Cleared Traditional

BIOMET VISION FOOTRING SYSTEM (K071395) - FDA 510(k) Clearance

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

K071395 · Biomet Manufacturing Corp · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2007
Decision
49d
Days
Class 2
Risk

K071395 is an FDA 510(k) clearance for the BIOMET VISION FOOTRING SYSTEM. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Biomet Manufacturing Corp (Warsaw, US). The FDA issued a Cleared decision on July 9, 2007 after a review of 49 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 Manufacturing Corp devices

Submission Details

510(k) Number K071395 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 2007
Decision Date July 09, 2007
Days to Decision 49 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
73d faster than avg
Panel avg: 122d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KTT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component
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 - KTT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component

All 175
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K071395.
HOFFMANN LIGHT SYSTEM
K073076 · Howmedica Osteonics Corp. · Feb 2008
VARIAX ELBOW SYSTEM
K073527 · Howmedica Osteonics Corp. · Feb 2008
SIDEKICK RAIL FIXATOR
K080071 · Wrightmedicaltechnologyinc · Feb 2008
OMEGA 3 SUPRACONDYLAR PLATE
K070454 · Howmedica Osteonics Corp. · Apr 2007
DEPUY PEAK FX HIP PLATE
K063509 · DePuy Orthopaedics, Inc. · Jan 2007
OMEGA 3 SYSTEM
K062066 · Howmedica Osteonics Corp. · Aug 2006