# K132740: Spinefrontier Lesplasty Posterior Cervical Laminoplasty System

- Pathway: 510(k) (Traditional)
- Applicant: Spinefrontier, Inc.
- Decided: Nov 26, 2013 after 84 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). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 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.
- K050082: Centerpiece Plate Fixation System, Medtronic Sofamor Danek, Inc. (2005) Summary page 1.

## Indications for use
The LESPIasty™ Posterior Cervical Laminoplasty System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) in laminoplasty procedures. The system is used to hold or buttress the allograft or autograft material in place in order to prevent the allograft or autograft material from expelling or impinging the spinal cord.

Source page: https://510kreport.com/device/K132740
Methodology: https://510kreport.com/methodology