Cleared Traditional

K081390 - BIOACTIF OSTEOTRANS INTERFENCE SCREW

K081390 is an FDA 510(k) clearance for BIOACTIF OSTEOTRANS INTERFENCE SCREW, manufactured by Takiron Co., Ltd.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K081390 · Takiron Co., Ltd. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2008
Decision
85d
Days
Class 2
Risk

K081390 is an FDA 510(k) clearance for the BIOACTIF OSTEOTRANS INTERFENCE SCREW. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Takiron Co., Ltd. (Kobe, Hyogo, JP). The FDA issued a Cleared decision on August 12, 2008 after a review of 85 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 - K081390

510(k) Number K081390 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 2008
Decision Date August 12, 2008
Days to Decision 85 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
37d faster than avg
Panel avg: 122d · This submission: 85d
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 1061
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K081390.
PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM HEXALOBULAR BONE SCREWS
K082516 · Smith & Nephew, Inc. · Sep 2008
EXTREMITY MEDICAL COMPRESSION SCREW
K081934 · Extremity Medical, LLC · Aug 2008
JMEA CANNULATED BONE SCREW SYSTEM
K080259 · Jmea Corporation · Aug 2008
BIOPRO GO-EZ SCREW
K081149 · Biopro, Inc. · 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
K081390 · BIOACTIF OSTEOTRANS INTERFENCE SCREW
Download PDF FDA Summary Takiron Co., Ltd.