# K201506: Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical Intervertebral Body Fusion System

- Pathway: 510(k) (Special)
- Applicant: Meditech Spine, LLC
- Decided: Sep 11, 2020 after 98 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
Longest line of descent: 18 generations back to K841189 (1984). 230 ancestors in all.
No later device cites it as a predicate yet.
1 of 231 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150788: Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion Devices, Talos -C (HA) Cervical Intervertebral Body Fusion Devices, Meditech Spine, LLC (2015) Summary page 4.
- K173347: STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX, ACTILIF M FLX, ACTILIF L FLX and ACTILIF Lateral-Oblique FLX, Centinel Spine, Inc. (2018) Summary page 4.
- K163491: NuVasive CoRoent Small Interbody System, Nu Vasive, Incorporated (2017) Summary page 4.

## Indications for use
Talos®-C Cervical Intervertebral Body Fusion Devices The Talos®-C Cervical Intervertebral Body Fusion Devices are indicated for intervertebral body fusion of the spine in skeletally mature patients. The Talos®-C Cervical Intervertebral Body Fusion Devices are intended for use for anterior cervical interbody fusion in patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 - T1. The Talos®-C Cervical Intervertebral Body Fusion Devices are intended to be used with supplemental fixation. The Talos®-C Cervical Intervertebral Body Fusion Devices are designed for use with autogenous and/or allogeneic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft to facilitate fusion. Non-operative treatment prior to treatment with Talos®-C Cervical Intervertebral Body Fusion Devices is six (6) weeks. Talos®-C Cervical IBF Devices are to be implemented via an open anterior approach approach. Talos®-C Cervical IBF Devices are also to be used with supplemental fixation. Additionally, the use of Hyperlordotic devices (lordotic angle greater than 7°) are intended to be used exclusively with anterior supplemental fixation. Talos®-C(HA) Cervical Intervertebral Body Fusion Devices The Talos®-C(HA) Cervical Intervertebral Body Fusion Devices are indicated for intervertebral body fusion of the spine in skeletally mature patients. The Talos®-C (HA) Cervical Intervertebral Body Fusion Devices are intended for use for anterior cervical interbody fusion in patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 - T1. The Talos®-C (HA) Cervical Intervertebral Body Fusion Devices are intended to be used with supplemental fixation. The Talos®-C (HA) Cervical Intervertebral Body Fusion Devices are designed for use with autogenous and/or allogeneic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft to facilitate fusion. Non-operative treatment prior to treatment with Talos®-C (HA) Cervical Intervertebral Body Fusion Devices is six (6) weeks. Talos®-C(HA) Cervical IBF Devices are to be implemented via an open anterior approach approach. Talos®-C (HA) Cervical IBF Devices are also to be used with supplemental fixation. Additionally, the use of Hyperlordotic devices (lordotic angle greater than 7°) are intended to be used exclusively with anterior supplemental fixation.

Source page: https://510kreport.com/device/K201506
Methodology: https://510kreport.com/methodology