# K061229: Unity LX Anterolateral Lumbar Plate Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Blackstone Medical, Inc.
- Decided: Jul 24, 2006 after 83 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: 3 generations back to K922543 (1993). 6 ancestors in all.
165 later devices descend from it; 4 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)
- K043548: Blackstone Unity Anterior Lumbar Plate Fixation System, Blackstone Medical, Inc. (2005) Summary page 1.
- K022791: Synthes Anterior Tension Band (Atb) System, Synthes (Usa) (2002) Summary page 1.

## Most influential descendants
- 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
- K182746: ATEC ALIF and LLIF Spacer System (2018), 110 descendants of its own

## Indications for use
The Unity LXTM Anterolateral Lumbar Plate Fixation System is indicated for use as an anteriorly or anterolaterally placed supplemental fixation device for the lumbar region of the spine above 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: I) Degenerative disc disease (defined as back pain of discogenic origin with degenerative disc confirmed by history and radiographic studies) 2) Pseudoarthrosis 3) Spondylolysis 4) Spondylolisthesis 5) Fracture 6) Neoplastic disease 7) Unsuccessful previous fusion surgery 8) Lordotic deformities of the spine 9) Idiopathic thoracoluinbar or lumbar scoliosis 10) Deformities (i.e., scoliosis, kyphosis, and/or lordosis) associated with deficient posterior elements such as that resulting friom laminectomy, spina bifida, or myelomenigocele 11) Ncuromuscular deformity (i.e., scoliosis, lordosis, and/or kyphosis) associated with pelvic obliquity

Source page: https://510kreport.com/device/K061229
Methodology: https://510kreport.com/methodology