Cleared Traditional

K001219 - MEMOGRAPH

Also marketed or referenced as:
OSSTAPLE - ORAL AND MAXILLIOFACIAL PROCEDURES FOR THE MEMOGRAPH STAPLE SYSTEM

K001219 is an FDA 510(k) clearance for MEMOGRAPH, manufactured by Biomedical Ent., Inc.. 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.

K001219 · Biomedical Ent., Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2000
Decision
65d
Days
Class 2
Risk

K001219 is an FDA 510(k) clearance for the MEMOGRAPH. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Biomedical Ent., Inc. (San Antonio, US). The FDA issued a Cleared decision on June 21, 2000 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 Biomedical Ent., Inc. devices

FDA 510(k) Submission Details - K001219

510(k) Number K001219 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 2000
Decision Date June 21, 2000
Days to Decision 65 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
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 208
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K001219.
MODIFICATION TO BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM
K002879 · Bioplate, Inc. · Oct 2000
CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM
K992905 · Codman & Shurtleff, Inc. · Aug 2000
THE BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM
K001530 · Bioplate, Inc. · Jul 2000
BIOSORBPDX BIOABSORBABLE FIXATION SYSTEM
K000836 · Bionx Implants, Inc. · Jun 2000
LORENZ TITANIUM FRACTURE / RECONSTRUCTION PLATING SYSTEM
K001238 · Walter Lorenz Surgical, Inc. · May 2000
MOD LINE OF MOLINA DISTRACTORS, 51-600 SERIES
K994154 · KLS-Martin L.P. · Feb 2000