# K173091: Boundary Anterior Lumbar Buttress Plate

- Pathway: 510(k) (Traditional)
- Applicant: Nvision Biomedical Technologies, LLC
- Decided: Dec 6, 2017 after 68 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: 7 generations back to K953730 (1995). 40 ancestors in all.
No later device cites it as a predicate yet.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092659: Spinal Usa RCS Anterior Lumbar Butress Plate System, Model 22-1001-25, Spinal USA (2009) Summary page 5.
- K133911: Genesys Spine Anterior Buttress Plate System, Genesys Spine (2014) Summary page 5.
- K161524: Tangis Anterior Cervical Plate, Nvision Biomedical Technologies, LLC (2016) Summary page 5.

## Indications for use
The Boundary Anterior Lumbar Buttress Plate is intended to stabilize the allograft or autograft at one level (L1-S1) as an aid to spinal fusion and to provide temporary stabilization and augment development of a solid spinal fusion. It may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials. This device is not intended for load bearing applications.

Source page: https://510kreport.com/device/K173091
Methodology: https://510kreport.com/methodology