Cleared Traditional

K163440 - Stealth Staple System

K163440 is an FDA 510(k) clearance for Stealth 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 55-day FDA review.

K163440 · First Ray, LLC · Orthopedic device
Download Printable Device Report (PDF)
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Feb 2017
Decision
55d
Days
Class 2
Risk

K163440 is an FDA 510(k) clearance for the Stealth 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 February 1, 2017 after a review of 55 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all First Ray, LLC devices

FDA 510(k) Submission Details - K163440

510(k) Number K163440 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 2016
Decision Date February 01, 2017
Days to Decision 55 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
67d faster than avg
Panel avg: 122d · This submission: 55d
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 K163440.
Sniper Staple System
K162354 · Trilliant Surgical, Ltd. · Apr 2017
EasyClip Xpress
K162321 · Restore Surgical, LLC Dba Instratek · Feb 2017
Memodyn Staple
K161587 · Austin & Associates, Inc./Telos Medical Equipment · Feb 2017
NeoSpan Compression Staple Impant w/instruments
K161426 · In2bones USA, LLC · Oct 2016
EasyStep
K160813 · Stryker GmbH · Jul 2016
First Ray Internal Bone Staple System
K153622 · First Ray, LLC · Apr 2016