Cleared Special

K162903 - Exactech Equinoxe Humeral Reconstructio...

K162903 is the FDA 510(k) clearance for Exactech Equinoxe Humeral Reconstructio... by Exactech, Inc.. It is a Class 2 Orthopedic device (product code KWT) cleared through the Special 510(k) pathway after a 133-day FDA review.

K162903 · Exactech, Inc. · Orthopedic device
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Feb 2017
Decision
133d
Days
Class 2
Risk

K162903 is an FDA 510(k) clearance for the Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-Small Proximal Bodies. 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 February 27, 2017 after a review of 133 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. 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Exactech, Inc. devices

Submission Details

510(k) Number K162903 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 2016
Decision Date February 27, 2017
Days to Decision 133 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
11d slower than avg
Panel avg: 122d · This submission: 133d
Pathway characteristics
Modification to existing cleared device.

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 59
Devices cleared under the same product code (KWT) and FDA review panel - the closest regulatory comparables to K162903.
Catalyst CSR Press-Fit Humeral Components
K182500 · Catalyst Orthoscience, Inc. · Jan 2019
Catalyst CSR Shoulder System
K181287 · Catalyst Orthoscience, Inc. · Jul 2018
Catalyst CSR 3 Peg Glenoids
K173812 · Catalyst Orthoscience, Inc. · Mar 2018
SMR Shoulder System
K161476 · Lima Corporate S.P.A. · Jun 2016
Equinoxe Mega Prosthesis
K143659 · Exactech, Inc. · Apr 2015
ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM, BASE PLATES & HUMERAL STEMS
K121543 · Zimmer, Inc. · Oct 2012