Cleared Traditional

MEMOMETAL MEMORY STAPLES (K070031) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K070031 · Memometal Technologies · Orthopedic device
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Optimized for regulatory review, auditing and printing
Mar 2007
Decision
75d
Days
Class 2
Risk

K070031 is an FDA 510(k) clearance for the MEMOMETAL MEMORY STAPLES. Classified as Staple, Fixation, Bone (product code JDR), Class II - Special Controls.

Submitted by Memometal Technologies (Bruz, FR). The FDA issued a Cleared decision on March 19, 2007 after a review of 75 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Memometal Technologies devices

Submission Details

510(k) Number K070031 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 2007
Decision Date March 19, 2007
Days to Decision 75 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
47d faster than avg
Panel avg: 122d · This submission: 75d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K070031.
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
ARTHROTEK MENISCAL HYBRID DEVICE
K041988 · Biomet, Inc. · Oct 2004