Exactech Equinoxe Resurfacing Humeral Head System

Q: What is the product code of K131298?

The FDA product code is HSD – Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented, a Class II (moderate risk) device regulated under 21 CFR 888.3690.

FDA 510(k) K131298 · Exactech, Inc.

Substantially Equivalent

510(k) numberK131298

Submission

Device name: Exactech Equinoxe Resurfacing Humeral Head System
Applicant: Exactech, Inc.
Gainesville, FL, US
Received: May 6, 2013
Decision date: November 26, 2013
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: HSD – Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Device class: Class II (moderate risk)
Regulation: 21 CFR 888.3690
Specialty: Orthopedic
Implant: Yes

Other 510(k)s with product code HSD

510(k)	Device	Applicant	Decision
K233260	Univers Revers CA Head and AdapterHSD · Traditional	Arthrex, Inc.	02/12/2024SE
K221232	Univers Revers Humeral Cup ImplantHSD · Special	Arthrex, Inc.	05/19/2022SE
K191433	AGILON® XO Shoulder Replacement SystemHSD · Traditional	Implantcast GmbH	11/12/2020SE
K193122	Biocore9 Humeral Resurfacing SystemHSD · Traditional	Biocore9, LLC	05/15/2020SE
K173964	OVOMotion Shoulder Arthroplasty SystemHSD · Traditional	Arthrosurface, Inc.	04/18/2018SE
K161782	Arthrex Univers Revers Shoulder Prosthesis SystemHSD · Traditional	Arthrex, Inc.	11/21/2016SE
K161620	Anatomical Shoulder Domelock Dome centricHSD · Traditional	Zimmer GmbH	11/01/2016SE
K151527	Arthrex Univers Revers CA Heads and AdaptersHSD · Traditional	Arthrex, Inc.	04/19/2016SE
K142942	HemiCAP Humeral Head XL (HHXL) Articular Resurfacing SystemHSD · Special	Arthrosurface, Inc.	12/19/2014SE
K130759	Humelock II Cementless Shoulder SystemHSD · Traditional	Fx Solutions	11/09/2013SE

More from Fx Solutions

510(k)	Device	Decision
K260583	Equinoxe® Shoulder SystemPHX · Traditional	04/14/2026SE
K250713	Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder ImplantsKWT · Traditional	12/01/2025SE
K243448	Equinoxe® Shoulder SystemPHX · Traditional	08/01/2025SE
K243275	Equinoxe® Scapula Fracture SystemHRS · Traditional	06/26/2025SE
K243839	Alteon® HA Femoral StemsMEH · Traditional	03/10/2025SE
K240393	Exactech® TRULIANT® Knee SystemMBH · Traditional	10/03/2024SE
K233482	Equinoxe® Central Screw Baseplate SystemPHX · Traditional	07/18/2024SE
K230717	Exactech® Vantage® Total Ankle SystemHSN · Traditional	10/12/2023SE
K223933	Exactech Equinoxe PHx Fracture System; Exactech EPIC ScrewsHRS · Traditional	09/25/2023SE
K223833	Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter TraysPHX · Traditional	09/14/2023SE

Questions and answers

When was Exactech Equinoxe Resurfacing Humeral Head System cleared by the FDA?

Exactech Equinoxe Resurfacing Humeral Head System (K131298) received a 510(k) decision of Substantially Equivalent on November 26, 2013, 204 days after the submission was received.

What is the product code of K131298?

The FDA product code is HSD – Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented, a Class II (moderate risk) device regulated under 21 CFR 888.3690.