Cleared Special

K132226 - METAFIX BLP PLATE, SIZE 31, LEFT, METAFIX BLP PLATE, SIZE 31,RIGHT (FDA 510(k) Clearance)

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K132226 · Merete Medical GmbH · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2013
Decision
23d
Days
Class 2
Risk

K132226 is an FDA 510(k) clearance for the METAFIX BLP PLATE, SIZE 31, LEFT, METAFIX BLP PLATE, SIZE 31,RIGHT. 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 (Berlin, DE). The FDA issued a Cleared decision on August 9, 2013 after a review of 23 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Merete Medical GmbH devices

Submission Details

510(k) Number K132226 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 2013
Decision Date August 09, 2013
Days to Decision 23 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 122d · This submission: 23d
Pathway characteristics
Modification to existing cleared device.

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 1306
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K132226.
OrthoPediatrics® Locking Cannulated Blade Plate System
K260323 · OrthoPediatrics Corp. · Apr 2026
PC Fix System
K260411 · Chest Wall Innovations, Inc. · Apr 2026
POYA 3.5mm Medial Proximal Tibia System
K260228 · Bonebridge AG · Apr 2026
I.T.S. PRS Phoenix II
K260054 · I.T.S. GmbH · Apr 2026
SMART Osteotomy System
K260090 · Actis Medical Pty., Ltd. · Apr 2026
enHAnce PEEK Bunion System
K253718 · Nvision Biomedical Technologies, Inc. · Apr 2026