510(k) · Cleared
ClearedAnatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System, Capstone™ Spinal System, Capstone PTC™ Spinal System, Capstone Control™ Spinal System, Capstone Control PTC™ Spinal System, Clydesdale™ Spinal System, Clydesdale PTC™ Spinal System, Cornerstone™ PSR Cervical Fusion System, Crescent™ Spinal System, Crescent™ Spinal System Titanium, Divergence™ Anterior Cervical Fusion System (For Stand-Alone Interbody Device Only), Divergence-L™ Anterior/Oblique Lumbar Fus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Sofamor Danek USA, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Jan 22, 2020 as substantially equivalent to K190959 (Medtronic Sofamor Danek USA, Inc., 2019) and 49 other predicates after a 132-day review. Its family tree reaches back 25 generations to 1984. 1 of the 550 devices in its family, counting itself, has a Class I recall. 4 later devices descend from it.
- Decided
- Jan 22, 2020
- Review
- 132 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 50
Its longest line of descent runs back 25 generations to K841189 (1984). 545 ancestors in all, the oldest K792352 (1979). 4 later devices descend from it, 3 citing it directly. 1 of the 550 devices in this family, counting this one, has a Class I recall.
- Root · 25 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 21 generations between
- 3 generations backK180364 HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC · 2018
- 2 generations backK183557 Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS…Titan Spine, Inc. · 2019 · Recalled
- 1 generation backK192018 Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS…Titan Spine, Inc. · 2019 · Recalled
- This deviceK192502 Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical…Medtronic Sofamor Danek USA, Inc. · 2020
- Descendant · cites it directly · 1 of its ownK241164 IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic) · 2024 · Recalled
- Descendant · 2 generations on · 0 of its ownK253577 IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic) · 2025
- Descendant · cites it directly · 0 of its ownK251431 FIX-C PEEK ACIF SA SystemJeil Medical Corporation · 2025
- Descendant · cites it directly · 0 of its ownK230936 Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC · 2023
Show all 25 generations
- Root · 25 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 24 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 23 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 22 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 21 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 20 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 19 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 18 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 17 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 16 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 15 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 14 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 13 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 12 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 11 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 10 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 9 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 8 generations backK143616 AccuLIF TL and PL CageStryker Corporation · 2015 · Recalled
- 7 generations backK152304 Tritanium PL CageStryker · 2015 · Recalled
- 6 generations backK160955 Tritanium® PL CageStryker · 2016
- 5 generations backK162262 Tritanium® PL CageStryker · 2016
- 4 generations backK171496 Tritanium C Anterior Cervical CageStryker Spine · 2017
- 3 generations backK180364 HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC · 2018
- 2 generations backK183557 Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS…Titan Spine, Inc. · 2019 · Recalled
- 1 generation backK192018 Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS…Titan Spine, Inc. · 2019 · Recalled
- This deviceK192502 Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical…Medtronic Sofamor Danek USA, Inc. · 2020
Class I recalls in this family
- K073202 Ardis Spacer5 generations back · 2008
Most influential descendants
Showing 4 of 4 · See all- K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic) · 2024 · cites it directly1descendant
- K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic) · 2025 · 2 generations on0descendants
- K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation · 2025 · cites it directly0descendants
- K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −25 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −24 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −23 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −22 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −21 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −20 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −19 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −18 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −17 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −16 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −15 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −14 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −13 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −12 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −11 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −10 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −9 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −8 | K143616 | AccuLIF TL and PL Cage | Stryker Corporation | 2015 | 4 |
| −7 | K152304 | Tritanium PL Cage | Stryker | 2015 | 1 |
| −6 | K160955 | Tritanium® PL Cage | Stryker | 2016 | — |
| −5 | K162262 | Tritanium® PL Cage | Stryker | 2016 | — |
| −4 | K171496 | Tritanium C Anterior Cervical Cage | Stryker Spine | 2017 | — |
| −3 | K180364 | HD LifeSciences Cervical IBFD System | Hd Lifesciences, LLC | 2018 | — |
| −2 | K183557 | Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion… | Titan Spine, Inc. | 2019 | 3 |
| −1 | K192018 | Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS… | Titan Spine, Inc. | 2019 | 4 |
| 0 (this device) | K192502 | Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion… | Medtronic Sofamor Danek USA, Inc. | 2020 | — |
| +1 | K241164 | IB3D™ PL Spinal System | Medicrea International S.A.S. (Medtronic) | 2024 | 2 |
| +2 | K253577 | IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter) | Medicrea International S.A.S. (Medtronic) | 2025 | — |
| +1 | K251431 | FIX-C PEEK ACIF SA System | Jeil Medical Corporation | 2025 | — |
| +1 | K230936 | Anatomic PEEK™ Cervical Fusion System with Nanotechnology | Nanovis, LLC | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 6 | 0 |
| 2000 | 5 | 0 |
| 2001 | 12 | 0 |
| 2002 | 15 | 0 |
| 2003 | 22 | 0 |
| 2004 | 42 | 0 |
| 2005 | 28 | 0 |
| 2006 | 19 | 0 |
| 2007 | 24 | 0 |
| 2008 | 51 | 1 |
| 2009 | 39 | 0 |
| 2010 | 29 | 0 |
| 2011 | 44 | 0 |
| 2012 | 31 | 0 |
| 2013 | 32 | 0 |
| 2014 | 34 | 0 |
| 2015 | 31 | 0 |
| 2016 | 22 | 0 |
| 2017 | 17 | 0 |
| 2018 | 2 | 0 |
| 2019 | 4 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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.
1 device in this family has 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 MAX device
- #1 K203714 NuVasive Thoracolumbar Interbody Systems…score 102.5 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (50)
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 |
|---|---|---|---|
| * | K190959 | ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Summary page 4…MAX; OVD; MQP; PLR; ODP; OVE Classificati on Code Predicate Primary Predicate: Devices ARTiC-L™ 3D and ARTiC-XL™ 3D Ti Spinal System with K190959 (S.E. 07/03/2019) TiONIC™ Technology Additional Predicate: Endoskeleton TA Inter… | 2019 |
| * | K192018 | Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Summary page 5…(S.E. 07/03/2019) TiONIC™ Technology Additional Predicate: Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS K192018 (S.E. 08/16/2019) and TAS Hyperlordotic Interbody Fusion Device, Endoskeleton TO Interbody Fusion Device, Endoskeleton TT Inter… | 2019 |
| * | K112444 | Anatomic Peek Cervical Fusion SystemSummary page 5…ndoskeleton TCS Interbody Fusion Device, Endoskeleton TL Interbody Fusion Device Additional Predicates: ANATOMIC PEEK™ Cervical Fusion System K112444 (S.E. 11/15/2011); K122037 (S.E. 03/22/2013);… | 2011 |
| * | K122037 | Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System Peek Prevail…Summary page 5…onal Predicates: ANATOMIC PEEK™ Cervical Fusion System K112444 (S.E. 11/15/2011); K122037 (S.E. 03/22/2013); K130177 (S.E. 09/23/2013) ANATOMIC PEEK™ PTC C… | 2013 |
| * | K130177 | Anatomic Peek Cervical Fusion SystemSummary page 5….E. 11/15/2011); K122037 (S.E. 03/22/2013); K130177 (S.E. 09/23/2013) ANATOMIC PEEK™ PTC Cervical Fusion Spinal System K133653 (S.E. 04/28/2014);… | 2013 |
| * | K133653 | Anatomic Peek PTC Cervical Fusion SystemSummary page 5…S.E. 03/22/2013); K130177 (S.E. 09/23/2013) ANATOMIC PEEK™ PTC Cervical Fusion Spinal System K133653 (S.E. 04/28/2014); K160528 (S.E. 03/28/2016) Capstone™ Spinal Sys… | 2014 |
| * | K160528 | ANATOMIC PEEK PTC Cervical Fusion SystemSummary page 5…S.E. 09/23/2013) ANATOMIC PEEK™ PTC Cervical Fusion Spinal System K133653 (S.E. 04/28/2014); K160528 (S.E. 03/28/2016) Capstone™ Spinal System K073291 (S.E. 04/24/2008);… | 2016 |
| * | K073291 | Capstone Spinal SystemSummary page 5…S.E. 04/28/2014); K160528 (S.E. 03/28/2016) Capstone™ Spinal System K073291 (S.E. 04/24/2008); K103731 (S.E. 07/18/2011);… | 2008 |
| * | K103731 | Capstone R Spinal SystemSummary page 5…S.E. 03/28/2016) Capstone™ Spinal System K073291 (S.E. 04/24/2008); K103731 (S.E. 07/18/2011); K121760 (S.E. 08/29/2012);… | 2011 |
| * | K121760 | Capstone Spinal SystemSummary page 5….E. 04/24/2008); K103731 (S.E. 07/18/2011); K121760 (S.E. 08/29/2012); K123978 (S.E. 04/09/2013);… | 2012 |
| * | K123978 | Capstone L Spinal SystemSummary page 5….E. 07/18/2011); K121760 (S.E. 08/29/2012); K123978 (S.E. 04/09/2013); K133650 (S.E. 12/20/2013);… | 2013 |
| * | K133650 | Capstone Spinal SystemSummary page 5….E. 08/29/2012); K123978 (S.E. 04/09/2013); K133650 (S.E. 12/20/2013); K151128 (S.E. 08/06/2015) Capstone Control™ Sp… | 2013 |
| * | K151128 | CAPSTONE Spinal System, CLYDESDALE Spinal SystemSummary page 5….E. 04/09/2013); K133650 (S.E. 12/20/2013); K151128 (S.E. 08/06/2015) Capstone Control™ Spinal System K120368 (S.E. 04/09/2012);… | 2015 |
| * | K120368 | Capstone Control Spinal SystemSummary page 5…S.E. 12/20/2013); K151128 (S.E. 08/06/2015) Capstone Control™ Spinal System K120368 (S.E. 04/09/2012); K171107 (S.E. 09/26/2017);… | 2012 |
| * | K171107 | CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal SystemSummary page 5…S.E. 08/06/2015) Capstone Control™ Spinal System K120368 (S.E. 04/09/2012); K171107 (S.E. 09/26/2017); K190165 (S.E. 05/06/2019) Capstone Control PTC… | 2017 |
| * | K190165 | Capstone Control™ Spinal SystemSummary page 5….E. 04/09/2012); K171107 (S.E. 09/26/2017); K190165 (S.E. 05/06/2019) Capstone Control PTC™ Spinal System K171107 (S.E. 09/26/2017) Capstone PTC™ Spinal… | 2019 |
| * | K133205 | Capstone PTC Spinal System, Clydesdale PTC Spinal SystemSummary page 5…(S.E. 05/06/2019) Capstone Control PTC™ Spinal System K171107 (S.E. 09/26/2017) Capstone PTC™ Spinal System K133205 (S.E. 03/12/2014); K172199 (S.E. 09/19/2017) Clydesdale™ Spinal S… | 2014 |
| * | K172199 | ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Summary page 5…S.E. 09/26/2017) Capstone PTC™ Spinal System K133205 (S.E. 03/12/2014); K172199 (S.E. 09/19/2017) Clydesdale™ Spinal System K083026 (S.E. 12/29/2008);… | 2017 |
| * | K083026 | Clydesdale Spinal SystemSummary page 5…S.E. 03/12/2014); K172199 (S.E. 09/19/2017) Clydesdale™ Spinal System K083026 (S.E. 12/29/2008); K100175 (S.E. 06/02/2010);… | 2008 |
| * | K100175 | Clydesdale Spinal SystemSummary page 5…S.E. 09/19/2017) Clydesdale™ Spinal System K083026 (S.E. 12/29/2008); K100175 (S.E. 06/02/2010); K112405 (S.E. 11/21/2011);… | 2010 |
| * | K112405 | Clydesdales Spinal SystemSummary page 5….E. 12/29/2008); K100175 (S.E. 06/02/2010); K112405 (S.E. 11/21/2011); K113528 (S.E. 12/20/2011);… | 2011 |
| * | K113528 | Clydesdale (R) Spinal SystemSummary page 5….E. 06/02/2010); K112405 (S.E. 11/21/2011); K113528 (S.E. 12/20/2011); K132897 (S.E. 12/11/2013);… | 2011 |
| * | K132897 | Clydesdale Spinal SystemSummary page 5….E. 11/21/2011); K113528 (S.E. 12/20/2011); K132897 (S.E. 12/11/2013); K151128 (S.E. 08/06/2015) Clydesdale PTC™ Spin… | 2013 |
| * | K100214 | Cornerstone PSR Cervical Interbody Fusion DeviceSummary page 5…(S.E. 08/06/2015) Clydesdale PTC™ Spinal System K133205 (S.E. 03/13/2014) Cornerstone™ PSR Cervical Fusion System K100214 (S.E. 06/25/2010); K111264 (S.E. 10/12/2011);… | 2010 |
| * | K111264 | Cornerstone (R) PSR Cervical Fusion SystemSummary page 5…S.E. 03/13/2014) Cornerstone™ PSR Cervical Fusion System K100214 (S.E. 06/25/2010); K111264 (S.E. 10/12/2011); K122037 (S.E. 03/22/2013);… | 2011 |
| * | K153373 | CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical…Summary page 5….E. 10/12/2011); K122037 (S.E. 03/22/2013); K153373 (S.E. 01/19/2016) Crescent™ Spinal System K172199 (S.E. 09/19/2017);… | 2016 |
| * | K171031 | CRESCENT™ Spinal SystemSummary page 5…S.E. 01/19/2016) Crescent™ Spinal System K172199 (S.E. 09/19/2017); K171031 (S.E. 07/06/2017); K133216 (S.E. 11/22/2013);… | 2017 |
| * | K133216 | Crescent Spinal SystemSummary page 5….E. 09/19/2017); K171031 (S.E. 07/06/2017); K133216 (S.E. 11/22/2013); K094025 (S.E. 04/26/2010) Crescent™ Spinal Sys… | 2013 |
| * | K094025 | Crescent Spinal SystemSummary page 5….E. 07/06/2017); K133216 (S.E. 11/22/2013); K094025 (S.E. 04/26/2010) Crescent™ Spinal System Titanium K172199 (S.E. 09/19/2017);… | 2010 |
| * | K110543 | Crescent (R) Spinal System TitaniumSummary page 5…S.E. 04/26/2010) Crescent™ Spinal System Titanium K172199 (S.E. 09/19/2017); K110543 (S.E. 08/09/2011) Divergence-L™ Anterior/Oblique Lumbar Fusion System K162212 (S.E. 05/19/2017);… | 2011 |
| * | K162212 | Divergence-L Anterior/Oblique Lumbar Fusion SystemSummary page 5…S.E. 09/19/2017); K110543 (S.E. 08/09/2011) Divergence-L™ Anterior/Oblique Lumbar Fusion System K162212 (S.E. 05/19/2017); K150135 (S.E. 06/11/2015) Divergence™ Anterior… | 2017 |
| * | K150135 | DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemSummary page 5…S.E. 08/09/2011) Divergence-L™ Anterior/Oblique Lumbar Fusion System K162212 (S.E. 05/19/2017); K150135 (S.E. 06/11/2015) Divergence™ Anterior Cervical Fusion System (For Stand- K142450 (S.E. 10/01/2014); Alone Interbody Devi… | 2015 |
| * | K142450 | DIVERGENCE Anterior Cervical Fusion SystemSummary page 5…S.E. 05/19/2017); K150135 (S.E. 06/11/2015) Divergence™ Anterior Cervical Fusion System (For Stand- K142450 (S.E. 10/01/2014); Alone Interbody Device Only) K141599 (S.E. 01/21/2015);… | 2014 |
| * | K141599 | Divergence Anterior Cervical Fusion SystemSummary page 5…S.E. 06/11/2015) Divergence™ Anterior Cervical Fusion System (For Stand- K142450 (S.E. 10/01/2014); Alone Interbody Device Only) K141599 (S.E. 01/21/2015); K182885 (S.E. 02/06/2019) Elevate™ Spinal Syst… | 2015 |
| * | K182885 | Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion System, Premier™…Summary page 5….E. 10/01/2014); Alone Interbody Device Only) K141599 (S.E. 01/21/2015); K182885 (S.E. 02/06/2019) Elevate™ Spinal System K142559 (S.E. 06/09/2015);… | 2019 |
| * | K142559 | ELEVATE Spinal SystemSummary page 5…S.E. 01/21/2015); K182885 (S.E. 02/06/2019) Elevate™ Spinal System K142559 (S.E. 06/09/2015); K172199 (S.E. 09/19/2017) Perimeter Interbody… | 2015 |
| * | K090353 | Perimeter Interbody Fusion DeviceSummary page 5…S.E. 06/09/2015); K172199 (S.E. 09/19/2017) Perimeter Interbody Fusion Device K090353 (S.E. 09/29/2009); K113642 (S.E. 02/06/2012);… | 2009 |
| * | K113642 | Perimeter Interbody Fusion DeviceSummary page 5…S.E. 09/19/2017) Perimeter Interbody Fusion Device K090353 (S.E. 09/29/2009); K113642 (S.E. 02/06/2012); K131669 (S.E. 11/01/2013);… | 2012 |
| * | K131669 | Perimeter Interbody Fusion DeviceSummary page 5….E. 09/29/2009); K113642 (S.E. 02/06/2012); K131669 (S.E. 11/01/2013); K132700 (S.E. 09/26/2013);… | 2013 |
| * | K132700 | Perimeter Interbody Fusion DeviceSummary page 5….E. 02/06/2012); K131669 (S.E. 11/01/2013); K132700 (S.E. 09/26/2013); K133645 (S.E. 01/03/2014);… | 2013 |
| * | K133645 | Perimeter C Spinal System, Capstone Spinal System, Capstone L Spinal System, Perimeter…Summary page 5….E. 11/01/2013); K132700 (S.E. 09/26/2013); K133645 (S.E. 01/03/2014); K160418 (S.E. 03/07/2016)… | 2014 |
| * | K160418 | PERIMETER Interbody Fusion DeviceSummary page 5….E. 09/26/2013); K133645 (S.E. 01/03/2014); K160418 (S.E. 03/07/2016) Pivox™ Oblique Lateral Spinal System K152277 (S.E… | 2016 |
| * | K152277 | PIVOX (tm) Oblique Lateral Spinal SystemSummary page 6…K160418 (S.E. 03/07/2016) Pivox™ Oblique Lateral Spinal System K152277 (S.E. 11/13/2015) Sovereign™ Spinal System K091813 (S.E. 11/17/2009);… | 2015 |
| * | K091813 | Intrepid Spinal SystemSummary page 6…Oblique Lateral Spinal System K152277 (S.E. 11/13/2015) Sovereign™ Spinal System K091813 (S.E. 11/17/2009); K121982 (S.E. 07/26/2012);… | 2009 |
| * | K121982 | Sovereign Spinal SystemSummary page 6…n™ Spinal System K091813 (S.E. 11/17/2009); K121982 (S.E. 07/26/2012); K162680 (S.E. 12/14/2016);… | 2012 |
| * | K162680 | SOVEREIGN® Spinal SystemSummary page 6…K121982 (S.E. 07/26/2012); K162680 (S.E. 12/14/2016); K172328 (S.E. 11/02/2017)… | 2016 |
| * | K172328 | SOVEREIGN™ Spinal SystemSummary page 6…K162680 (S.E. 12/14/2016); K172328 (S.E. 11/02/2017) T2 Stratosphere™ Expandable Corpectomy System (Cervical K173125 (S.E. 12/20/2017);… | 2017 |
| * | K173125 | T2 STRATOSPHERE™ Expandable Corpectomy SystemSummary page 6…K172328 (S.E. 11/02/2017) T2 Stratosphere™ Expandable Corpectomy System (Cervical K173125 (S.E. 12/20/2017); and Thoracolumbar) K181328 (S.E. 09/19/2018);… | 2017 |
| * | K181328 | T2 STRATOSPHERE™ Expandable Corpectomy SystemSummary page 6…osphere™ Expandable Corpectomy System (Cervical K173125 (S.E. 12/20/2017); and Thoracolumbar) K181328 (S.E. 09/19/2018); K183510 (S.E. 01/16/2019)… | 2018 |
| * | K183510 | T2 STRATOSPHERE Expandable Corpectomy SystemSummary page 6…acolumbar) K181328 (S.E. 09/19/2018); K183510 (S.E. 01/16/2019) These predicate devices have not been subject to a design related recall Description ANATOM… | 2019 |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 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.
- K073202Ardis SpacerAbbott Spine, Inc. · 2008 · 5 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 36 years and passes through 15 companies; a new generation was cleared every 9 months on median.
- 62 of the 545 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K241164 (Medicrea International S.A.S. (Medtronic), 2024) has gone furthest, with 1 descendant of its own.
- 6 other devices also cite its predicate K190959.
How does its category compare?
All MAX devicesMAX Intervertebral Fusion Device With Bone Graft, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · MAX
29in 2025
2007high 76 (2017) · low 7 (2007)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · MAX
85in 2025
2007high 137 (2010) · low 69 (2012)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MAX
5in 2025
2007high 11 (2012) · low 0 (2007)2026
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · MAX
811in 2025
2007high 811 (2025) · low 12 (2007)2025
MAUDE reports naming product code MAX, 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 | 7 | 86 | 0 | 12 |
| 2008 | 35 | 88 | 2 | 19 |
| 2009 | 31 | 102 | 9 | 90 |
| 2010 | 29 | 137 | 0 | 154 |
| 2011 | 49 | 98 | 3 | 201 |
| 2012 | 48 | 69 | 11 (1) | 327 |
| 2013 | 58 | 102 | 0 | 380 |
| 2014 | 58 | 115 | 3 | 366 |
| 2015 | 53 | 113 | 1 | 524 |
| 2016 | 64 | 124 | 6 | 647 |
| 2017 | 76 | 116 | 1 | 596 |
| 2018 | 64 | 114 | 4 | 616 |
| 2019 | 60 | 131 | 1 | 699 |
| 2020 | 56 | 106 | 0 | 640 |
| 2021 | 53 | 109 | 0 | 622 |
| 2022 | 41 | 95 | 1 | 618 |
| 2023 | 30 | 87 | 0 | 576 |
| 2024 | 38 | 91 | 1 | 729 |
| 2025 | 29 | 85 | 5 | 811 |
| 2026 | 18 | 95 | 0 | — |
What is it indicated for?
The document contains separate Indications for Use statements for 18 device configurations. They are provided on pages 22–42, including continuation pages 34 and 39.
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/K192502 · printed Nov 4, 2026
Cite this page
510(k) Report. “K192502: Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System, Capstone™ Spinal System, Capstone PTC™ Spinal System, Capstone Control™ Spinal System, Capstone Control PTC™ Spinal System, Clydesdale™ Spinal System, Clydesdale PTC™ Spinal System, Cornerstone™ PSR Cervical Fusion System, Crescent™ Spinal System, Crescent™ Spinal System Titanium, Divergence™ Anterior Cervical Fusion System (For Stand-Alone Interbody Device Only), Divergence-L™ Anterior/Oblique Lumbar Fus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K192502
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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