Cleared Traditional

K180670 - ICONN Campbell Interference Screw

K180670 is an FDA 510(k) clearance for ICONN Campbell Interference Screw, manufactured by Iconn Orthopedics, LLC. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 268-day FDA review.

K180670 · Iconn Orthopedics, LLC · Orthopedic device
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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.

View all Iconn Orthopedics, LLC devices

FDA 510(k) Submission Details - K180670

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
146d slower than avg
Panel avg: 122d · This submission: 268d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HWC Device Classification - Class 2, Special Controls

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 920
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K180670.
PROSTEP MICA Screw System
K181377 · Wrightmedicaltechnologyinc · Jan 2019
Arthrex Compression FT Screws
K182361 · Arthrex, Inc. · Dec 2018
AURORA™ Screw System
K182989 · MiRus, LLC · Dec 2018
Healix™ Compression Screw System
K182949 · Nvision Biomedical Technologies, LLC · Dec 2018
Responsive Arthroscopy Interference Screw System
K180573 · Responsive Arthroscopy, LLC · Nov 2018
HammerTechTM Fixation System
K182684 · Fusion Orthopedics, LLC · Nov 2018