Cleared Traditional

LineSider™ Spinal System (K190360) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K190360 · Integrity Implants, Inc. · Orthopedic device
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Jun 2019
Decision
126d
Days
Class 2
Risk

K190360 is an FDA 510(k) clearance for the LineSider™ Spinal System. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Integrity Implants, Inc. (Jupiter, US). The FDA issued a Cleared decision on June 21, 2019 after a review of 126 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Integrity Implants, Inc. devices

Submission Details

510(k) Number K190360 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 2019
Decision Date June 21, 2019
Days to Decision 126 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 122d · This submission: 126d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NKB Thoracolumbosacral Pedicle Screw System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
Definition Intended To Provide Immobilization And Stabilization Of Spinal Segments In Thoracic, Lumbar, And Sacral Spine As An Adjunct To Fusion.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Consultant

Empirical Consulting, LLC
Meredith Lee May

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - NKB Thoracolumbosacral Pedicle Screw System

All 447
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K190360.
Mariner MIS Pedicle Screw System
K191648 · SeaSpine Orthopedics Corporation · Jul 2019
EUROPA Pedicle Screw System
K191757 · MiRus, LLC · Jul 2019
Salvo™ Spine System
K191045 · Spine Wave, Inc. · Jul 2019
VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0
K190545 · Icotec AG · Jun 2019
The JASPER Spinal Fixation System II
K190762 · Gbs Commonwealth Co., Ltd. · Jun 2019
NOVA Minimally Invasive System
K182416 · Baui Biotech Co., Ltd. · Jun 2019