# K160114: Xspan Laminoplasty Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: X-Spine Systems, Inc.
- Decided: Mar 15, 2016 after 56 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: 5 generations back to K761228 (1976). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103284: Laminoplasy Plating System, Aesculap Implant Systems, Inc. (2010) Summary page 5.
- K090354: Laminoplasty Plating System, Aesculap Implant System, Inc. (2009) Summary page 5.
- K091623: Laminoplasty Fixation System, Nuvasive, Inc. (2009) Summary page 5.

## Indications for use
The Xspan™ Laminoplasty Fixation System is intended for use in the lower cervical and upper thoracic spine (C3-T3) after a laminoplasty has been performed. The Xspan 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/K160114
Methodology: https://510kreport.com/methodology