# K080588: Scient'x Tribeca VBR

- Pathway: 510(k) (Traditional)
- Applicant: Scient'X USA, Inc.
- Decided: May 30, 2008 after 88 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: 2 generations back to P950002 (1996). 2 ancestors in all.
250 later devices descend from it; 7 cite it directly.
1 of 253 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073202: Ardis Spacer, Abbott Spine, Inc. (2008) Summary page 2.

## Most influential descendants
- K170503: EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular Titanium TLIF Cages, and EIT Cellular Titanium ALIF Cages (2017), 199 descendants of its own
- K172888: EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular Titanium® TLIF Cages, EIT Cellular Titanium® ALIF Cages (2017), 159 descendants of its own
- K181644: EIT Cellular Titanium® Lumbar Cage LLIF (2018), 141 descendants of its own
- K183447: EIT Cellular Titanium Lumbar Cage - T/PLIF (2019), 131 descendants of its own
- K201605: EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular Titanium TLIF Cage, EIT Cellular Titanium LLIF Cage, EIT Cellular Titanium T/PLIF Cage (2020), 130 descendants of its own

## Indications for use
The Scient'x TribecaTM Cage implants are indicated for use with autogenous bone graft as an intervertebral body fusion device at either one or two contiguous levels in the lumbosacral spine, from L2 to SI, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The TribecaTM Cage is to be used in skeletally mature patients who have had six months of non-operative care. The TribecaTM Cage is implanted using an anterior or posterior approach and is intended to be used single or in pairs with ISOBAR o6.2mm Hemispherical Screws with Offset Clamps and o5.5mm Rods.

Source page: https://510kreport.com/device/K080588
Methodology: https://510kreport.com/methodology