510(k) · Cleared
ClearedGMK Revision Femoral Distal Augmentation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medacta International S.A. · KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Cleared on Dec 21, 2016 as substantially equivalent to K102437 (Medacta International S.A., 2010) and 1 other predicate after a 28-day review. Its family tree reaches back 10 generations to 1994. 2 later devices descend from it.
- Decided
- Dec 21, 2016
- Review
- 28 days
- Class
- Class II
- Product code
- KRO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K941847 (1994). 95 ancestors in all, the oldest K840643 (1984). 2 later devices descend from it, 1 citing it directly.
- Root · 10 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 6 generations between
- 3 generations backK081023 Evolis Total Knee SystemMedacta International S.A. · 2008 · Recalled
- 2 generations backK090988 GMK Total Knee SystemMedacta International S.A. · 2009 · Recalled
- 1 generation backK102437 GMK Revision Knee SystemMedacta International S.A. · 2010
- This deviceK163311 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
Show all 10 generations
- Root · 10 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 9 generations backK964650 TCP-Coated Porocoat Aml Femoral Hip ProsthesisDepuy, Inc. · 1997
- 8 generations backK980711 Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic…Zimmer, Inc. · 1998 · Recalled
- 7 generations backK001277 Triflange Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2000
- 6 generations backK031495 Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc. · 2003
- 5 generations backK042344 Excia Total Hip SystemAesculap, Inc. · 2005 · Recalled
- 4 generations backK070981 Search Evolution (LC) Total Knee System (Plasmapore)Aesculap Implant Systems, Inc. · 2007
- 3 generations backK081023 Evolis Total Knee SystemMedacta International S.A. · 2008 · Recalled
- 2 generations backK090988 GMK Total Knee SystemMedacta International S.A. · 2009 · Recalled
- 1 generation backK102437 GMK Revision Knee SystemMedacta International S.A. · 2010
- This deviceK163311 GMK Revision Femoral Distal AugmentationMedacta International S.A. · 2016
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 |
|---|---|---|---|---|---|
| −10 | K941847 | 5/8 Porocoat Aml Hip Porocoat Porous Coating | Depuy, Inc. | 1994 | — |
| −9 | K964650 | TCP-Coated Porocoat Aml Femoral Hip Prosthesis | Depuy, Inc. | 1997 | — |
| −8 | K980711 | Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic Coating | Zimmer, Inc. | 1998 | 1 |
| −7 | K001277 | Triflange Acetabular Cup System | DePuy Orthopaedics, Inc. | 2000 | — |
| −6 | K031495 | Pinnacle Duofix HA Acetabular Cup Prosthesis | DePuy Orthopaedics, Inc. | 2003 | — |
| −5 | K042344 | Excia Total Hip System | Aesculap, Inc. | 2005 | 10 |
| −4 | K070981 | Search Evolution (LC) Total Knee System (Plasmapore) | Aesculap Implant Systems, Inc. | 2007 | — |
| −3 | K081023 | Evolis Total Knee System | Medacta International S.A. | 2008 | 1 |
| −2 | K090988 | GMK Total Knee System | Medacta International S.A. | 2009 | 1 |
| −1 | K102437 | GMK Revision Knee System | Medacta International S.A. | 2010 | — |
| 0 (this device) | 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 |
|---|---|---|
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1987 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 3 | 0 |
| 1994 | 5 | 0 |
| 1995 | 5 | 0 |
| 1996 | 9 | 0 |
| 1997 | 4 | 0 |
| 1998 | 5 | 0 |
| 1999 | 3 | 0 |
| 2000 | 7 | 0 |
| 2001 | 8 | 0 |
| 2002 | 9 | 0 |
| 2003 | 5 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K102437 | GMK Revision Knee SystemSummary page 5…JWH Device Classification 2 III. Predicate Device Substantial equivalence is claimed to the following devices: Primary Predicate: GMK Revision, K102437, Medacta International SA Reference Predicate GMK Hinge, K130299, Medacta International SA IV. Device Description… | 2010 |
| * | K130299 | GMK HingeSummary page 5…antial equivalence is claimed to the following devices: Primary Predicate: GMK Revision, K102437, Medacta International SA Reference Predicate GMK Hinge, K130299, Medacta International SA IV. Device Description The GMK Revision-Femoral Distal Augmentations have been designed to allow… | 2013 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K210010 | GMK Revision & Hinge Extension - TiNbN Coating | 2021 | 1 |
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 22 years and passes through 6 companies; a new generation was cleared every 1.8 years on median.
- 42 of the 94 ancestors have a recall of any class.
- Of its descendants, K210010 (Medacta International S.A., 2021) has gone furthest, with 1 descendant of its own.
- 10 other devices also cite its predicate K102437.
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. 2016, 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® 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 (253 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 wedges cemented are to be attached to the tibial baseplate with both the fixing cylinders and bone cement.
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 augmentation are to be screwed to the tibial baseplate with both 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K163311 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163311: GMK Revision Femoral Distal Augmentation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163311
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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