Cleared Special

K162903 - Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-Small Proximal Bodies

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

K162903 · Exactech, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K162903

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.

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 71
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K150730 · Zimmer · Jun 2015
K162903 · Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-Small Proximal Bodies
Download PDF FDA Summary Exactech, Inc.