Cleared Traditional

K152253 - Biomet Microfixation RibFix Blu Thoraci...

K152253 is an FDA 510(k) clearance for Biomet Microfixation RibFix Blu Thoraci..., manufactured by Biomet Microfixation. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 227-day FDA review.

K152253 · Biomet Microfixation · Orthopedic device
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Mar 2016
Decision
227d
Days
Class 2
Risk

K152253 is an FDA 510(k) clearance for the Biomet Microfixation RibFix Blu Thoracic Fixation 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 Microfixation (Jacksonville, US). The FDA issued a Cleared decision on March 24, 2016 after a review of 227 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Biomet Microfixation devices

FDA 510(k) Submission Details - K152253

510(k) Number K152253 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 2015
Decision Date March 24, 2016
Days to Decision 227 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
105d slower than avg
Panel avg: 122d · This submission: 227d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HRS Device Classification - Class 2, Special Controls

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 1005
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K152253.
BIOFOAM Bone Wedge
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Align Anterior Ankle Fusion Plate
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Piccolo Composite(R) Distal Volar Radius Plate System
K160002 · CarboFix Orthopedics , Ltd. · Mar 2016
TriMed Humeral Supracondylar Fixation System
K151735 · TriMed, Inc. · Jan 2016
Cable-Ready Cable Grip System: Cable-Ready Bone Plate System
K151716 · Zimmer, Inc. · Jan 2016