Atlas FDA

AGILON® XO Shoulder Replacement System

FDA 510(k) clearance K241944 · decided 2025-03-10

Clearance details

K-number
K241944
Device name
AGILON® XO Shoulder Replacement System
Applicant
Implantcast GmbH
Decision
Substantially Equivalent
Date received
2024-07-02
Decision date
2025-03-10
Days to decision
251 days
Clearance type
Traditional
Product code
KWT
Device class
2
Regulation number
888.3650
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Buxtehude, DE
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.

RecordFirmDate
Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants (K250713)Exactech, Inc.2025-12-01
Tornier Humeral Reconstruction System Max (Tornier HRS Max) (K251686)Tornier, Inc.2025-10-30
InSet Total Shoulder System (K241817)Shoulder Innovations, Inc.2025-02-11
AGILON® XO Shoulder Replacement System (K231657)Implantcast GmbH2024-02-16
Comprehensive Segmental Revision System(SRS) (K223631)Biomet Orthopedics2023-07-12
AGILON XO Shoulder System (K222482)Implantcast GmbH2022-09-28
LINK Embrace Shoulder System- Anatomical Configuration (K210899)Waldemar Link GmbH & Co. KG2021-06-21
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.