510(k) · Cleared
Recalled · Class II · 2017GMK Hinge
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medacta International · KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Cleared on Aug 15, 2013 as substantially equivalent to K003504 (Plus Orthopedics, 2001) and 4 other predicates after a 189-day review. Its family tree reaches back 6 generations to 1992. 4 later devices descend from it. It has been recalled 2 times.
- Decided
- Aug 15, 2013
- Review
- 189 days
- Class
- Class II
- Product code
- KRO
- Recalls
- 2
- Predicates
- 5
Its longest line of descent runs back 6 generations to K915192 (1992). 20 ancestors in all, the oldest K896048 (1990). 4 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK915192 7000 Series Modular Tibial ComponentsOsteonics Corp. · 1992
- 5 generations backK994128 Scorpio Total Stablizer (TS) Total Knee SystemHowmedica Osteonics Corp. · 2000 · Recalled
- 4 generations backK021313 Search Evolution Total Knee SystemAesculap, Inc. · 2002
- 3 generations backK022672 Columbus Total Knee System (CR)Aesculap, Inc. · 2002 · Recalled
- 2 generations backK083772 Columbus Revision Knee SystemAesculap Implant System, Inc. · 2009 · Recalled
- 1 generation backK101815 Enduro Knee SystemAesculap Implant Systems · 2010
- This deviceK130299 GMK HingeMedacta International · 2013
- Descendant · cites it directly · 2 of its ownK172347 GMK Hinge, GMK RevisionMedacta International S.A. · 2017
- Descendant · cites it directly · 2 of its ownK163311 GMK Revision Femoral Distal AugmentationMedacta International S.A. · 2016
- Descendant · cites it directly · 1 of its ownK210010 GMK Revision & Hinge Extension - TiNbN CoatingMedacta International S.A. · 2021
- Descendant · 2 generations on · 0 of its ownK211664 GMK Sphere RevisionMedacta International S.A. · 2021
Most influential descendants
Showing 4 of 4 · See all- K172347GMK Hinge, GMK RevisionMedacta International S.A. · 2017 · cites it directly2descendants
- K163311GMK Revision Femoral Distal AugmentationMedacta International S.A. · 2016 · cites it directly2descendants
- K210010GMK Revision & Hinge Extension - TiNbN CoatingMedacta International S.A. · 2021 · cites it directly1descendant
- K211664GMK Sphere RevisionMedacta International S.A. · 2021 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K915192 | 7000 Series Modular Tibial Components | Osteonics Corp. | 1992 | — |
| −5 | K994128 | Scorpio Total Stablizer (TS) Total Knee System | Howmedica Osteonics Corp. | 2000 | 8 |
| −4 | K021313 | Search Evolution Total Knee System | Aesculap, Inc. | 2002 | — |
| −3 | K022672 | Columbus Total Knee System (CR) | Aesculap, Inc. | 2002 | 1 |
| −2 | K083772 | Columbus Revision Knee System | Aesculap Implant System, Inc. | 2009 | 4 |
| −1 | K101815 | Enduro Knee System | Aesculap Implant Systems | 2010 | — |
| 0 (this device) | K130299 | GMK Hinge | Medacta International | 2013 | — |
| +1 | K172347 | GMK Hinge, GMK Revision | Medacta International S.A. | 2017 | — |
| +1 | K163311 | GMK Revision Femoral Distal Augmentation | Medacta International S.A. | 2016 | — |
| +1 | K210010 | GMK Revision & Hinge Extension - TiNbN Coating | Medacta International S.A. | 2021 | — |
| +2 | K211664 | GMK Sphere Revision | Medacta International S.A. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 3 | 0 |
| 1998 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2021 | 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 KRO? 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 KRO device
- #1 K251665 Triathlon® Hinge Knee Systemscore 19.0 · 12 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 |
|---|---|---|---|
| * | K003504 | RT-Plus Modular Cemented Knee ComponentsSummary page 2…________ _ _______ 510(k) Product 510(k) Holder Dlaae _K003504 RT-Plus Plus Orthopedics 5/11/2001 K01 3385 NexGen Rotating Hi… | 2001 |
| * | K013385 | Nexgen Complete Knee Solution Rotatng Hinge KneeSummary page 2…Product 510(k) Holder Dlaae _K003504 RT-Plus Plus Orthopedics 5/11/2001 K01 3385 NexGen Rotating Hinge Knee Zimmer 1/9/2002 K002552 Modular Rotating Hi… | 2002 |
| * | K002552 | Howmedica Osteonics Modular Rotating Hinge KneeSummary page 2…RT-Plus Plus Orthopedics 5/11/2001 K01 3385 NexGen Rotating Hinge Knee Zimmer 1/9/2002 K002552 Modular Rotating Hinge Knee Stryker/Howmedica 11/13/2000 _K101815 Enduro RH… | 2000 |
| * | K101815 | Enduro Knee SystemSummary page 2…Rotating Hinge Knee Zimmer 1/9/2002 K002552 Modular Rotating Hinge Knee Stryker/Howmedica 11/13/2000 _K101815 Enduro RHK Aesculap 12/20/2010 K896048 S-ROM/NOILE… | 2010 |
| * | K896048 | S-Rom/Noiles Mark 3Summary page 2…Rotating Hinge Knee Stryker/Howmedica 11/13/2000 _K101815 Enduro RHK Aesculap 12/20/2010 K896048 S-ROM/NOILES Depuy 03/14/1990 Product Description The GMK Hinge Sys… | 1990 |
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 19, 2017 | Class II | Z-2661-2017 | Nonconforming Material/Component | One lot of product does not include a screw for attachment to the tibial base plate. |
| Apr 17, 2015 | Class II | Z-0275-2016 | Employee error | Incorrect parts: Packages of the GMK Hinge Tibial Augmentation size 4-10 mm have 5 mm screws instead of 10 mm screws. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 6 companies; a new generation was cleared every 2.7 years on median.
- 10 of the 20 ancestors have a recall of any class.
- Of its descendants, K172347 (Medacta International S.A., 2017) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K003504.
How does its category compare?
All KRO devicesKRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, 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 · KRO
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KRO
56in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KRO
14so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KRO
915in 2025
MAUDE reports naming product code KRO, 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 | 1 | — | 1 | 37 |
| 2008 | 3 | 126 | 3 | 44 |
| 2009 | 3 | 86 | 8 | 66 |
| 2010 | 1 | — | 0 | 110 |
| 2011 | 2 | — | 1 | 119 |
| 2012 | 2 | — | 1 | 173 |
| 2013 | 3 | 189 | 2 | 194 |
| 2014 | 2 | — | 0 | 406 |
| 2015 | 6 | 113 | 1 | 333 |
| 2016 | 3 | 148 | 5 | 369 |
| 2017 | 1 | — | 4 | 543 |
| 2018 | 0 | — | 1 | 614 |
| 2019 | 3 | 244 | 0 | 759 |
| 2020 | 1 | — | 0 | 749 |
| 2021 | 3 | 57 | 1 | 770 |
| 2022 | 1 | — | 0 | 892 |
| 2023 | 4 | 148 | 0 | 746 |
| 2024 | 3 | 87 | 0 | 855 |
| 2025 | 3 | 56 | 1 | 915 |
| 2026 | 1 | — | 14 | — |
What is it indicated for?
The GMK HINGE® knee prosthesis is designed for cemented use in total knee arthroplasty when the preoperative diagnosis of the joint determines that the bone and stability situation require the implantation of a constrained prosthesis. The GMK HINGE® knee system is indicated in the following cases: * Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid arthritis or polyarthritis associated with bone loss and/or…
Read the full statement (163 words)
The GMK HINGE® knee prosthesis is designed for cemented use in total knee arthroplasty when the preoperative diagnosis of the joint determines that the bone and stability situation require the implantation of a constrained prosthesis.
The GMK HINGE® knee system is indicated in the following cases:
* Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid arthritis or polyarthritis associated with bone loss and/or severe joint instability
* Considerable loss of function of the knee joint
* High-grade joint destruction requiring additional stabilization with stems and reconstruction of bone defects with metal augmentation
* Failure of a primary prosthesis (e.g. infection, loosening)
* Former revision arthroplasty
* Post traumatic loss of joint configuration
* Avascular necrosis of femoral condyle
Tibial augmentations are to be screwed to the tibial baseplate with both of the two provided fixing screws.
When a GMK HINGE® implant is used it is mandatory to implant both the femoral and tibial components with an extension stem.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130299 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130299: GMK Hinge.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130299
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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