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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
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 Consultant

Empirical Testing Corp
KENNETH C. MAXWELL

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HWC Screw, Fixation, Bone

All 1065
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K150188.
Life Spine Cannulated Screws
K150126 · Life Spine, Inc. · May 2015
Subtalar Spacer System (STS)
K150213 · Wrightmedicaltechnologyinc · May 2015
Snap-Off Self-Compressive Screw
K150772 · Neosteo · 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
K150188 · SMV Scientific 4.5 mm Bone Screws
Download PDF FDA Summary Summit Medventures