# K153122: Endoskeleton (r) TCS System

- Pathway: 510(k) (Traditional)
- Applicant: Titan Spine, LLC
- Decided: Dec 14, 2015 after 46 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: 17 generations back to K841189 (1984). 148 ancestors in all.
106 later devices descend from it; 3 cite it directly.
0 of 255 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142940: Endoskeleton TCS System, Titan Spine, LLC (2015) Summary page 4.
- K151596: Endoskeleton TCS Interbody Fusion Device, Titan Spine, LLC (2015) Summary page 4.
- K141953: Endoskeleton; TA Ibd and VBR, to and TT, Tas, TC, TL, Titan Spine, LLC (2014) Summary page 4.

## 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

## 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 System is an anterior cervical intervertebral body fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) (defined as neck 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. 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.

Source page: https://510kreport.com/device/K153122
Methodology: https://510kreport.com/methodology