Cleared Special

K003756 - BIOSORBFX TACK AND BIOSORBPDX TACK BIOABSORBABLE FIXATION FASTENER, USED WITH PLATES

K003756 is an FDA 510(k) clearance for BIOSORBFX TACK AND BIOSORBPDX TACK BIOA..., manufactured by Bionx Implants, Inc.. The device is a Class 2 Dental device with product code JEY cleared through the Special 510(k) pathway after a 28-day FDA review.

K003756 · Bionx Implants, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2001
Decision
28d
Days
Class 2
Risk

K003756 is an FDA 510(k) clearance for the BIOSORBFX TACK AND BIOSORBPDX TACK BIOABSORBABLE FIXATION FASTENER, USED WITH.... Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Bionx Implants, Inc. (Blue Bell, US). The FDA issued a Cleared decision on January 3, 2001 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4760 - the FDA dental device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K003756

510(k) Number K003756 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 2000
Decision Date January 03, 2001
Days to Decision 28 days
Submission Type Special
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
100d faster than avg
Panel avg: 128d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 286
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K003756.
MOLINA ORBITAL MALAR DISTRACTOR
K003883 · KLS-Martin L.P. · Jan 2001
MAXILLARY DISTRACTOR
K003393 · Synthes (Usa) · Jan 2001
SYNTHES (USA) RESORBABLE TACK SYSTEM
K000560 · Synthes (Usa) · Jan 2001
LEIBINGER NEURO CLIP SYSTEM
K003660 · Stryker Instruments · Dec 2000
LOCKING SCREW MANDIBULAR RECONSTRUCTION PLATE
K000594 · Stryker Leibinger · Dec 2000
CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM DRILL BITS
K002798 · Codman & Shurtleff, Inc. · Dec 2000
K003756 · BIOSORBFX TACK AND BIOSORBPDX TACK BIOABSORBABLE FIXATION FASTENER, USED WITH PLATES
Download PDF FDA Summary Bionx Implants, Inc.