Product code PKC
- Device name
- Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
- Medical specialty
- Orthopedic
- Device class
- 2
- Regulation number
- 888.3660
- Review panel
- OR
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- Replacement of the humeral head for total anatomic shoulder arthroplasty
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K254154 | FX V135 EASYTECH® Shoulder System | FX Shoulder Solutions, Inc. | 2026-05-01 |
| K252129 | AETOS Shoulder System Stemless Humeral Prosthesis | Smith & Nephew, Inc. | 2025-10-03 |
| K243248 | INHANCE INTACT™ | Depuy Ireland UC | 2024-12-23 |
| K241873 | OsseoFit Stemless Shoulder System | Zimmer, Inc. | 2024-12-11 |
| K240716 | AETOS Shoulder System Stemless Humeral Prosthesis | Smith & Nephew, Inc. | 2024-11-20 |
| K221758 | SMR Stemless Anatomic | Lima Corporate S.P.A. | 2023-03-17 |
| K220418 | Tornier Perform Humeral System – Stemless | Tornier, Inc. | 2022-09-14 |
| K213615 | Shoulder Innovations Total Shoulder System | Shoulder Innovations, Inc. | 2022-03-11 |
| K212683 | GLOBAL ICON Stemless Shoulder System | Depuy(Ireland) | 2022-01-19 |
| K203108 | Ignite Stemless Anatomic Shoulder System | Ignite Orthopedics, LLC | 2021-07-16 |
| K201391 | Easytech® Anatomical Shoulder System | Fx Shoulder USA, Inc. | 2021-02-16 |
| K203100 | Arthrex Eclipse Titanium Humeral Head | Arthrex, Inc. | 2020-11-20 |
| K201542 | Arthrex Eclipse Shoulder Prosthesis System | Arthrex, Inc. | 2020-07-08 |
| K193226 | AltiVate Anatomic Canal-Sparing (CS) Shoulder | Encore Medical L.P. | 2020-06-03 |
| K192097 | Exactech® Equinoxe® Stemless Humeral Components | Exactech, Inc. | 2020-04-29 |
| K182516 | Comprehensive Nano Stemless Shoulder | Biomet Manufacturing Corp | 2019-04-22 |
| K173388 | Exactech Equinoxe Stemless Shoulder | Exactech, Inc. | 2018-03-09 |
| K171858 | Sidus Stem-Free Shoulder | Zimmer GmbH | 2017-12-18 |
| K143552 | Simpliciti Shoulder System | Tornier, Inc. | 2015-03-04 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00885556915943 | AETOS Shoulder System | Smith & Nephew, Inc. | 2026-05-18 |
| B1132G1HB300020 | Shoulder Innovations Humeral Stemless System | Shoulder Innovations, Inc. | 2026-05-04 |
| B1132G1HB300010 | Shoulder Innovations Humeral Stemless System | Shoulder Innovations, Inc. | 2026-05-04 |
| 00885556919361 | AETOS Shoulder System | Smith & Nephew, Inc. | 2025-11-17 |
| 00885556919354 | AETOS Shoulder System | Smith & Nephew, Inc. | 2025-11-17 |
| 00885556910122 | AETOS Shoulder System | Smith & Nephew, Inc. | 2025-11-17 |
| 00885556910139 | AETOS Shoulder System | Smith & Nephew, Inc. | 2025-11-17 |
| 00885556910153 | AETOS Shoulder System | Smith & Nephew, Inc. | 2025-11-17 |
| 10603295553205 | INHANCE | DEPUY (IRELAND) | 2023-12-29 |
| 10603295553212 | INHANCE | DEPUY (IRELAND) | 2023-12-29 |
| 10603295553199 | INHANCE | DEPUY (IRELAND) | 2023-12-29 |
| 10603295551652 | INHANCE | DEPUY (IRELAND) | 2023-12-29 |
| 10603295551645 | INHANCE | DEPUY (IRELAND) | 2023-12-29 |
| 10603295551638 | INHANCE | DEPUY (IRELAND) | 2023-12-29 |
| 10603295551621 | INHANCE | DEPUY (IRELAND) | 2023-12-29 |
| B1132G1IB212800 | Shoulder Innovations Humeral Stemless System | Shoulder Innovations, Inc. | 2023-01-06 |
| B1132G2SC213400 | Shoulder Innovations InSet Humeral Stemless | Shoulder Innovations, Inc. | 2022-09-13 |
| B1132G2SC213200 | Shoulder Innovations InSet Humeral Stemless | Shoulder Innovations, Inc. | 2022-09-13 |
| B1132G2SC212800 | Shoulder Innovations InSet Humeral Stemless | Shoulder Innovations, Inc. | 2022-09-13 |
| 10603295550112 | INHANCE | DEPUY (IRELAND) | 2022-03-04 |
| 10603295538264 | INHANCE | DEPUY (IRELAND) | 2021-11-17 |
| 10603295538240 | INHANCE | DEPUY (IRELAND) | 2021-11-17 |
| 10603295546139 | INHANCE | DEPUY (IRELAND) | 2021-08-30 |
| 10603295546122 | INHANCE | DEPUY (IRELAND) | 2021-08-30 |
| 10885862536792 | Equinoxe | Exactech, Inc. | 2018-03-20 |
| 10885862536785 | Equinoxe | Exactech, Inc. | 2018-03-20 |
| 10885862536778 | Equinoxe | Exactech, Inc. | 2018-03-20 |
| 10885862536761 | Equinoxe | Exactech, Inc. | 2018-03-20 |
| 10885862536754 | Equinoxe | Exactech, Inc. | 2018-03-20 |
| 10885862536747 | Equinoxe | Exactech, Inc. | 2018-03-20 |