Cleared Traditional

K180670 - ICONN Campbell Interference Screw (FDA 510(k) Clearance)

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

K180670 · Iconn Orthopedics, LLC · Orthopedic device
Dec 2018
Decision
268d
Days
Class 2
Risk

K180670 is an FDA 510(k) clearance for the ICONN Campbell Interference Screw. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Iconn Orthopedics, LLC (Birmingham, US). The FDA issued a Cleared decision on December 7, 2018 after a review of 268 days - an extended review 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: 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.

Submission Details

510(k) Number K180670 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 2018
Decision Date December 07, 2018
Days to Decision 268 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
152d slower than avg
Panel avg: 116d · This submission: 268d
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 45
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K180670.
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