# 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

- Pathway: 510(k) (Special)
- Applicant: Titan Spine, Inc.
- Decided: Feb 11, 2019 after 53 days
- Product code: ODP (Intervertebral Fusion Device With Bone Graft, Cervical)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 23 generations back to K841189 (1984). 388 ancestors in all.
104 later devices descend from it; 3 cite it directly.
1 of 493 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170676: HD Lumbar Interbody System, Hd Lifesciences, LLC (2017) Summary page 11.
- K180364: HD LifeSciences Cervical IBFD System, Hd Lifesciences, LLC (2018) Summary page 11.
- K172676: NuVasive® Modulus-C Interbody System, Nu Vasive, Incorporated (2017) Summary page 11.
- K171686: Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) System, Choicespine (2017) Summary page 12.
- K173535: Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody Fusion Device and Endoskeleton® TCS Interbody Fusion Device, Titan Spine, LLC (2018) Summary page 12.
- K170399: Endoskeleton TO Interbody Fusion Device (IBD), Titan Spine, LLC (2017) Summary page 12.
- K141953: Endoskeleton; TA Ibd and VBR, to and TT, Tas, TC, TL, Titan Spine, LLC (2014) Summary page 12.

## Most influential descendants
- 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
- K211258: Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA Interbody System, Endoskeleton TAS & TAS Hyp Interbody System, Endoskeleton TL Interbody System, Endoskeleton TL Hyp. Interbody System, Endoskeleton TO Interbody System, Endoskeleton TT Interbody System (2021), 75 descendants of its own
- K210425: Catalyft PL Expandable Interbody System (2021), 56 descendants of its own

## Recalls of this device
- Sep 2, 2021 · Class II · Z-0086-2022: Engraving on implants may not match what is listed on the pouch labels.
- Sep 2, 2021 · Class II · Z-0085-2022: Engraving on implants may not match what is listed on the pouch labels.
- Mar 17, 2021 · Class II · Z-1440-2021: The shelf box identifies a small device actually contains a large device, and the shelf box identifying a large device actually contains a small device.

## 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 devices. The device is intended to be used with supplemental fixation that has been cleared by the FDA for use in the lumbar spine. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). ENDOSKELETON® TA is indicated to be used with autograft bone or allograft bone comprised of cancellous and/ or corticocancellous 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. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device is a standalone system that is intended to be used with the bone screws provided and requires no additional supplementary fixation. The Device is indicated to be used with autograft bone or allograft bone comprised of cancellous and/ or corticocancellous bone. Hyperlordotic Devices ≥16°: The ENDOSKELETON® TAS Hyperlordotic Interbody Fusion Device (≥ 16°) 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. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device is indicated to be used with autograft bone or allograft bone comprised of cancellous and/ or corticocancellous bone. The ENDOSKELETON® TAS Hyperlordotic Interbody Fusion Device must be used with a posterior supplemental internal spinal fixation that has been cleared by the FDA for use in the lumbar spine. The ENDOSKELETON® TO 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 must be used with supplemental fixation that has been cleared by the FDA for use in the lumbar spine. 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 or allograft bone comprised of cancellous and/ or corticocancellous bone. The ENDOSKELETON® TT 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 must be used with supplemental fixation that has been cleared by the FDA for use in the lumbar spine. 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 or allograft bone comprised of cancellous and/ or corticocancellous bone. The ENDOSKELETON® TC Interbody Fusion Device 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 Interbody Fusion Device is indicated to be used with supplemental fixation that has been cleared by the FDA for use in the cervical spine and autograft bone or allograft bone comprised of cancellous and/ or corticocancellous bone. The Endoskeleton® TCS Interbody Fusion Device System is an anterior cervical intervertebral body fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) (defined as pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) at one disc level from C2 to T1. Patients should have received 6 weeks of non-operative treatment prior to treatment with the device. The device is indicated to be used with autograft bone or allograft bone comprised of cancellous and/ or corticocancellous bone. The device is a stand-alone system when used with Endoskeleton® TCS integrated screws and when used without the integrated screws it requires additional supplemental fixation cleared for the cervical spine. The ENDOSKELETON® TL Interbody Fusion Device 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 previous non-fusion spinal surgery at the involved level(s) may be treated with the device. It is indicated to be used with autograft bone or allograft bone comprised of cancellous and/ or corticocancellous bone. The ENDOSKELETON® TA Vertebral Body Replacement 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 Vertebral Body Replacement is intended for use with supplemental internal spinal fixation systems that has been cleared by the FDA for use in the lumbar spine. The ENDOSKELETON® TA Vertebral Body Replacement may be used with bone graft material and/or allogeneic bone graft.

Source page: https://510kreport.com/device/K183557
Methodology: https://510kreport.com/methodology