# K081196: Spinal Usa VBR System

- Pathway: 510(k) (Traditional)
- Applicant: Spinal USA
- Decided: Oct 16, 2008 after 171 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 K010530 (2001). 12 ancestors in all.
13 later devices descend from it; 2 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P960025: Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws, Depuy Spine, Inc. (1999) Summary page 1.
- K072253: Synfix-LR Spacer, Synthes Spine Co.Lp (2007) Summary page 1.
- K072226: Impix Spacer, Medicrea Technologies (2007) Summary page 1.
- K073470: Avs PL Peek Spacers, Models 48351XXX and 48353XXX, Stryker Spine (2008) Summary page 1.
- K080758: Avs PL Peek Spacers, Models 48351 and 48353, Stryker Corp. (2008) Summary page 1.

## Most influential descendants
- K110442: Nanovis Intervertebral Body Fusion System (2011), 10 descendants of its own
- K140280: Forticore (2014), 9 descendants of its own
- K161485: Nanovis Intervertebral Body Fusion System and Forticore (R) (2016), 5 descendants of its own
- K160874: Nanovis Intervertebral Body Fusion System and FortiCore® (2016), 4 descendants of its own
- K171312: FortiCore® (2018), 3 descendants of its own

## Indications for use
The Spinal USA Interbody Fusion Device is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion. One device is used per intervertebral space for the ALIF and TLIF system. Two devices are used per intervertebral space for the PLIF system. The Spinal USA Interbody Fusion Device ALIF, PLIF, TLIF System are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, 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 lumbar device is to be used with supplemental fixation and autogenuos bone graft. Patients should have at least six months of non-operative treatment prior to treatment with a lumbar intervertebral fusion device.

Source page: https://510kreport.com/device/K081196
Methodology: https://510kreport.com/methodology