510(k) · Cleared
ClearedNextAR Hip 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 Jan 9, 2026 as substantially equivalent to K243751 (Mako Surgical Corp., 2025) and 4 other predicates after a 123-day review. Its family tree reaches back 17 generations to 1991. 2 of the 228 devices in its family, counting itself, have a Class I recall.
- Decided
- Jan 9, 2026
- Review
- 123 days
- Class
- Class II
- Product code
- SBF
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 17 generations to K905070 (1991). 228 ancestors in all, the oldest K800494 (1980). No later device cites it as a predicate yet. 2 of the 228 devices in this family, counting this one, have a Class I recall.
- Root · 17 generations backK905070 VistarPhilips Medical Systems (Cleveland), Inc. · 1991
- 13 generations between
- 3 generations backK191998 Mako Total Hip Application, Mako Total Knee ApplicationMako Surgical Corp. · 2019
- 2 generations backK193128 Mako Total Hip ApplicationMako Surgical Corp. · 2020
- 1 generation backK243751 Mako Total Hip Application 5.0Mako Surgical Corp. · 2025
- This deviceK252847 NextAR Hip PlatformMedacta International S.A. · 2026
Show all 17 generations
- Root · 17 generations backK905070 VistarPhilips Medical Systems (Cleveland), Inc. · 1991
- 16 generations backK961168 ViewpointPhilips Medical Systems (Cleveland), Inc. · 1996
- 15 generations backK963221 Optical Digitizer Option for View PointPhilips Medical Systems (Cleveland), Inc. · 1997
- 14 generations backK970604 Viewpoint - 3.0 SoftwarePhilips Medical Systems (Cleveland), Inc. · 1997
- 13 generations backK984298 Z Kat Flurotactic Guidance System MkiZ-Kat, Inc. · 1999
- 12 generations backK013025 Modification to Flourolab PlusZ-Kat, Inc. · 2001
- 11 generations backK031337 Acumen Surgical Navigation SystemBiomet, Inc. · 2003
- 10 generations backK072806 Mako Surgical Tactile Guidance System (TGS)Mako Surgical Corp. · 2008 · Recalled
- 9 generations backK081867 Mako Surgical Tactile Guidance System Version 2.0Mako Surgical Corp. · 2008 · Recalled
- 8 generations backK091998 Robotic Arm Interactive Orthopedic System-HipMako Surgical Corp. · 2009
- 7 generations backK093425 Mako Surgical Corp Robotic Arm Interactive Orthopedic System-ThaMako Surgical Corp. · 2010 · Recalled
- 6 generations backK121064 Makoplasty Total Hip Application, Rio Standard SystemMako Surgical Corporation · 2012 · Recalled
- 5 generations backK141989 Makoplasty Total Hip Allpication, Rio Standard SystemMako Surgical Corporation · 2014 · Recalled
- 4 generations backK170593 Mako Total Hip ApplicationMako Surgical Corp. · 2017 · Recalled
- 3 generations backK191998 Mako Total Hip Application, Mako Total Knee ApplicationMako Surgical Corp. · 2019
- 2 generations backK193128 Mako Total Hip ApplicationMako Surgical Corp. · 2020
- 1 generation backK243751 Mako Total Hip Application 5.0Mako Surgical Corp. · 2025
- This deviceK252847 NextAR Hip PlatformMedacta International S.A. · 2026
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K905070 | Vistar | Philips Medical Systems (Cleveland), Inc. | 1991 | — |
| −16 | K961168 | Viewpoint | Philips Medical Systems (Cleveland), Inc. | 1996 | — |
| −15 | K963221 | Optical Digitizer Option for View Point | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −14 | K970604 | Viewpoint - 3.0 Software | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −13 | K984298 | Z Kat Flurotactic Guidance System Mki | Z-Kat, Inc. | 1999 | — |
| −12 | K013025 | Modification to Flourolab Plus | Z-Kat, Inc. | 2001 | — |
| −11 | K031337 | Acumen Surgical Navigation System | Biomet, Inc. | 2003 | — |
| −10 | K072806 | Mako Surgical Tactile Guidance System (TGS) | Mako Surgical Corp. | 2008 | 1 |
| −9 | K081867 | Mako Surgical Tactile Guidance System Version 2.0 | Mako Surgical Corp. | 2008 | 2 |
| −8 | K091998 | Robotic Arm Interactive Orthopedic System-Hip | Mako Surgical Corp. | 2009 | — |
| −7 | K093425 | Mako Surgical Corp Robotic Arm Interactive Orthopedic System-Tha | Mako Surgical Corp. | 2010 | 2 |
| −6 | K121064 | Makoplasty Total Hip Application, Rio Standard System | Mako Surgical Corporation | 2012 | 12 |
| −5 | K141989 | Makoplasty Total Hip Allpication, Rio Standard System | Mako Surgical Corporation | 2014 | 3 |
| −4 | K170593 | Mako Total Hip Application | Mako Surgical Corp. | 2017 | 1 |
| −3 | K191998 | Mako Total Hip Application, Mako Total Knee Application | Mako Surgical Corp. | 2019 | — |
| −2 | K193128 | Mako Total Hip Application | Mako Surgical Corp. | 2020 | — |
| −1 | K243751 | Mako Total Hip Application 5.0 | Mako Surgical Corp. | 2025 | — |
| 0 (this device) | K252847 | NextAR Hip Platform | Medacta International S.A. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 2 | 0 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 3 | 0 |
| 1993 | 5 | 0 |
| 1994 | 8 | 0 |
| 1995 | 7 | 0 |
| 1996 | 11 | 0 |
| 1997 | 8 | 0 |
| 1998 | 8 | 0 |
| 1999 | 11 | 0 |
| 2000 | 12 | 0 |
| 2001 | 15 | 0 |
| 2002 | 17 | 0 |
| 2003 | 12 | 0 |
| 2004 | 10 | 0 |
| 2005 | 11 | 0 |
| 2006 | 13 | 0 |
| 2007 | 8 | 0 |
| 2008 | 4 | 0 |
| 2009 | 6 | 0 |
| 2010 | 4 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 4 | 1 |
| 2016 | 2 | 1 |
| 2017 | 8 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 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? (5)
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 |
|---|---|---|---|
| * | K243751 | Mako Total Hip Application 5.0Summary page 5…II III. Predicate Device Substantial equivalence is claimed to the following predicate devices. Primary Predicate device: • Mako Total Hip Application, K243751, Mako Surgical Corp. Additional Predicate devices: • Intellijoint® Navigation System, K191507, Intellijoint Sur… | 2025 |
| * | K191507 | Intellijoint® Navigation SystemSummary page 5…ry Predicate device: • Mako Total Hip Application, K243751, Mako Surgical Corp. Additional Predicate devices: • Intellijoint® Navigation System, K191507, Intellijoint Surgical Inc. • NextAR RSA Platform, K210153, Medacta International SA • NextAR™ Spine Platform… | 2019 |
| * | K210153 | NextAR RSA PlatformSummary page 5…ko Surgical Corp. Additional Predicate devices: • Intellijoint® Navigation System, K191507, Intellijoint Surgical Inc. • NextAR RSA Platform, K210153, Medacta International SA • NextAR™ Spine Platform, K210859, Medacta International SA • NextAR TKA Platform,… | 2021 |
| * | K210859 | NextAR™ Spine PlatformSummary page 5…tellijoint® Navigation System, K191507, Intellijoint Surgical Inc. • NextAR RSA Platform, K210153, Medacta International SA • NextAR™ Spine Platform, K210859, Medacta International SA • NextAR TKA Platform, K193559, Medacta International SA Reference device:… | 2021 |
| * | K193559 | NextAR TKA PlatformSummary page 5…• NextAR RSA Platform, K210153, Medacta International SA • NextAR™ Spine Platform, K210859, Medacta International SA • NextAR TKA Platform, K193559, Medacta International SA Reference device: • NextARTM Spine, K250477, Medacta International SA… | 2020 |
| † | K250477 | NextAR (TM) Spine | 2025 |
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 35 years and passes through 6 companies; a new generation was cleared every 2.1 years on median.
- 77 of the 227 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. 2026, 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?
NextAR Hip is intended to support the surgeon during Total Hip Arthroplasty (THA) procedures by providing navigational information during bone preparation and positioning of acetabular cup components in skeletally mature individuals during supine or lateral approaches. NextAR Hip is indicated for use with Medacta hip prosthesis as described in the implants’ instruction for use. NextAR Hip provides stereotaxic guidance in reference to a patient’s rigid…
Read the full statement (121 words)
NextAR Hip is intended to support the surgeon during Total Hip Arthroplasty (THA) procedures by providing navigational information during bone preparation and positioning of acetabular cup components in skeletally mature individuals during supine or lateral approaches.
NextAR Hip is indicated for use with Medacta hip prosthesis as described in the implants’ instruction for use. NextAR Hip provides stereotaxic guidance in reference to a patient’s rigid anatomy as registered in CT based or imageless workflows.
As an optional display, the smart glasses can be used auxiliary to the NextAR Hip to view the same information as presented by the NextAR Hip. NextAR 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/K252847 · printed Nov 4, 2026
Cite this page
510(k) Report. “K252847: NextAR Hip Platform.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K252847
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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