# K191927: Hinged Laminoplasty System

- Pathway: 510(k) (Traditional)
- Applicant: Life Spine, Inc.
- Decided: Sep 20, 2019 after 63 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). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181717: Life Spine Laminoplasty System, Life Spine, Inc. (2018) Summary page 4.
- K032534: Synthes Afs, Synthes Spine (2004) Summary page 4.
- K173215: Choice Spine Laminoplasty™ Fixation System, Choicespine, LP (2018) Summary page 4.

## Indications for use
The Life Spine Hinged Laminoplasty System is indicated for use in the lower cervical and upper thoracic spine (C3-T3) after a laminoplasty has been performed. The Life Spine Hinged Laminoplasty System is used to hold or buttresses the allograft or autograft material in place in order to prevent the graft material from expulsion or impinging the spinal cord.

Source page: https://510kreport.com/device/K191927
Methodology: https://510kreport.com/methodology