Cleared Traditional

BIGLIANI / FLATOW (R) THE COMPLETE SHOULDER SOLUTION (K110791) - FDA 510(k) Clearance

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

K110791 · Zimmer, Inc. · Orthopedic device
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Sep 2011
Decision
165d
Days
Class 2
Risk

K110791 is an FDA 510(k) clearance for the BIGLIANI / FLATOW (R) THE COMPLETE SHOULDER SOLUTION. Classified as Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented (product code KWT), Class II - Special Controls.

Submitted by Zimmer, Inc. (Warsaw, US). The FDA issued a Cleared decision on September 2, 2011 after a review of 165 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3650 - 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 Zimmer, Inc. devices

Submission Details

510(k) Number K110791 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 2011
Decision Date September 02, 2011
Days to Decision 165 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
43d slower than avg
Panel avg: 122d · This submission: 165d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KWT Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3650
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 - KWT Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented

All 42
Devices cleared under the same product code (KWT) and FDA review panel - the closest regulatory comparables to K110791.
Equinoxe Mega Prosthesis
K143659 · Exactech, Inc. · Apr 2015
ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM, BASE PLATES & HUMERAL STEMS
K121543 · Zimmer, Inc. · Oct 2012
COMPREHENSIVE SEGMENTAL REVISION SYSTEM (SRS)
K111746 · Biomet, Inc. · Dec 2011
EXACTECH EQUINOXE CUFF TEAR ARTHROPLASTY (CTA) HEAD
K110706 · Exactech, Inc. · May 2011
ZIMMER TRABECULAR METAL HUMERAL STEM, SIZES 6MM AND 8MM
K050761 · Zimmer, Inc. · Apr 2005
DISCOVERY-MOSAIC TOTAL HUMERUS SYSTEM
K043505 · Biomet, Inc. · Feb 2005