Cleared Traditional

K081149 - BIOPRO GO-EZ SCREW

K081149 is an FDA 510(k) clearance for BIOPRO GO-EZ SCREW, manufactured by Biopro, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K081149 · Biopro, Inc. · Orthopedic device
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Aug 2008
Decision
105d
Days
Class 2
Risk

K081149 is an FDA 510(k) clearance for the BIOPRO GO-EZ SCREW. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Biopro, Inc. (Port Huron, US). The FDA issued a Cleared decision on August 5, 2008 after a review of 105 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 - K081149

510(k) Number K081149 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 2008
Decision Date August 05, 2008
Days to Decision 105 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 122d · This submission: 105d
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 1069
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K081149.
EXTREMITY MEDICAL COMPRESSION SCREW
K081934 · Extremity Medical, LLC · Aug 2008
JMEA CANNULATED BONE SCREW SYSTEM
K080259 · Jmea Corporation · Aug 2008
BIOACTIF OSTEOTRANS INTERFENCE SCREW
K081390 · Takiron Co., Ltd. · Aug 2008
TIGER CANNULATED SCREW SYSTEM
K081510 · Trilliant Surgical, Ltd. · Aug 2008
TRAUSON BONE SCREW, MODELS HA 3.5 AND 4.5
K073159 · Trauson (Jiangsu) Medical Instrument Co., Ltd. · Jul 2008
MERETE 3.0 AND 3.5 MM LOCKING SCREWS
K081513 · Merete Medical GmbH · Jul 2008
K081149 · BIOPRO GO-EZ SCREW
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