Biocore9 Humeral Resurfacing System

Q: What is the product code of K193122?

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) K193122 · Biocore9, LLC

Substantially Equivalent

510(k) numberK193122

Submission

Device name: Biocore9 Humeral Resurfacing System
Applicant: Biocore9, LLC
Whippany, NJ, US
Received: November 12, 2019
Decision date: May 15, 2020
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
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
K131298	Exactech Equinoxe Resurfacing Humeral Head SystemHSD · Traditional	Exactech, Inc.	11/26/2013SE
K130759	Humelock II Cementless Shoulder SystemHSD · Traditional	Fx Solutions	11/09/2013SE

510(k)	Device	Decision
K212761	Biocore9 Acetabular Cup SystemLPH · Traditional	05/17/2022SE
K201219	Biocore9 Femoral Head Resurfacing ComponentKXA · Traditional	01/19/2021SE

Questions and answers

When was Biocore9 Humeral Resurfacing System cleared by the FDA?

Biocore9 Humeral Resurfacing System (K193122) received a 510(k) decision of Substantially Equivalent on May 15, 2020, 185 days after the submission was received.

What is the product code of K193122?

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