Cleared Special

InFrame™ Cannulated Fixation System (K201430) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K201430 · Exsomed Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2020
Decision
19d
Days
Class 2
Risk

K201430 is an FDA 510(k) clearance for the InFrame™ Cannulated Fixation System. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Exsomed Corp. (Aliso Viejo, US). The FDA issued a Cleared decision on June 20, 2020 after a review of 19 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 Corp. devices

Submission Details

510(k) Number K201430 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2020
Decision Date June 20, 2020
Days to Decision 19 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
103d faster than avg
Panel avg: 122d · This submission: 19d
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 Consultant

Regulatory and Quality Solutions, LLC
Patricia Kontoudis

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 - HWC Screw, Fixation, Bone

All 417
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K201430.
Intraosseous Fixation System
K201556 · Extremity Medical, LLC · Jul 2020
RetroFix
K200226 · Retrofix Screws, LLC · Jun 2020
DuoHex CH Cannulated Hammertoe System
K200840 · Nextremity Solutions, Inc. · Jun 2020
Medline UNITE Jones Fracture Screw System
K201319 · Medline Industires, Inc. · Jun 2020
InCore MPJ System
K200124 · Nextremity Solutions, Inc. · May 2020
Healix Compression Screw System
K200914 · Nvision Biomedical Technologies, Inc. · May 2020