Cleared Special

Memodyn Staple (K161587) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K161587 · Austin & Associates, Inc./Telos Medical Equipment · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2017
Decision
238d
Days
Class 2
Risk

K161587 is an FDA 510(k) clearance for the Memodyn Staple. Classified as Staple, Fixation, Bone (product code JDR), Class II - Special Controls.

Submitted by Austin & Associates, Inc./Telos Medical Equipment (Millersville, US). The FDA issued a Cleared decision on February 1, 2017 after a review of 238 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Austin & Associates, Inc./Telos Medical Equipment devices

Submission Details

510(k) Number K161587 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 2016
Decision Date February 01, 2017
Days to Decision 238 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
116d slower than avg
Panel avg: 122d · This submission: 238d
Pathway characteristics
Modification to existing cleared device.

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 65
Devices cleared under the same product code (JDR) and FDA review panel - the closest regulatory comparables to K161587.
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
ARTHREX COMPRESSION STAPLE
K080111 · Arthrex, Inc. · Feb 2008
MEMORY STAPLE
K060746 · DePuy Orthopaedics, Inc. · May 2006
COMPRESSION STAPLE AND SIMPLE STAPLE
K043059 · Wrightmedicaltechnologyinc · Jan 2005