Cleared Traditional

K153622 - First Ray Internal Bone Staple System

K153622 is the FDA 510(k) clearance for First Ray Internal Bone Staple System by First Ray, LLC. It is a Class 2 Orthopedic device (product code JDR) cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K153622 · First Ray, LLC · Orthopedic device
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Apr 2016
Decision
112d
Days
Class 2
Risk

K153622 is an FDA 510(k) clearance for the First Ray Internal Bone Staple System. Classified as Staple, Fixation, Bone (product code JDR), Class II - Special Controls.

Submitted by First Ray, LLC (Logan, US). The FDA issued a Cleared decision on April 8, 2016 after a review of 112 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 First Ray, LLC devices

Submission Details

510(k) Number K153622 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 2015
Decision Date April 08, 2016
Days to Decision 112 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
10d faster than avg
Panel avg: 122d · This submission: 112d
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 98
Devices cleared under the same product code (JDR) and FDA review panel - the closest regulatory comparables to K153622.
ExoToe Staple
K172205 · Exotoe, LLC · Jan 2018
Arthrex DynaNite Nitinol Staple
K172052 · Arthrex, Inc. · Dec 2017
EasyStep
K160813 · Stryker GmbH · Jul 2016
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