Cleared Traditional

K093820 - SUBFIX ARTHROEREISIS IMPLANT, MODELS SUT0065, SUT0080, SUT0090, SUT0100, SUT0115

K093820 is an FDA 510(k) clearance for SUBFIX ARTHROEREISIS IMPLANT, manufactured by Memometal Technologies. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K093820 · Memometal Technologies · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2010
Decision
156d
Days
Class 2
Risk

K093820 is an FDA 510(k) clearance for the SUBFIX ARTHROEREISIS IMPLANT, MODELS SUT0065, SUT0080, SUT0090, SUT0100, SUT0115. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Memometal Technologies (Bruz, FR). The FDA issued a Cleared decision on May 19, 2010 after a review of 156 days - an extended review cycle.

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 - K093820

510(k) Number K093820 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 2009
Decision Date May 19, 2010
Days to Decision 156 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
34d slower than avg
Panel avg: 122d · This submission: 156d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HWC Device Classification - Class 2, Special Controls

Product Code HWC Screw, Fixation, Bone
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 - HWC Screw, Fixation, Bone

All 767
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K093820.
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K100457 · Arthrocare Corp. · Mar 2010