Cleared Abbreviated

K190600 - ORION Spinal System

K190600 is the FDA 510(k) clearance for ORION Spinal System by Orion Biotech, Inc.. It is a Class 2 Orthopedic device (product code NKB) cleared through the Abbreviated 510(k) pathway after a 529-day FDA review.

K190600 · Orion Biotech, Inc. · Orthopedic device
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Aug 2020
Decision
529d
Days
Class 2
Risk

K190600 is an FDA 510(k) clearance for the ORION 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 Orion Biotech, Inc. (Taipei, TW). The FDA issued a Cleared decision on August 18, 2020 after a review of 529 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - the FDA orthopedic device regulatory framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: High-complexity regulatory submission. Standards-verified equivalence. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Orion Biotech, Inc. devices

Submission Details

510(k) Number K190600 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 2019
Decision Date August 18, 2020
Days to Decision 529 days
Submission Type Abbreviated
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
407d slower than avg
Panel avg: 122d · This submission: 529d
Pathway characteristics
Standards-based clearance path.

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 Peers - NKB Thoracolumbosacral Pedicle Screw System

All 649
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K190600.
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