# 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 - Pathway: 510(k) (Traditional) - Applicant: Medtronic Sofamor Danek USA, Inc. - Decided: Jan 22, 2020 after 132 days - Product code: MAX (Intervertebral Fusion Device With Bone Graft, Lumbar) - Device class: 2 - Regulation: 21 CFR 888.3080 - Recalls of this device: none - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 25 generations back to K841189 (1984). 545 ancestors in all. 4 later devices descend from it; 3 cite it directly. 1 of 550 devices in its family (counting itself) has a Class I recall. ## Predicates on the family tree (from the FDA summary) - K190959: ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with TiONIC Technology, Medtronic Sofamor Danek USA, Inc. (2019) Summary page 4. - K192018: Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic Interbody Fusion Device, Endoskeleton TO Interbody Fusion Device, Endoskeleton TT Interbody Fusion Device, Endoskeleton TC Interbody Fusion Device, Endoskeleton TCS Interbody Fusion Device, Endoskeleton TL Interbody Fusion Device, Titan Spine, Inc. (2019) Summary page 5. - K112444: Anatomic Peek Cervical Fusion System, Medtronic Sofamor Danck USA, Inc. (2011) Summary page 5. - K122037: Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System Peek Prevail Cervical Interbody Device Capst, Medtronic Sofamor Danek, Inc. (2013) Summary page 5. - K130177: Anatomic Peek Cervical Fusion System, Medtronic Sofamor Danek USA, Inc. (2013) Summary page 5. - K133653: Anatomic Peek PTC Cervical Fusion System, Medtronic Sofamor Danek USA, Inc. (2014) Summary page 5. - K160528: ANATOMIC PEEK PTC Cervical Fusion System, Medtronic Sofamor Danek USA, Inc. (2016) Summary page 5. - K073291: Capstone Spinal System, Medtronic Sofamor Danek USA, Inc. (2008) Summary page 5. - K103731: Capstone R Spinal System, Medtronic Sofamor Danek (2011) Summary page 5. - K121760: Capstone Spinal System, Medtronic Sofamor Danek USA, Inc. (2012) Summary page 5. - K123978: Capstone L Spinal System, Medtronic Sofamor Danek USA (2013) Summary page 5. - K133650: Capstone Spinal System, Medtronic Sofamor Danek USA, Inc. (2013) Summary page 5. - K151128: CAPSTONE Spinal System, CLYDESDALE Spinal System, Medtronic Sofamor Danek USA, Inc. (2015) Summary page 5. - K120368: Capstone Control Spinal System, Medtronic Sofamor Danek USA, Inc. (2012) Summary page 5. - K171107: CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal System, Medtronic Sofamor Danek USA, Inc. (2017) Summary page 5. - K190165: Capstone Control™ Spinal System, Medtronic Sofamor Danek USA, Inc. (2019) Summary page 5. - K133205: Capstone PTC Spinal System, Clydesdale PTC Spinal System, Medtronic Sofamor Danek USA, Inc. (2014) Summary page 5. - K172199: ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium, Medtronic Sofamor Danek (2017) Summary page 5. - K083026: Clydesdale Spinal System, Medtronic Sofamor Danek (2008) Summary page 5. - K100175: Clydesdale Spinal System, Medtronic Sofamor Danek (2010) Summary page 5. - K112405: Clydesdales Spinal System, Medtronic Sofamor Danek USA, Inc. (2011) Summary page 5. - K113528: Clydesdale (R) Spinal System, Medtronic Sofamor Danek USA, Inc. (2011) Summary page 5. - K132897: Clydesdale Spinal System, Medtronic Sofamor Danek, Inc. (2013) Summary page 5. - K100214: Cornerstone PSR Cervical Interbody Fusion Device, Medtronic Sofamor Danek (2010) Summary page 5. - K111264: Cornerstone (R) PSR Cervical Fusion System, Medtronic Sofamor Danek USA (2011) Summary page 5. - K153373: CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical Interbody Device, Medtronic Sofamor Danek (2016) Summary page 5. - K171031: CRESCENT™ Spinal System, Medtronic Sofamor Danek (2017) Summary page 5. - K133216: Crescent Spinal System, Medtronic Sofamor Danek, Inc. (2013) Summary page 5. - K094025: Crescent Spinal System, Medtronic Sofamor Danek (2010) Summary page 5. - K110543: Crescent (R) Spinal System Titanium, Medtronic Sofamor Danek USA, Inc. (2011) Summary page 5. - K162212: Divergence-L Anterior/Oblique Lumbar Fusion System, Medtronic Sofamor Danek USA, Inc. (2017) Summary page 5. - K150135: DIVERGENCE-L Anterior/Oblique Lumbar Fusion System, Medtronic Sofamor Danek USA, Inc. (2015) Summary page 5. - K142450: DIVERGENCE Anterior Cervical Fusion System, Medtronic Sofamor Danek USA, Inc. (2014) Summary page 5. - K141599: Divergence Anterior Cervical Fusion System, Medtronic Sofamor Danek USA, Inc. (2015) Summary page 5. - K182885: Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion System, Premier™ Anterior Cervical Plate, Venture™ Anterior Cervical Plate, Zephir™ Anterior Cervical Plate System and Zevo™ Anterior Cervical Plate System, Medtronic Sofamor Danek USA, Inc. (2019) Summary page 5. - K142559: ELEVATE Spinal System, Medtronic Sofamor Danek USA, Inc. (2015) Summary page 5. - K090353: Perimeter Interbody Fusion Device, Medtronic Sofamor Danek (2009) Summary page 5. - K113642: Perimeter Interbody Fusion Device, Medtronic Sofamor Danek USA (2012) Summary page 5. - K131669: Perimeter Interbody Fusion Device, Medtronic Sofamor Danek USA, Inc. (2013) Summary page 5. - K132700: Perimeter Interbody Fusion Device, Medtronic Sofamor Danek, Inc. (2013) Summary page 5. - K133645: Perimeter C Spinal System, Capstone Spinal System, Capstone L Spinal System, Perimeter Spinal System, Medtronic Sofamor Danek USA, Inc. (2014) Summary page 5. - K160418: PERIMETER Interbody Fusion Device, Medtronic Sofamor Danek USA, Inc. (2016) Summary page 5. - K152277: PIVOX (tm) Oblique Lateral Spinal System, Medtronic Sofamor Danek USA, Inc. (2015) Summary page 6. - K091813: Intrepid Spinal System, Medtronic Sofamor Danek (2009) Summary page 6. - K121982: Sovereign Spinal System, Medtronic Sofamor Danek (2012) Summary page 6. - K162680: SOVEREIGN® Spinal System, Medtronic Sofamor Danek USA, Inc. (2016) Summary page 6. - K172328: SOVEREIGN™ Spinal System, Medtronic Sofamor Danek USA, Inc. (2017) Summary page 6. - K173125: T2 STRATOSPHERE™ Expandable Corpectomy System, Medtronic Sofamor Danek (2017) Summary page 6. - K181328: T2 STRATOSPHERE™ Expandable Corpectomy System, Medtronic Sofamor Danek USA, Inc. (2018) Summary page 6. - K183510: T2 STRATOSPHERE Expandable Corpectomy System, Medtronic Sofamor Danek USA, Inc. (2019) Summary page 6. ## Most influential descendants - K241164: IB3D™ PL Spinal System (2024), 1 descendant of its own - K253577: IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter) (2025), 0 descendants of its own - K251431: FIX-C PEEK ACIF SA System (2025), 0 descendants of its own - K230936: Anatomic PEEK™ Cervical Fusion System with Nanotechnology (2023), 0 descendants of its own ## Indications for use 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. Source page: https://510kreport.com/device/K192502 Methodology: https://510kreport.com/methodology