Cleared Traditional

K132704 - DISTAL RADIUS VOLAR RIM PLATE STANDARD

K132704 is an FDA 510(k) clearance for DISTAL RADIUS VOLAR RIM PLATE STANDARD, manufactured by Biomet. The device is a Class 2 Orthopedic device with product code LXT cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K132704 · Biomet · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2013
Decision
41d
Days
Class 2
Risk

K132704 is an FDA 510(k) clearance for the DISTAL RADIUS VOLAR RIM PLATE STANDARD, DISTAL RADIUS VOLAR RIM PLATE NARROW. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component, Metal Composite (product code LXT), Class II - Special Controls.

Submitted by Biomet (Warsaw, US). The FDA issued a Cleared decision on October 9, 2013 after a review of 41 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Biomet devices

FDA 510(k) Submission Details - K132704

510(k) Number K132704 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 2013
Decision Date October 09, 2013
Days to Decision 41 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
81d faster than avg
Panel avg: 122d · This submission: 41d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LXT Device Classification - Class 2, Special Controls

Product Code LXT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component, Metal Composite
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 - LXT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component, Metal Composite

All 36
Devices cleared under the same product code (LXT) and FDA review panel - the closest regulatory comparables to K132704.
Para-Fix External Fixation System
K230067 · New Paradigm Biomedical · Sep 2023
POLARUS CONNECT
K131636 · Acumed, LLC · Oct 2013
DISTAL VOLAR RADIUS PLATING SYSTEMS
K112345 · Medos International SARL · Oct 2011
STERILE DVR ANATOMIC PLATES VARIOUS CONFIGURATIONS) MODEL (S) 131212001,2, 5-10 2.5MM THREADED AND SMOOTH PEGS, MODEL(S
K090374 · DePuy Orthopaedics, Inc. · Mar 2009
SYNTHES (USA) HYBRID EXTERNAL FIXATOR MODIFICATIONS
K073135 · Synthes (Usa) · Jan 2008
SYNTHES (USA) ELBOW HINGE FIXATOR
K063832 · Synthes (Usa) · Mar 2007