Cleared Special

K112197 - MEMOMETAL INTRA-MEDULLARY BONE FASTENER

K112197 is an FDA 510(k) clearance for MEMOMETAL INTRA-MEDULLARY BONE FASTENER, manufactured by Memometal Technologies. The device is a Class 2 Orthopedic device with product code HTY cleared through the Special 510(k) pathway after a 108-day FDA review.

K112197 · Memometal Technologies · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2011
Decision
108d
Days
Class 2
Risk

K112197 is an FDA 510(k) clearance for the MEMOMETAL INTRA-MEDULLARY BONE FASTENER. Classified as Pin, Fixation, Smooth (product code HTY), Class II - Special Controls.

Submitted by Memometal Technologies (Bruz, FR). The FDA issued a Cleared decision on November 17, 2011 after a review of 108 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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.

FDA 510(k) Submission Details - K112197

510(k) Number K112197 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2011
Decision Date November 17, 2011
Days to Decision 108 days
Submission Type Special
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
14d faster than avg
Panel avg: 122d · This submission: 108d
Pathway characteristics
Modification to existing cleared device.

HTY Device Classification - Class 2, Special Controls

Product Code HTY Pin, Fixation, Smooth
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - HTY Pin, Fixation, Smooth

All 198
Devices cleared under the same product code (HTY) and FDA review panel - the closest regulatory comparables to K112197.
NEWDEAL INTERPHALANGEAL IMPLANT
K103623 · Newdeal Sas · Mar 2012
ACL TIGHTROPE,ACL TIGHTROPE DUUBLE BUNDLE
K112990 · Arthrex, Inc. · Dec 2011
ARROW-LOK DIGITAL SYSTEM
K112675 · Arrowhead Medical Device Technologies, LLC · Dec 2011
APEX KIRSCHNER WIRES AND STEINMANN PINS
K112254 · Apex Tools & Orthopedics Co. · Oct 2011
PCL TIGHTROPE
K110123 · Arthrex, Inc. · Apr 2011
VERTICOR K-WIRE SYSTEM
K110047 · Verticor, Ltd. · Feb 2011
K112197 · MEMOMETAL INTRA-MEDULLARY BONE FASTENER
Download PDF FDA Summary Memometal Technologies