Cleared Traditional

REVCON (TM) Screw System (K223392) - FDA 510(k) Clearance

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

K223392 · Voom Medical Devices, Inc. · Orthopedic device
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Feb 2023
Decision
112d
Days
Class 2
Risk

K223392 is an FDA 510(k) clearance for the REVCON (TM) Screw System. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Voom Medical Devices, Inc. (New York City, US). The FDA issued a Cleared decision on February 28, 2023 after a review of 112 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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 Voom Medical Devices, Inc. devices

Submission Details

510(k) Number K223392 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 2022
Decision Date February 28, 2023
Days to Decision 112 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
10d faster than avg
Panel avg: 122d · This submission: 112d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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

Jalex Medical
Morgan Hill

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 K223392.
Hand Trauma Threaded Nail System
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TriMed Threaded Intramedullary Nail System
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PROstep(TM) MIS 5mm Chamfer Screw System
K221645 · Wright Medical Technology · Feb 2023
Bony Trauma Extremity System (BTES) Screw Range, NX Nail
K230118 · Field Orthopaedics Pty, Ltd. · Feb 2023
OIC Intramedullary Screw System
K223761 · Orthopaedic Implant Company · Feb 2023