Cleared Traditional

K070033 - MEMOMETAL VARISATION, MODELS AV26-08, AV26-10, AV90-08 AND AV90-10

K070033 is an FDA 510(k) clearance for MEMOMETAL VARISATION, manufactured by Memometal Technologies. The device is a Class 2 Orthopedic device with product code JDR cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K070033 · Memometal Technologies · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2007
Decision
75d
Days
Class 2
Risk

K070033 is an FDA 510(k) clearance for the MEMOMETAL VARISATION, MODELS AV26-08, AV26-10, AV90-08 AND AV90-10. 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.

FDA 510(k) Submission Details - K070033

510(k) Number K070033 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
Combination Product No
PCCP Authorized No
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.

JDR Device Classification - Class 2, Special Controls

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 223
Devices cleared under the same product code (JDR) and FDA review panel - the closest regulatory comparables to K070033.
MINI QUICKANCHOR AND QUICKANCHOR PLUS WITH ORTHOCORD
K071257 · Depuy Mitek, A Johnson & Johnson Company · Jun 2007
NEXFIX COMPRESSION STAPLE
K070688 · Nexa Orthopedics, Inc. · May 2007
MEMOMETAL MEMORY STAPLES
K070031 · Memometal Technologies · Mar 2007
ADJUST-RIGHT FIXATION DEVICES
K062734 · Valpo Orthopedic Technology, Inc. · Nov 2006
PANALOK QUICKANCHOR PLUS, PANALOK RC QUICKANCHOR PLUS DUAL SUTURE, PANALOK ANCHOR
K063273 · Depuy Miltek, A Johnson & Johnson Co. · Nov 2006
ARTHROTEK MAXFIRE MENISCAL REPAIR DEVICE
K061776 · Arthrotek, Inc. · Sep 2006
K070033 · MEMOMETAL VARISATION, MODELS AV26-08, AV26-10, AV90-08 AND AV90-10
Download PDF FDA Summary Memometal Technologies