# K122771: Spinal Elements Cervical Intervertebral Body Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Spinal Elements, Inc.
- Decided: Jan 10, 2013 after 122 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: 2 generations back to K072991 (2008). 3 ancestors in all.
147 later devices descend from it; 3 cite it directly.
0 of 151 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071833: Mosaic Devices, Spinal Elements, Inc. (2007) Summary page 2.
- K083389: Coalition Spacer, Globus Medical, Inc. (2009) Summary page 2.

## Most influential descendants
- K133218: Crystal ®; Mosaic ®; Vertu ® (2014), 130 descendants of its own
- K181837: Spinal Elements Ti-Bond coated devices (2018), 98 descendants of its own
- K190546: NEXXT MATRIXX Stand Alone Cervical System (2019), 93 descendants of its own
- K200543: NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) System (2020), 72 descendants of its own
- K202812: IdentiTi Cervical Standalone Interbody System (2020), 67 descendants of its own

## Indications for use
The Spinal Elements Cervical Intervertebral Body Fusion System is a stand-alone interbody fusion device intended for spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autogenous bone. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with these devices. The implant is designed to accommodate two screws. Two screws should be used to ensure adequate fixation of the implant.

Source page: https://510kreport.com/device/K122771
Methodology: https://510kreport.com/methodology