Cleared Traditional

K000560 - SYNTHES (USA) RESORBABLE TACK SYSTEM

K000560 is an FDA 510(k) clearance for SYNTHES (USA) RESORBABLE TACK SYSTEM, manufactured by Synthes (Usa). The device is a Class 2 Dental device with product code JEY cleared through the Traditional 510(k) pathway after a 326-day FDA review.

K000560 · Synthes (Usa) · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2001
Decision
326d
Days
Class 2
Risk

K000560 is an FDA 510(k) clearance for the SYNTHES (USA) RESORBABLE TACK SYSTEM. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Synthes (Usa) (Paoli, US). The FDA issued a Cleared decision on January 9, 2001 after a review of 326 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Synthes (Usa) devices

FDA 510(k) Submission Details - K000560

510(k) Number K000560 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 2000
Decision Date January 09, 2001
Days to Decision 326 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
199d slower than avg
Panel avg: 127d · This submission: 326d
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 249
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K000560.
THE BIOPLATE RESORBABLE BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY, BIOLACTATE
K994060 · Bioplate, Inc. · Jan 2001
MOLINA ORBITAL MALAR DISTRACTOR
K003883 · KLS-Martin L.P. · Jan 2001
MAXILLARY DISTRACTOR
K003393 · Synthes (Usa) · Jan 2001
BIOSORBFX TACK AND BIOSORBPDX TACK BIOABSORBABLE FIXATION FASTENER, USED WITH PLATES
K003756 · Bionx Implants, Inc. · Jan 2001
LEIBINGER NEURO CLIP SYSTEM
K003660 · Stryker Instruments · Dec 2000
CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM DRILL BITS
K002798 · Codman & Shurtleff, Inc. · Dec 2000