Cleared Traditional

OSTEOMEDICS RESORBABLE SMALL FIXATION SYSTEM, OSTEOSORB (K022035) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K022035 · Osteomedics, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2003
Decision
210d
Days
Class 2
Risk

K022035 is an FDA 510(k) clearance for the OSTEOMEDICS RESORBABLE SMALL FIXATION SYSTEM, OSTEOSORB. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Osteomedics, Inc. (Paramus, US). The FDA issued a Cleared decision on January 17, 2003 after a review of 210 days - an extended review 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: 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 Osteomedics, Inc. devices

Submission Details

510(k) Number K022035 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 2002
Decision Date January 17, 2003
Days to Decision 210 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
83d slower than avg
Panel avg: 127d · This submission: 210d
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 96
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K022035.
SYNTHES STERILE LOW PROFILE NEURO CONTOURABLE MESH PLATES
K033160 · Synthes (Usa) · Oct 2003
SYNTHES (USA) NEW/STERIAL ORBITAL PLATES
K031761 · Synthes (Usa) · Sep 2003
SYNTHES POLY (L-LACTIDE-CO-GLYCOLIDE) RESORBABLE FIXATION SYSTEM
K030069 · Synthes (Usa) · Apr 2003
SYNTHES RESORBABLE CONTOURABLE MESH
K022844 · Synthes (Usa) · Jan 2003
SYNTHES LOW PROFILE NEURO SYSTEM
K022012 · Synthes (Usa) · Nov 2002
SYNTHES (USA) RESORBABLE FIXATION SYSTEM
K021928 · Synthes (Usa) · Sep 2002