Cleared Traditional

BIOSORBFX 2.0/2.4 ORTHOGNATHIC AND MANDIBULAR FIXATION SYSTEM (K982721) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K982721 · Bionx Implants, Inc. · Dental device
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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

Submission Details

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
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.

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 K982721.
CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM DRILL BITS
K002798 · Codman & Shurtleff, Inc. · Dec 2000
CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM
K992905 · Codman & Shurtleff, Inc. · Aug 2000
LACTOSORB SHEETS
K992158 · Biomet, Inc. · Aug 1999
MICRO DYNAMIC MESH
K983528 · Howmedica Corp. · Dec 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