510(k) · Cleared
ClearedGMK Full PE Tibial Components
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medacta International · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Aug 22, 2013 as substantially equivalent to K951987 (Smith & Nephew Richards, Inc., 1995) and 9 other predicates after a 107-day review. Its family tree reaches back 13 generations to 1994. 2 later devices descend from it.
- Decided
- Aug 22, 2013
- Review
- 107 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 10
Its longest line of descent runs back 13 generations to K941847 (1994). 95 ancestors in all, the oldest K840643 (1984). 2 later devices descend from it, 2 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 backK120790 GMK - Line ExtensionMedacta International · 2012
- 1 generation backK122232 GMK NarrowMedacta International · 2012
- This deviceK131310 GMK Full PE Tibial ComponentsMedacta International · 2013
- Descendant · cites it directly · 0 of its ownK262057 GMK ExtensionMedacta International SA · 2026
- Descendant · cites it directly · 0 of its ownK210062 Mectaplug PE IIMedacta International S.A. · 2021
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 backK120790 GMK - Line ExtensionMedacta International · 2012
- 1 generation backK122232 GMK NarrowMedacta International · 2012
- This deviceK131310 GMK Full PE Tibial ComponentsMedacta International · 2013
Most influential descendants
Showing 2 of 2 · See allView 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 | K120790 | GMK - Line Extension | Medacta International | 2012 | — |
| −1 | K122232 | GMK Narrow | Medacta International | 2012 | — |
| 0 (this device) | K131310 | GMK Full PE Tibial Components | Medacta International | 2013 | — |
| +1 | K262057 | GMK Extension | Medacta International SA | 2026 | — |
| +1 | K210062 | Mectaplug PE II | Medacta International S.A. | 2021 | — |
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 | 9 | 0 |
| 1997 | 5 | 0 |
| 1998 | 5 | 0 |
| 1999 | 3 | 0 |
| 2000 | 6 | 0 |
| 2001 | 7 | 0 |
| 2002 | 8 | 0 |
| 2003 | 4 | 0 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 4 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2026 | 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? (10)
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 |
|---|---|---|---|
| * | K951987 | Genesis II Total Knee SystemSummary page 1…Device Product Codes: JWH Predicate Devices: 510O(k) Product 510(k) Holder Clearance Date K951987 Genesis 11CR Smith and Nephew, Inc. 08/22/1995 K953274 Genesis 11PS Smith an… | 1995 |
| * | K953274 | Genesis Porous Tibial Trays & Revision Knee SystemSummary page 1…Product 510(k) Holder Clearance Date K951987 Genesis 11CR Smith and Nephew, Inc. 08/22/1995 K953274 Genesis 11PS Smith and Nephew, Inc. 02/05/1 996 K090988, K113571, GMK Total Knee MdcaIt… | 1996 |
| * | K090988 | GMK Total Knee SystemSummary page 1…987 Genesis 11CR Smith and Nephew, Inc. 08/22/1995 K953274 Genesis 11PS Smith and Nephew, Inc. 02/05/1 996 K090988, K113571, GMK Total Knee MdcaItrtinl 7/10/2009,1/27/2012, K120790, K122232 System… | 2009 |
| * | K113571 | GMK Resufacing Patella Size 4Summary page 1…Genesis 11CR Smith and Nephew, Inc. 08/22/1995 K953274 Genesis 11PS Smith and Nephew, Inc. 02/05/1 996 K090988, K113571, GMK Total Knee MdcaItrtinl 7/10/2009,1/27/2012, K120790, K122232 System MdcaIt… | 2012 |
| * | K120790 | GMK - Line ExtensionSummary page 1…Genesis 11PS Smith and Nephew, Inc. 02/05/1 996 K090988, K113571, GMK Total Knee MdcaItrtinl 7/10/2009,1/27/2012, K120790, K122232 System MdcaItrtinl 6/8/2012, 9/28/2012 K081 023 Evolis Total Knee… | 2012 |
| * | K122232 | GMK NarrowSummary page 1…Genesis 11PS Smith and Nephew, Inc. 02/05/1 996 K090988, K113571, GMK Total Knee MdcaItrtinl 7/10/2009,1/27/2012, K120790, K122232 System MdcaItrtinl 6/8/2012, 9/28/2012 K081 023 Evolis Total Knee Medacta… | 2012 |
| * | K081023 | Evolis Total Knee SystemSummary page 1…GMK Total Knee MdcaItrtinl 7/10/2009,1/27/2012, K120790, K122232 System MdcaItrtinl 6/8/2012, 9/28/2012 K081 023 Evolis Total Knee Medacta International 10/22/2008 System… | 2008 |
| * | K991581 | Nexgen Complete Knee Solution Legacy Posterior Stabilized (LPS); LPS-Flex Fixed Bearing…Summary page 1…81 023 Evolis Total Knee Medacta International 10/22/2008 System __________ K991581, K042271 NexGen LIPS Zimmer 7/30/1999, 10/13/2004 K070214 -Natural Knee… | 1999 |
| * | K042271 | Nexgen Complete Knee Solution LPS-Flex Prolong Highly Crosslinked Polyethylene Articular…Summary page 1…Evolis Total Knee Medacta International 10/22/2008 System __________ K991581, K042271 NexGen LIPS Zimmer 7/30/1999, 10/13/2004 K070214 -Natural Knee… | 2004 |
| * | K070214 | Gender Solutions Natural-Knee Flex SystemSummary page 1…System __________ K991581, K042271 NexGen LIPS Zimmer 7/30/1999, 10/13/2004 K070214 -Natural Knee Zimmer 3/16/2007 GMK Full PE Tibial Components 510(k)… | 2007 |
What descends from it? (2)
2 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 19 years and passes through 7 companies; a new generation was cleared every 1.2 years on median.
- 40 of the 94 ancestors have a recall of any class.
- Of its descendants, K262057 (Medacta International SA, 2026) has gone furthest, with 0 descendants of its own.
- 31 other devices also cite its predicate K951987.
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. 2013, 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® Total Knee System 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…
Read the full statement (108 words)
The GMK® Total Knee System 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 augments are to be attached to the tibial baseplate with both the fixing cylinders and bone cement.
If a semi-constrained insert is used, it is mandatory to implant an extension stem both on the tibial and the femoral components.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131310 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131310: GMK Full PE Tibial Components.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131310
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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