# K083714: Endoskeleton TT Interbody Fusion Device (Ibd)

- Pathway: 510(k) (Traditional)
- Applicant: Titan Spine, LLC
- Decided: Apr 15, 2009 after 121 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, 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: 5 generations back to K003275 (2001). 18 ancestors in all.
412 later devices descend from it; 6 cite it directly.
0 of 431 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P950002: Bak Interbody Fusion System, Zimmer Spine, Inc. (1996) Summary page 1.
- P970015: Inter Fix Threaded Fusion Device, Sofamor Danek (1999) Summary page 1.
- P950019: Ray Threaded Fusion Cage (TFC)(TM) with Instrumentation, Stryker Spine (1996) Summary page 1.
- P960025: Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws, Depuy Spine, Inc. (1999) Summary page 1.
- K080615: Endoskeleton TA Interbody Fusion Device (Ibd), Titan Spine, LLC (2008) Summary page 1.
- K031672: Spinal Concepts, Inc. Infix System, Spinal Concepts, Inc. (2003) Summary page 1.
- K071724: Lucent, Spinal Elements, Inc. (2007) Summary page 1.

## Most influential descendants
- K102067: Endoskeleton to (2010), 337 descendants of its own
- K140055: Endoskeleton (R) TL Interbody Fusion Device (2014), 267 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
- K140348: Interbody Cage (2015), 235 descendants of its own

## Indications for use
The Endoskeleton® TT IBD 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. 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.

Source page: https://510kreport.com/device/K083714
Methodology: https://510kreport.com/methodology