# K090707: Talos Intervertebral Body Fusion Device

- Pathway: 510(k) (Traditional)
- Applicant: Meditech Advisors, LLC
- Decided: Jul 15, 2009 after 120 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, Lumbar)
- 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.
281 later devices descend from it; 5 cite it directly.
0 of 282 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- 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
- K183557: Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TO Interbody Fusion Device, Endoskeleton® TT Interbody Fusion Device, Endoskeleton® TC Interbody Fusion Device, Endoskeleton® TCS Interbody Fusion Device, Endoskeleton® TL Interbody Fusion Device, Endoskeleton® TA Vertebral Body Replacement (VBR) Device (2019), 104 descendants of its own

## Indications for use
The TalosTM IBF Device is an intervertebral body device intended for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the lumbar spine with up to Grade 1 spondylolisthesis at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. TalosTM IBF devices are intended to be used with autologous bone graft to facilitate fusion. The TalosTM IBF device is to be used in patients who have had six months of non-operative treatment. Talos TM IBF devices are to be implanted via a direct posterior, transforaminal, lateral or anterior approach. The TalosTM-P device is implanted in pairs, and the TalosTM-A, TalosTM-L and TalosTM-T devices may be implanted singly or in pairs in the lumbosacral spine. The TalosTM-A, TalosTM-L, TalosTM-P, and TalosTM-T are intended to be used with supplemental fixation.

Source page: https://510kreport.com/device/K090707
Methodology: https://510kreport.com/methodology