Cleared Traditional

K150188 - SMV Scientific 4.5 mm Bone Screws

K150188 is an FDA 510(k) clearance for SMV Scientific 4.5 mm Bone Screws, manufactured by Summit Medventures. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K150188 · Summit Medventures · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2015
Decision
92d
Days
Class 2
Risk

K150188 is an FDA 510(k) clearance for the SMV Scientific 4.5 mm Bone Screws. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Summit Medventures (Austin, US). The FDA issued a Cleared decision on April 29, 2015 after a review of 92 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 Summit Medventures devices

FDA 510(k) Submission Details - K150188

510(k) Number K150188 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2015
Decision Date April 29, 2015
Days to Decision 92 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
30d faster than avg
Panel avg: 122d · This submission: 92d
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 854
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K150188.
Arthrex RetroFusion Screw
K151078 · Arthrex, Inc. · May 2015
Life Spine Cannulated Screws
K150126 · Life Spine, Inc. · May 2015
Subtalar Spacer System (STS)
K150213 · Wrightmedicaltechnologyinc · May 2015
PHALINX Hammertoe System
K150252 · Wrightmedicaltechnologyinc · Apr 2015
aap Cortical Screw 1.5, self-tapping, aap Cortical Screw 1.5, self-tapping, Titanium
K150974 · Aap Implantate AG · Apr 2015
Herbert/Whipple Bone Screw System, Herbert/Whipple Bone Screw System, Herbert Cannulated Bone Screw System, Herbert Mini Bone Screw
K143165 · Zimmer, Inc. · Mar 2015