Cleared Traditional

K022012 - SYNTHES LOW PROFILE NEURO SYSTEM

K022012 is an FDA 510(k) clearance for SYNTHES LOW PROFILE NEURO 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 134-day FDA review.

K022012 · Synthes (Usa) · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2002
Decision
134d
Days
Class 2
Risk

K022012 is an FDA 510(k) clearance for the SYNTHES LOW PROFILE NEURO 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 1, 2002 after a review of 134 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 - K022012

510(k) Number K022012 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 2002
Decision Date November 01, 2002
Days to Decision 134 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
7d slower than avg
Panel avg: 127d · This submission: 134d
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 K022012.
UNIVERSAL CMF SYSTEM
K022185 · Stryker Instruments · Dec 2002
MODIFICATION TO BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY
K023810 · Bioplate, Inc. · Dec 2002
MODIFICATION TO BIOPLATE RIGID BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY
K023665 · Bioplate, Inc. · Nov 2002
SYNTHES (USA) RESORBABLE FIXATION SYSTEM
K021928 · Synthes (Usa) · Sep 2002
MODIFIED SCREW DESIGNS FOR USE WITH THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY
K022890 · Bioplate, Inc. · Sep 2002
SYNTHES MIDFACE DISTRACTOR
K022005 · Synthes (Usa) · Sep 2002