Cleared Traditional

K133270 - SPEED ARC

K133270 is an FDA 510(k) clearance for SPEED ARC, manufactured by Biomedical Enterprises, Inc.. The device is a Class 2 Orthopedic device with product code JDR cleared through the Traditional 510(k) pathway after a 176-day FDA review.

K133270 · Biomedical Enterprises, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K133270

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.

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 141
Devices cleared under the same product code (JDR) and FDA review panel - the closest regulatory comparables to K133270.
SnapShot Fixation System
K143037 · Biomet Manufacturing Corp · Jan 2015
TOGGLELOC AND JUGGERLOC IMPLANTS/INSTRUMENTS/KITS
K141263 · Biomet Manufacturing Corp · Nov 2014
ORTHOHELIX STAPLE SYSTEM
K142148 · Orthohelix Surgical Designs, Inc. · Aug 2014
ORTHOHELIX STAPLE SYSTEM
K130832 · Orthohelix Surgical Designs, Inc. · Aug 2013
MEMORY METAL STAPLES, EASYCLIP
K122113 · Stryker Corp. · Mar 2013
COMPOSITE HITCH SUTURE ANCHOR
K081172 · Biomet Manufacturing Corp · Jul 2008