Cleared Traditional

METAGEN HIGH TIBIAL OSTEOTOMY SYSTEM (K963700) - FDA 510(k) Clearance

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

K963700 · Metagen, LLC · Orthopedic device
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Feb 1997
Decision
149d
Days
Class 2
Risk

K963700 is an FDA 510(k) clearance for the METAGEN HIGH TIBIAL OSTEOTOMY SYSTEM. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Metagen, LLC (Menomonie, US). The FDA issued a Cleared decision on February 12, 1997 after a review of 149 days - within the typical 510(k) review window.

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 Metagen, LLC devices

Submission Details

510(k) Number K963700 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 1996
Decision Date February 12, 1997
Days to Decision 149 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
27d slower than avg
Panel avg: 122d · This submission: 149d
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 K963700.
LACTOSORB TRAUMA PLATING SYSTEM
K971870 · Biomet, Inc. · Aug 1997
OSTEO COMPRESSION CONDYLE SCREW SYSTEM
K971321 · Osteonics Corp. · Jul 1997
SYNTHES TITANIUM (TI) ALLOY HIGH TIBIAL OSTEOTOMY (HTO) SYSTEM
K963325 · Synthes (Usa) · Mar 1997
SYNTHES HIGH TIBIAL OSTEOTOMY (HTO) SYSTEM
K962894 · Synthes (Usa) · Dec 1996
SYNTHES TITANIUM ALLOY VOLAR DISTAL RADIUS PLATE (TI ALLOY VDRP) SYSTEM
K963798 · Synthes (Usa) · Nov 1996
SYNTHES DORSAL DISTAL RADIUS PLATE (DDRP) SYSTEM
K962616 · Synthes (Usa) · Sep 1996