Cleared Traditional

K042365 - SYNTHES (USA) NEURO PLATE AND SCREW SYSTEM

K042365 is an FDA 510(k) clearance for SYNTHES (USA) NEURO PLATE AND SCREW 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 79-day FDA review.

K042365 · Synthes (Usa) · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2004
Decision
79d
Days
Class 2
Risk

K042365 is an FDA 510(k) clearance for the SYNTHES (USA) NEURO PLATE AND SCREW 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 November 18, 2004 after a review of 79 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. 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 Synthes (Usa) devices

FDA 510(k) Submission Details - K042365

510(k) Number K042365 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 2004
Decision Date November 18, 2004
Days to Decision 79 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
48d faster than avg
Panel avg: 127d · This submission: 79d
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 K042365.
SYNTHES RAPID RESORBABLE TACK SYSTEM
K050204 · Synthes (Usa) · Mar 2005
MEDICON 2.4 MANDIBULAR RECONSTRUCTION PLATING SYSTEM
K043297 · Medicon EG · Feb 2005
MODIFICATION TO SYNTHES CRANIAL PLATES
K042987 · Synthes (Usa) · Nov 2004
BIOSORB FX AND BIOSORB PDX 1.5 AND 2.0 SCREWS
K042517 · Linvatec Biomaterials, Ltd. · Oct 2004
LORENZ RESORBABLE DISTRACTION SYSTEM OR EXPANDER
K030425 · Walter Lorenz Surgical, Inc. · May 2004
SYNTHES (USA) CRANIOFACIAL PLATES
K040272 · Synthes (Usa) · Feb 2004