Cleared Traditional

K061881 - OSTEOTRANS -MX BIOABSORBABLE BONE FIXATION SYSTEM

K061881 is an FDA 510(k) clearance for OSTEOTRANS -MX BIOABSORBABLE BONE FIXAT..., manufactured by Takiron Co., Ltd.. The device is a Class 2 Dental device with product code JEY cleared through the Traditional 510(k) pathway after a 254-day FDA review.

K061881 · Takiron Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2007
Decision
254d
Days
Class 2
Risk

K061881 is an FDA 510(k) clearance for the OSTEOTRANS -MX BIOABSORBABLE BONE FIXATION SYSTEM. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Takiron Co., Ltd. (Himeji, Hyogo, JP). The FDA issued a Cleared decision on March 14, 2007 after a review of 254 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4760 - the FDA dental 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 Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Takiron Co., Ltd. devices

FDA 510(k) Submission Details - K061881

510(k) Number K061881 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2006
Decision Date March 14, 2007
Days to Decision 254 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
127d slower than avg
Panel avg: 127d · This submission: 254d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JEY Device Classification - Class 2, Special Controls

Product Code JEY Plate, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4760
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 Dental devices follow this clearance model.

Regulatory Peers - JEY Plate, Bone

All 235
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K061881.
MODUS TRILOCK 2.0/2.3/2.5
K071612 · Medartis AG · Sep 2007
XSORB BIOABSORBABLE CRANIOFACIAL BONE FIXATION SYSTEM & ACCESSORIES
K070737 · Prosurg, Inc. · Jul 2007
THE SYNTHES MATRIXMANDIBLE PLATE AND SCREW SYSTEM
K063790 · Synthes (Usa) · Apr 2007
SYNTHES (USA) RAPID RESORBABLE FIXATION SYSTEM
K062789 · Synthes (Usa) · Feb 2007
LORENZ TITANIUM FRACTURE / RECONSTRUCTION DEVICES AND PRE-BENT PLATES
K063052 · Walter Lorenz Surgical, Inc. · Jan 2007
SONICWELD RX ENDOBROW FIXATION
K061507 · KLS-Martin L.P. · Sep 2006