Cleared Traditional

K162354 - Sniper Staple System

K162354 is an FDA 510(k) clearance for Sniper Staple System, manufactured by Trilliant Surgical, Ltd.. The device is a Class 2 Orthopedic device with product code JDR cleared through the Traditional 510(k) pathway after a 240-day FDA review.

K162354 · Trilliant Surgical, Ltd. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2017
Decision
240d
Days
Class 2
Risk

K162354 is an FDA 510(k) clearance for the Sniper Staple System. Classified as Staple, Fixation, Bone (product code JDR), Class II - Special Controls.

Submitted by Trilliant Surgical, Ltd. (Houston, US). The FDA issued a Cleared decision on April 20, 2017 after a review of 240 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.

FDA 510(k) Submission Details - K162354

510(k) Number K162354 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 2016
Decision Date April 20, 2017
Days to Decision 240 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
118d slower than avg
Panel avg: 122d · This submission: 240d
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 220
Devices cleared under the same product code (JDR) and FDA review panel - the closest regulatory comparables to K162354.
Compressyn™ Staple
K171473 · Dallen Medical, Inc. · Nov 2017
JAWS(TM) Nitinol Staple System
K170923 · Paragon 28 · Jul 2017
EPIC Extremely Small Staple
K163226 · Epic Extremely, LLC · May 2017
EasyClip Xpress
K162321 · Restore Surgical, LLC Dba Instratek · Feb 2017
Memodyn Staple
K161587 · Austin & Associates, Inc./Telos Medical Equipment · Feb 2017
Stealth Staple System
K163440 · First Ray, LLC · Feb 2017