Cleared Special

K183603 - INnate Cannulated Screw System

K183603 is the FDA 510(k) clearance for INnate Cannulated Screw System by Exsomed Corporation. It is a Class 2 Orthopedic device (product code HWC) cleared through the Special 510(k) pathway after a 76-day FDA review.

K183603 · Exsomed Corporation · Orthopedic device
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Mar 2019
Decision
76d
Days
Class 2
Risk

K183603 is an FDA 510(k) clearance for the INnate Cannulated Screw System. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Exsomed Corporation (Phoenix, US). The FDA issued a Cleared decision on March 12, 2019 after a review of 76 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Exsomed Corporation devices

Submission Details

510(k) Number K183603 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2018
Decision Date March 12, 2019
Days to Decision 76 days
Submission Type Special
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
46d faster than avg
Panel avg: 122d · This submission: 76d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code HWC Screw, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - HWC Screw, Fixation, Bone

All 553
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