510(k) · Cleared
ClearedNextAR™ TSA 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 Oct 29, 2023 as substantially equivalent to K210153 (Medacta International S.A., 2021) after a 90-day review. Its family tree reaches back 13 generations to 1994. 2 of the 164 devices in its family, counting itself, have a Class I recall. 1 later device descends from it.
- Decided
- Oct 29, 2023
- Review
- 90 days
- Class
- Class II
- Product code
- SBF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K941847 (1994). 163 ancestors in all, the oldest K800494 (1980). 1 later device descends from it, 1 citing it directly. 2 of the 164 devices in this family, counting this one, have a Class I recall.
- Root · 13 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 9 generations between
- 3 generations backK193559 NextAR TKA PlatformMedacta Inernational SA · 2020
- 2 generations backK202152 NextAR TKA PlatformMedacta International S.A. · 2020
- 1 generation backK210153 NextAR RSA PlatformMedacta International S.A. · 2021 · Recalled
- This deviceK232280 NextAR™ TSA PlatformMedacta International S.A. · 2023
- Descendant · cites it directly · 0 of its ownK251737 NextAR (TM) Shoulder PlatformMedacta International S.A. · 2025
Show all 13 generations
- Root · 13 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 12 generations backK964650 TCP-Coated Porocoat Aml Femoral Hip ProsthesisDepuy, Inc. · 1997
- 11 generations backK980711 Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic…Zimmer, Inc. · 1998 · Recalled
- 10 generations backK001277 Triflange Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2000
- 9 generations backK031495 Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc. · 2003
- 8 generations backK042344 Excia Total Hip SystemAesculap, Inc. · 2005 · Recalled
- 7 generations backK070981 Search Evolution (LC) Total Knee System (Plasmapore)Aesculap Implant Systems, Inc. · 2007
- 6 generations backK081023 Evolis Total Knee SystemMedacta International S.A. · 2008 · Recalled
- 5 generations backK090988 GMK Total Knee SystemMedacta International S.A. · 2009 · Recalled
- 4 generations backK093806 Myknee Cutting BlocksMedacta International S.A. · 2010
- 3 generations backK193559 NextAR TKA PlatformMedacta Inernational SA · 2020
- 2 generations backK202152 NextAR TKA PlatformMedacta International S.A. · 2020
- 1 generation backK210153 NextAR RSA PlatformMedacta International S.A. · 2021 · Recalled
- This deviceK232280 NextAR™ TSA PlatformMedacta International S.A. · 2023
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K251737NextAR (TM) Shoulder PlatformMedacta International S.A. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K941847 | 5/8 Porocoat Aml Hip Porocoat Porous Coating | Depuy, Inc. | 1994 | — |
| −12 | K964650 | TCP-Coated Porocoat Aml Femoral Hip Prosthesis | Depuy, Inc. | 1997 | — |
| −11 | K980711 | Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic Coating | Zimmer, Inc. | 1998 | 1 |
| −10 | K001277 | Triflange Acetabular Cup System | DePuy Orthopaedics, Inc. | 2000 | — |
| −9 | K031495 | Pinnacle Duofix HA Acetabular Cup Prosthesis | DePuy Orthopaedics, Inc. | 2003 | — |
| −8 | K042344 | Excia Total Hip System | Aesculap, Inc. | 2005 | 10 |
| −7 | K070981 | Search Evolution (LC) Total Knee System (Plasmapore) | Aesculap Implant Systems, Inc. | 2007 | — |
| −6 | K081023 | Evolis Total Knee System | Medacta International S.A. | 2008 | 1 |
| −5 | K090988 | GMK Total Knee System | Medacta International S.A. | 2009 | 1 |
| −4 | K093806 | Myknee Cutting Blocks | Medacta International S.A. | 2010 | — |
| −3 | K193559 | NextAR TKA Platform | Medacta Inernational SA | 2020 | — |
| −2 | K202152 | NextAR TKA Platform | Medacta International S.A. | 2020 | — |
| −1 | K210153 | NextAR RSA Platform | Medacta International S.A. | 2021 | 1 |
| 0 (this device) | K232280 | NextAR™ TSA Platform | Medacta International S.A. | 2023 | — |
| +1 | K251737 | NextAR (TM) Shoulder Platform | Medacta International S.A. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 2 | 0 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1987 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 3 | 0 |
| 1993 | 5 | 0 |
| 1994 | 6 | 0 |
| 1995 | 6 | 0 |
| 1996 | 9 | 0 |
| 1997 | 6 | 0 |
| 1998 | 7 | 0 |
| 1999 | 10 | 0 |
| 2000 | 10 | 0 |
| 2001 | 15 | 0 |
| 2002 | 14 | 0 |
| 2003 | 7 | 0 |
| 2004 | 6 | 0 |
| 2005 | 6 | 0 |
| 2006 | 8 | 0 |
| 2007 | 5 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2013 | 2 | 0 |
| 2015 | 2 | 1 |
| 2016 | 2 | 1 |
| 2017 | 3 | 0 |
| 2019 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 20.4 · 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? (1)
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 |
|---|---|---|---|
| * | K210153 | NextAR RSA PlatformSummary page 4…Device Classification II III. Predicate Device Substantial equivalence is claimed to the following devices: Primary predicate device: NextAR™ RSA Platform K210153 Reference predicate devices: NextAR Spine K223769 Page 1 of 4.… | 2021 |
| † | K223769 | NextAR™ Spine Platform | 2023 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K251737 | NextAR (TM) Shoulder Platform | 2025 | 0 |
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 29 years and passes through 7 companies; a new generation was cleared every 1.6 years on median.
- 57 of the 162 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K251737 (Medacta International S.A., 2025) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K210153.
How does its category compare?
All SBF devicesSBF Orthopedic Augmented Reality: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 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 Anatomic (TSA – Total Shoulder Arthroplasty). As an optional display, the smart…
Read the full statement (158 words)
The NextAR Shoulder™ Platform supports the surgeon during glenoid implantation in anatomic 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 Anatomic (TSA – Total Shoulder Arthroplasty). As an optional display, the smart glasses can be used auxiliary to the NextAR Shoulder™ Platform to view the same 2D 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/K232280 · printed Nov 4, 2026
Cite this page
510(k) Report. “K232280: NextAR™ TSA Platform.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K232280
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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