# K130830: Integra Laminoplasty System

- Pathway: 510(k) (Traditional)
- Applicant: Seaspine, Inc.
- Decided: May 9, 2013 after 44 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: 4 generations back to K761228 (1976). 12 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091623: Laminoplasty Fixation System, Nuvasive, Inc. (2009) Summary page 1.

## Cited in the summary but kept off the family tree
- K000290: Lazersmile, Lazerwhite, Biolase Technology, Inc. (2000). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K050829: Nurse's Assistant 1.7 O.R. Control System, Conmed Integrated Systems (Cmis) (2005). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K150469: Integra Laminoplasty System (2015), 1 descendant of its own
- K253420: Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody Sy (2026), 0 descendants of its own

## Indications for use
The Integra® Laminoplasty System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) after laminoplasty procedures. The Integra® Laminoplasty System is used to hold the allograft material in place in order to prevent the allograft material from expulsion, or impinging the spinal cord.

Source page: https://510kreport.com/device/K130830
Methodology: https://510kreport.com/methodology