Product code KWT
- Device name
- Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
- Medical specialty
- Orthopedic
- Device class
- 2
- Regulation number
- 888.3650
- Review panel
- OR
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250713 | Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants | Exactech, Inc. | 2025-12-01 |
| K251686 | Tornier Humeral Reconstruction System Max (Tornier HRS Max) | Tornier, Inc. | 2025-10-30 |
| K241944 | AGILON® XO Shoulder Replacement System | Implantcast GmbH | 2025-03-10 |
| K241817 | InSet Total Shoulder System | Shoulder Innovations, Inc. | 2025-02-11 |
| K231657 | AGILON® XO Shoulder Replacement System | Implantcast GmbH | 2024-02-16 |
| K223631 | Comprehensive Segmental Revision System(SRS) | Biomet Orthopedics | 2023-07-12 |
| K222482 | AGILON XO Shoulder System | Implantcast GmbH | 2022-09-28 |
| K210899 | LINK Embrace Shoulder System- Anatomical Configuration | Waldemar Link GmbH & Co. KG | 2021-06-21 |
| K191698 | TiN Coated Humeral Head | Fx Shoulder USA, Inc. | 2020-07-16 |
| K192365 | Shoulder Innovations Total Shoulder System | Shoulder Innovations, Inc. | 2019-11-29 |
| K191811 | Catalyst OrthoScience CSR Shoulder System | Catalyst Orthoscience, Inc. | 2019-09-11 |
| K190595 | Signature ONE System | Orthosoft Inc (D/B/A Zimmer Cas) | 2019-06-05 |
| K182500 | Catalyst CSR Press-Fit Humeral Components | Catalyst Orthoscience, Inc. | 2019-01-11 |
| K181287 | Catalyst CSR Shoulder System | Catalyst Orthoscience, Inc. | 2018-07-12 |
| K173812 | Catalyst CSR 3 Peg Glenoids | Catalyst Orthoscience, Inc. | 2018-03-09 |
| K162903 | Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-Small Proximal Bodies | Exactech, Inc. | 2017-02-27 |
| K161476 | SMR Shoulder System | Lima Corporate S.P.A. | 2016-06-24 |
| K152825 | Catalyst CSR Shoulder System | Catalyst Orthoscience, LLC | 2016-05-11 |
| K150730 | Zimmer PSI Shoulder System | Zimmer | 2015-06-16 |
| K143659 | Equinoxe Mega Prosthesis | Exactech, Inc. | 2015-04-09 |
| K140071 | HUMELOCK II CEMENTED SHOULDER SYSTEM | Fx Solutions | 2014-07-28 |
| K123814 | HUMELOCK II CEMENTED SHOULDER SYSTEM | Fx Solutions | 2013-08-13 |
| K121543 | ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM, BASE PLATES & HUMERAL STEMS | Zimmer, Inc. | 2012-10-11 |
| K111746 | COMPREHENSIVE SEGMENTAL REVISION SYSTEM (SRS) | Biomet, Inc. | 2011-12-15 |
| K110791 | BIGLIANI / FLATOW (R) THE COMPLETE SHOULDER SOLUTION | Zimmer, Inc. | 2011-09-02 |
| K110706 | EXACTECH EQUINOXE CUFF TEAR ARTHROPLASTY (CTA) HEAD | Exactech, Inc. | 2011-05-17 |
| K103404 | ANA0TOMICAL SHOULDER TM COMBINED SYSTEM | Zimmer GmbH | 2011-03-15 |
| K101263 | LIMA-LTO SMR SHOULDER SYSTEM - FINNED HUMERAL STEMS, LIMA-LTO SMR SHOULDER SYSTEM - FINNED HUMERAL BODIES, | Lima-Lto S.P.A. | 2011-01-28 |
| K100858 | LIMA-LIO SMR SHOULDER SYSTEM - HUMERAL STEMS, LIMA-LIO SMR SHOULDER SYSTEM - HUMERAL BODIES, | Lima-Lto S.P.A. | 2010-12-10 |
| K071147 | NEXA ORTHOPEDICS TOTAL SHOULDER SYSTEM | Nexa Orthopedics, Inc. | 2007-07-20 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08033390023221 | SMR Shoulder | LIMACORPORATE SPA | 2016-06-08 |
| 08033390023214 | SMR Shoulder | LIMACORPORATE SPA | 2016-06-08 |
| 08033390023009 | SMR Shoulder | LIMACORPORATE SPA | 2016-04-05 |
| 08033390022989 | SMR Shoulder | LIMACORPORATE SPA | 2016-04-05 |
| 08033390022972 | SMR Shoulder | LIMACORPORATE SPA | 2016-04-05 |
| 08033390022965 | SMR Shoulder | LIMACORPORATE SPA | 2016-04-05 |
| 08033390022941 | SMR Shoulder | LIMACORPORATE SPA | 2016-04-02 |
| 08033390000895 | SMR Shoulder | LIMACORPORATE SPA | 2015-07-29 |
| 08033390019941 | SMR Shoulder | LIMACORPORATE SPA | 2015-07-29 |
| 08033390019934 | SMR Shoulder | LIMACORPORATE SPA | 2015-07-29 |
| 08033390019927 | SMR Shoulder | LIMACORPORATE SPA | 2015-07-29 |
| 08033390002035 | SMR Shoulder | LIMACORPORATE SPA | 2015-07-29 |
| 08033390002028 | SMR Shoulder | LIMACORPORATE SPA | 2015-07-29 |
| 08033390002011 | SMR Shoulder | LIMACORPORATE SPA | 2015-07-29 |
| 08033390002004 | SMR Shoulder | LIMACORPORATE SPA | 2015-07-29 |
| 08033390000987 | SMR Shoulder | LIMACORPORATE SPA | 2015-07-29 |
| 08033390000970 | SMR Shoulder | LIMACORPORATE SPA | 2015-07-29 |
| 08033390000963 | SMR Shoulder | LIMACORPORATE SPA | 2015-07-29 |
| 08033390000956 | SMR Shoulder | LIMACORPORATE SPA | 2015-07-29 |
| 08033390000949 | SMR Shoulder | LIMACORPORATE SPA | 2015-07-29 |
| 08033390000932 | SMR Shoulder | LIMACORPORATE SPA | 2015-07-29 |
| 08033390000925 | SMR Shoulder | LIMACORPORATE SPA | 2015-07-29 |
| 08033390000918 | SMR Shoulder | LIMACORPORATE SPA | 2015-07-29 |
| 08033390000901 | SMR Shoulder | LIMACORPORATE SPA | 2015-07-29 |
| 08033390000888 | SMR Shoulder | LIMACORPORATE SPA | 2015-07-29 |
| 08033390001038 | SMR Shoulder | LIMACORPORATE SPA | 2015-07-23 |
| 08033390001021 | SMR Shoulder | LIMACORPORATE SPA | 2015-07-23 |
| 08033390001014 | SMR Shoulder | LIMACORPORATE SPA | 2015-07-23 |
| 08033390001007 | SMR Shoulder | LIMACORPORATE SPA | 2015-07-23 |
| 08033390000994 | SMR Shoulder | LIMACORPORATE SPA | 2015-07-23 |