Skip to content

ISSYS LP Spinal Fixation System

by Custom Spine, Inc. 510(k)

Active United States

510(k) K070281

Overview

The ISSYS LP Spinal Fixation System is a posterior/anterior spinal stabilization hardware system designed for spinal immobilization and stabilization as an adjunct to fusion procedures. It provides mechanical stability to the spine to promote fusion and includes components such as auxiliary connectors (side-to-side, axial, offset) and pre-bent 6.0mm rods.

The system is used by surgeons in clinical settings for spinal fixation during fusion procedures. It is supplied as non-sterile, reusable hardware and is not indicated as MRI safe or single-use. The device received FDA 510(k) clearance under K070281 and is classified under product code NKB with Orthopedic advisory committee review.

AI-generated from registry data, 24 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK070281 Date11 Jun 2007ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

1 recall · FDA

    • Terminated Z-1819-2013 FDA Class II initiated 28 Mar 2013

    On March 28, 2013, Custom Spine, Inc. issued a minor removal of a lot of 18 screws that were found to be out of specification. The screw length was 5 mm shorter in length than the required specification for the screw size. The product is laser marked 8.5mm X 45mm, but its length measured 40mm.

Specification

510(k)

510(k) Number
FDA Product Code
NKB
Device Class
Class II
Regulation
21 CFR Part 888.3070
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Other devices from Custom Spine, Inc.

See all devices from Custom Spine, Inc. →

Questions

  • What is the ISSYS LP Spinal Fixation System used for?

    The ISSYS LP Spinal Fixation System is designed for spinal immobilization and stabilization as an adjunct to fusion procedures. It provides mechanical stability to the spine to promote bone fusion and is used by surgeons in clinical settings during spinal fixation surgeries.

  • Is the ISSYS LP Spinal Fixation System sterile or single-use?

    The system is supplied as non-sterile, reusable hardware. It is not indicated as single-use or MRI safe, and must be properly cleaned and sterilized by the healthcare facility before each use according to established reprocessing protocols.

  • What components are included in the ISSYS LP Spinal Fixation System?

    The system includes auxiliary connectors such as side-to-side, axial, and offset types, along with pre-bent 6.0mm rods. These components work together to provide posterior and/or anterior spinal stabilization during fusion procedures.

  • How was the ISSYS LP Spinal Fixation System cleared for market?

    The device received FDA 510(k) clearance under submission number K070281 on June 11, 2007. It was determined to be substantially equivalent to predicate devices and is classified under product code NKB with review by the Orthopedic advisory committee.