# K100889: Endoskeleton TC

- Pathway: 510(k) (Traditional)
- Applicant: Titan Spine, LLC
- Decided: Jul 29, 2010 after 120 days
- Product code: ODP (Intervertebral Fusion Device With Bone Graft, Cervical)
- 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: 12 generations back to K003155 (2001). 55 ancestors in all.
455 later devices descend from it; 12 cite it directly.
0 of 511 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P980048: Bak/Cervical (Bak/C) Interbody Fusion System, Sulzer Spine-Tech (2001) Summary page 2.
- K082801: Phantom Plus Cage System, Us Spine (2008) Summary page 2.
- K081614: Zeus Small Cervical Cage and Large, Extra Large, Curved and Straight Lumbar Cages, Interbody Innovations, Llp (2008)
- K083311: Aesculap Cespace Peek Intervertebral Body Fusion System, Aesculap Implant Systems, Inc. (2009) Summary page 2.

## Most influential descendants
- K121649: Construx Mini Peek TI Spacer System (2012), 289 descendants of its own
- K142152: Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand Alone System (2015), 280 descendants of its own
- K141953: Endoskeleton; TA Ibd and VBR, to and TT, Tas, TC, TL (2014), 265 descendants of its own
- K152475: FORZA PTC Spacer System (2016), 236 descendants of its own
- K150788: Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion Devices, Talos -C (HA) Cervical Intervertebral Body Fusion Devices (2015), 202 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K100889
Methodology: https://510kreport.com/methodology