Cleared Traditional

K170923 - JAWS(TM) Nitinol Staple System

K170923 is the FDA 510(k) clearance for JAWS(TM) Nitinol Staple System by Paragon 28. It is a Class 2 Orthopedic device (product code JDR) cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K170923 · Paragon 28 · Orthopedic device
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Jul 2017
Decision
117d
Days
Class 2
Risk

K170923 is an FDA 510(k) clearance for the JAWS(TM) Nitinol Staple System. Classified as Staple, Fixation, Bone (product code JDR), Class II - Special Controls.

Submitted by Paragon 28 (Englewood, US). The FDA issued a Cleared decision on July 24, 2017 after a review of 117 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 Paragon 28 devices

Submission Details

510(k) Number K170923 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 2017
Decision Date July 24, 2017
Days to Decision 117 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
5d faster than avg
Panel avg: 122d · This submission: 117d
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 100
Devices cleared under the same product code (JDR) and FDA review panel - the closest regulatory comparables to K170923.
Orbitum Bone Staple Implant, X and VI
K173693 · Orthovestments, LLC · Feb 2018
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