Cleared Traditional

K120787 - MERETE LOCKING BONE PLATE SYSTEM III

K120787 is an FDA 510(k) clearance for MERETE LOCKING BONE PLATE SYSTEM III, manufactured by Merete Medical GmbH. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 257-day FDA review.

K120787 · Merete Medical GmbH · Orthopedic device
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Nov 2012
Decision
257d
Days
Class 2
Risk

K120787 is an FDA 510(k) clearance for the MERETE LOCKING BONE PLATE SYSTEM III. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Merete Medical GmbH (Rye, US). The FDA issued a Cleared decision on November 27, 2012 after a review of 257 days - an extended review 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: 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 Merete Medical GmbH devices

FDA 510(k) Submission Details - K120787

510(k) Number K120787 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 2012
Decision Date November 27, 2012
Days to Decision 257 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
135d slower than avg
Panel avg: 122d · This submission: 257d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HRS Device Classification - Class 2, Special Controls

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 1005
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K120787.
MAXLOCK EXTREME SYSTEM MODEL MXL
K123203 · Orthohelix Surgical Designs, Inc. · Dec 2012
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K121495 · Aap Implantate AG · Dec 2012
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K122334 · Arthrosurface, Inc. · Nov 2012
PICCOLO COMPOSITE PLATE SYSTEM
K120409 · CarboFix Orthopedics , Ltd. · Nov 2012
LOQTEQ DISTAL LATERAL FEMUR PLATE 4.5 (LEFT AND RIGHT VERSION) LOQREQ CORTICAL SCREW 4.5 T25, SELF-TAPPING
K121494 · Aap Implantate AG · Nov 2012
ACUMED PELVIC BONE PLATE SYSTEM
K122538 · Acumed, LLC · Nov 2012