Cleared Traditional

K151160 - Arcus Staple System

K151160 is an FDA 510(k) clearance for Arcus Staple System, manufactured by Nextremity Solutions, Inc.. The device is a Class 2 Orthopedic device with product code JDR cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K151160 · Nextremity Solutions, Inc. · Orthopedic device
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Sep 2015
Decision
126d
Days
Class 2
Risk

K151160 is an FDA 510(k) clearance for the Arcus Staple System. Classified as Staple, Fixation, Bone (product code JDR), Class II - Special Controls.

Submitted by Nextremity Solutions, Inc. (Red Bank, US). The FDA issued a Cleared decision on September 4, 2015 after a review of 126 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.

View all Nextremity Solutions, Inc. devices

FDA 510(k) Submission Details - K151160

510(k) Number K151160 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2015
Decision Date September 04, 2015
Days to Decision 126 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
4d slower than avg
Panel avg: 122d · This submission: 126d
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 131
Devices cleared under the same product code (JDR) and FDA review panel - the closest regulatory comparables to K151160.
EasyStep
K160813 · Stryker GmbH · Jul 2016
PediatrOS RigidTack/FlexTack
K151762 · Merete Medical GmbH · Dec 2015
TiTHON Staple with OsseoTi Technology
K151615 · Biomet Manufacturing Corp · Oct 2015
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