510(k) · Cleared
ClearedNextAR TKA Platform
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medacta Inernational SA · SBF Orthopedic Augmented Reality
Cleared on Jul 10, 2020 as substantially equivalent to K083872 (Medacta International S.A., 2009) and 3 other predicates after a 200-day review. Its family tree reaches back 10 generations to 1994. 2 of the 117 devices in its family, counting itself, have a Class I recall. 12 later devices descend from it.
- Decided
- Jul 10, 2020
- Review
- 200 days
- Class
- Class II
- Product code
- SBF
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 10 generations to K941847 (1994). 105 ancestors in all, the oldest K840643 (1984). 12 later devices descend from it, 6 citing it directly. 2 of the 117 devices in this family, counting this one, have a Class I recall.
- 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 backK093806 Myknee Cutting BlocksMedacta International S.A. · 2010
- This deviceK193559 NextAR TKA PlatformMedacta Inernational SA · 2020
- Descendant · cites it directly · 11 of its ownK202152 NextAR TKA PlatformMedacta International S.A. · 2020
- Descendant · cites it directly · 5 of its ownK210153 NextAR RSA PlatformMedacta International S.A. · 2021 · Recalled
- Descendant · cites it directly · 4 of its ownK210859 NextAR™ Spine PlatformMedacta International S.A. · 2021
- Descendant · 2 generations on · 2 of its ownK223769 NextAR™ Spine PlatformMedacta International S.A. · 2023
- Descendant · 2 generations on · 1 of its ownK250108 OptiVu™ ShoulderMr Surgical Solutions, LLC · 2025
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 backK093806 Myknee Cutting BlocksMedacta International S.A. · 2010
- This deviceK193559 NextAR TKA PlatformMedacta Inernational SA · 2020
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 12 · See all- K202152NextAR TKA PlatformMedacta International S.A. · 2020 · cites it directly11descendants
- K210153NextAR RSA PlatformMedacta International S.A. · 2021 · cites it directly5descendants
- K210859NextAR™ Spine PlatformMedacta International S.A. · 2021 · cites it directly4descendants
- K223769NextAR™ Spine PlatformMedacta International S.A. · 2023 · 2 generations on2descendants
- K250108OptiVu™ ShoulderMr Surgical Solutions, LLC · 2025 · 2 generations on1descendant
View 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 | K093806 | Myknee Cutting Blocks | Medacta International S.A. | 2010 | — |
| 0 (this device) | K193559 | NextAR TKA Platform | Medacta Inernational SA | 2020 | — |
| +1 | K202152 | NextAR TKA Platform | Medacta International S.A. | 2020 | — |
| +1 | K210153 | NextAR RSA Platform | Medacta International S.A. | 2021 | 1 |
| +1 | K210859 | NextAR™ Spine Platform | Medacta International S.A. | 2021 | — |
| +2 | K223769 | NextAR™ Spine Platform | Medacta International S.A. | 2023 | — |
| +2 | K250108 | OptiVu™ Shoulder | Mr Surgical Solutions, LLC | 2025 | — |
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 | 5 | 0 |
| 1996 | 8 | 0 |
| 1997 | 4 | 0 |
| 1998 | 5 | 0 |
| 1999 | 4 | 0 |
| 2000 | 7 | 0 |
| 2001 | 11 | 0 |
| 2002 | 11 | 0 |
| 2003 | 4 | 0 |
| 2004 | 3 | 0 |
| 2005 | 3 | 0 |
| 2006 | 3 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2015 | 1 | 1 |
| 2016 | 1 | 1 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 4 | 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.
2 devices in this family have a Class I recall. 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 SBF device
- #1 K250108 OptiVu™ Shoulderscore 17.4 · 17 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K083872 | Imns Medacta Navigation SystemSummary page 4…fication II III. Predicate Device Substantial equivalence is claimed to the following devices: Primary predicate device: iMNS Medacta Navigation System, K083872 and K100314, Medacta International SA Additional predicate device: MyKnee Cutting Blocks, K093806, Medacta International SA… | 2009 |
| * | K100314 | Imns Medacta Navigation System,33.221000USSummary page 4…II III. Predicate Device Substantial equivalence is claimed to the following devices: Primary predicate device: iMNS Medacta Navigation System, K083872 and K100314, Medacta International SA Additional predicate device: MyKnee Cutting Blocks, K093806, Medacta International SA Xvisio… | 2010 |
| * | K093806 | Myknee Cutting BlocksSummary page 4…: Primary predicate device: iMNS Medacta Navigation System, K083872 and K100314, Medacta International SA Additional predicate device: MyKnee Cutting Blocks, K093806, Medacta International SA Xvision Spine System, K190929, Augmedics Ltd.… | 2010 |
| * | K190929 | xvision Spine system (XVS)Summary page 4…tem, K083872 and K100314, Medacta International SA Additional predicate device: MyKnee Cutting Blocks, K093806, Medacta International SA Xvision Spine System, K190929, Augmedics Ltd. Page 1 of 4. === Page 5 ==… | 2019 |
What descends from it? (12)
See all 126 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
What does this lineage say?
- The line of descent spans 26 years and passes through 7 companies; a new generation was cleared every 1.8 years on median.
- 42 of the 104 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K202152 (Medacta International S.A., 2020) has gone furthest, with 11 descendants of its own.
- 1 other device also cites its predicate K083872.
How does its category compare?
All SBF devicesSBF Orthopedic Augmented Reality: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · SBF
13in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · SBF
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · SBF
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · SBF
1in 2025
MAUDE reports naming product code SBF, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 4 | 162 | 0 | 0 |
| 2022 | 7 | 234 | 0 | 0 |
| 2023 | 7 | 104 | 0 | 0 |
| 2024 | 6 | 89 | 0 | 0 |
| 2025 | 13 | 90 | 1 | 1 |
| 2026 | 3 | 123 | 1 | — |
What is it indicated for?
The NextAR™ TKA Platform is intended to be used to support the surgeon during total knee replacement procedures by providing information on bone resections, ligaments behavior, instrument and implant positioning. The NextAR™ TKA Platform is intended to be used in combination with NextAR™ stereotaxic instruments, the MyKnee® NextAR™ cutting guides, and general surgical instruments to implant the GMK Sphere Total knee system and perform ligament balancing.…
Read the full statement (249 words)
The NextAR™ TKA Platform is intended to be used to support the surgeon during total knee replacement procedures by providing information on bone resections, ligaments behavior, instrument and implant positioning.
The NextAR™ TKA Platform is intended to be used in combination with NextAR™ stereotaxic instruments, the MyKnee® NextAR™ cutting guides, and general surgical instruments to implant the GMK Sphere Total knee system and perform ligament balancing. As an optional display, the smart glasses can be used auxiliary to the NextAR Platform to view the same 2D stereotaxic information as presented by the NextAR Platform.
The smart glasses should not be relied upon solely and should always be used in conjunction with the primary computer display.
The MyKnee® NextAR cutting guides include a camera/target holder and a PSI MyKnee® cutting guide both for tibia and femur. The MyKnee® cutting guides must be used as anatomical cutting blocks specific for a single patient anatomy, to assist in the positioning of total knee replacement components intraoperatively and in guiding the marking of bone before cutting. MyKnee® NextAR TKA cutting guides are for single use only.
The NextAR™ stereotaxic instruments are intended to be used to support the surgeon during specific orthopedic surgical procedures by providing information on bone resections, ligaments behavior, instrument and implant positioning. The NextAR™ stereotaxic instruments, when registered with the myKnee NextAR TKA cutting guides, provide reference to a patient’s rigid anatomical structures, such as the femur and tibia, that can be identified relative to pre-operative CT based planning.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193559 · printed Nov 5, 2026
Cite this page
510(k) Report. “K193559: NextAR TKA Platform.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K193559
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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