Cleared Traditional

K133939 - MODIFIED DISTAL RADIUS PLATING SYSTEM

K133939 is an FDA 510(k) clearance for MODIFIED DISTAL RADIUS PLATING SYSTEM, manufactured by Biomet. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K133939 · Biomet · Orthopedic device
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Apr 2014
Decision
99d
Days
Class 2
Risk

K133939 is an FDA 510(k) clearance for the MODIFIED DISTAL RADIUS PLATING 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 Biomet (Warsaw, US). The FDA issued a Cleared decision on April 1, 2014 after a review of 99 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 Biomet devices

FDA 510(k) Submission Details - K133939

510(k) Number K133939 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2013
Decision Date April 01, 2014
Days to Decision 99 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
23d faster than avg
Panel avg: 122d · This submission: 99d
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 1046
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K133939.
LOCKING BONE PLATE STYLE 14, METAFIX LOCKING SCREW 3.8, MERETE CANNULATED PCS 3.0
K140069 · Merete Medical GmbH · Apr 2014
FRAGMENT PLATE SYSTEM
K140372 · Skeletal Dynamics, LLC · Apr 2014
VARIAX 2 SYSTEM
K140376 · Stryker Trauma AG · Apr 2014
VARIAX CLAVICLE HOOK PLATE
K140259 · Stryker Trauma AG · Apr 2014
CHARLOTTE CLAW PLATE SYSTEM
K133715 · Wrightmedicaltechnologyinc · Feb 2014
EXTRIMILOCK ANKLE PLATING SYSTEM
K133691 · Osteomed LP · Feb 2014