510(k) · Cleared
ClearedGMK Spherika Femurs and Fixed Tibial Trays Plus
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 May 13, 2021 as substantially equivalent to K121416 (Medacta International, 2012) after a 41-day review. Its family tree reaches back 13 generations to 1994. 4 later devices descend from it.
- Decided
- May 13, 2021
- Review
- 41 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K941847 (1994). 94 ancestors in all, the oldest K840643 (1984). 4 later devices descend from it, 3 citing it directly.
- Root · 13 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 9 generations between
- 3 generations backK103170 GMK Revision Knee SC LinersMedacta International S.A. · 2011
- 2 generations backK113571 GMK Resufacing Patella Size 4Medacta International · 2012
- 1 generation backK121416 GMK SphereMedacta International · 2012
- This deviceK211004 GMK Spherika Femurs and Fixed Tibial Trays PlusMedacta International S.A. · 2021
- Descendant · cites it directly · 1 of its ownK223548 GMK Sphere & GMK SpheriKA CementlessMedacta International S.A. · 2023
- Descendant · cites it directly · 1 of its ownK221850 GMK 3D Metal Tibial TrayMedacta International S.A. · 2022
- Descendant · cites it directly · 0 of its ownK262057 GMK ExtensionMedacta International SA · 2026
- Descendant · 2 generations on · 0 of its ownK253328 GMK 3D Metal Tibial Tray ExtensionMedacta International S.A. · 2026
Show all 13 generations
- Root · 13 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 12 generations backK964650 TCP-Coated Porocoat Aml Femoral Hip ProsthesisDepuy, Inc. · 1997
- 11 generations backK980711 Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic…Zimmer, Inc. · 1998 · Recalled
- 10 generations backK001277 Triflange Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2000
- 9 generations backK031495 Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc. · 2003
- 8 generations backK042344 Excia Total Hip SystemAesculap, Inc. · 2005 · Recalled
- 7 generations backK070981 Search Evolution (LC) Total Knee System (Plasmapore)Aesculap Implant Systems, Inc. · 2007
- 6 generations backK081023 Evolis Total Knee SystemMedacta International S.A. · 2008 · Recalled
- 5 generations backK090988 GMK Total Knee SystemMedacta International S.A. · 2009 · Recalled
- 4 generations backK102437 GMK Revision Knee SystemMedacta International S.A. · 2010
- 3 generations backK103170 GMK Revision Knee SC LinersMedacta International S.A. · 2011
- 2 generations backK113571 GMK Resufacing Patella Size 4Medacta International · 2012
- 1 generation backK121416 GMK SphereMedacta International · 2012
- This deviceK211004 GMK Spherika Femurs and Fixed Tibial Trays PlusMedacta International S.A. · 2021
Most influential descendants
Showing 4 of 4 · See all- K223548GMK Sphere & GMK SpheriKA CementlessMedacta International S.A. · 2023 · cites it directly1descendant
- K221850GMK 3D Metal Tibial TrayMedacta International S.A. · 2022 · cites it directly1descendant
- K262057GMK ExtensionMedacta International SA · 2026 · cites it directly0descendants
- K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A. · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K941847 | 5/8 Porocoat Aml Hip Porocoat Porous Coating | Depuy, Inc. | 1994 | — |
| −12 | K964650 | TCP-Coated Porocoat Aml Femoral Hip Prosthesis | Depuy, Inc. | 1997 | — |
| −11 | K980711 | Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic Coating | Zimmer, Inc. | 1998 | 1 |
| −10 | K001277 | Triflange Acetabular Cup System | DePuy Orthopaedics, Inc. | 2000 | — |
| −9 | K031495 | Pinnacle Duofix HA Acetabular Cup Prosthesis | DePuy Orthopaedics, Inc. | 2003 | — |
| −8 | K042344 | Excia Total Hip System | Aesculap, Inc. | 2005 | 10 |
| −7 | K070981 | Search Evolution (LC) Total Knee System (Plasmapore) | Aesculap Implant Systems, Inc. | 2007 | — |
| −6 | K081023 | Evolis Total Knee System | Medacta International S.A. | 2008 | 1 |
| −5 | K090988 | GMK Total Knee System | Medacta International S.A. | 2009 | 1 |
| −4 | K102437 | GMK Revision Knee System | Medacta International S.A. | 2010 | — |
| −3 | K103170 | GMK Revision Knee SC Liners | Medacta International S.A. | 2011 | — |
| −2 | K113571 | GMK Resufacing Patella Size 4 | Medacta International | 2012 | — |
| −1 | K121416 | GMK Sphere | Medacta International | 2012 | — |
| 0 (this device) | K211004 | GMK Spherika Femurs and Fixed Tibial Trays Plus | Medacta International S.A. | 2021 | — |
| +1 | K223548 | GMK Sphere & GMK SpheriKA Cementless | Medacta International S.A. | 2023 | — |
| +1 | K221850 | GMK 3D Metal Tibial Tray | Medacta International S.A. | 2022 | — |
| +1 | K262057 | GMK Extension | Medacta International SA | 2026 | — |
| +2 | 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 |
|---|---|---|
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1987 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 3 | 0 |
| 1994 | 5 | 0 |
| 1995 | 6 | 0 |
| 1996 | 8 | 0 |
| 1997 | 6 | 0 |
| 1998 | 6 | 0 |
| 1999 | 4 | 0 |
| 2000 | 6 | 0 |
| 2001 | 7 | 0 |
| 2002 | 8 | 0 |
| 2003 | 4 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 2 | 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? (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 |
|---|---|---|---|
| * | K121416 | GMK SphereSummary page 4…ice Classification II III. Predicate Device Substantial equivalence is claimed to the following device: Medacta International SA, GMK Sphere K121416 Reference predicates: Medacta International SA, GMK Sphere Extension, K140826 Medacta International SA, GMK Sphere Ext… | 2012 |
| † | K140826 | GMK Sphere Extension | 2014 |
| † | K162035 | GMK Sphere | 2017 |
| † | K173890 | GMK Sphere - Kinematic Alignment | 2018 |
| † | K202022 | GMK-SPHERE Tibial inserts FLEX Tibial Insert CR and Resurfacing Patella made of E-CROSS… | 2020 |
| † | K202684 | GMK Total Knee System - TiNbN Coating | 2020 |
| † | K090988 | GMK Total Knee System | 2009 |
| † | K120790 | GMK - Line Extension | 2012 |
| † | K122232 | GMK Narrow | 2012 |
| † | K142069 | GMK Extension | 2014 |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 1.4 years on median.
- 39 of the 93 ancestors have a recall of any class.
- Of its descendants, K223548 (Medacta International S.A., 2023) has gone furthest, with 1 descendant of its own.
- 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, rheumatoid arthritis or polyarthritis. • Avascular necrosis of femoral condyle. • Post traumatic loss of joint configuration. •…
Read the full statement (200 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, rheumatoid 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 tibial tray is used, an extension stem must be implanted.
GMK Sphere/Spherika can be implanted using a kinematic alignment approach. When a kinematic alignment approach is utilized, 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/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/K211004 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211004: GMK Spherika Femurs and Fixed Tibial Trays Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211004
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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