Cleared Traditional

K143092 - Tensyn Plug

K143092 is an FDA 510(k) clearance for Tensyn Plug, manufactured by Dallen Medical, Inc.. The device is a Class 2 Orthopedic device with product code HTN cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K143092 · Dallen Medical, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2015
Decision
106d
Days
Class 2
Risk

K143092 is an FDA 510(k) clearance for the Tensyn Plug. Classified as Washer, Bolt Nut (product code HTN), Class II - Special Controls.

Submitted by Dallen Medical, Inc. (San Clemente, US). The FDA issued a Cleared decision on February 11, 2015 after a review of 106 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K143092

510(k) Number K143092 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 2014
Decision Date February 11, 2015
Days to Decision 106 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
16d faster than avg
Panel avg: 122d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HTN Device Classification - Class 2, Special Controls

Product Code HTN Washer, Bolt Nut
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 - HTN Washer, Bolt Nut

All 91
Devices cleared under the same product code (HTN) and FDA review panel - the closest regulatory comparables to K143092.
Akros Fibulink Syndesmosis Repair Kit
K162805 · Akros Medical · Jan 2017
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K153211 · Coracoid Solutions, Inc. · Feb 2016
Tensyn Plug
K150359 · Dallen Medical, Inc. · May 2015
FASTFORWARD
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K141219 · Biomet Manufacturing Corp · Jul 2014