Cleared Traditional

THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY (K021684) - FDA 510(k) Clearance

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

K021684 · Bioplate, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Jun 2002
Decision
35d
Days
Class 2
Risk

K021684 is an FDA 510(k) clearance for the THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Bioplate, Inc. (Los Angeles, US). The FDA issued a Cleared decision on June 26, 2002 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 872.4760 - the FDA orthopedic 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Bioplate, Inc. devices

Submission Details

510(k) Number K021684 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 2002
Decision Date June 26, 2002
Days to Decision 35 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 122d · This submission: 35d
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 Orthopedic 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 K021684.
SYNTHES (USA) RESORBABLE FIXATION SYSTEM
K021928 · Synthes (Usa) · Sep 2002
SYNTHES MIDFACE DISTRACTOR
K022005 · Synthes (Usa) · Sep 2002
SYNTHES CRANIOFACIAL PLATES
K021642 · Synthes (Usa) · Aug 2002
SYNTHES (USA) AUTOMATED TACK DRIVER
K021382 · Synthes (Usa) · May 2002
SYNTHES TRANSLATING MAXILLARY DISTRACTOR
K020505 · Synthes (Usa) · Apr 2002
SYNTHES CRANIAL PLATES
K020087 · Synthes (Usa) · Feb 2002