510(k) · Cleared
ClearedNextAR (TM) Spine
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 Jul 31, 2025 as substantially equivalent to K233172 (Medacta International S.A., 2024) and 1 other predicate after a 162-day review. Its family tree reaches back 15 generations to 1994. 2 of the 110 devices in its family, counting itself, have a Class I recall.
- Decided
- Jul 31, 2025
- Review
- 162 days
- Class
- Class II
- Product code
- SBF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 15 generations to K941847 (1994). 110 ancestors in all, the oldest K840643 (1984). No later device cites it as a predicate yet. 2 of the 110 devices in this family, counting this one, have a Class I recall.
- Root · 15 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 11 generations between
- 3 generations backK210859 NextAR™ Spine PlatformMedacta International S.A. · 2021
- 2 generations backK223769 NextAR™ Spine PlatformMedacta International S.A. · 2023
- 1 generation backK233172 NextAR™ Spine PlatformMedacta International S.A. · 2024
- This deviceK250477 NextAR (TM) SpineMedacta International S.A. · 2025
Show all 15 generations
- Root · 15 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 14 generations backK964650 TCP-Coated Porocoat Aml Femoral Hip ProsthesisDepuy, Inc. · 1997
- 13 generations backK980711 Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic…Zimmer, Inc. · 1998 · Recalled
- 12 generations backK001277 Triflange Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2000
- 11 generations backK031495 Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc. · 2003
- 10 generations backK042344 Excia Total Hip SystemAesculap, Inc. · 2005 · Recalled
- 9 generations backK070981 Search Evolution (LC) Total Knee System (Plasmapore)Aesculap Implant Systems, Inc. · 2007
- 8 generations backK081023 Evolis Total Knee SystemMedacta International S.A. · 2008 · Recalled
- 7 generations backK090988 GMK Total Knee SystemMedacta International S.A. · 2009 · Recalled
- 6 generations backK093806 Myknee Cutting BlocksMedacta International S.A. · 2010
- 5 generations backK193559 NextAR TKA PlatformMedacta Inernational SA · 2020
- 4 generations backK202152 NextAR TKA PlatformMedacta International S.A. · 2020
- 3 generations backK210859 NextAR™ Spine PlatformMedacta International S.A. · 2021
- 2 generations backK223769 NextAR™ Spine PlatformMedacta International S.A. · 2023
- 1 generation backK233172 NextAR™ Spine PlatformMedacta International S.A. · 2024
- This deviceK250477 NextAR (TM) SpineMedacta 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 |
|---|---|---|---|---|---|
| −15 | K941847 | 5/8 Porocoat Aml Hip Porocoat Porous Coating | Depuy, Inc. | 1994 | — |
| −14 | K964650 | TCP-Coated Porocoat Aml Femoral Hip Prosthesis | Depuy, Inc. | 1997 | — |
| −13 | K980711 | Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic Coating | Zimmer, Inc. | 1998 | 1 |
| −12 | K001277 | Triflange Acetabular Cup System | DePuy Orthopaedics, Inc. | 2000 | — |
| −11 | K031495 | Pinnacle Duofix HA Acetabular Cup Prosthesis | DePuy Orthopaedics, Inc. | 2003 | — |
| −10 | K042344 | Excia Total Hip System | Aesculap, Inc. | 2005 | 10 |
| −9 | K070981 | Search Evolution (LC) Total Knee System (Plasmapore) | Aesculap Implant Systems, Inc. | 2007 | — |
| −8 | K081023 | Evolis Total Knee System | Medacta International S.A. | 2008 | 1 |
| −7 | K090988 | GMK Total Knee System | Medacta International S.A. | 2009 | 1 |
| −6 | K093806 | Myknee Cutting Blocks | Medacta International S.A. | 2010 | — |
| −5 | K193559 | NextAR TKA Platform | Medacta Inernational SA | 2020 | — |
| −4 | K202152 | NextAR TKA Platform | Medacta International S.A. | 2020 | — |
| −3 | K210859 | NextAR™ Spine Platform | Medacta International S.A. | 2021 | — |
| −2 | K223769 | NextAR™ Spine Platform | Medacta International S.A. | 2023 | — |
| −1 | K233172 | NextAR™ Spine Platform | Medacta International S.A. | 2024 | — |
| 0 (this device) | K250477 | NextAR (TM) Spine | Medacta International S.A. | 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 |
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? (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 |
|---|---|---|---|
| * | K233172 | NextAR™ Spine PlatformSummary page 6…ce Classification: II III. Predicate Device Substantial equivalence is claimed to the following devices: Primary predicate device NextARTM Spine Platform K233172, Medacta International SA Additional predicate device NextARTM Spine Platform K210859, Medacta International SA IV. De… | 2024 |
| * | K210859 | NextAR™ Spine PlatformSummary page 6…o the following devices: Primary predicate device NextARTM Spine Platform K233172, Medacta International SA Additional predicate device NextARTM Spine Platform K210859, Medacta International SA IV. Device Description The NextAR™ Spine platform is a CT based computer-assisted surgical naviga… | 2021 |
| † | K200391 | MPACT Extension | 2021 |
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 31 years and passes through 7 companies; a new generation was cleared every 1.4 years on median.
- 42 of the 109 ancestors have a recall of any class; 2 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 Spine platform is intended as an aid for precisely locating anatomical structures in either open/mini-open or percutaneous spine procedures. It is indicated for any medical condition in which the use of stereotaxic surgery may be appropriate, when reference to a rigid anatomical structure, such as vertebrae or pelvis, can be identified relative to images of the anatomy. This can include posterior approach spinal procedures, such as: • Pedicle…
Read the full statement (278 words)
The NextAR Spine platform is intended as an aid for precisely locating anatomical structures in either open/mini-open or percutaneous spine procedures. It is indicated for any medical condition in which the use of stereotaxic surgery may be appropriate, when reference to a rigid anatomical structure, such as vertebrae or pelvis, can be identified relative to images of the anatomy. This can include posterior approach spinal procedures, such as:
• Pedicle Screw Placement (Thoracic and Lumbosacral spine)
• Sacro-Iliac Screw Placement
NextAR Spine is also intended to provide planning tools for measuring and selecting the fixation rod for the thoracic and lumbosacral spine.
The NextAR Spine platform is intended to be used in combination with NextAR TM Stereotaxic instruments and / or Medacta preoperative planning. In the case of pre-operative planning, surgical planning software is used pre-operatively to plan the surgical placement of pedicle screws based upon radiological images of the patient. As an optional display, the NextAR Smart Glasses can be used auxiliary to the NextAR Spine Platform to view stereotaxic information as presented by the NextAR Spine Platform. The NextAR Smart Glasses should not be relied upon solely and should always be used in conjunction with the primary computer display.
The sterile drills, pins and iliac pins are part of the NextAR Spine platform which is intended as an aid for precisely locating anatomical structures in either open / mini open or percutaneous spine procedures. The NextAR Spine sterile drills pins and iliac pins are intended for use with the NextAR Spine platform according to its approved indications for use. All the drills are motorized. Pins may be used either motorized or manually. Iliac pins are manual.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250477 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250477: NextAR (TM) Spine.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250477
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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