Cleared Special

BIOSORBFX AND BIOSORBPDX MESH (K010687) - FDA 510(k) Clearance

Class II Dental device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K010687 · Bionx Implants, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2001
Decision
6d
Days
Class 2
Risk

K010687 is an FDA 510(k) clearance for the BIOSORBFX AND BIOSORBPDX MESH. 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 March 14, 2001 after a review of 6 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.

View all Bionx Implants, Inc. devices

Submission Details

510(k) Number K010687 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 2001
Decision Date March 14, 2001
Days to Decision 6 days
Submission Type Special
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
121d faster than avg
Panel avg: 127d · This submission: 6d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 96
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K010687.
SYNTHES CRANIAL PLATES
K020087 · Synthes (Usa) · Feb 2002
LACTOSORB RAPIDFLAP
K003281 · Biomet, Inc. · Aug 2001
SYNTHES (USA) MIDFACE DISTRACTOR
K010499 · Synthes (Usa) · May 2001
SMF RESORBABLE MESHES AND SHEETS
K003786 · Synthes (Usa) · Feb 2001
CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM PURPLE RIVETS
K003549 · Codman & Shurtleff, Inc. · Feb 2001
MAXILLARY DISTRACTOR
K003393 · Synthes (Usa) · Jan 2001