Cleared Traditional

Equinoxe? Humeral Reconstruction Prosthesis; Equinoxe? Stemless Shoulder Implants

K250713 · Exactech, Inc. · Orthopedic

Dec 2025

Decision

266d

Days

Class 2

Risk

About This 510(k) Submission

K250713 is an FDA 510(k) clearance for the Equinoxe? Humeral Reconstruction Prosthesis; Equinoxe? Stemless Shoulder Implants, a Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented (Class II — Special Controls, product code KWT), submitted by Exactech, Inc. (Gainesville, US). The FDA issued a Cleared decision on December 1, 2025, 266 days after receiving the submission on March 10, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3650.

Submission Details

510(k) Number	K250713 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 10, 2025
Decision Date	December 01, 2025
Days to Decision	266 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	KWT — Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3650