# K141599: Divergence Anterior Cervical Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek USA, Inc.
- Decided: Jan 21, 2015 after 222 days
- Product code: OVE (Intervertebral Fusion Device With Integrated Fixation, Cervical)
- 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: 14 generations back to K003155 (2001). 105 ancestors in all.
16 later devices descend from it; 3 cite it directly.
0 of 122 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113252: Peek Prevail Cervical Interbody Device, Medtronic Sofamor Danek (2012) Summary page 4.
- K094042: Peek Prevail Cervical Interbody Device, Medtronic Sofamor Danek (2010) Summary page 7.
- K111264: Cornerstone (R) PSR Cervical Fusion System, Medtronic Sofamor Danek USA (2011) Summary page 4.
- K100214: Cornerstone PSR Cervical Interbody Fusion Device, Medtronic Sofamor Danek (2010) Summary page 4.
- P000028: Affinity (TM) Cage System, Medtronic Sofamor Danek USA, Inc. (2002) Summary page 4.
- K030327: Zephir Anterior Cervical System, Medtronic Sofamor Danek (2003) Summary page 4.
- K130640: Atlantis Anterior Cervical Plate System, Medtronic Sofamor Danek USA, Inc. (2013) Summary page 5.

## Most influential descendants
- 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 (2019), 8 descendants of its own
- K212358: Romero Cervical Cage (2022), 6 descendants of its own
- K240893: ARTFX MEDICAL Cervical PEEK Cages (2024), 4 descendants of its own
- 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

## Indications for use
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 the C2-C3 disc to the C7-T1 disc. 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 non-operative treatment. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.

Source page: https://510kreport.com/device/K141599
Methodology: https://510kreport.com/methodology