Cleared Traditional

K130298 - BIOPRO KWICK-WIRE UNIVERSAL SCREW SYSTEM

K130298 is an FDA 510(k) clearance for BIOPRO KWICK-WIRE UNIVERSAL SCREW SYSTEM, manufactured by Biopro, Inc.. The device is a Class 2 Orthopedic device with product code JDW cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K130298 · Biopro, Inc. · Orthopedic device
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Jun 2013
Decision
131d
Days
Class 2
Risk

K130298 is an FDA 510(k) clearance for the BIOPRO KWICK-WIRE UNIVERSAL SCREW SYSTEM. Classified as Pin, Fixation, Threaded (product code JDW), Class II - Special Controls.

Submitted by Biopro, Inc. (Prior Lake, US). The FDA issued a Cleared decision on June 18, 2013 after a review of 131 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 Biopro, Inc. devices

FDA 510(k) Submission Details - K130298

510(k) Number K130298 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 2013
Decision Date June 18, 2013
Days to Decision 131 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
9d slower than avg
Panel avg: 122d · This submission: 131d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDW Device Classification - Class 2, Special Controls

Product Code JDW Pin, Fixation, Threaded
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 - JDW Pin, Fixation, Threaded

All 84
Devices cleared under the same product code (JDW) and FDA review panel - the closest regulatory comparables to K130298.
VILEX ULTIMA EXTERNAL FIXATION SYSTEM WITH HA COATED PINS AND WIRES
K132820 · Vilex, Inc. · Jul 2014
OPTOSSOL COMPRESSION DEVICE SYSTEM
K140875 · Genossis, LLC · May 2014
AAP K-WIRE, STEINMANN PIN, CERCLAGE WIRE
K131459 · Aap Implantate AG · Oct 2013
SMITH & NEPHEW, INC. EXTERNAL FIXATION SYSTEM INSTRUMENTATION
K120871 · Smith & Nephew, Inc. · Jun 2012
ROCKWOOD CLAVICLE PINS
K103001 · DePuy Orthopaedics, Inc. · Feb 2011
TWISTCUT ENDOSORB SCREWS
K102777 · Merete Medical GmbH · Dec 2010