Cleared Traditional

K080694 - OSTEOMED MODULAR LOCKING FIXATION SYSTEM

K080694 is an FDA 510(k) clearance for OSTEOMED MODULAR LOCKING FIXATION SYSTEM, manufactured by Osteomed LP. The device is a Class 2 Dental device with product code JEY cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K080694 · Osteomed LP · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2008
Decision
65d
Days
Class 2
Risk

K080694 is an FDA 510(k) clearance for the OSTEOMED MODULAR LOCKING FIXATION SYSTEM. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Osteomed LP (Addison, US). The FDA issued a Cleared decision on May 15, 2008 after a review of 65 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 Osteomed LP devices

FDA 510(k) Submission Details - K080694

510(k) Number K080694 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 2008
Decision Date May 15, 2008
Days to Decision 65 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
62d faster than avg
Panel avg: 127d · This submission: 65d
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 254
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K080694.
MAX-FACE MAXILLOFACIAL OSTEOSYNTHESIS SYSTEM
K073307 · Bio-Technology USA, Inc. · Oct 2008
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K082757 · Bioplate, Inc. · Oct 2008
SONICWELD RX (RESORB-X)
K080862 · KLS-Martin L.P. · Jul 2008
FRACTURE/RECONSTRUCTION SYSTEM (TRAUMAONE)
K081067 · Biomet Microfixation, Inc. · May 2008
SYNTHES CRANIOFACIAL PLATE AND SCREW SYSTEM
K080331 · Synthes (Usa) · Apr 2008
ADJUSTABLE BONE PLATES BIOABSORBABLE, SELF COMPRESSION BONE FIXATION SYSTEM & ACCESSORIES
K072528 · Prosurg, Inc. · Dec 2007