Cleared Traditional

K143023 - Nitinol Compression Plating System

K143023 is an FDA 510(k) clearance for Nitinol Compression Plating System, 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 87-day FDA review.

K143023 · Biomedical Enterprises, Inc. · Orthopedic device
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Jan 2015
Decision
87d
Days
Class 2
Risk

K143023 is an FDA 510(k) clearance for the Nitinol Compression Plating 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 Biomedical Enterprises, Inc. (San Antonio, US). The FDA issued a Cleared decision on January 16, 2015 after a review of 87 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 Biomedical Enterprises, Inc. devices

FDA 510(k) Submission Details - K143023

510(k) Number K143023 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 2014
Decision Date January 16, 2015
Days to Decision 87 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
35d faster than avg
Panel avg: 122d · This submission: 87d
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 K143023.
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