Cleared Special

K133844 - SPEED TRIAD

K133844 is an FDA 510(k) clearance for SPEED TRIAD, manufactured by Biomedical Ent., Inc.. The device is a Class 2 Orthopedic device with product code JDR cleared through the Special 510(k) pathway after a 110-day FDA review.

K133844 · Biomedical Ent., Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2014
Decision
110d
Days
Class 2
Risk

K133844 is an FDA 510(k) clearance for the SPEED TRIAD. Classified as Staple, Fixation, Bone (product code JDR), Class II - Special Controls.

Submitted by Biomedical Ent., Inc. (San Antonio, US). The FDA issued a Cleared decision on April 7, 2014 after a review of 110 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K133844

510(k) Number K133844 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 2013
Decision Date April 07, 2014
Days to Decision 110 days
Submission Type Special
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
12d faster than avg
Panel avg: 122d · This submission: 110d
Pathway characteristics
Modification to existing cleared device.

JDR Device Classification - Class 2, Special Controls

Product Code JDR Staple, 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 - JDR Staple, Fixation, Bone

All 222
Devices cleared under the same product code (JDR) and FDA review panel - the closest regulatory comparables to K133844.
INSTAFIX SHAPE MEMORY FIXATION SYSTEM
K141550 · Ot Medical · Jul 2014
COMPRESSYN STAPLE
K140358 · Dallen Medical, Inc. · Jun 2014
SPEED ARC
K133270 · Biomedical Enterprises, Inc. · Apr 2014
SPEED XL
K133780 · Biomedical Ent., Inc. · Mar 2014
STAPIX SUPERELASTIC IMPLANT BONE STAPLES
K133523 · Instratek, Inc. · Feb 2014
COMPRESSYN STAPLE
K132875 · Dallen Medical, Inc. · Dec 2013