# K080615: Endoskeleton TA Interbody Fusion Device (Ibd)

- Pathway: 510(k) (Traditional)
- Applicant: Titan Spine, LLC
- Decided: Jun 17, 2008 after 105 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: 4 generations back to K003275 (2001). 11 ancestors in all.
564 later devices descend from it; 7 cite it directly.
1 of 576 devices in its family (counting itself) has 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.
- K032812: Endoskeleton TA Vertebral Body Replacement, Orthovita, Inc. (2003) Summary page 1.

## Most influential descendants
- K101310: VU Apod Intervertebral Body Fusion Device (2010), 480 descendants of its own
- K133286: Midline (TM) (2014), 460 descendants of its own
- K141942: Midline II TI (2014), 459 descendants of its own
- K083714: Endoskeleton TT Interbody Fusion Device (Ibd) (2009), 412 descendants of its own
- K150643: Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti (2015), 368 descendants of its own

## Indications for use
The Endoskeleton TA® 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. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device may 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 use with autograft bone.

Source page: https://510kreport.com/device/K080615
Methodology: https://510kreport.com/methodology