# K043548: Blackstone Unity Anterior Lumbar Plate Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Blackstone Medical, Inc.
- Decided: Jun 14, 2005 after 173 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: 2 generations back to K922543 (1993). 4 ancestors in all.
211 later devices descend from it; 5 cite it directly.
0 of 216 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013665: Pyramid Anterior Plate Fixation System, Medtronic Sofamor Danek, Inc. (2002) Summary page 1.

## Most influential descendants
- K061229: Unity LX Anterolateral Lumbar Plate Fixation System (2006), 165 descendants of its own
- K070922: Modification to Spinal Usa VBR System (2007), 161 descendants of its own
- 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

## Indications for use
The Blackstone Unity TM Anterior Lumbar Plate Fixation System is indicated for use as an anteriorly placed supplemental fixation device for the lumbosacral (L5-S1) level below the bifurcation of the vascular structures. When properly used, this system will help provide temporary stabilization until a solid spinal fusion develops. Specific indications include: a) Degenerative disc disease (defined as back pain of discogenic origin with degenerative disc confirmed by history and radiographic studies) b) Pseudoarthrosis c) Spondylolysis d) Spondylolisthesis e) Fracture f) Neoplastic disease g) Unsuccessful previous fusion surgery h) Lordotic deformities of the spine i) Idiopathic thoracolumbar or lumbar scoliosis j) Deformity (i.e., scoliosis, kyphosis, and/or lordosis) associated with deficient posterior elements such as that resulting from laminectomy, spina bifida, or myelomenigocele k) Neuromuscular deformity (i.e., scoliosis, lordosis, and/or kyphosis) associated with pelvic obliquity

Source page: https://510kreport.com/device/K043548
Methodology: https://510kreport.com/methodology