Cleared Traditional

MEMOMETAL ANCHORAGE BONE PLATE SYSTEM, MODELS PLSS/PLSL, PLP10/PLP20/PLP30/PLP40/PLP50 (K083447) - FDA 510(k) Clearance

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

K083447 · Memometal Technologies · Orthopedic device
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Feb 2009
Decision
77d
Days
Class 2
Risk

K083447 is an FDA 510(k) clearance for the MEMOMETAL ANCHORAGE BONE PLATE SYSTEM, MODELS PLSS/PLSL, PLP10/PLP20/PLP30/PL.... Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Memometal Technologies (Bruz, FR). The FDA issued a Cleared decision on February 6, 2009 after a review of 77 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 K083447 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2008
Decision Date February 06, 2009
Days to Decision 77 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
45d faster than avg
Panel avg: 122d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HRS Plate, 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 - HRS Plate, Fixation, Bone

All 696
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K083447.
SYNTHES (USA) 3.5MM LOCKING ATTACHMENT PLATES
K083573 · Synthes (Usa) · Mar 2009
ZIMMER UNIVERSAL LOCKING SYSTEM 2.7 MM LOCKING PLATES AND SCREWS ( TIVANIUM TI-6A1-4V ALLOY, CP GRADE TITANIUM)
K083654 · Zimmer, Inc. · Feb 2009
ANATOMIC LOCKING PLATING SYSTEM
K082300 · DePuy Orthopaedics, Inc. · Feb 2009
SYNTHES 4.5 MM VA-LCP CURVED CONDYLAR SYSTEM
K083025 · Synthes (Usa) · Jan 2009
PERI-LOC BONE PLATING AND SCREW SYSTEM
K083032 · Smith & Nephew, Inc. · Jan 2009
SYNTHES 2.7 MM/3.5 MM LCP DISTAL FIBULA PLATES
K083213 · Synthes (Usa) · Dec 2008