Cleared Traditional

K160813 - EasyStep

K160813 is an FDA 510(k) clearance for EasyStep, manufactured by Stryker GmbH. The device is a Class 2 Orthopedic device with product code JDR cleared through the Traditional 510(k) pathway after a 124-day FDA review.

K160813 · Stryker GmbH · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2016
Decision
124d
Days
Class 2
Risk

K160813 is an FDA 510(k) clearance for the EasyStep. Classified as Staple, Fixation, Bone (product code JDR), Class II - Special Controls.

Submitted by Stryker GmbH (Mahwah, US). The FDA issued a Cleared decision on July 26, 2016 after a review of 124 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 Stryker GmbH devices

FDA 510(k) Submission Details - K160813

510(k) Number K160813 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 2016
Decision Date July 26, 2016
Days to Decision 124 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
2d slower than avg
Panel avg: 122d · This submission: 124d
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 197
Devices cleared under the same product code (JDR) and FDA review panel - the closest regulatory comparables to K160813.
Memodyn Staple
K161587 · Austin & Associates, Inc./Telos Medical Equipment · Feb 2017
Stealth Staple System
K163440 · First Ray, LLC · Feb 2017
NeoSpan Compression Staple Impant w/instruments
K161426 · In2bones USA, LLC · Oct 2016
First Ray Internal Bone Staple System
K153622 · First Ray, LLC · Apr 2016
OS2(R)-VP Varisation Staple
K153770 · In2bones Sas · Mar 2016
OS2-C Compression Staple
K153395 · In2bones Sas · Feb 2016