Cleared Traditional

K143659 - Equinoxe Mega Prosthesis

K143659 is an FDA 510(k) clearance for Equinoxe Mega Prosthesis, manufactured by Exactech, Inc.. The device is a Class 2 Orthopedic device with product code KWT cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K143659 · Exactech, Inc. · Orthopedic device
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Apr 2015
Decision
107d
Days
Class 2
Risk

K143659 is an FDA 510(k) clearance for the Equinoxe Mega Prosthesis. Classified as Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented (product code KWT), Class II - Special Controls.

Submitted by Exactech, Inc. (Gainesville, US). The FDA issued a Cleared decision on April 9, 2015 after a review of 107 days - within the typical 510(k) review window.

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 Exactech, Inc. devices

FDA 510(k) Submission Details - K143659

510(k) Number K143659 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2014
Decision Date April 09, 2015
Days to Decision 107 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
15d faster than avg
Panel avg: 122d · This submission: 107d
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 K143659.
SMR Shoulder System
K161476 · Lima Corporate S.P.A. · Jun 2016
Catalyst CSR Shoulder System
K152825 · Catalyst Orthoscience, LLC · May 2016
Zimmer PSI Shoulder System
K150730 · Zimmer · Jun 2015
HUMELOCK II CEMENTED SHOULDER SYSTEM
K140071 · Fx Solutions · Jul 2014
HUMELOCK II CEMENTED SHOULDER SYSTEM
K123814 · Fx Solutions · Aug 2013
ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM, BASE PLATES & HUMERAL STEMS
K121543 · Zimmer, Inc. · Oct 2012