Cleared Traditional

3.Omm Biomet Cannulated Screw System (K143188) - FDA 510(k) Clearance

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

K143188 · Biomet Manufacturing Corp · Orthopedic device
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Dec 2014
Decision
55d
Days
Class 2
Risk

K143188 is an FDA 510(k) clearance for the 3.Omm Biomet Cannulated Screw System. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Biomet Manufacturing Corp (Warsaw, US). The FDA issued a Cleared decision on December 30, 2014 after a review of 55 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 Biomet Manufacturing Corp devices

Submission Details

510(k) Number K143188 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 2014
Decision Date December 30, 2014
Days to Decision 55 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
67d faster than avg
Panel avg: 122d · This submission: 55d
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 402
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K143188.
Herbert/Whipple Bone Screw System, Herbert/Whipple Bone Screw System, Herbert Cannulated Bone Screw System, Herbert Mini Bone Screw
K143165 · Zimmer, Inc. · Mar 2015
Cannulated Screw System
K143460 · Wrightmedicaltechnologyinc · Jan 2015
Arthrex Low Profile Screws
K143614 · Arthrex, Inc. · Jan 2015
PhaLinx Hammertoe System
K142585 · Wrightmedicaltechnologyinc · Nov 2014
MAGNA-FX AND MINI MAGNA-FX CANNULATED SCREW FIXATION SYSTEM
K142442 · Zimmer, Inc. · Oct 2014
BIOMET CANNULATED SCREW SYSTEM
K140891 · Biomet, Inc. · Jun 2014