Cleared Traditional

Inion CompressOn Screw (K203105) - FDA 510(k) Clearance

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

K203105 · Inion OY · Orthopedic device
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Jan 2021
Decision
90d
Days
Class 2
Risk

K203105 is an FDA 510(k) clearance for the Inion CompressOn Screw. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Inion OY (Tampere, FI). The FDA issued a Cleared decision on January 13, 2021 after a review of 90 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 Inion OY devices

Submission Details

510(k) Number K203105 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 2020
Decision Date January 13, 2021
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
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 406
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K203105.
Cannulated Fasteners and Nuts
K210754 · OsteoCentric Technologies · Apr 2021
LTJ Screws and Washer
K210268 · Azurmeds, Inc. · Feb 2021
Dynanail Mini Hybrid
K203381 · MedShape, Inc. · Jan 2021
Fixone Biocomposite Interference Screw
K193497 · Aju Pharm Co., Ltd. · Jan 2021
Arthrex Low Profile Screws
K203239 · Arthrex, Inc. · Dec 2020
WishBone Medical Plate and Screw System
K203467 · Wishbone Medical, Inc. · Dec 2020