Cleared Traditional

K982721 - BIOSORBFX 2.0/2.4 ORTHOGNATHIC AND MANDIBULAR FIXATION SYSTEM

K982721 is an FDA 510(k) clearance for BIOSORBFX 2.0/2.4 ORTHOGNATHIC AND MAND..., 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 197-day FDA review.

K982721 · Bionx Implants, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1999
Decision
197d
Days
Class 2
Risk

K982721 is an FDA 510(k) clearance for the BIOSORBFX 2.0/2.4 ORTHOGNATHIC AND MANDIBULAR 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 February 17, 1999 after a review of 197 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 - K982721

510(k) Number K982721 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 1998
Decision Date February 17, 1999
Days to Decision 197 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
70d slower than avg
Panel avg: 127d · This submission: 197d
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 K982721.
MODUS 2.5 MANDIBULAR TRAUMA SET
K992683 · Medartis AG · Nov 1999
LACTOSORB SHEETS
K992158 · Biomet, Inc. · Aug 1999
NORMED BONE TRANSPORT
K990140 · Ace Surgical Supply Co., Inc. · Mar 1999
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