Cleared Traditional

K982139 - BIOSORBFX 1.5/2.0 BIOABSORBABLE FIXATION SYSTEM

K982139 is an FDA 510(k) clearance for BIOSORBFX 1.5/2.0 BIOABSORBABLE FIXATIO..., 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 90-day FDA review.

K982139 · Bionx Implants, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1998
Decision
90d
Days
Class 2
Risk

K982139 is an FDA 510(k) clearance for the BIOSORBFX 1.5/2.0 BIOABSORBABLE FIXATION SYSTEM. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Bionx Implants, Inc. (Washington, US). The FDA issued a Cleared decision on September 15, 1998 after a review of 90 days - within the typical 510(k) review window.

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 - K982139

510(k) Number K982139 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 1998
Decision Date September 15, 1998
Days to Decision 90 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
37d faster than avg
Panel avg: 127d · This submission: 90d
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 K982139.
BURR HOLE COVERS, CRANIOMAXILLOFACIAL PLATES
K983885 · Howmedica, Inc. · Jan 1999
MICRO DYNAMIC MESH
K983528 · Howmedica Corp. · Dec 1998
ACE ALVEOLAR DISTRACTOR
K981526 · Ace Surgical Supply Co., Inc. · Nov 1998
SYNTHES (USA) [SYNTHES] MMFS - 2.0 MM SAGITTAL SPLIT PLATES
K981890 · Synthes (Usa) · Aug 1998
LACTOSORB PANELS AND FASTENERS
K980927 · Biomet, Inc. · Jun 1998
20-HOLE ADAPTATION PLATE
K981070 · Biomet, Inc. · May 1998