# K122850: Talos-C Cervical Intervertebral Body Fusion Devices

- Pathway: 510(k) (Traditional)
- Applicant: Meditech Advisors, LLC
- Decided: Mar 28, 2013 after 191 days
- Product code: ODP (Intervertebral Fusion Device With Bone Graft, 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
No predicates in its family tree.
240 later devices descend from it; 2 cite it directly.
0 of 241 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K142345: Talos-C (HA) Cervical Intervertebral Body Fusion Devices (2015), 239 descendants of its own
- K150788: Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion Devices, Talos -C (HA) Cervical Intervertebral Body Fusion Devices (2015), 202 descendants of its own
- K160924: Amendia Interbody Fusion Devices (2016), 166 descendants of its own
- K171496: Tritanium C Anterior Cervical Cage (2017), 129 descendants of its own
- K180364: HD LifeSciences Cervical IBFD System (2018), 106 descendants of its own

## Indications for use
The Tabos®-C Cervical Intervertebral Body Fusion Device is an intervertebral body device intended for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the cervical spine at one level from C2-T1. Cervical degenerative disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on the posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by history and radiographic studies. Tabos®-C Cervical IBE Devices are intended to be used with autologous bone graft to facilitate fusion. Non-operative treatment prior to treatment with Tabos®-C Cervical Intervertebral Body Fusion Devices is six (6) weeks. Tabos®-C Cervical IBE Devices are to be implanted via an open anterior approach. Tabos®-C Cervical IBF Devices are also to be used with supplemental fixation.

Source page: https://510kreport.com/device/K122850
Methodology: https://510kreport.com/methodology