Cleared Traditional

K111746 - COMPREHENSIVE SEGMENTAL REVISION SYSTEM (SRS)

K111746 is an FDA 510(k) clearance for COMPREHENSIVE SEGMENTAL REVISION SYSTEM..., manufactured by Biomet, Inc.. The device is a Class 2 Orthopedic device with product code KWT cleared through the Traditional 510(k) pathway after a 177-day FDA review.

K111746 · Biomet, Inc. · Orthopedic device
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Dec 2011
Decision
177d
Days
Class 2
Risk

K111746 is an FDA 510(k) clearance for the COMPREHENSIVE SEGMENTAL REVISION SYSTEM (SRS). Classified as Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented (product code KWT), Class II - Special Controls.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on December 15, 2011 after a review of 177 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 Biomet, Inc. devices

FDA 510(k) Submission Details - K111746

510(k) Number K111746 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 2011
Decision Date December 15, 2011
Days to Decision 177 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
55d slower than avg
Panel avg: 122d · This submission: 177d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWT Device Classification - Class 2, Special Controls

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 66
Devices cleared under the same product code (KWT) and FDA review panel - the closest regulatory comparables to K111746.
HUMELOCK II CEMENTED SHOULDER SYSTEM
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K121543 · Zimmer, Inc. · Oct 2012
BIGLIANI / FLATOW (R) THE COMPLETE SHOULDER SOLUTION
K110791 · Zimmer, Inc. · Sep 2011
EXACTECH EQUINOXE CUFF TEAR ARTHROPLASTY (CTA) HEAD
K110706 · Exactech, Inc. · May 2011
ANA0TOMICAL SHOULDER TM COMBINED SYSTEM
K103404 · Zimmer GmbH · Mar 2011