Cleared Traditional

K150981 - SMV Scientific Bone Screws

K150981 is an FDA 510(k) clearance for SMV Scientific Bone Screws, manufactured by Smv Scientific. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K150981 · Smv Scientific · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2015
Decision
70d
Days
Class 2
Risk

K150981 is an FDA 510(k) clearance for the SMV Scientific Bone Screws. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Smv Scientific (Austin, US). The FDA issued a Cleared decision on June 23, 2015 after a review of 70 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.

FDA 510(k) Submission Details - K150981

510(k) Number K150981 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 2015
Decision Date June 23, 2015
Days to Decision 70 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
52d faster than avg
Panel avg: 122d · This submission: 70d
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 1042
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K150981.
N-Force Fixation System
K151146 · Innovision, Inc. · Jul 2015
OsteoMed Cannulated Screw System
K151021 · Osteomed Corp. · Jul 2015
Monster Screw System
K151418 · Paragon 28 · Jul 2015
Sonoma Cancellous Bone Screw and Washer
K150376 · Sonoma Orthopedics Products, Inc. · Jun 2015
ToeTac Hammertoe Fixation System
K150443 · Restore Surgical, LLC Dba Instratek · Jun 2015
Biomet Microfixation RibFix Blu Thoracic Fixation System
K151173 · Biomet Microfixation · May 2015