# K150788: Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion Devices, Talos -C (HA) Cervical Intervertebral Body Fusion Devices - Pathway: 510(k) (Traditional) - Applicant: Meditech Spine, LLC - Decided: Oct 14, 2015 after 203 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: 17 generations back to K841189 (1984). 142 ancestors in all. 202 later devices descend from it; 4 cite it directly. 0 of 345 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K142152: Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand Alone System, Orthofix, Inc. (2015) Summary page 5. - K143163: AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer, AVS® Navigator PEEK Spacer, AVS® ARIA PEEK Spacer, AccuLIF TL and PL Cage, AVS® Anchor-L Spacer, Aero-AL Lumbar Cage System, Stryker Corporation (2015) Summary page 5. - K090707: Talos Intervertebral Body Fusion Device, Meditech Advisors, LLC (2009) Summary page 5. - K122850: Talos-C Cervical Intervertebral Body Fusion Devices, Meditech Advisors, LLC (2013) Summary page 5. - K142345: Talos-C (HA) Cervical Intervertebral Body Fusion Devices, Meditech Spine, LLC (2015) Summary page 5. ## Most influential descendants - 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 - K192018: Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic 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 (2019), 102 descendants of its own ## Indications for use Talos® Intervertebral Body Fusion Devices: The Talos® 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® IBF Devices are intended to be used with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft. The Talos® IBF Device is to be used in patients who have had six months of non-operative treatment. Talos® IBF devices are to be implanted via a direct posterior, transforaminal, lateral, or anterior approach in the lumbosacral spine. The Talos®-A, Talos®-L, Talos®-P and Talos®-T are intended to be used with supplemental fixation. Talos®-C Cervical Intervertebral Body Fusion Devices: The Talos®-C Cervical Intervertebral Body Fusion Device is an intervertebral body device intended for use in skeletally mature patients with Degenerative Disc (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. Talos®-C Cervical IBF Devices are intended to be used with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft. 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 implanted via an open anterior approach. Talos®-C Cervical IBF Devices are also to be used with supplemental fixation. Talos®-C (HA) Cervical Intervertebral Body Fusion Devices: Talos®-C (HA) Cervical Intervertebral Body Fusion Devices are intervertebral body devices 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. Talos®-C (HA) Cervical IBF Devices are intended to be used with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft. 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 implanted via an open anterior approach. Talos®-C (HA) Cervical IBF Devices are also to be used with supplemental fixation. Source page: https://510kreport.com/device/K150788 Methodology: https://510kreport.com/methodology