Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
FDA product code KWT · Class II (moderate risk) · 21 CFR 888.3650 · Orthopedic
72510(k) clearances
0PMA approvals
27recalls
Implantimplanted device
Manufacturers
- Biomet, Inc. 11
- Zimmer, Inc. 8
- Intermedics Orthopedics 5
- Catalyst Orthoscience, Inc. 5
- Kirschner Medical Corp. 4
- Exactech, Inc. 4
- Depuy, Inc. 3
- Shoulder Innovations, Inc. 3
- Implantcast GmbH 3
- Biomet Orthopedics, Inc. 3
- Howmedica Corp. 2
- Fx Solutions 2
- Lima-Lto S.P.A. 2
- 3M Company 2
- Stelkast Company 1
- Argomedical AG 1
- Encore Orthopedics, Inc. 1
- DePuy Orthopaedics, Inc. 1
- Tornier, Inc. 1
- Osteo Technology, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262173 | N22 Offset Humeral HeadKWT · Traditional | Shoulder Innovations, Inc. | 09/08/2026SE |
| K250713 | Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder ImplantsKWT · Traditional | Exactech, Inc. | 12/01/2025SE |
| K251686 | Tornier Humeral Reconstruction System Max (Tornier HRS Max)KWT · Traditional | Tornier, Inc. | 10/30/2025SE |
| K241944 | AGILON® XO Shoulder Replacement SystemKWT · Traditional | Implantcast GmbH | 03/10/2025SE |
| K241817 | InSet Total Shoulder SystemKWT · Traditional | Shoulder Innovations, Inc. | 02/11/2025SE |
| K231657 | AGILON® XO Shoulder Replacement SystemKWT · Traditional | Implantcast GmbH | 02/16/2024SE |
| K223631 | Comprehensive Segmental Revision System(SRS)KWT · Traditional | Biomet Orthopedics | 07/12/2023SE |
| K222482 | AGILON XO Shoulder SystemKWT · Traditional | Implantcast GmbH | 09/28/2022SE |
| K210899 | LINK Embrace Shoulder System- Anatomical ConfigurationKWT · Traditional | Waldemar Link GmbH & Co. KG | 06/21/2021SE |
| K191698 | TiN Coated Humeral HeadKWT · Traditional | Fx Shoulder USA, Inc. | 07/16/2020SE |
| K192365 | Shoulder Innovations Total Shoulder SystemKWT · Special | Shoulder Innovations, Inc. | 11/29/2019SE |
| K191811 | Catalyst OrthoScience CSR Shoulder SystemKWT · Special | Catalyst Orthoscience, Inc. | 09/11/2019SE |
| K190595 | Signature ONE SystemKWT · Traditional | Orthosoft Inc (D/B/A Zimmer Cas) | 06/05/2019SE |
| K182500 | Catalyst CSR Press-Fit Humeral ComponentsKWT · Traditional | Catalyst Orthoscience, Inc. | 01/11/2019SE |
| K181287 | Catalyst CSR Shoulder SystemKWT · Special | Catalyst Orthoscience, Inc. | 07/12/2018SE |
| K173812 | Catalyst CSR 3 Peg GlenoidsKWT · Traditional | Catalyst Orthoscience, Inc. | 03/09/2018SE |
| K162903 | Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-Small Proximal BodiesKWT · Special | Exactech, Inc. | 02/27/2017SE |
| K161476 | SMR Shoulder SystemKWT · Special | Lima Corporate S.P.A. | 06/24/2016SE |
| K152825 | Catalyst CSR Shoulder SystemKWT · Traditional | Catalyst Orthoscience, LLC | 05/11/2016SE |
| K150730 | Zimmer PSI Shoulder SystemKWT · Traditional | Zimmer | 06/16/2015SE |
| K143659 | Equinoxe Mega ProsthesisKWT · Traditional | Exactech, Inc. | 04/09/2015SE |
| K140071 | Humelock II Cemented Shoulder SystemKWT · Traditional | Fx Solutions | 07/28/2014SE |
| K123814 | Humelock II Cemented Shoulder SystemKWT · Traditional | Fx Solutions | 08/13/2013SE |
| K121543 | Zimmer Trabecular Metal Reverse Shoulder System, Base Plates & Humeral StemsKWT · Traditional | Zimmer, Inc. | 10/11/2012SE |
| K111746 | Comprehensive Segmental Revision System (SRS)KWT · Traditional | Biomet, Inc. | 12/15/2011SE |
| K110791 | Bigliani / Flatow (R) the Complete Shoulder SolutionKWT · Traditional | Zimmer, Inc. | 09/02/2011SE |
| K110706 | Exactech Equinoxe Cuff Tear Arthroplasty (Cta) HeadKWT · Traditional | Exactech, Inc. | 05/17/2011SE |
| K103404 | ANA0TOMICAL Shoulder TM Combined SystemKWT · Traditional | Zimmer GmbH | 03/15/2011SE |
| K101263 | Lima-Lto SMR Shoulder System - Finned Humeral Stems, Lima-Lto SMR Shoulder System -…KWT · Traditional | Lima-Lto S.P.A. | 01/28/2011SE |
| K100858 | Lima-Lio SMR Shoulder System - Humeral Stems, Lima-Lio SMR Shoulder System - Humeral…KWT · Traditional | Lima-Lto S.P.A. | 12/10/2010SE |
| K071147 | Nexa Orthopedics Total Shoulder SystemKWT · Traditional | Nexa Orthopedics, Inc. | 07/20/2007SE |
| K050761 | Zimmer Trabecular Metal Humeral Stem, Sizes 6MM and 8MMKWT · Special | Zimmer, Inc. | 04/11/2005SE |
| K043505 | Discovery-Mosaic Total Humerus SystemKWT · Traditional | Biomet, Inc. | 02/09/2005SE |
| K042321 | Mosaic Non-Modular Proximal Body and Eas Offset Modular Humeral HeadKWT · Traditional | Biomet Manufacturing Corp | 01/28/2005SE |
| K041549 | Zimmer Trabecular Metal Humeral StemKWT · Traditional | Zimmer, Inc. | 09/01/2004SE |
| K032507 | Interlok Bio-Modular Humeral StemsKWT · Special | Biomet, Inc. | 09/05/2003SE |
| K030710 | Bio-Modular Shoulder SystemKWT · Traditional | Biomet, Inc. | 06/04/2003SE |
| K023063 | Comprehensive Humeral Fracture SystemKWT · Traditional | Biomet Orthopedics, Inc. | 12/13/2002SE |
| K022377 | The Trabecular Metal Glenoid-Bigliani/Flatow the Complete Shoulder Solution, Model 4306KWT · Traditional | Implex Corp. | 12/10/2002SE |
| K022079 | Short and Long Soft Tissue AttachmentKWT · Traditional | Biomet, Inc. | 09/24/2002SE |
| K020045 | 3-PIECE Proximal Humeral Replacement SystemKWT · Special | Biomet Orthopedics, Inc. | 01/30/2002SE |
| K014049 | Epoca Codr Stem and HeadKWT · Special | Stelkast Company | 01/09/2002SE |
| K010869 | Epoca Custom Offset Shoulder SystemKWT · Traditional | Argomedical AG | 10/11/2001SE |
| K002998 | Biomet Bi-Polar Shoulder SystemKWT · Special | Biomet, Inc. | 10/06/2000SE |
| K991585 | Bipolar Shoulder ProsthesisKWT · Traditional | Biomet, Inc. | 08/18/1999SE |
| K991603 | Grit Blasted Humeral StemKWT · Traditional | Encore Orthopedics, Inc. | 06/29/1999SE |
| K984541 | Global FX Humeral Stem, Global Advantage Humeral HeadKWT · Special | DePuy Orthopaedics, Inc. | 01/14/1999SE |
| K982981 | New Zimmer Shoulder SystemKWT · Traditional | Zimmer, Inc. | 12/17/1998SE |
| K970567 | Select Shoulder Curved-Back Pegged All Poly GlenoidsKWT · Traditional | Intermedics Orthopedics | 02/27/1997SE |
| K962315 | Select Shoulder Cocr Humeral Stem ComponentKWT · Traditional | Intermedics Orthopedics | 09/03/1996SE |
| K960424 | Buechel-Pappas Polyethylene Glenoid Component (02-11-YYXX) Note:Yy=Id & Xx=OdKWT · Traditional | Endotec, Inc. | 08/26/1996SE |
| K962244 | Select Shoulder Pegged All-Poly GlenoidKWT · Traditional | Intermedics Orthopedics | 08/09/1996SN |
| K962238 | Select Shoulder Keeled All-Poly GlenoidsKWT · Traditional | Intermedics Orthopedics | 08/09/1996SN |
| K961571 | Cocr Bi-Angular Humeral ComponentKWT · Traditional | Biomet, Inc. | 08/05/1996SE |
| K940537 | Kirschner(R) Modular Ii-C(Tm) Total Shoulder SystemKWT · Traditional | Kirschner Medical Corp. | 08/29/1995SE |
| K925613 | Proximal Humeral Replacement SystemKWT · Traditional | Biomet, Inc. | 10/14/1994SE |
| K931114 | Select(R) Shoulder All-Poly GlenoidKWT · Traditional | Intermedics Orthopedics | 05/09/1994SE |
| K922865 | Neer Type Shoulder Prosthesis SystemKWT · Traditional | Osteo Technology, Inc. | 12/10/1992SE |
| K915596 | Biomodular Shoulder Humeral Head W/ IonguardKWT · Traditional | Biomet, Inc. | 03/11/1992SN |
| K914695 | Global Total ShoulderKWT · Traditional | Depuy, Inc. | 01/16/1992SE |
| K914000 | Global(Tm) Total Shoulder W/Dupont Enhanced UhmwpeKWT · Traditional | Depuy, Inc. | 12/04/1991SE |
| K905786 | Global Total ShoulderKWT · Traditional | Depuy, Inc. | 03/26/1991SE |
| K895802 | Non Constrained Total Shoulder SystemKWT · Traditional | Orthopaedic Medical Group, Inc. | 12/27/1989SN |
| K873621 | Neer-Iii Solid Keel Glenoid Resurfacing ProsthesisKWT · Traditional | Kirschner Medical Corp. | 10/15/1987SN |
| K873620 | Neer-Iii Osteoarthritis Glenoid Resurface Prosthe.KWT · Traditional | Kirschner Medical Corp. | 10/15/1987SN |
| K873104 | Neer-Iii Glenoid Resurfacing ProsthesisKWT · Traditional | Kirschner Medical Corp. | 10/15/1987SN |
| K872454 | Biomet Modular Shoulder ProsthesisKWT · Traditional | Biomet, Inc. | 08/27/1987SN |
| K833409 | Monospherical Resurfacing Glenoid ProsKWT · Traditional | Howmedica Corp. | 11/07/1983SE |
| K831233 | Glenoid Resurfacing COMPONENT-3M-10816KWT · Traditional | 3M Company | 06/03/1983SE |
| K831234 | Glenoid Resurface Component PMN 3MKWT · Traditional | 3M Company | 06/02/1983SE |
| K802124 | Gristina Glenoid ProsthesisKWT · Traditional | Howmedica Corp. | 12/01/1980SE |
| K790987 | Zimmer R Total Shoulder IIKWT · Traditional | Zimmer, Inc. | 06/22/1979SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0579-2024 Class II | Exactech Equinoxe Reverse Shoulder System, Catalog Numbers: a) 320-36-00, b) 320-36-03…Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag. | Exactech, Inc. | 11/21/2023Open, Classified |
| Z-0302-2020 Class II | Various Custom Devices, Item Nos. 32855090246 32855090252 32855090256 32855090265…Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | Zimmer Biomet, Inc. | 10/10/2019Terminated |
| Z-0299-2020 Class II | Trabecular Metal Reverse Shoulder System, Item Nos. 00434210613 00430900103 00434210613…Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | Zimmer Biomet, Inc. | 10/10/2019Terminated |
| Z-0298-2020 Class II | BF Humeral Stem, Various Sizes, Item Nos. 00430000606 00430000613 00430000706…Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | Zimmer Biomet, Inc. | 10/10/2019Terminated |
| Z-0012-2019 Class II | Equinoxe Reverse Drill Bit Kit, Catalog Number 321-20-00 Product Usage: Shoulder surgeryThe Equinoxe Reverse Drill Bit Kits may contain two 2mm diameter drill bits instead of one 2mm diameter… | Exactech, Inc. | 08/21/2018Open, Classified |
| Z-1173-2018 Class II | Zimmer Biomet Comprehensive Segmental Revision System (SRS). Orthopedic implants for…During assembly, an SRS Humeral Distal Body implant failed to engage correctly at the point of reduction… | Biomet, Inc. | 02/28/2018Terminated |
| Z-0298-2018 Class II | COMP 12MM HUM FRAC STEM MACRO, model # 11-113562Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and… | Zimmer Biomet, Inc. | 06/05/2017Terminated |
| Z-3144-2017 Class II | Zimmer Trabecular Metal Reverse Shoulder System Instrumentation, Drill 2.5 mm Diameter…Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material… | Zimmer Biomet, Inc. | 05/22/2017Terminated |
| Z-0900-2017 Class II | Equinoxe Reverse Shoulder Fixed Angle Torque Defining Screw KitDisengaged screw head could potentially not be retained in the Torque Defining Screwdriver. | Exactech, Inc. | 10/25/2016Terminated |
| Z-2539-2015 Class II | SMR Shoulder/Spalla Trial Humeral Head diameter .42 mm, REF 9013.22.425; SMR…The dimensions of the mating features of the recalled products are out of specification causing the device… | Limacorporate S.p.A | 08/14/2015Terminated |
| Z-1092-2014 Class II | 00434811113, REF I4348-111-13 Zimmer Trabecular Metal Shoulder Humeral Stem 48 Degrees…This single manufacturing lot has the potential for the bond strength between the Trabecular Metal material… | Zimmer, Inc. | 01/10/2014Terminated |
| Z-0609-2014 Class II | Trabecular Metal (TM) Reverse Glenosphere 36mm Part 00-4349-036-11 The reverse shoulder…Zimmer is initiating a lot specific recall of the CPT Hip Stem, Versys Build-Up Block, and Trabecular Metal… | Zimmer, Inc. | 12/10/2013Terminated |
| Z-1079-2014 Class II | Trabecular Metal" Reverse Shoulder SystemAs a result of complaints for disassociation of the TM Reverse Glenosphere from the Baseplate, Zimmer… | Zimmer, Inc. | 10/17/2013Terminated |
| Z-2055-2013 Class II | 00 4309-049-00 Trabecular Metal Reverse Shoulder Glenosphere Distractor Rx, Non sterile…Zimmer is initiating a lot specific recall of the Trabecular Metal" Reverse Glenosphere Distractor due to… | Zimmer, Inc. | 08/01/2013Terminated |
| Z-0474-2013 Class II | Bio-Modular Humeral Head 48mm x 24mm Ti 6AI4V/Ion Implanted (Orthopedic Implant) Product…The items in this lot are missing the ion implantation feature. The surface of the head may be softer and… | Biomet, Inc. | 11/01/2012Terminated |
| Z-0228-2013 Class II | Zimmer Inverse/Reverse Screw system,Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by… | Zimmer, Inc. | 09/04/2012Terminated |
| Z-2119-2012 Class II | Equinoxe Reverse Glenosphere Locking Screw Intended for Primary and Reverse Total…Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinoxe… | Exactech, Inc. | 06/15/2012Terminated |
| Z-2117-2012 Class II | Equinoxe Reverse Compression Screw Intended for Primary and Reverse Total Shoulder…Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinoxe… | Exactech, Inc. | 06/15/2012Terminated |
| Z-1895-2012 Class II | Bigliani/Flatow The Complete Shoulder Solution Trabecular Metal Glenoid Instrument Drill…Bigliani/Flatow The Complete Shoulder Solution Trabecular Metal Glenoid Instrument Drill with Stop, 6 mm.… | Zimmer, Inc. | 05/12/2012Terminated |
| Z-0576-2011 | Zimmer Trabecular Metal Reverse Shoulder System Surgical Technique. Catalog Number…The results of an investigation into complaints revealed that Trabecular Metal Humeral and/or Zimmer… | Zimmer Inc. | 09/10/2010Terminated |
| Z-0575-2011 | Zimmer Trabecular Metal Humeral Stem 4-Part Fracture Surgical Technique. Catalog Number…The results of an investigation into complaints revealed that Trabecular Metal Humeral and/or Zimmer… | Zimmer Inc. | 09/10/2010Terminated |
| Z-0574-2011 | Zimmer Trabecular Metal Humeral Stem Surgical Technique. Catalog Number: 97-4309-002-00…The results of an investigation into complaints revealed that Trabecular Metal Humeral and/or Zimmer… | Zimmer Inc. | 09/10/2010Terminated |
| Z-0573-2011 | TRABECULAR METAL" SHOULDER REAMER CASE used for implantation of the Zimmer Trabecular…The results of an investigation into complaints revealed that Trabecular Metal Humeral and/or Zimmer… | Zimmer Inc. | 09/10/2010Terminated |
| Z-0572-2011 | BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION INTRAMEDULLARY REAMER used for…The results of an investigation into complaints revealed that Trabecular Metal Humeral and/or Zimmer… | Zimmer Inc. | 09/10/2010Terminated |
| Z-0571-2011 | ZIMMER TRABECULAR METAL" SHOULDER INSTRUMENTATION, DISTAL PILOT used for implantation of…The results of an investigation into complaints revealed that Trabecular Metal Humeral and/or Zimmer… | Zimmer Inc. | 09/10/2010Terminated |
| Z-0570-2011 | ZIMMER TRABECULAR METAL SHOULDER INSTRUMENTATION, DISTAL PILOT used for implantation of…The results of an investigation into complaints revealed that Trabecular Metal Humeral and/or Zimmer… | Zimmer Inc. | 09/10/2010Terminated |
| Z-1658-2008 | Biomet Hybrid Glenoid Boss Cutter; item 406150. - Surgical instrument used to prepare…The glenoid implant may not seat fully on the face of the natural glenoid due to inadequate measurement… | Biomet, Inc. | 03/13/2008Terminated |