 | 6 | 0 |
| 1993 | 5 | 0 |
| 1994 | 11 | 0 |
| 1995 | 13 | 0 |
| 1996 | 13 | 0 |
| 1997 | 11 | 0 |
| 1998 | 9 | 0 |
| 1999 | 6 | 0 |
| 2000 | 10 | 0 |
| 2001 | 13 | 0 |
| 2002 | 15 | 0 |
| 2003 | 17 | 0 |
| 2004 | 15 | 0 |
| 2005 | 16 | 0 |
| 2006 | 11 | 0 |
| 2007 | 16 | 0 |
| 2008 | 7 | 0 |
| 2009 | 3 | 0 |
| 2010 | 6 | 0 |
| 2011 | 1 | 0 |
| 2012 | 5 | 0 |
| 2013 | 5 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 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 MBH? 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 MBH device
- #1 K241597 Freedom® Total Knee System - Porous Tibial…score 20.0 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K221850 | GMK 3D Metal Tibial TraySummary page 5….3560 Device Classification II III. Predicate Device Substantial equivalence is claimed to the following predicate device: • GMK 3D Metal Tibial Tray, K221850, Medacta International SA IV. Device Description The subject devices are sterile, single use, individually packaged implants… | 2022 |
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 1.8 years on median.
- 108 of the 254 ancestors have a recall of any class.
How does its category compare?
All MBH devicesMBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, 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 · MBH
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MBH
98in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MBH
1in 2024
Class I (5 since 2007) Class II/III not classified
Adverse event reports per year · MBH
1,561in 2025
MAUDE reports naming product code MBH, 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 | 10 | 59 | 0 | 27 |
| 2008 | 3 | 70 | 0 | 21 |
| 2009 | 3 | 209 | 2 | 89 |
| 2010 | 4 | 84 | 0 | 121 |
| 2011 | 5 | 84 | 15 | 247 |
| 2012 | 5 | 90 | 1 (1) | 370 |
| 2013 | 6 | 138 | 4 (4) | 308 |
| 2014 | 9 | 114 | 0 | 385 |
| 2015 | 8 | 100 | 0 | 955 |
| 2016 | 4 | 74 | 1 | 1,034 |
| 2017 | 4 | 115 | 9 | 1,007 |
| 2018 | 6 | 89 | 1 | 1,191 |
| 2019 | 1 | — | 1 | 1,394 |
| 2020 | 7 | 112 | 2 | 1,089 |
| 2021 | 6 | 48 | 0 | 1,539 |
| 2022 | 7 | 57 | 0 | 1,261 |
| 2023 | 6 | 94 | 2 | 1,263 |
| 2024 | 10 | 84 | 1 | 1,497 |
| 2025 | 8 | 98 | 0 | 1,561 |
| 2026 | 7 | 153 | 4 | — |
What is it indicated for?
The GMK® knee 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 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…
Read the full statement (258 words)
The GMK® knee 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 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 wedges cemented are to be attached to the tibial baseplate with both the fixing cylinders and bone cement. The screwed 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 wedges and extension stems with the GMK 3D Metal® Tibial Baseplate.
Limitations for use for GMK SPHERE/GMK SPHERIKA used with kinematic alignment
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/K253328 · printed Nov 4, 2026
Cite this page
510(k) Report. “K253328: GMK 3D Metal Tibial Tray Extension.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253328
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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