510(k) · Cleared
ClearedGMK Sphere Revision
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medacta International S.A. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Jul 29, 2021 as substantially equivalent to K121416 (Medacta International, 2012) and 4 other predicates after a 58-day review. Its family tree reaches back 17 generations to 1994.
- Decided
- Jul 29, 2021
- Review
- 58 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 17 generations to K941847 (1994). 134 ancestors in all, the oldest K810520 (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 backK142069 GMK ExtensionMedacta International · 2014
- 2 generations backK202684 GMK Total Knee System - TiNbN CoatingMedacta International S.A. · 2020
- 1 generation backK210010 GMK Revision & Hinge Extension - TiNbN CoatingMedacta International S.A. · 2021
- This deviceK211664 GMK Sphere RevisionMedacta International S.A. · 2021
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 backK142069 GMK ExtensionMedacta International · 2014
- 2 generations backK202684 GMK Total Knee System - TiNbN CoatingMedacta International S.A. · 2020
- 1 generation backK210010 GMK Revision & Hinge Extension - TiNbN CoatingMedacta International S.A. · 2021
- This deviceK211664 GMK Sphere RevisionMedacta International S.A. · 2021
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 | K142069 | GMK Extension | Medacta International | 2014 | — |
| −2 | K202684 | GMK Total Knee System - TiNbN Coating | Medacta International S.A. | 2020 | — |
| −1 | K210010 | GMK Revision & Hinge Extension - TiNbN Coating | Medacta International S.A. | 2021 | — |
| 0 (this device) | K211664 | GMK Sphere Revision | Medacta International S.A. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1984 | 2 | 0 |
| 1985 | 1 | 0 |
| 1987 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 2 | 0 |
| 1992 | 2 | 0 |
| 1993 | 3 | 0 |
| 1994 | 10 | 0 |
| 1995 | 9 | 0 |
| 1996 | 12 | 0 |
| 1997 | 6 | 0 |
| 1998 | 6 | 0 |
| 1999 | 4 | 0 |
| 2000 | 8 | 0 |
| 2001 | 9 | 0 |
| 2002 | 10 | 0 |
| 2003 | 6 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 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 |
|---|---|---|---|
| * | K121416 | GMK SphereSummary page 4…88.3560 Device Classification II III. Predicate Device Substantial equivalence is claimed to the following devices: Primary predicate device GMK Sphere, K121416, Medacta International SA Secondary predicate devices GMK Revision, K102437, Medacta International SA GMK Revision Ext… | 2012 |
| * | K102437 | GMK Revision Knee SystemSummary page 4…ivalence is claimed to the following devices: Primary predicate device GMK Sphere, K121416, Medacta International SA Secondary predicate devices GMK Revision, K102437, Medacta International SA GMK Revision Extension, K123721, Medacta International SA GMK Total Knee System – TiNbN Coati… | 2010 |
| * | K123721 | GMK Revision ExtensionSummary page 4…device GMK Sphere, K121416, Medacta International SA Secondary predicate devices GMK Revision, K102437, Medacta International SA GMK Revision Extension, K123721, Medacta International SA GMK Total Knee System – TiNbN Coating, K202684, Medacta International SA GMK Revision & Hinge… | 2013 |
| * | K202684 | GMK Total Knee System - TiNbN CoatingSummary page 4…e devices GMK Revision, K102437, Medacta International SA GMK Revision Extension, K123721, Medacta International SA GMK Total Knee System – TiNbN Coating, K202684, Medacta International SA GMK Revision & Hinge – TiNbN Coating, K210010, Medacta International SA IV. Device Description… | 2020 |
| * | K210010 | GMK Revision & Hinge Extension - TiNbN CoatingSummary page 4…ion Extension, K123721, Medacta International SA GMK Total Knee System – TiNbN Coating, K202684, Medacta International SA GMK Revision & Hinge – TiNbN Coating, K210010, Medacta International SA IV. Device Description The GMK Sphere Revision is a Medacta GMK line extension to provide a larger… | 2021 |
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 27 years and passes through 7 companies; a new generation was cleared every 1.2 years on median.
- 56 of the 133 ancestors have a recall of any class.
- 11 other devices also cite its predicate K121416.
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. 2021, 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 Evolis® GMK® knee prosthesis is designed for cemented use in total knee arthroplasty, 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, theumatoid arthritis or polyarthritis. * Avascular necrosis of femoral condyle. * Post traumatic loss of joint configuration. *…
Read the full statement (144 words)
The Evolis® GMK® knee prosthesis is designed for cemented use in total knee arthroplasty, 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, theumatoid arthritis or polyarthritis.
* Avascular necrosis of 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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K211664 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211664: GMK Sphere Revision.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211664
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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