Cleared Special

K133437 - 1ST MTP PLATE

K133437 is an FDA 510(k) clearance for 1ST MTP PLATE, manufactured by Osteomed. The device is a Class 2 Orthopedic device with product code HRS cleared through the Special 510(k) pathway after a 25-day FDA review.

K133437 · Osteomed · Orthopedic device
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Dec 2013
Decision
25d
Days
Class 2
Risk

K133437 is an FDA 510(k) clearance for the 1ST MTP PLATE. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Osteomed (Addison, US). The FDA issued a Cleared decision on December 2, 2013 after a review of 25 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 Osteomed devices

FDA 510(k) Submission Details - K133437

510(k) Number K133437 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 2013
Decision Date December 02, 2013
Days to Decision 25 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 122d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

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 1016
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K133437.
LOQTEQ DISTAL DORSOLATERAL HUMERUS PLATE
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K132876 · Jeil Medical Corporation · Dec 2013
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K133246 · Zimmer, Inc. · Dec 2013
A.L.P.S. CALCANEAL PLATING SYSTEM
K132898 · Biomet Manufacturing Corp · Nov 2013
LOQTEQ HIGH TIBIA OSTEOTOMY PLATE 4.5
K131782 · Aap Implantate AG · Nov 2013
ARIX HAND SYSTEM
K131566 · Jeil Medical Corporation · Nov 2013