Cleared Traditional

K012413 - MACROPORE FX, PS, NS, LP

K012413 is an FDA 510(k) clearance for MACROPORE FX, manufactured by Macropore Biosurgery, Inc.. The device is a Class 2 Dental device with product code JEY cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K012413 · Macropore Biosurgery, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2001
Decision
50d
Days
Class 2
Risk

K012413 is an FDA 510(k) clearance for the MACROPORE FX, PS, NS, LP. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Macropore Biosurgery, Inc. (San Diego, US). The FDA issued a Cleared decision on September 18, 2001 after a review of 50 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 Macropore Biosurgery, Inc. devices

FDA 510(k) Submission Details - K012413

510(k) Number K012413 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 2001
Decision Date September 18, 2001
Days to Decision 50 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
77d faster than avg
Panel avg: 127d · This submission: 50d
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 256
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K012413.
THE BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM
K013055 · Bioplate, Inc. · Dec 2001
THE BIOPLATE MANDIBLE FIXATION SYSTEM
K012910 · Bioplate, Inc. · Nov 2001
INION CPS 2.0 ORTHOGNATHIC PLATE
K013039 · Inion , Ltd. · Oct 2001
STRAUMANN GBR SYSTEM
K011698 · Institut Straumann AG · Aug 2001
LACTOSORB RAPIDFLAP
K003281 · Biomet, Inc. · Aug 2001
MACROPOREPX PEDIATRIC SYSTEM
K002207 · Macropore Biosurgery, Inc. · Jul 2001