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 |
|---|---|---|---|
| K262173 | N22 Offset Humeral Head | Shoulder Innovations, Inc. | 2026-09-08 |
| 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 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 03701037320440 | FX V135 Shoulder Prosthesis | FX SOLUTIONS | 2026-09-22 |
| 00811596033484 | CSR Shoulder System | CATALYST ORTHOSCIENCE INC. | 2026-09-22 |
| 00811596033477 | CSR Shoulder System | CATALYST ORTHOSCIENCE INC. | 2026-09-22 |
| 00811596033460 | CSR Shoulder System | CATALYST ORTHOSCIENCE INC. | 2026-09-22 |
| 00889024707047 | Signature ONE Software Package | Orthosoft Inc | 2026-07-10 |
| 00887868554407 | Signature™ Comprehensive® | Orthosoft Inc | 2024-02-09 |
| 00887868554391 | Signature™ Comprehensive® | Orthosoft Inc | 2024-02-09 |
| 00887868522994 | Signature ONE | Orthosoft Inc | 2022-07-20 |
| 00887868522987 | Signature ONE | Orthosoft Inc | 2022-07-20 |
| 00889024647046 | Signature ONE Software Package | Orthosoft Inc | 2022-07-05 |
| 00889024563438 | Shoulder Pure Planning | Orthosoft Inc | 2019-08-26 |
| 00889024563360 | Comprehensive® Total Shoulder Guide and Bone Model Right | Orthosoft Inc | 2019-08-26 |
| 00889024563353 | Comprehensive® Total Shoulder Guide and Bone Model Left | Orthosoft Inc | 2019-08-26 |
| 00889024563377 | Comprehensive® Reverse Shoulder Mini Guide and Bone Model Left | Orthosoft Inc | 2019-08-26 |
| 00889024563421 | Shoulder Bone Model Only 2.5mm Pin | Orthosoft Inc | 2019-08-26 |
| 00889024563414 | Shoulder Bone Model Only 3.2mm Pin | Orthosoft Inc | 2019-08-26 |
| 00889024563346 | TMR+™ Shoulder Guide and Bone Model Right | Orthosoft Inc | 2019-08-26 |
| 00889024563339 | TMR+™ Shoulder Guide and Bone Model Left | Orthosoft Inc | 2019-08-26 |
| 00889024563384 | Comprehensive® Reverse Shoulder Mini Guide and Bone Model Right | Orthosoft Inc | 2019-08-26 |
| 00889024563391 | Comprehensive® Reverse Shoulder Augmented Guide and Bone Model Left | Orthosoft Inc | 2019-08-26 |
| 00889024563407 | Comprehensive® Reverse Shoulder Augmented Guide and Bone Model Right | Orthosoft Inc | 2019-08-26 |
| 00889024304178 | PSI Shoulder | Orthosoft Inc | 2017-09-12 |
| 00889024304147 | PSI Shoulder | Orthosoft Inc | 2017-09-12 |
| 00889024305816 | PSI Shoulder | Orthosoft Inc | 2017-06-13 |
| 00889024304154 | Bigliani/Flatow | Orthosoft Inc | 2016-09-12 |
| 00889024304130 | Trabecular Metal | Orthosoft Inc | 2016-09-12 |
| 00889024304161 | Bigliani/Flatow | Orthosoft Inc | 2016-09-12 |
| 00889024304079 | Trabecular Metal | Orthosoft Inc | 2016-09-12 |
| 00889024305809 | Trabecular Metal | Orthosoft Inc | 2016-09-07 |
| 00889024305793 | Trabecular Metal | Orthosoft Inc | 2016-09-07 |