Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
FDA product code MBF · Class II (moderate risk) · 21 CFR 888.3670 · Orthopedic
37510(k) clearances
0PMA approvals
20recalls
Implantimplanted device
Manufacturers
- Lima Corporate S.P.A. 8
- Biomet, Inc. 5
- Zimmer, Inc. 5
- Biomet Manufacturing Corp 4
- DePuy Orthopaedics, Inc. 3
- Depuy Ireland UC 3
- Depuy, Inc. 1
- Smith & Nephew, Inc. 1
- Encore Medical L.P. 1
- Synthes (Usa) 1
- Biomet Orthopedics, Inc. 1
- Biomet Manufactuting Corp. 1
- Fournitures Hospitalieres Industrie 1
- Shoulder Innovations, Inc. 1
- Ignite Orthopedics, LLC 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253592 | Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral…MBF · Traditional | Zimmer, Inc. | 04/13/2026SE |
| K251098 | Identity Revision Humeral StemsMBF · Traditional | Zimmer, Inc. | 08/11/2025SE |
| K250848 | Identity Shoulder SystemMBF · Traditional | Zimmer, Inc. | 07/02/2025SE |
| K240876 | Identity Shoulder SystemMBF · Traditional | Zimmer, Inc. | 06/12/2024SE |
| K233712 | PRIMA Humeral System; PRIMA TT GlenoidMBF · Traditional | Lima Corporate S.P.A. | 01/11/2024SE |
| K231099 | SMR Hybrid Glenoid SystemMBF · Traditional | Lima Corporate S.P.A. | 12/21/2023SE |
| K230831 | INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible GlenoidMBF · Traditional | Depuy Ireland UC | 11/13/2023SE |
| K231516 | INHANCE Shoulder System, Sterile Single Use InstrumentationMBF · Traditional | Depuy Ireland UC | 07/21/2023SE |
| K223876 | SMR Shoulder SystemMBF · Traditional | Lima Corporate S.P.A. | 02/03/2023SE |
| K222427 | PRIMA TT GlenoidMBF · Traditional | Lima Corporate S.P.A. | 10/06/2022SE |
| K213856 | Identity Shoulder SystemMBF · Traditional | Zimmer, Inc. | 09/15/2022SE |
| K212933 | INHANCETM Hybrid Anatomic Glenoid ImplantMBF · Traditional | Depuy Ireland UC | 06/08/2022SE |
| K220792 | SMR Reverse LinerMBF · Traditional | Lima Corporate S.P.A. | 05/19/2022SE |
| K202716 | Ignite Anatomic Shoulder SystemMBF · Traditional | Ignite Orthopedics, LLC | 05/20/2021SE |
| K201905 | SMR 140° Reverse Humeral BodyMBF · Traditional | Lima Corporate S.P.A. | 12/17/2020SE |
| K193038 | Comprehensive Shoulder SystemMBF · Traditional | Biomet Manufacturing Corp | 10/28/2020SE |
| K191963 | SMR Finned Short StemsMBF · Traditional | Lima Corporate S.P.A. | 10/10/2019SE |
| K183553 | Compress and Mini Compress Anti-Rotation SpindlesMBF · Traditional | Biomet, Inc. | 01/22/2019SE |
| K173824 | Humeral Short Stem SystemMBF · Traditional | Shoulder Innovations, Inc. | 10/23/2018SE |
| K163397 | SMR Hybrid Glenoid SystemMBF · Traditional | Lima Corporate S.P.A. | 06/29/2017SE |
| K162068 | ARROW Anatomical Porous glenoidMBF · Traditional | Fournitures Hospitalieres Industrie | 04/10/2017SE |
| K140390 | Titanium Versa-Dial Humeral Head ProsthesisMBF · Traditional | Biomet Manufacturing Corp | 09/10/2014SE |
| K130126 | Signature Personalized Patient Care System - Glenoid Guide SystemMBF · Traditional | Biomet, Inc. | 08/06/2013SE |
| K123297 | Compress Segmental Humeral Replacement SystemMBF · Special | Biomet Manufactuting Corp. | 11/20/2012SE |
| K112905 | Compress(R) Segmental Humeral Replacement SystemMBF · Traditional | Biomet Orthopedics, LLC | 05/24/2012SE |
| K083439 | Synthes Epoca Shoulder Prosthesis SystemMBF · Traditional | Synthes (Usa) | 02/05/2009SE |
| K081448 | Encore Shoulder Revision GlenoidMBF · Traditional | Encore Medical L.P. | 09/30/2008SE |
| K070565 | Cofield Total Shoulder SystemMBF · Abbreviated | Smith & Nephew, Inc. | 05/18/2007SE |
| K063652 | Global Ap Porous Coated Humeral StemMBF · Traditional | DePuy Orthopaedics, Inc. | 02/01/2007SE |
| K060716 | Versa-Dial Humeral Head ProsthesisMBF · Traditional | Biomet Manufacturing Corp | 06/12/2006SE |
| K060692 | Comprehensive Primary Shoulder StemsMBF · Traditional | Biomet Manufacturing Corp | 05/30/2006SE |
| K043100 | Bio-Modular Shoulder System with Hydroxyapatite (Ha) Coated Glenoid ComponentsMBF · Special | Biomet, Inc. | 02/17/2005SE |
| K032895 | Bi-Angular Shoulder SystemMBF · Traditional | Biomet, Inc. | 11/20/2003SE |
| K010635 | Interlok / Ha Copeland Resurfacing HeadsMBF · Traditional | Biomet, Inc. | 08/20/2001SE |
| K011099 | Global FX Porous-Coated Humeral StemMBF · Traditional | DePuy Orthopaedics, Inc. | 07/06/2001SE |
| K011047 | Global Advantage Humeral Stem with PorocoatMBF · Traditional | DePuy Orthopaedics, Inc. | 06/28/2001SE |
| K844415 | Porocoat New Jersey Shoulder Replacement SysMBF · Traditional | Depuy, Inc. | 01/23/1985SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1403-2025 Class II | Comprehensive Shoulder Stem, Comprehensive Micro Stem, Comprehensive Mini Stem…Five complaints received where surgeon was unable to remove and/or connect the inserter with the stem during… | Zimmer Orthopedics Manfacturing… | 03/03/2025Open, Classified |
| Z-0726-2024 Class II | PRIMA TT Glenoid Monoblock/Modular reverse TT baseplates: Description/Product Code:…Potential for baseplate peripheral holes to be out of specification due to a manufacturing issue, which… | Limacorporate S.p.A | 08/29/2023Open, Classified |
| Z-2010-2023 Class II | REF 1975.14.800, Prima TT Genoid Modular Reverse TT Baseplate, Sterile RDue to manufacturing issue, their is a potential for peripheral holes to be out of specification. | Limacorporate S.p.A | 05/30/2023Open, Classified |
| Z-2009-2023 Class II | REF 1975.14.500, Prima TT Genoid Monoblock Reverse TT Baseplate, STERILE RDue to manufacturing issue, their is a potential for peripheral holes to be out of specification. | Limacorporate S.p.A | 05/30/2023Open, Classified |
| Z-1317-2023 Class II | SMR TT Hybrid glenoid Std - Peg S, REF: 1379.59.210Shoulder glenoid fossa prosthesis was manufactured without tantalum markers so in the absence of the… | Limacorporate S.p.A | 02/21/2023Open, Classified |
| Z-0677-2022 Class II | Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 15 MM, 83 MM Long Item…The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating.… | Biomet, Inc. | 01/07/2022Terminated |
| Z-0676-2022 Class II | Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 13 MM, 83 MM Long Item…The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating.… | Biomet, Inc. | 01/07/2022Terminated |
| Z-0675-2022 Class II | Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 12 MM, 83 MM Long Item…The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating.… | Biomet, Inc. | 01/07/2022Terminated |
| Z-0674-2022 Class II | Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 11 MM, 83 MM Long Item…The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating.… | Biomet, Inc. | 01/07/2022Terminated |
| Z-0673-2022 Class II | Comprehensive Shoulder System Primary Shoulder Stem, Micro Length, Porous Plasma, 18 MM…The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating.… | Biomet, Inc. | 01/07/2022Terminated |
| Z-0672-2022 Class II | Comprehensive Shoulder System Primary Shoulder Stem, Micro Length, Porous Plasma, 14 MM…The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating.… | Biomet, Inc. | 01/07/2022Terminated |
| Z-0671-2022 Class II | Comprehensive Shoulder System Primary Shoulder Stem, Micro Length, Porous Plasma, 11 MM…The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating.… | Biomet, Inc. | 01/07/2022Terminated |
| Z-0670-2022 Class II | Arcos Modular Revision Hip System, Standard Cone Prox Body, Porous Plasma,Size A, 60 MM…The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating.… | Biomet, Inc. | 01/07/2022Terminated |
| Z-1543-2020 Class II | Comprehensive Shoulder System Mini Humeral Stem 9mm,, Model No. 113629 - Product Usage:…A 15mm Shoulder Mini Humeral Stem was misidentified as a 9mm Shoulder Mini Humeral Stem. | Biomet, Inc. | 02/17/2020Terminated |
| Z-0533-2020 Class II | BIOMOD PORCOAT HA GLENTRAY; Custom Shoulder Products Item Nos. PM0000097 PM555140…Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. | Zimmer Biomet, Inc. | 08/21/2019Terminated |
| Z-0527-2020 Class II | Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641 11-114642 11-114643…Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. | Zimmer Biomet, Inc. | 08/21/2019Terminated |
| Z-0591-2019 Class II | Comprehensive Mini Stem, Item No. 113631:Zimmer Biomet is conducting a lot specific medical device recall for two lots of the Orthopedic Salvage… | Zimmer Biomet, Inc. | 10/10/2018Terminated |
| Z-0299-2018 Class II | COMP PRIMARY STEM 8MM MINI, model # 113628Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and… | Zimmer Biomet, Inc. | 06/05/2017Terminated |
| Z-1755-2015 Class III | Comprehensive Shoulder System, 4 mm, 122 mm long, Primary Shoulder Stem, Ti-6Al-4V…Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains incorrect… | Biomet, Inc. | 04/16/2015Terminated |
| Z-1992-2009 | Turon Revision Glenoid Poly Liner. The Metal Backed Revision Glenoid is a two piece…Product devices used for testing are not identical to what was manufactured. Under certain circumstances… | Encore Medical, Lp | 07/20/2009Terminated |