Cleared Traditional

BIOACTIF OSTEOTRANS INTERFENCE SCREW (K081390) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K081390 · Takiron Co., Ltd. · Orthopedic device
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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.

View all Takiron Co., Ltd. devices

Submission Details

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
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.

Device Classification

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 404
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K081390.
MEDACTA BONE SCREWS - EVOLIS AND VERSAFIT
K091069 · Medacta International S.A. · Jun 2009
DARCO SMALL SCREW
K082320 · Wrightmedicaltechnologyinc · Nov 2008
PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM HEXALOBULAR BONE SCREWS
K082516 · Smith & Nephew, Inc. · Sep 2008
SYNTHES (USA) STERNAL FIXATION SYSTEM - LINE EXTENSION
K081700 · Synthes (Usa) · Jul 2008
SYNTHES 6.5MM MIDFOOT FUSION BOLT
K081071 · Synthes (Usa) · May 2008
SYNTHES 4.5 MM AND 6.5 MM HEADLESS COMPRESSION SCREWS
K080943 · Synthes (Usa) · Apr 2008