Cleared Traditional

MACROPOREPX PEDIATRIC SYSTEM (K002207) - FDA 510(k) Clearance

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

K002207 · Macropore Biosurgery, Inc. · Dental device
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Jul 2001
Decision
355d
Days
Class 2
Risk

K002207 is an FDA 510(k) clearance for the MACROPOREPX PEDIATRIC SYSTEM. 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 July 11, 2001 after a review of 355 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Macropore Biosurgery, Inc. devices

Submission Details

510(k) Number K002207 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 2000
Decision Date July 11, 2001
Days to Decision 355 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
228d slower than avg
Panel avg: 127d · This submission: 355d
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 K002207.
SYNTHES TRANSLATING MAXILLARY DISTRACTOR
K020505 · Synthes (Usa) · Apr 2002
SYNTHES CRANIAL PLATES
K020087 · Synthes (Usa) · Feb 2002
LACTOSORB RAPIDFLAP
K003281 · Biomet, Inc. · Aug 2001
SYNTHES (USA) MIDFACE DISTRACTOR
K010499 · Synthes (Usa) · May 2001
SMF RESORBABLE MESHES AND SHEETS
K003786 · Synthes (Usa) · Feb 2001
CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM PURPLE RIVETS
K003549 · Codman & Shurtleff, Inc. · Feb 2001