Cleared Traditional

Biomet Microfixation RibFix Advantage System (K203474) - FDA 510(k) Clearance

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

K203474 · Biomet Micofixation · Orthopedic device
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Jan 2021
Decision
64d
Days
Class 2
Risk

K203474 is an FDA 510(k) clearance for the Biomet Microfixation RibFix Advantage System. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Biomet Micofixation (Jacksonville, US). The FDA issued a Cleared decision on January 28, 2021 after a review of 64 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 Biomet Micofixation devices

Submission Details

510(k) Number K203474 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 2020
Decision Date January 28, 2021
Days to Decision 64 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 122d · This submission: 64d
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 697
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K203474.
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K200062 · Leith Medical, LLC · Feb 2021
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EVOS Large Fragment Plating System
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ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating System
K201259 · Wrightmedicaltechnologyinc · Jan 2021
Baby Gorilla/Gorilla Plating System
K203511 · Paragon 28, Inc. · Dec 2020