Cleared Traditional

MACROPORE OS TRAUMA (K021164) - FDA 510(k) Clearance

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

K021164 · Macropore Biosurgery, Inc. · Orthopedic device
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Jul 2002
Decision
81d
Days
Class 2
Risk

K021164 is an FDA 510(k) clearance for the MACROPORE OS TRAUMA. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Macropore Biosurgery, Inc. (San Diego, US). The FDA issued a Cleared decision on July 1, 2002 after a review of 81 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - the FDA orthopedic 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

Submission Details

510(k) Number K021164 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 2002
Decision Date July 01, 2002
Days to Decision 81 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 122d · This submission: 81d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HRS Plate, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 Orthopedic devices follow this clearance model.

Regulatory Peers - HRS Plate, Fixation, Bone

All 696
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K021164.
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K022255 · Synthes (Usa) · Jul 2002
SYNTHES IN-SITU BENDER/CUTTER
K021458 · Synthes (Usa) · Jul 2002
SYNTHES 3.5 MM BROAD LC-DCP PLATES
K020872 · Synthes (Usa) · Jun 2002
SYNTHES CALCANEAL PLATE
K020401 · Synthes (Usa) · May 2002
DISTAL RADIUS PLATING SYSTEM
K020819 · Biomet, Inc. · Apr 2002