Cleared Traditional

K111437 - SYNTHES RIA SYSTEM (EXPANDED INDICATIONS) (FDA 510(k) Clearance)

Class I Orthopedic device.

K111437 · Synthes USA Products, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2011
Decision
78d
Days
Class 1
Risk

K111437 is an FDA 510(k) clearance for the SYNTHES RIA SYSTEM (EXPANDED INDICATIONS). Classified as Reamer (product code HTO), Class I - General Controls.

Submitted by Synthes USA Products, LLC (West Chester, US). The FDA issued a Cleared decision on August 10, 2011 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.4540 - 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 Synthes USA Products, LLC devices

Submission Details

510(k) Number K111437 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 2011
Decision Date August 10, 2011
Days to Decision 78 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
44d faster than avg
Panel avg: 122d · This submission: 78d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HTO Reamer
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 888.4540
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.