Cleared Special

K043061 - THE TRABECULAR METAL GLENOID - BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION, MODEL 4316-XX-XX

K043061 is an FDA 510(k) clearance for THE TRABECULAR METAL GLENOID - BIGLIANI..., manufactured by Zimmer Trabecular. The device is a Class 2 Orthopedic device with product code KWS cleared through the Special 510(k) pathway after a 18-day FDA review.

K043061 · Zimmer Trabecular · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2004
Decision
18d
Days
Class 2
Risk

K043061 is an FDA 510(k) clearance for the THE TRABECULAR METAL GLENOID - BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION.... Classified as Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented (product code KWS), Class II - Special Controls.

Submitted by Zimmer Trabecular (Allendale, US). The FDA issued a Cleared decision on November 23, 2004 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3660 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K043061

510(k) Number K043061 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 2004
Decision Date November 23, 2004
Days to Decision 18 days
Submission Type Special
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
104d faster than avg
Panel avg: 122d · This submission: 18d
Pathway characteristics
Modification to existing cleared device.

KWS Device Classification - Class 2, Special Controls

Product Code KWS Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3660
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 - KWS Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented

All 190
Devices cleared under the same product code (KWS) and FDA review panel - the closest regulatory comparables to K043061.
ANATOMICAL SHOULDER KEELED GLENOID
K051623 · Zimmer GmbH · Jul 2005
GENESIS TOTAL SHOULDER REPLACEMENT, MODEL 100-01-00
K043346 · Genesis Medical LLC · Jan 2005
MODIFICATION TO AEQUALIS SHOULDER FRACTURE SYSTEM
K043077 · Tornier · Dec 2004
EXACTECH EQUINOXE SHOULDER SYSTEM
K042021 · Exactech, Inc. · Oct 2004
AEQUALIS SHOULDER SYSTEM
K041339 · Tornier · Jun 2004
VERSA-DIAL HUMERAL HEAD
K040610 · Biomet Manufacturing, Inc. · Jun 2004
K043061 · THE TRABECULAR METAL GLENOID - BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION, MODEL 4316-XX-XX
Download PDF FDA Summary Zimmer Trabecular