Cleared Traditional

K153573 - Converge

K153573 is an FDA 510(k) clearance for Converge, manufactured by Biomedical Enterprises, Inc.. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 240-day FDA review.

K153573 · Biomedical Enterprises, Inc. · Orthopedic device
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Aug 2016
Decision
240d
Days
Class 2
Risk

K153573 is an FDA 510(k) clearance for the Converge. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Biomedical Enterprises, Inc. (San Antonio, US). The FDA issued a Cleared decision on August 11, 2016 after a review of 240 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 Biomedical Enterprises, Inc. devices

FDA 510(k) Submission Details - K153573

510(k) Number K153573 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 2015
Decision Date August 11, 2016
Days to Decision 240 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
118d slower than avg
Panel avg: 122d · This submission: 240d
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 1043
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K153573.
ARIX Hand System
K161746 · Jeil Medical Corporation · Sep 2016
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Tarsa-Link Stand-Alone Wedge Fixation System
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ARIX Foot System
K161864 · Jeil Medical Corporation · Aug 2016
Biomet Microfixation Sternal Closure System
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NEOVIEW Plating System
K160995 · In2bones Sas · Jun 2016