# K192054: Endoskeleton TAS Plate

- Pathway: 510(k) (Special)
- Applicant: Titan Spine, Inc.
- Decided: Aug 29, 2019 after 29 days
- Product code: OVD (Intervertebral Fusion Device With Integrated Fixation, 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: 25 generations back to K841189 (1984). 418 ancestors in all.
No later device cites it as a predicate yet.
1 of 419 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111626: Endoskeleton (R) Tas, Titan Spine, LLC (2011) Summary page 4.
- K141953: Endoskeleton; TA Ibd and VBR, to and TT, Tas, TC, TL, Titan Spine, LLC (2014) Summary page 4.
- K142589: Endoskeleton TA IBD and VBR, Endoskeleton TO and TT, Endoskeleton TAS, Endoskeleton TAS, Endoskeleton TC, Endoskeleton TL, Titan Spine, LLC (2014) Summary page 4.
- K163269: Endoskeleton (R) TAS Interbody Fusion Device / Endoskeleton (R) TAS Hyperlordotic Interbody Fusion Device, Titan Spine, LLC (2017) Summary page 4.
- K173535: Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody Fusion Device and Endoskeleton® TCS Interbody Fusion Device, Titan Spine, LLC (2018) Summary page 4.
- 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, Titan Spine, Inc. (2019) Summary page 4.
- 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, Titan Spine, Inc. (2019). Cleared while this submission was under review Summary page 4.
- K180215: DYNA-LINK ELITE Stand-Alone Anterior Lumbar System, Life Spine, Inc. (2018) Summary page 4.

## Indications for use
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 nonoperative 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 and/or allograft bone comprised of cancellous and/or corticocancellous bone and/or demineralized allograft bone with bone marrow aspirate. 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 and/or allograft bone comprised of cancellous and/or corticocancellous bone and/ or demineralized allograft bone with bone marrow aspirate.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 must be used with a posterior supplemental internal spinal fixation that has been cleared by the FDA for use in the lumbar spine.

Source page: https://510kreport.com/device/K192054
Methodology: https://510kreport.com/methodology