510(k) · Cleared
ClearedNextAR™ TKA Platform My Knee PPS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medacta International S.A. · SBF Orthopedic Augmented Reality
Cleared on Mar 10, 2022 as substantially equivalent to K202152 (Medacta International S.A., 2020) and 2 other predicates after a 100-day review. Its family tree reaches back 12 generations to 1994. 2 of the 108 devices in its family, counting itself, have a Class I recall.
- Decided
- Mar 10, 2022
- Review
- 100 days
- Class
- Class II
- Product code
- SBF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 12 generations to K941847 (1994). 108 ancestors in all, the oldest K840643 (1984). No later device cites it as a predicate yet. 2 of the 108 devices in this family, counting this one, have a Class I recall.
- Root · 12 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 8 generations between
- 3 generations backK093806 Myknee Cutting BlocksMedacta International S.A. · 2010
- 2 generations backK193559 NextAR TKA PlatformMedacta Inernational SA · 2020
- 1 generation backK202152 NextAR TKA PlatformMedacta International S.A. · 2020
- This deviceK213751 NextAR™ TKA Platform My Knee PPSMedacta International S.A. · 2022
Show all 12 generations
- Root · 12 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 11 generations backK964650 TCP-Coated Porocoat Aml Femoral Hip ProsthesisDepuy, Inc. · 1997
- 10 generations backK980711 Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic…Zimmer, Inc. · 1998 · Recalled
- 9 generations backK001277 Triflange Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2000
- 8 generations backK031495 Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc. · 2003
- 7 generations backK042344 Excia Total Hip SystemAesculap, Inc. · 2005 · Recalled
- 6 generations backK070981 Search Evolution (LC) Total Knee System (Plasmapore)Aesculap Implant Systems, Inc. · 2007
- 5 generations backK081023 Evolis Total Knee SystemMedacta International S.A. · 2008 · Recalled
- 4 generations backK090988 GMK Total Knee SystemMedacta International S.A. · 2009 · Recalled
- 3 generations backK093806 Myknee Cutting BlocksMedacta International S.A. · 2010
- 2 generations backK193559 NextAR TKA PlatformMedacta Inernational SA · 2020
- 1 generation backK202152 NextAR TKA PlatformMedacta International S.A. · 2020
- This deviceK213751 NextAR™ TKA Platform My Knee PPSMedacta International S.A. · 2022
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K941847 | 5/8 Porocoat Aml Hip Porocoat Porous Coating | Depuy, Inc. | 1994 | — |
| −11 | K964650 | TCP-Coated Porocoat Aml Femoral Hip Prosthesis | Depuy, Inc. | 1997 | — |
| −10 | K980711 | Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic Coating | Zimmer, Inc. | 1998 | 1 |
| −9 | K001277 | Triflange Acetabular Cup System | DePuy Orthopaedics, Inc. | 2000 | — |
| −8 | K031495 | Pinnacle Duofix HA Acetabular Cup Prosthesis | DePuy Orthopaedics, Inc. | 2003 | — |
| −7 | K042344 | Excia Total Hip System | Aesculap, Inc. | 2005 | 10 |
| −6 | K070981 | Search Evolution (LC) Total Knee System (Plasmapore) | Aesculap Implant Systems, Inc. | 2007 | — |
| −5 | K081023 | Evolis Total Knee System | Medacta International S.A. | 2008 | 1 |
| −4 | K090988 | GMK Total Knee System | Medacta International S.A. | 2009 | 1 |
| −3 | K093806 | Myknee Cutting Blocks | Medacta International S.A. | 2010 | — |
| −2 | K193559 | NextAR TKA Platform | Medacta Inernational SA | 2020 | — |
| −1 | K202152 | NextAR TKA Platform | Medacta International S.A. | 2020 | — |
| 0 (this device) | K213751 | NextAR™ TKA Platform My Knee PPS | Medacta International S.A. | 2022 | — |
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 | 2 | 0 |
| 2019 | 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 K193559 NextAR TKA Platformscore 20.3 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K202152 | NextAR TKA PlatformSummary page 5…cation II III. Predicate Device Substantial equivalence is claimed to the following devices: Primary predicate device: NextARTM TKA Platform, K202152 NextARTM TKA Platform, K193559 K213751… | 2020 |
| * | K193559 | NextAR TKA PlatformSummary page 5…ice Substantial equivalence is claimed to the following devices: Primary predicate device: NextARTM TKA Platform, K202152 NextARTM TKA Platform, K193559 K213751 - Page 1 of 5 Additional… | 2020 |
| * | K170106 | MyKnee PPS-Pin PositionersSummary page 6…Page 1 of 5 Additional predicate device: MyKnee® NextAR™ Cutting Blocks, K193559, Medacta International SA MyKnee® Pin Positioners, K170106, Medacta International SA IV. Device Description The NextAR™ TKA Platform is a CT based computer-assisted surgical naviga… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
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 28 years and passes through 7 companies; a new generation was cleared every 1.6 years on median.
- 42 of the 107 ancestors have a recall of any class; 2 have a Class I recall.
- 2 other devices also cite its predicate K202152.
How does its category compare?
All SBF devicesSBF Orthopedic Augmented Reality: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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™ Knee 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™ Knee Platform is intended to be used in combination with NextAR™ stereotaxic instruments and general surgical instruments to implant the GMK® Sphere Total knee system and perform ligament balancing. As an optional display, the smart…
Read the full statement (323 words)
The NextAR™ Knee 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™ Knee Platform is intended to be used in combination with NextAR™ stereotaxic instruments 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.
The MyKnee® PPS NextAR™ blocks include a PSI MyKnee® pin positioners block both for tibia and femur. The MyKnee® PPS NextAR™ blocks must be used as anatomical Pin positioners blocks 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.
The use of MyKnee® NextAR™ cutting guides or MyKnee® PPS NextAR™ blocks are applicable only for the “PSI-based” approach. MyKnee® NextAR™ cutting guides or MyKnee® PPS NextAR™ blocks 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™ Knee stereotaxic instruments, when registered with the MyKnee® NextAR™ Knee 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K213751 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213751: NextAR™ TKA Platform My Knee PPS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213751
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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