Product Code: MBF FDA class 2 21 CFR 888.3670

Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented

Orthopedic

The semi-constrained uncemented metal/polymer shoulder prosthesis is an orthopedic implant designed to replace the glenohumeral joint surfaces in patients with shoulder arthritis or rotator cuff deficiency, providing joint stability through its semi-constrained design and bone ingrowth fixation. It is classified as FDA Class II under 21 CFR 888.3670 within the Orthopedic specialty, requiring 510(k) premarket clearance. The product code is MBF and it carries an implant flag. Full GMP quality system requirements apply.

View on FDA

510(k)s

FEI Numbers

100

Registration Numbers

100

Unique Applicants

Years Active

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Basic Information

Product Code: MBF
Device Class: FDA class 2
Regulation Number: 888.3670
Medical Specialty: Orthopedic
Review Panel: OR
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✓

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 37 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K253592	Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter)	Apr 13, 2026	Substantially Equivalent	Zimmer, Inc.
K251098	Identity Revision Humeral Stems	Aug 11, 2025	Substantially Equivalent	Zimmer, Inc.
K250848	Identity Shoulder System	Jul 02, 2025	Substantially Equivalent	Zimmer, Inc.
K240876	Identity Shoulder System	Jun 12, 2024	Substantially Equivalent	Zimmer, Inc.
K233712	PRIMA Humeral System; PRIMA TT Glenoid	Jan 11, 2024	Substantially Equivalent	Lima Corporate S.P.A.
K231099	SMR Hybrid Glenoid System	Dec 21, 2023	Substantially Equivalent	Lima Corporate S.P.A.
K230831	INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible Glenoid	Nov 13, 2023	Substantially Equivalent	Depuy Ireland UC
K231516	INHANCE Shoulder System, Sterile Single Use Instrumentation	Jul 21, 2023	Substantially Equivalent	Depuy Ireland UC
K223876	SMR Shoulder System	Feb 03, 2023	Substantially Equivalent	Lima Corporate S.P.A.
K222427	PRIMA TT Glenoid	Oct 06, 2022	Substantially Equivalent	Lima Corporate S.P.A.
K213856	Identity Shoulder System	Sep 15, 2022	Substantially Equivalent	Zimmer, Inc.
K212933	INHANCETM Hybrid Anatomic Glenoid Implant	Jun 08, 2022	Substantially Equivalent	Depuy Ireland UC
K220792	SMR Reverse Liner	May 19, 2022	Substantially Equivalent	Lima Corporate S.P.A.
K202716	Ignite Anatomic Shoulder System	May 20, 2021	Substantially Equivalent	Ignite Orthopedics, LLC
K201905	SMR 140° Reverse Humeral Body	Dec 17, 2020	Substantially Equivalent	Lima Corporate S.P.A.
K193038	Comprehensive Shoulder System	Oct 28, 2020	Substantially Equivalent	Biomet Manufacturing Corp
K191963	SMR Finned Short Stems	Oct 10, 2019	Substantially Equivalent	Lima Corporate S.P.A.
K183553	Compress and Mini Compress Anti-Rotation Spindles	Jan 22, 2019	Substantially Equivalent	Biomet, Inc.
K173824	Humeral Short Stem System	Oct 23, 2018	Substantially Equivalent	Shoulder Innovations, Inc.
K163397	SMR Hybrid Glenoid System	Jun 29, 2017	Substantially Equivalent	Lima Corporate S.P.A.
K162068	ARROW Anatomical Porous glenoid	Apr 10, 2017	Substantially Equivalent	Fournitures Hospitalieres Industrie
K140390	TITANIUM VERSA-DIAL HUMERAL HEAD PROSTHESIS	Sep 10, 2014	Substantially Equivalent	Biomet Manufacturing Corp
K130126	SIGNATURE PERSONALIZED PATIENT CARE SYSTEM - GLENOID GUIDE SYSTEM	Aug 06, 2013	Substantially Equivalent	Biomet, Inc.
K123297	COMPRESS SEGMENTAL HUMERAL REPLACEMENT SYSTEM	Nov 20, 2012	Substantially Equivalent	Biomet Manufactuting Corp.
K112905	COMPRESS(R) SEGMENTAL HUMERAL REPLACEMENT SYSTEM	May 24, 2012	Substantially Equivalent	Biomet Orthopedics, LLC
K083439	SYNTHES EPOCA SHOULDER PROSTHESIS SYSTEM	Feb 05, 2009	Substantially Equivalent	Synthes (Usa)
K081448	ENCORE SHOULDER REVISION GLENOID	Sep 30, 2008	Substantially Equivalent	Encore Medical L.P.
K070565	COFIELD TOTAL SHOULDER SYSTEM	May 18, 2007	Substantially Equivalent	Smith & Nephew, Inc.
K063652	GLOBAL AP POROUS COATED HUMERAL STEM	Feb 01, 2007	Substantially Equivalent	DePuy Orthopaedics, Inc.
K060716	VERSA-DIAL HUMERAL HEAD PROSTHESIS	Jun 12, 2006	Substantially Equivalent	Biomet Manufacturing Corp
K060692	COMPREHENSIVE PRIMARY SHOULDER STEMS	May 30, 2006	Substantially Equivalent	Biomet Manufacturing Corp
K043100	BIO-MODULAR SHOULDER SYSTEM WITH HYDROXYAPATITE (HA) COATED GLENOID COMPONENTS	Feb 17, 2005	Substantially Equivalent	Biomet, Inc.
K032895	BI-ANGULAR SHOULDER SYSTEM	Nov 20, 2003	Substantially Equivalent	Biomet, Inc.
K010635	INTERLOK / HA COPELAND RESURFACING HEADS	Aug 20, 2001	Substantially Equivalent	Biomet, Inc.
K011099	GLOBAL FX POROUS-COATED HUMERAL STEM	Jul 06, 2001	Substantially Equivalent	DePuy Orthopaedics, Inc.
K011047	GLOBAL ADVANTAGE HUMERAL STEM WITH POROCOAT	Jun 28, 2001	Substantially Equivalent	DePuy Orthopaedics, Inc.
K844415	POROCOAT NEW JERSEY SHOULDER REPLACEMENT SYS	Jan 23, 1985	Substantially Equivalent	Depuy, Inc.