# K191565: Endoskeleton TCS Interbody Fusion Device

- Pathway: 510(k) (Special)
- Applicant: Titan Spine, Inc.
- Decided: Aug 6, 2019 after 54 days
- Product code: OVE (Intervertebral Fusion Device With Integrated Fixation, Cervical)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 24 generations back to K841189 (1984). 396 ancestors in all.
No later device cites it as a predicate yet.
1 of 397 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142940: Endoskeleton TCS System, Titan Spine, LLC (2015) Summary page 4.
- K153122: Endoskeleton (r) TCS System, Titan Spine, LLC (2015) 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.
- K180642: Pro-Link® Ti Stand-Alone Cervical Spacer System, Life Spine, Inc. (2018) Summary page 4.

## 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.

## Indications for use
The Endoskeleton® TCS Interbody Fusion Device 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 Interbody Fusion Device integrated screws and when used without the integrated screws it requires additional supplemental fixation cleared for the cervical spine.

Source page: https://510kreport.com/device/K191565
Methodology: https://510kreport.com/methodology