Cleared Traditional

K083490 - BIOPRO K-WIRE, MODELS 16863, 17231, 17232, 18577, 18682-18685

K083490 is an FDA 510(k) clearance for BIOPRO K-WIRE, manufactured by Biopro, Inc.. The device is a Class 2 Orthopedic device with product code HTY cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K083490 · Biopro, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Mar 2009
Decision
113d
Days
Class 2
Risk

K083490 is an FDA 510(k) clearance for the BIOPRO K-WIRE, MODELS 16863, 17231, 17232, 18577, 18682-18685. Classified as Pin, Fixation, Smooth (product code HTY), Class II - Special Controls.

Submitted by Biopro, Inc. (Port Huron, US). The FDA issued a Cleared decision on March 18, 2009 after a review of 113 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 - K083490

510(k) Number K083490 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 2008
Decision Date March 18, 2009
Days to Decision 113 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 faster than avg
Panel avg: 122d · This submission: 113d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HTY Device Classification - Class 2, Special Controls

Product Code HTY Pin, Fixation, Smooth
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 - HTY Pin, Fixation, Smooth

All 167
Devices cleared under the same product code (HTY) and FDA review panel - the closest regulatory comparables to K083490.
ACL TIGHTROPE
K100652 · Arthrex, Inc. · Jun 2010
STRYKER SONICPIN SYSTEM
K091955 · Howmedica Osteonics Corp. · Apr 2010
APTUS K-WIRE SYSTEM
K092038 · Medartis AG · Sep 2009
ORTHOPEDIATRICS PEDIFLEX FLEXIBLE NAIL SYSTEM
K082375 · OrthoPediatrics Corp. · Oct 2008
ARC SURGICAL BIOTRAK PIN SYSTEM
K071616 · Arc Surgical, LLC · Dec 2007
ACTIVAPIN, NEXFIX RFS PIN, NEXFIX RESORBABLE FIXATION SYSTEM (RFS)
K071863 · Bioretec, Ltd. · Aug 2007