Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants
FDA 510(k) clearance K250713 · decided 2025-12-01
Clearance details
- K-number
- K250713
- Device name
- Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants
- Applicant
- Exactech, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-03-10
- Decision date
- 2025-12-01
- Days to decision
- 266 days
- Clearance type
- Traditional
- Product code
- KWT
- Device class
- 2
- Regulation number
- 888.3650
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Gainesville, FL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Tornier Humeral Reconstruction System Max (Tornier HRS Max) (K251686) | Tornier, Inc. | 2025-10-30 |
| AGILON® XO Shoulder Replacement System (K241944) | Implantcast GmbH | 2025-03-10 |
| InSet Total Shoulder System (K241817) | Shoulder Innovations, Inc. | 2025-02-11 |
| AGILON® XO Shoulder Replacement System (K231657) | Implantcast GmbH | 2024-02-16 |
| Comprehensive Segmental Revision System(SRS) (K223631) | Biomet Orthopedics | 2023-07-12 |
| AGILON XO Shoulder System (K222482) | Implantcast GmbH | 2022-09-28 |
| LINK Embrace Shoulder System- Anatomical Configuration (K210899) | Waldemar Link GmbH & Co. KG | 2021-06-21 |
| TiN Coated Humeral Head (K191698) | Fx Shoulder USA, Inc. | 2020-07-16 |
| Shoulder Innovations Total Shoulder System (K192365) | Shoulder Innovations, Inc. | 2019-11-29 |
| Catalyst OrthoScience CSR Shoulder System (K191811) | Catalyst Orthoscience, Inc. | 2019-09-11 |
| Signature ONE System (K190595) | Orthosoft Inc (D/B/A Zimmer Cas) | 2019-06-05 |
| Catalyst CSR Press-Fit Humeral Components (K182500) | Catalyst Orthoscience, Inc. | 2019-01-11 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| NOVATION CERAMIC ARTICULATION HIP SYSTEM (P050039/S021) | Exactech, Inc. | 2017-04-03 |
| NOVATION CERAMIC ARTICULATION HIP SYSTEM (P050039/S020) | Exactech, Inc. | 2016-09-28 |
| NOVATION CERAMIC ARTICULATION HIP SYSTEM (P050039/S019) | Exactech, Inc. | 2016-07-21 |
| NOVATION CERAMIC ARTICULATION HIP SYSTEM (AHS) (P050039/S017) | Exactech, Inc. | 2016-04-26 |
| NOVATION CERAMIC ARTICULATION HIP SYSTEM (AHS) (P050039/S018) | Exactech, Inc. | 2015-12-30 |
| EXACTECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM (P050039/S016) | Exactech, Inc. | 2014-06-18 |
| EXACTECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM (P050039/S015) | Exactech, Inc. | 2013-02-07 |
| EXACTECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM (P050039/S014) | Exactech, Inc. | 2012-12-05 |