# K142589: Endoskeleton TA IBD and VBR, Endoskeleton TO and TT, Endoskeleton TAS, Endoskeleton TAS, Endoskeleton TC, Endoskeleton TL

- Pathway: 510(k) (Special)
- Applicant: Titan Spine, LLC
- Decided: Oct 17, 2014 after 32 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: 13 generations back to K003155 (2001). 68 ancestors in all.
106 later devices descend from it; 2 cite it directly.
0 of 175 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080615: Endoskeleton TA Interbody Fusion Device (Ibd), Titan Spine, LLC (2008) Summary page 8.
- K083714: Endoskeleton TT Interbody Fusion Device (Ibd), Titan Spine, LLC (2009) Summary page 8.
- K102067: Endoskeleton to, Titan Spine, LLC (2010) Summary page 8.
- K100889: Endoskeleton TC, Titan Spine, LLC (2010) Summary page 8.
- K140055: Endoskeleton (R) TL Interbody Fusion Device, Titan Spine, LLC (2014) Summary page 8.
- K032812: Endoskeleton TA Vertebral Body Replacement, Orthovita, Inc. (2003) Summary page 8.

## Cited in the summary but kept off the family tree
- K111626: Endoskeleton (R) Tas, Titan Spine, LLC (2011). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K173535: Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody Fusion Device and Endoskeleton® TCS Interbody Fusion Device (2018), 105 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
- K191581: Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion Device (2020), 81 descendants of its own
- K201267: Adaptix Interbody System with Titan nanoLOCK Surface Technology (2020), 79 descendants of its own

## Indications for use
The ENDOSKELETON® TA Interbody Fusion Device is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the device. The device may be used with supplemental fixation. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be used with autograft bone. The Endoskeleton® TAS Interbody Fusion Device is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device is a standalone system intended to be used with the bone screws provided and requires no additional supplementary fixation. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be used with autograft bone. The Endoskeleton® TO IBD is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device must be used with supplemental fixation. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be used with autograft bone. The Endoskeleton® TT IBD is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device must be used with supplemental fixation. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be used with autograft bone. The Endoskeleton® TC is indicated for use for anterior cervical interbody fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level from C-3 to C-7. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. Patients should have received 6 weeks of non-operative treatment prior to treatment with the device. The Endoskeleton® TC is indicated to be used with supplemental fixation and autograft bone. The Endoskeleton® TL IBD is indicated for use in spinal fusion procedures in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. This device is intended for use with supplemental fixation systems cleared for use in the lumbar spine. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Patients with non-fusion spinal surgery at the involved level(s) may be treated with the device. It is indicated to be used with autograft bone. The ENDOSKELETON® TA VBR is for use in the thoracolumbar spine (T1 – L5) to replace all or part of a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). The ENDOSKELETON® TA VBR is intended for use with supplemental internal spinal fixation systems. The ENDOSKELETON® TA VBR may be used with bone graft material or bone graft substitute.

Source page: https://510kreport.com/device/K142589
Methodology: https://510kreport.com/methodology