Cleared Traditional

K192049 - Oryx Cervical Plate System (FDA 510(k) Clearance)

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

K192049 · Innovasis, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2019
Decision
100d
Days
Class 2
Risk

K192049 is an FDA 510(k) clearance for the Oryx Cervical Plate System. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Innovasis, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on November 8, 2019 after a review of 100 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - 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 Innovasis, Inc. devices

Submission Details

510(k) Number K192049 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 2019
Decision Date November 08, 2019
Days to Decision 100 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 122d · This submission: 100d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KWQ Appliance, Fixation, Spinal Intervertebral Body
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
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 - KWQ Appliance, Fixation, Spinal Intervertebral Body

All 663
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K192049.
corra™ cervical plating system
K260570 · Carlsmed, Inc. · Apr 2026
VyPlate™ Anterior Cervical Plate System
K260697 · Vy Spine, LLC · Mar 2026
ANTERIS Thoracolumbar Plate System
K260015 · SpineCraft · Mar 2026
PathLoc Lumbar Plate System
K251940 · L & K Biomed Co., Ltd. · Mar 2026
Aster
K254182 · Osteonic Co., Ltd. · Feb 2026
Lumbar Spine Truss System - Plating Solution (LSTS-PS)
K253201 · 4Web, Inc. · Feb 2026