# K070922: Modification to Spinal Usa VBR System

- Pathway: 510(k) (Traditional)
- Applicant: Spinal USA
- Decided: Sep 19, 2007 after 170 days
- Product code: KWQ (Appliance, Fixation, Spinal Intervertebral Body)
- Device class: 2
- Regulation: 21 CFR 888.3060
- 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 K922543 (1993). 10 ancestors in all.
161 later devices descend from it; 3 cite it directly.
0 of 172 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022791: Synthes Anterior Tension Band (Atb) System, Synthes (Usa) (2002) Summary page 1.
- K052546: Aegis Anterior Lumbar Plate System, Depuy Spine, Inc. (2006) Summary page 1.
- K013665: Pyramid Anterior Plate Fixation System, Medtronic Sofamor Danek, Inc. (2002)
- K061229: Unity LX Anterolateral Lumbar Plate Fixation System, Blackstone Medical, Inc. (2006) Summary page 1.
- K061353: Trinica Anterior Lumbar Plate System, Zimmer Spine, Inc. (2006) Summary page 1.

## Most influential descendants
- K091044: Spinal Usa Anterior Lumbar Plate System (2009), 159 descendants of its own
- K121791: Zou Anterior Lumbar Plate System (2012), 113 descendants of its own
- K101255: Alphatec Spine Anterior Lumbar Plating System (2010), 113 descendants of its own
- K182746: ATEC ALIF and LLIF Spacer System (2018), 110 descendants of its own
- K183705: IdentiTi Porous Ti Interbody System (2019), 99 descendants of its own

## Indications for use
The Spinal USA Anterior Lumbar Plate System is intended for use as an anteriorly placed supplemental fixation device via the lateral or anterolateral surgical approach above the bifurcation of the great vessel or via the anterior surgical approach, below the bifurcation of the great vessels. The device is intended as a temporary fixation device until fusion is achieved. The Spinal USA Anterior Lumbar Plate System is intended for anterior lumbar (LI -SI) fixation for the following indications: degenerative disc disease (DDD), defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tunmor, pseudoarthrosis, and failed previous fusion.

Source page: https://510kreport.com/device/K070922
Methodology: https://510kreport.com/methodology