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FDA 510(k)

Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants

K-Number: K250713 · 2025-12-01

ApplicantExactech, Inc.
Decision Date2025-12-01
Product CodeKWT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants is a medical device manufactured by Exactech, Inc.. It received FDA 510(k) clearance on 2025-12-01 under approval number K250713. The device is classified under product code KWT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants?

Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants is a medical device that received FDA 510(k) clearance on 2025-12-01. It is manufactured by Exactech, Inc.. The 510(k) number is K250713.

When was Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants approved by the FDA?

Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants received FDA 510(k) clearance on 2025-12-01, under approval number K250713.

What company makes Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants?

Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants is manufactured by Exactech, Inc..

What is the FDA product code for Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants?

The FDA product code for Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants is KWT.

Related Clinical Trials

NCT05883202 Effect of the Abutment-Prosthesis Connection on Marginal Bone Loss and Gingival Sealing Around Dental Implants SUSPENDED NCT05859113 Evaluation of Marginal Bone Loss and Associated Factors Around Ziacom Dental Implants With Different Prosthetic Connection ACTIVE_NOT_RECRUITING NCT02724371 A Study of the Safety and Effectiveness of the Mentor Larger Size MemoryGel Ultra High Profile Breast Implants in Subjects Who Are Undergoing Primary Breast Reconstruction or Revision Reconstruction ACTIVE_NOT_RECRUITING NCT02919592 Memory Gel and Shape Combined Cohort ACTIVE_NOT_RECRUITING NCT06323980 INHANCE Stemless Reverse Shoulder IDE RECRUITING NCT07574099 Loading Protocols for Dental Implants Placed in Healed Fully Edentulous Maxilla ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 42173476 Feasibility of applying the Orthopaedic Data Evaluation Panel (ODEP) shoulder criteria for implants used in a United States-based integrated healthcare system. Journal of shoulder and elbow surgery (2026) PMID: 42014629 Clinical implementation of an EU MDR-compliant point-of-care manufacturing framework for patient-specific 3D-printed PEEK implants in craniomaxillofacial reconstruction. 3D printing in medicine (2026) PMID: 40781789 Resorbable Bio-Inductive Collagen Implant for Rotator Cuff Repair: What We Know, What We Need to Know, and the Path Forward. Orthopaedic surgery (2025) PMID: 40528079 The Challenges in the Regulatory Approval of Additive-Manufactured Medical Devices: A Quantitative Survey. Therapeutic innovation & regulatory science (2025)

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Related Devices (Code: KWT)

K161476SMR Shoulder SystemLima Corporate S.P.A. K152825Catalyst CSR Shoulder SystemCatalyst Orthoscience, LLC K162903Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-Small Proximal BodiesExactech, Inc. K181287Catalyst CSR Shoulder SystemCatalyst Orthoscience, Inc. K173812Catalyst CSR 3 Peg GlenoidsCatalyst Orthoscience, Inc. K192365Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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