Cleared Traditional

K131640 - SMOOTH OR THREADED METALLIC BONE FASTENER

K131640 is an FDA 510(k) clearance for SMOOTH OR THREADED METALLIC BONE FASTENER, manufactured by Biomedical Ent., Inc.. The device is a Class 2 Orthopedic device with product code HTY cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K131640 · Biomedical Ent., Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2013
Decision
134d
Days
Class 2
Risk

K131640 is an FDA 510(k) clearance for the SMOOTH OR THREADED METALLIC BONE FASTENER. Classified as Pin, Fixation, Smooth (product code HTY), Class II - Special Controls.

Submitted by Biomedical Ent., Inc. (San Antonio, US). The FDA issued a Cleared decision on October 16, 2013 after a review of 134 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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 Ent., Inc. devices

FDA 510(k) Submission Details - K131640

510(k) Number K131640 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 2013
Decision Date October 16, 2013
Days to Decision 134 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
12d slower than avg
Panel avg: 122d · This submission: 134d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HTY Device Classification - Class 2, Special Controls

Product Code HTY Pin, Fixation, Smooth
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - HTY Pin, Fixation, Smooth

All 115
Devices cleared under the same product code (HTY) and FDA review panel - the closest regulatory comparables to K131640.
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