510(k) · Cleared
ClearedNextAR (TM) Shoulder Platform
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 Sep 4, 2025 as substantially equivalent to K232280 (Medacta International S.A., 2023) and 5 other predicates after a 90-day review. Its family tree reaches back 16 generations to 1991. 3 of the 229 devices in its family, counting itself, have a Class I recall.
- Decided
- Sep 4, 2025
- Review
- 90 days
- Class
- Class II
- Product code
- SBF
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 16 generations to K911686 (1991). 229 ancestors in all, the oldest K790987 (1979). No later device cites it as a predicate yet. 3 of the 229 devices in this family, counting this one, have a Class I recall.
- Root · 16 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 12 generations between
- 3 generations backK173900 Arthrex Univers Revers Modular Glenoid SystemArthrex, Inc. · 2018
- 2 generations backK193372 Univers Revers Modular Glenoid System (Augemented baseplates)Arthrex, Inc. · 2020
- 1 generation backK231911 Glenoid Reconstruction System – Full Wedge BaseplateMedacta International S.A. · 2023
- This deviceK251737 NextAR (TM) Shoulder PlatformMedacta International S.A. · 2025
Show all 16 generations
- Root · 16 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 15 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 14 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 13 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
- 12 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 11 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 10 generations backK050316 Aequalis Reversed Shoulder ProsthesisTornier · 2005
- 9 generations backK061439 Aequalis Reversed ProsthesisTornier · 2006
- 8 generations backK071948 Aequalis Reversed AdapterTornier · 2007
- 7 generations backK082120 Aequalis Reversed Fracture Shoulder ProthesisTornier · 2008
- 6 generations backK100142 Aequalis Reversed Shoulder ProsthesisTornier · 2010
- 5 generations backK130129 Univers Revers Shoulder Prosthesis SystemArthrex, Inc. · 2013
- 4 generations backK142863 Univers Rivers Shoulder Prosthesis SystemArthrex, Inc. · 2014
- 3 generations backK173900 Arthrex Univers Revers Modular Glenoid SystemArthrex, Inc. · 2018
- 2 generations backK193372 Univers Revers Modular Glenoid System (Augemented baseplates)Arthrex, Inc. · 2020
- 1 generation backK231911 Glenoid Reconstruction System – Full Wedge BaseplateMedacta International S.A. · 2023
- This deviceK251737 NextAR (TM) Shoulder PlatformMedacta International S.A. · 2025
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −15 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −14 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −13 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| −12 | K030941 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −11 | K041873 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −10 | K050316 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2005 | — |
| −9 | K061439 | Aequalis Reversed Prosthesis | Tornier | 2006 | — |
| −8 | K071948 | Aequalis Reversed Adapter | Tornier | 2007 | — |
| −7 | K082120 | Aequalis Reversed Fracture Shoulder Prothesis | Tornier | 2008 | — |
| −6 | K100142 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2010 | — |
| −5 | K130129 | Univers Revers Shoulder Prosthesis System | Arthrex, Inc. | 2013 | — |
| −4 | K142863 | Univers Rivers Shoulder Prosthesis System | Arthrex, Inc. | 2014 | — |
| −3 | K173900 | Arthrex Univers Revers Modular Glenoid System | Arthrex, Inc. | 2018 | — |
| −2 | K193372 | Univers Revers Modular Glenoid System (Augemented baseplates) | Arthrex, Inc. | 2020 | — |
| −1 | K231911 | Glenoid Reconstruction System – Full Wedge Baseplate | Medacta International S.A. | 2023 | — |
| 0 (this device) | K251737 | NextAR (TM) Shoulder Platform | Medacta International S.A. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 2 | 0 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 5 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 4 | 0 |
| 1993 | 6 | 0 |
| 1994 | 8 | 0 |
| 1995 | 8 | 0 |
| 1996 | 13 | 0 |
| 1997 | 7 | 0 |
| 1998 | 9 | 0 |
| 1999 | 9 | 0 |
| 2000 | 15 | 0 |
| 2001 | 17 | 0 |
| 2002 | 14 | 0 |
| 2003 | 9 | 0 |
| 2004 | 9 | 0 |
| 2005 | 13 | 0 |
| 2006 | 11 | 0 |
| 2007 | 9 | 0 |
| 2008 | 7 | 1 |
| 2009 | 6 | 0 |
| 2010 | 4 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2015 | 2 | 1 |
| 2016 | 3 | 1 |
| 2017 | 4 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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.
3 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 20.4 · 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? (6)
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 |
|---|---|---|---|
| * | K232280 | NextAR™ TSA PlatformSummary page 5…II III. Predicate Device Substantial equivalence is claimed to the following predicate devices. Primary Predicate device: NextAR™ TSA Platform, K232280, Medacta International SA Additional Predicate devices: NextAR RSA Platform, K210153, Medacta International S… | 2023 |
| * | K210153 | NextAR RSA PlatformSummary page 5…ces. Primary Predicate device: NextAR™ TSA Platform, K232280, Medacta International SA Additional Predicate devices: NextAR RSA Platform, K210153, Medacta International SA Glenoid Reconstruction System – Full Wedge Baseplate, K231911, Medacta International… | 2021 |
| * | K231911 | Glenoid Reconstruction System – Full Wedge BaseplateSummary page 5…Additional Predicate devices: NextAR RSA Platform, K210153, Medacta International SA Glenoid Reconstruction System – Full Wedge Baseplate, K231911, Medacta International SA Glenoid Reconstruction System, K213459, Medacta International SA … | 2023 |
| * | K213459 | Glenoid Reconstruction SystemSummary page 5…rnational SA Glenoid Reconstruction System – Full Wedge Baseplate, K231911, Medacta International SA Glenoid Reconstruction System, K213459, Medacta International SA NextAR TKA Platform, K193559, Medacta International SA Medacta Shoulder System,… | 2022 |
| * | K193559 | NextAR TKA PlatformSummary page 5…Baseplate, K231911, Medacta International SA Glenoid Reconstruction System, K213459, Medacta International SA NextAR TKA Platform, K193559, Medacta International SA Medacta Shoulder System, K170452, Medacta International SA IV. Device Description The N… | 2020 |
| * | K170452 | Medacta Shoulder SystemSummary page 5…Glenoid Reconstruction System, K213459, Medacta International SA NextAR TKA Platform, K193559, Medacta International SA Medacta Shoulder System, K170452, Medacta International SA IV. Device Description The NextAR™ Shoulder Platform is a CT based computer-assisted surgical navig… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (3 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.
- K080642Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · 3 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
- K153660StealthStation System with Cranial SoftwareMedtronic Navigation, Inc. · 2016 · 4 generations back · ◆ in the 2016 ancestors bar of FIG. 13 Class I recalls
- K150216Synergy CranialMedtronic Navigation, Inc. · 2015 · 5 generations back · ◆ in the 2015 ancestors bar of FIG. 13 Class I recalls
What does this lineage say?
- The line of descent spans 34 years and passes through 5 companies; a new generation was cleared every 1.5 years on median.
- 75 of the 228 ancestors have a recall of any class; 3 have a Class I recall.
How does its category compare?
All SBF devicesSBF Orthopedic Augmented Reality: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 Shoulder ™ Platform supports the surgeon during glenoid implantation in anatomic and reverse shoulder replacement procedures providing information on bone preparation, instrument guidance, and implant positioning. The NextAR Shoulder ™ Platform works in conjunction with NextAR ™ stereotaxic instruments and general surgical instruments to implant the Medacta Shoulder System shoulder prosthesis. As an optional display, the smart glasses can be…
Read the full statement (163 words)
The NextAR Shoulder ™ Platform supports the surgeon during glenoid implantation in anatomic and reverse shoulder replacement procedures providing information on bone preparation, instrument guidance, and implant positioning.
The NextAR Shoulder ™ Platform works in conjunction with NextAR ™ stereotaxic instruments and general surgical instruments to implant the Medacta Shoulder System shoulder prosthesis.
As an optional display, the smart glasses can be used auxiliary to the NextAR Shoulder ™ Platform to view the same 20 stereotaxic information as presented by the NextAR Shoulder ™ Platform.
The NextAR Shoulder ™ stereotaxic instruments are to support the surgeon during specific orthopedic surgical procedures by providing information on bone preparation, instrument guidance, and implant positioning. Once registered, the NextAR ™ stereotaxic instruments provide reference to a patient's rigid anatomical structures on the surface of the glenoid that are identified relative to preoperative C.T. based planning.
The smart glasses should not be relied upon solely and should always be used in conjunction with the primary computer display
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251737 · printed Nov 5, 2026
Cite this page
510(k) Report. “K251737: NextAR (TM) Shoulder Platform.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K251737
Report an extraction error
Are you the manufacturer?
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