# K170395: Talos® Lumbar (HA) PEEK IBF Devices

- Pathway: 510(k) (Traditional)
- Applicant: Meditech Spine, LLC
- Decided: Jun 2, 2017 after 114 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
Longest line of descent: 18 generations back to K841189 (1984). 143 ancestors in all.
10 later devices descend from it; 3 cite it directly.
0 of 154 devices in its family (counting itself) have 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.
- K090707: Talos Intervertebral Body Fusion Device, Meditech Advisors, LLC (2009) Summary page 4.

## Most influential descendants
- K181589: Curiteva Lumbar Interbody Fusion System (2018), 6 descendants of its own
- K233744: Curiteva Porous PEEK Lumbar Interbody Fusion System (2024), 2 descendants of its own
- K250845: Curiteva Porous PEEK Standalone ALIF System (2025), 1 descendant of its own
- K212075: ShurFit Lumbar Interbody System (2021), 1 descendant of its own
- K180891: EVOL Spinal Interbody System, EVOS Lumbar Interbody System (2018), 1 descendant of its own

## Indications for use
The Talos® Lumbar (HA) PEEK 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. Talos® Lumbar (HA) PEEK IBF devices are intended to be used with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft. The Talos® Lumbar (HA) PEEK IBF Device is to be used in patients who have had six months of non-operative treatment. Talos® Lumbar (HA) PEEK IBF devices are to be implanted via a direct posterior, transforaminal, lateral, anterior or anteriolateral approach in the lumbosacral spine. The Talos®-P (HA), Talos®-P WB (HA), Talos®-TL (HA), Talos®-T (HA), Talos®-L (HA), and Talos®-A (HA) are intended to be used with supplemental fixation. Additionally, the use of Hyperlordotic Talos®-A (HA) devices (lordotic angle greater than 20°) are intended to be used exclusively with anterior supplemental fixation.

Source page: https://510kreport.com/device/K170395
Methodology: https://510kreport.com/methodology