Cleared Special

K112197 - MEMOMETAL INTRA-MEDULLARY BONE FASTENER (FDA 510(k) Clearance)

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

K112197 · Memometal Technologies · Orthopedic device
Download Printable Device Report (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.

View all Memometal Technologies devices

Submission Details

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
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 122d · This submission: 108d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 203
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