Cleared Traditional

SPEED ARC (K133270) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K133270 · Biomedical Enterprises, Inc. · Orthopedic device
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Apr 2014
Decision
176d
Days
Class 2
Risk

K133270 is an FDA 510(k) clearance for the SPEED ARC. Classified as Staple, Fixation, Bone (product code JDR), Class II - Special Controls.

Submitted by Biomedical Enterprises, Inc. (San Antonio, US). The FDA issued a Cleared decision on April 17, 2014 after a review of 176 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

Submission Details

510(k) Number K133270 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 2013
Decision Date April 17, 2014
Days to Decision 176 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d slower than avg
Panel avg: 122d · This submission: 176d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 65
Devices cleared under the same product code (JDR) and FDA review panel - the closest regulatory comparables to K133270.
Orbitum Bone Staple Implant, X and VI
K173693 · Orthovestments, LLC · Feb 2018
ExoToe Staple
K172205 · Exotoe, LLC · Jan 2018
Arthrex DynaNite Nitinol Staple
K172052 · Arthrex, Inc. · Dec 2017
ARTHREX COMPRESSION STAPLE
K080111 · Arthrex, Inc. · Feb 2008
MEMORY STAPLE
K060746 · DePuy Orthopaedics, Inc. · May 2006
COMPRESSION STAPLE AND SIMPLE STAPLE
K043059 · Wrightmedicaltechnologyinc · Jan 2005