FDA.reportPublic FDA data

510(k) K250713

Device
Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants
Applicant
Exactech, Inc.
510(k) number
K250713
Product code
KWT
Decision
Substantially Equivalent (SESE)
Decision date
2025-12-01
Date received
2025-03-10
Regulation
888.3650
Classification name
Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Kiel Johnson
Address
2320 NW 66th Ct. Gainesville FL US 32653 32653

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KWT#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc.2025-10-30
K241944AGILON® XO Shoulder Replacement SystemImplantcast GmbH2025-03-10
K241817InSet Total Shoulder SystemShoulder Innovations, Inc.2025-02-11
K231657AGILON® XO Shoulder Replacement SystemImplantcast GmbH2024-02-16
K223631Comprehensive Segmental Revision System(SRS)Biomet Orthopedics2023-07-12
K222482AGILON XO Shoulder SystemImplantcast GmbH2022-09-28
K210899LINK Embrace Shoulder System- Anatomical ConfigurationWaldemar Link GmbH & Co. KG2021-06-21
K191698TiN Coated Humeral HeadFx Shoulder USA, Inc.2020-07-16
K192365Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.2019-11-29
K191811Catalyst OrthoScience CSR Shoulder SystemCatalyst Orthoscience, Inc.2019-09-11
K190595Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)2019-06-05
K182500Catalyst CSR Press-Fit Humeral ComponentsCatalyst Orthoscience, Inc.2019-01-11
K181287Catalyst CSR Shoulder SystemCatalyst Orthoscience, Inc.2018-07-12
K173812Catalyst CSR 3 Peg GlenoidsCatalyst Orthoscience, Inc.2018-03-09
K162903Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-Small Proximal BodiesExactech, Inc.2017-02-27