Cleared Traditional

K060545 - UNITY HUMERAL PLATE

K060545 is the FDA 510(k) clearance for UNITY HUMERAL PLATE by Tornier. It is a Class 2 Orthopedic device (product code KTT) cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K060545 · Tornier · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2006
Decision
51d
Days
Class 2
Risk

K060545 is an FDA 510(k) clearance for the UNITY HUMERAL PLATE. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Tornier (St. Ismier, FR). The FDA issued a Cleared decision on April 21, 2006 after a review of 51 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 Tornier devices

Submission Details

510(k) Number K060545 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2006
Decision Date April 21, 2006
Days to Decision 51 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 122d · This submission: 51d
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 271
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K060545.
DEPUY PEAK FX HIP PLATE
K063509 · DePuy Orthopaedics, Inc. · Jan 2007
AEQUALIS HUMERAL PLATE
K063551 · Tornier · Dec 2006
OMEGA 3 SYSTEM
K062066 · Howmedica Osteonics Corp. · Aug 2006
VARIAX LOCKING PLATE SYSTEM
K060613 · Howmedica Osteonics Corp. · Apr 2006
REPROCESSED EXTERNAL FIXATION DEVICES
K052918 · Alliance Medical Corp. · Jan 2006
HOFFMANN II MRI EXTERNAL FIXATION SYSTEM
K053472 · Howmedica Osteonics Corp. · Jan 2006