Cleared Traditional

OIC Intramedullary Screw System (K223761) - FDA 510(k) Clearance

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

K223761 · Orthopaedic Implant Company · Orthopedic device
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Feb 2023
Decision
60d
Days
Class 2
Risk

K223761 is an FDA 510(k) clearance for the OIC Intramedullary Screw System. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Orthopaedic Implant Company (Reno, US). The FDA issued a Cleared decision on February 13, 2023 after a review of 60 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Orthopaedic Implant Company devices

Submission Details

510(k) Number K223761 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 2022
Decision Date February 13, 2023
Days to Decision 60 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
62d faster than avg
Panel avg: 122d · This submission: 60d
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 Peers - HWC Screw, Fixation, Bone

All 416
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K223761.
REVCON (TM) Screw System
K223392 · Voom Medical Devices, Inc. · Feb 2023
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
CREED™ Cannulated Screws
K223847 · Glw, Inc. · Jan 2023
Metal Cannulated Screw
K221090 · Double Medical Technology, Inc. · Jan 2023
Haymaker® Screw System
K222799 · Orthocircle Spine D.B.A. OC Medical Devices · Jan 2023