# 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 - Pathway: 510(k) (Traditional) - Applicant: Medtronic Sofamor Danek USA, Inc. - Decided: Feb 6, 2019 after 114 days - Product code: KWQ (Appliance, Fixation, Spinal Intervertebral Body) - Device class: 2 - Regulation: 21 CFR 888.3060 - Recalls of this device: none - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 16 generations back to K003155 (2001). 117 ancestors in all. 8 later devices descend from it; 2 cite it directly. 0 of 126 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K152623: ATLANTIS Anterior Cervical Plate System, Medtronic Sofamor Danek USA, Inc. (2015) Summary page 6. - K130640: Atlantis Anterior Cervical Plate System, Medtronic Sofamor Danek USA, Inc. (2013) Summary page 6. - K081038: Atlantis Anterior Cervical Plate System, Medtronic Sofamor Danek (2008) Summary page 6. - K063100: Atlantis Anterior Cervical Plate System, Translational Plate, Medtronic Sofamor Danek, Inc. (2007) Summary page 6. - K021461: Atlantis Vision Anterior Cervical Plate System, Medtronic Sofamor Danek (2002) Summary page 6. - K970806: Acpii Anterior Cervical Plate System, Sofamor Danek USA,Inc. (1997) Summary page 7. - K140417: Divergence Mini-Plate Anterior Cervical Fusion System, Medtronic Sofamor Danek, Inc. (2014) Summary page 7. - K141599: Divergence Anterior Cervical Fusion System, Medtronic Sofamor Danek USA, Inc. (2015) Summary page 7. - K021761: Premier Anterior Cervical Plate System, Medtronic Sofamor Danek (2002) Summary page 7. - K992110: Premier Anterior Cervical Plate System, Sofamor Danek USA (1999) Summary page 7. - K061274: Venture Anterior Cervical Plate System, Medtronic Sofamor Danek (2006) Summary page 7. - K042922: Venture Anterior Cervical Plating System, Medtronic Sofamor Danek, Inc. (2004) Summary page 7. - K030327: Zephir Anterior Cervical System, Medtronic Sofamor Danek (2003) Summary page 7. - K994239: Zephir Anterior Cervical Plate System, Medtronic Sofamor Danek, Inc. (2000) Summary page 7. - K141632: Zevo (TM) Anterior Cervical Plate System, Medtronic Sofamor Danek USA, Inc. (2014) Summary page 7. ## Most influential descendants - 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 (2020), 4 descendants of its own - K191584: FORTICO Anterior Cervical Fixation System (2019), 2 descendants of its own - 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 ## Indications for use Atlantis™ Anterior Cervical Plate System: Properly used, this system is intended for anterior interbody screw fixation from C2 to T1. The indications and contraindications of spinal instrumentation systems should be well understood by the surgeon. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) degenerative disc disease (DDD - as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) trauma (including fractures), 3) tumors, 4) deformity (defined as kyphosis, lordosis, or scoliosis), 5) pseudarthrosis, and/or 6) failed previous fusions. Nota bene: this device system is intended for anterior cervical intervertebral body fusions only. Warning: this device is not approved for screw attachment to posterior elements (pedicles) of the cervical, thoracic, or lumbar spine. Divergence™ Anterior Cervical Fusion System: The Divergence™ anterior cervical plate and bone screw components are intended for anterior interbody screw fixation from C2-T1. The indications and contraindications of spinal instrumentation systems should be well understood by the surgeon. Plate and bone screw components are indicated for use in the temporary stabilization of the anterior spine during the development of spinal fusions in patients with: 1) degenerative disc disease (DDD - as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); 2) trauma (including fractures); 3) tumors; 4) deformity (defined as kyphosis, lordosis, or scoliosis); 5) pseudoarthrosis; and/or 6) failed previous fusions. The Divergence™ anterior cervical cage component is intended to be used for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from C2-C3 to C7-T1. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. This cage is to be used in patients who have had six weeks of non operative treatment. The Divergence™ cage must be used with supplemental fixation. The Divergence™ cage is also required to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and is to be implanted via an open, anterior approach. When used together, the Divergence™ components can be used only to treat cervical disc disease. Divergence™ Anterior Cervical Fusion System (Stand-Alone Interbody) The Divergence™ Anterior Cervical Fusion System consists of a stand-alone interbody device indicated for use in anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from C2-C3 to C7-T1. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. The Divergence™ stand-alone cervical interbody device must be used with internal screw fixation. The Divergence™ stand-alone cervical interbody device is also required to be used with autogenous bone graft and is to be implanted via an open, anterior approach. This cervical device is to be used in patients who have had six weeks of nonoperative treatment. Patients with previous non-fusion spinal surgery at involved level may be treated with the device. Premier™ Anterior Cervical Plate System: Properly used, this system is intended for anterior interbody screw fixation of the cervical spine. The indications and contraindications of spinal instrumentation systems should be well understood by the surgeon. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) degenerative disc disease (DDD - as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) trauma (including fractures), 3) tumors, 4) deformity (defined as kyphosis, lordosis, or scoliosis), 5) pseudarthrosis, and/or 6) failed previous fusions. Nota bene: this device system is intended for anterior cervical intervertebral body fusions only. Warning: this device is not approved for screw attachment to posterior elements (pedicles) of the cervical, thoracic, or lumbar spine. Venture™ Anterior Cervical Plate System: Properly used, this system is intended for anterior interbody screw fixation of the cervical spine. The indications and contraindications of spinal instrumentation systems should be well understood by the surgeon. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) degenerative disc disease (DDD - as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) trauma (including fractures), 3) tumors, 4) deformity (defined as kyphosis, lordosis, or scoliosis), 5) pseudarthrosis, and/or 6) failed previous fusions. Nota bene: this device system is intended for anterior cervical intervertebral body fusions only. Zephir™ Anterior Cervical Plate System: Properly used, this system is intended for anterior interbody screw/plate fixation of the cervical spine. The indications and contraindications of spinal instrumentation systems should be well understood by the surgeon. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) degenerative disc disease (DDD - as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) trauma (including fractures), 3) tumors, 4) deformity (defined as kyphosis, lordosis, or scoliosis), 5) pseudarthrosis, and/or 6) failed previous fusions. Nota bene: this device system is intended for anterior cervical intervertebral body fusions only. Warning: this device is not approved for screw attachment to posterior elements (pedicles) of the cervical, thoracic, or lumbar spine. Zevo™ Anterior Cervical Plate System: The Zevo™ Anterior Cervical Plate System is intended for anterior interbody screw fixation from C2 to T1. The system is indicated for use in the temporary stabilization of the anterior spine during development of cervical spinal fusions in patients with: 1) degenerative disc disease (DDD - as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) trauma (including fractures), 3) tumors, 4) deformity (defined as kyphosis, lordosis, or scoliosis), 5) pseudarthrosis, and/or 6) failed previous fusions. Nota bene: this device system is intended for anterior cervical intervertebral body fusions only. Warning: this device is not approved for screw attachment to posterior elements (pedicles) of the cervical, thoracic, or lumbar spine. Source page: https://510kreport.com/device/K182885 Methodology: https://510kreport.com/methodology