Cleared Traditional

K102072 - MEMOMETAL IMPLANTS (K-SNAP & TI-FUSE)

K102072 is an FDA 510(k) clearance for MEMOMETAL IMPLANTS (K-SNAP & TI-FUSE), manufactured by Memometal Technologies. The device is a Class 2 Orthopedic device with product code HTY cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K102072 · Memometal Technologies · Orthopedic device
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Nov 2010
Decision
103d
Days
Class 2
Risk

K102072 is an FDA 510(k) clearance for the MEMOMETAL IMPLANTS (K-SNAP & TI-FUSE). 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 3, 2010 after a review of 103 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. 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 Memometal Technologies devices

FDA 510(k) Submission Details - K102072

510(k) Number K102072 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 2010
Decision Date November 03, 2010
Days to Decision 103 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
19d faster than avg
Panel avg: 122d · This submission: 103d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 119
Devices cleared under the same product code (HTY) and FDA review panel - the closest regulatory comparables to K102072.
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STRYKER SONICPIN SYSTEM
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K092038 · Medartis AG · Sep 2009