Cleared Traditional

K000560 - SYNTHES (USA) RESORBABLE TACK SYSTEM

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

K000560 · Synthes (Usa) · Dental device
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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

Submission Details

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.

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 K000560.
LORENZ RESORBABLE DISTRACTOR SYSTEM
K002083 · Walter Lorenz Surgical, Inc. · Feb 2001
MOLINA ORBITAL MALAR DISTRACTOR
K003883 · KLS-Martin L.P. · Jan 2001
MAXILLARY DISTRACTOR
K003393 · Synthes (Usa) · Jan 2001
LEIBINGER NEURO CLIP SYSTEM
K003660 · Stryker Instruments · Dec 2000
CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM DRILL BITS
K002798 · Codman & Shurtleff, Inc. · Dec 2000
NEWGEN SYSTEM
K002619 · Stryker Instruments · Nov 2000