Cleared Traditional

K152000 - SMV Scientific Bone Plate and Screw System

K152000 is an FDA 510(k) clearance for SMV Scientific Bone Plate and Screw System, manufactured by Smv Scientific. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K152000 · Smv Scientific · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2015
Decision
128d
Days
Class 2
Risk

K152000 is an FDA 510(k) clearance for the SMV Scientific Bone Plate and Screw System. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Smv Scientific (Austin, US). The FDA issued a Cleared decision on November 25, 2015 after a review of 128 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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 Smv Scientific devices

FDA 510(k) Submission Details - K152000

510(k) Number K152000 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 2015
Decision Date November 25, 2015
Days to Decision 128 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
6d slower than avg
Panel avg: 122d · This submission: 128d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HRS Device Classification - Class 2, Special Controls

Product Code HRS Plate, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - HRS Plate, Fixation, Bone

All 1040
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K152000.
aap LOQTEQ VA Radius Set 2.5
K153034 · Aap Implantate AG · Jan 2016
ARIX Wrist System
K151468 · Jeil Medical Corporation · Jan 2016
ORTHOLOC® 3Di Foot Plating Reconstruction System
K152974 · Wrightmedicaltechnologyinc · Dec 2015
VLP Mini-Mod Talus Plates
K152976 · Smith & Nephew, Inc. · Nov 2015
SternaLock® 360 Sternal Closure System
K151019 · Biomet Microfixation · Nov 2015
Acumed Ankle and Small Fragment Base Set Update
K151886 · Acumed, LLC · Oct 2015