# K043338: Blakstone Laminoplasty Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Blackstone Medical, Inc.
- Decided: Feb 18, 2005 after 77 days
- Product code: NQW (Orthosis, Spine, Plate, Laminoplasty, Metal)
- Device class: 2
- Regulation: 21 CFR 888.3050
- 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 K761228 (1976). 11 ancestors in all.
17 later devices descend from it; 3 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032534: Synthes Afs, Synthes Spine (2004) Summary page 1.

## Most influential descendants
- K080664: Relieve Laminoplasty Fixation System (2008), 11 descendants of its own
- K121732: Canopy Laminoplasty Fixation System (2012), 10 descendants of its own
- K171413: HAVEN™ Laminoplasty System, CANOPY® Laminoplasty Fixation System (2017), 6 descendants of its own
- K180156: SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation System (2018), 5 descendants of its own
- K181846: ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP Anterior Cervical Plate System, XTEND Anterior Cervical Plate System, UNIFY Dynamic Anterior Cervical Plate System, CITADEL Anterior Lumbar Plate System, TRUSS Thoracolumbar Plate System, PLYMOUTH Thoracolumbar Plate System, SP-Fix Spinous Process Fixation Plate, RELIEVE Laminoplasty Fixation System (2018), 4 descendants of its own

## Indications for use
The Blackstone Laminoplasty Fixation System is intended for use in the lower cervical and upper thoracic spine (C3-T3) after a laminoplasty has been performed. The Laminoplasty Fixation System holds or buttresses the allograft in place in order to prevent expulsion of the allograft, or impingement of the spinal cord.

Source page: https://510kreport.com/device/K043338
Methodology: https://510kreport.com/methodology