Cleared Special

K021382 - SYNTHES (USA) AUTOMATED TACK DRIVER

K021382 is the FDA 510(k) clearance for SYNTHES (USA) AUTOMATED TACK DRIVER by Synthes (Usa). It is a Class 2 Dental device (product code JEY) cleared through the Special 510(k) pathway after a 14-day FDA review.

K021382 · Synthes (Usa) · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2002
Decision
14d
Days
Class 2
Risk

K021382 is an FDA 510(k) clearance for the SYNTHES (USA) AUTOMATED TACK DRIVER. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Synthes (Usa) (Paoli, US). The FDA issued a Cleared decision on May 16, 2002 after a review of 14 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 Synthes (Usa) devices

Submission Details

510(k) Number K021382 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 2002
Decision Date May 16, 2002
Days to Decision 14 days
Submission Type Special
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
113d faster than avg
Panel avg: 127d · This submission: 14d
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 156
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K021382.
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 TRANSLATING MAXILLARY DISTRACTOR
K020505 · Synthes (Usa) · Apr 2002
RESORB-X RESORBABLE PLATING SYSTEM
K011590 · KLS-Martin L.P. · Mar 2002
NEWGEN/UNIVERSAL MANDIBULAR SYSTEM
K014263 · Stryker Instruments · Mar 2002