Product code KWS
- Device name
- Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
- 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
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K254084 | AETOS Shoulder System - CONCELOC Glenoids | Smith & Nephew, Inc. | 2026-04-06 |
| K252418 | Catalyst F1x Shoulder System | Catalyst Orthoscience, Inc. | 2025-11-06 |
| K252416 | AETOS Shoulder System Meta Humeral Prosthesis Size 0 | Smith & Nephew, Inc. | 2025-10-29 |
| K241292 | MyShoulder Planner (5.3SSWPL) | Medacta International S.A. | 2025-01-30 |
| K241878 | Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem) | Stryker Corporation (Tornier, Inc.) | 2024-12-06 |
| K241609 | Tornier Humeral Reconstruction System (Tornier HRS) | Stryker Corporation (Tornier, Inc.) | 2024-09-10 |
| K230513 | Arthrex Univers Apex OptiFit Humeral Stem | Arthrex, Inc. | 2023-09-26 |
| K222592 | AltiVate® Anatomic Shoulder AG e+™ with Markers | Encore Medical L.P. | 2023-06-23 |
| K230572 | AETOS Shoulder System | Smith & Nephew, Inc. | 2023-06-07 |
| K220847 | AETOS Shoulder System | Smith & Nephew, Inc. | 2023-01-03 |
| K222317 | Catalyst EA Convertible Stemmed Shoulder | Catalyst Orthoscience, Inc. | 2022-11-10 |
| K213387 | AltiVate® Anatomic Shoulder AG e+™ with Markers | Encore Medical L.P. | 2022-07-07 |
| K213785 | SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented Glenoid | Limacorporate | 2022-05-13 |
| K213827 | TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral Resurfacing Arthroplasty System (HRA), Modular Radial Head System (MRH), Katalyst Bipolar Radial Head System (Katalyst) | Smith & Nephew, Inc. | 2022-03-11 |
| K212356 | Exactech® Equinoxe® Laser Cage Glenoid | Exactech, Inc. | 2022-03-04 |
| K212435 | Comprehensive Humeral Fracture Positioning Sleeves | Biomet, Inc. | 2021-12-10 |
| K210861 | ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA) | Stryker GmbH | 2021-09-03 |
| K210050 | Augmented VaultLock Glenoid | Arthrex, Inc. | 2021-06-07 |
| K203315 | BLUEPRINT™ Patient Specific Instrumentation | Tornier S.A.S. | 2021-04-15 |
| K203230 | Global Shoulder and Delta CTA systems | Depuy Lnc. | 2021-04-02 |
| K203026 | AltiVate® Anatomic Pegged Glenoid with Markers | Encore Medical L.P. | 2020-12-23 |
| K202289 | ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA) | Stryker GmbH | 2020-12-16 |
| K193180 | Alliance Augmented Glenoid | Zimmer, Inc. | 2020-02-24 |
| K191247 | SmartSPACE Shoulder System | Techmah Medical, LLC | 2019-11-15 |
| K191814 | Alliance Glenoid | Zimmer, Inc. | 2019-10-23 |
| K190286 | Materialise Glenoid Positioning System | Materialise NV | 2019-07-08 |
| K191318 | AEQUALIS FLEX REVIVE Shoulder System | Tornier, Inc. | 2019-06-14 |
| K190521 | Aequalis Ascend Flex Shoulder System | Tornier S.A.S. | 2019-06-12 |
| K190290 | AltiVate Reverse Humeral Stem, 48mm | Encore Medical L.P. | 2019-04-26 |
| K182799 | Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral Heads | Arthrex, Inc. | 2019-03-08 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07613327172942 | REUNION | Stryker GmbH | 2017-05-31 |
| 07613327172881 | REUNION | Stryker GmbH | 2017-05-31 |
| 07613252645863 | REUNION | Stryker GmbH | 2016-09-24 |
| 07613252645856 | REUNION | Stryker GmbH | 2016-09-24 |
| 07613327138115 | SOLAR | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327137736 | SOLAR | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327139778 | ReUnion | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327139723 | ReUnion | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327139648 | ReUnion | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327139587 | ReUnion | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327139570 | ReUnion | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327139563 | ReUnion | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327139556 | ReUnion | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327139525 | ReUnion | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327139495 | ReUnion | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327139471 | ReUnion | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327139457 | ReUnion | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327137743 | SOLAR | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327138054 | SOLAR | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327138016 | SOLAR | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327138009 | SOLAR | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327137989 | SOLAR | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327137965 | SOLAR | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327137941 | SOLAR | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327137934 | SOLAR | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327137873 | SOLAR | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327137842 | SOLAR | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327137828 | SOLAR | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327137798 | SOLAR | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327137750 | SOLAR | Howmedica Osteonics Corp. | 2015-09-24 |