Cleared Traditional

K153622 - First Ray Internal Bone Staple System

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

K153622 · First Ray, LLC · Orthopedic device
Download Printable Device Report (PDF)
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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

FDA 510(k) Submission Details - K153622

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
Combination Product No
PCCP Authorized No
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.

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 190
Devices cleared under the same product code (JDR) and FDA review panel - the closest regulatory comparables to K153622.
Stealth Staple System
K163440 · First Ray, LLC · Feb 2017
NeoSpan Compression Staple Impant w/instruments
K161426 · In2bones USA, LLC · Oct 2016
EasyStep
K160813 · Stryker GmbH · Jul 2016
OS2(R)-VP Varisation Staple
K153770 · In2bones Sas · Mar 2016
OS2-C Compression Staple
K153395 · In2bones Sas · Feb 2016
dynaMX Tabbed Staple
K153129 · Mx Orthopedics, Corp. · Jan 2016