Cleared Traditional

K030069 - SYNTHES POLY (L-LACTIDE-CO-GLYCOLIDE) R...

K030069 is the FDA 510(k) clearance for SYNTHES POLY (L-LACTIDE-CO-GLYCOLIDE) R... by Synthes (Usa). It is a Class 2 Dental device (product code JEY) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K030069 · Synthes (Usa) · Dental device
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Apr 2003
Decision
90d
Days
Class 2
Risk

K030069 is an FDA 510(k) clearance for the SYNTHES POLY (L-LACTIDE-CO-GLYCOLIDE) RESORBABLE FIXATION 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 April 8, 2003 after a review of 90 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

Submission Details

510(k) Number K030069 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 2003
Decision Date April 08, 2003
Days to Decision 90 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
37d faster than avg
Panel avg: 127d · This submission: 90d
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 K030069.
SYNTHES STERILE LOW PROFILE NEURO CONTOURABLE MESH PLATES
K033160 · Synthes (Usa) · Oct 2003
UNIVERSAL NEURO SYSTEM
K031659 · Stryker Instruments · Sep 2003
SYNTHES (USA) NEW/STERIAL ORBITAL PLATES
K031761 · Synthes (Usa) · Sep 2003
SYNTHES RESORBABLE CONTOURABLE MESH
K022844 · Synthes (Usa) · Jan 2003
UNIVERSAL CMF SYSTEM
K022185 · Stryker Instruments · Dec 2002
SYNTHES LOW PROFILE NEURO SYSTEM
K022012 · Synthes (Usa) · Nov 2002