Cleared Traditional

K011569 - BIOSORBFX O/M 2.0/2/4 SYSTEM

K011569 is an FDA 510(k) clearance for BIOSORBFX O/M 2.0/2/4 SYSTEM, manufactured by Bionx Implants, Inc.. The device is a Class 2 Dental device with product code JEY cleared through the Traditional 510(k) pathway after a 277-day FDA review.

K011569 · Bionx Implants, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2002
Decision
277d
Days
Class 2
Risk

K011569 is an FDA 510(k) clearance for the BIOSORBFX O/M 2.0/2/4 SYSTEM. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Bionx Implants, Inc. (Tampere, FI). The FDA issued a Cleared decision on February 22, 2002 after a review of 277 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 Bionx Implants, Inc. devices

FDA 510(k) Submission Details - K011569

510(k) Number K011569 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 2001
Decision Date February 22, 2002
Days to Decision 277 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
150d slower than avg
Panel avg: 127d · This submission: 277d
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 207
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K011569.
SYNTHES TRANSLATING MAXILLARY DISTRACTOR
K020505 · Synthes (Usa) · Apr 2002
RESORB-X RESORBABLE PLATING SYSTEM
K011590 · KLS-Martin L.P. · Mar 2002
NEWGEN/UNIVERSAL MANDIBULAR SYSTEM
K014263 · Stryker Instruments · Mar 2002
SYNTHES CRANIAL PLATES
K020087 · Synthes (Usa) · Feb 2002
THE BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM
K013055 · Bioplate, Inc. · Dec 2001
THE BIOPLATE MANDIBLE FIXATION SYSTEM
K012910 · Bioplate, Inc. · Nov 2001