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FDA 510(k)

OsseoFit Stemless Shoulder System

K-Number: K241873 · 2024-12-11

ApplicantZimmer, Inc.
Decision Date2024-12-11
Product CodePKC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OsseoFit Stemless Shoulder System is a medical device manufactured by Zimmer, Inc.. It received FDA 510(k) clearance on 2024-12-11 under approval number K241873. The device is classified under product code PKC. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OsseoFit Stemless Shoulder System?

OsseoFit Stemless Shoulder System is a medical device that received FDA 510(k) clearance on 2024-12-11. It is manufactured by Zimmer, Inc.. The 510(k) number is K241873.

When was OsseoFit Stemless Shoulder System approved by the FDA?

OsseoFit Stemless Shoulder System received FDA 510(k) clearance on 2024-12-11, under approval number K241873.

What company makes OsseoFit Stemless Shoulder System?

OsseoFit Stemless Shoulder System is manufactured by Zimmer, Inc..

What is the FDA product code for OsseoFit Stemless Shoulder System?

The FDA product code for OsseoFit Stemless Shoulder System is PKC.

Related Clinical Trials

NCT04816825 Home-monitored Telerehabilitation in COPD Patients COMPLETED NCT06323980 INHANCE Stemless Reverse Shoulder IDE RECRUITING NCT05951491 Improving Arm Function Using Wearable Exoskeletons SUSPENDED NCT04984291 Zimmer Biomet Shoulder Arthroplasty PMCF RECRUITING NCT01480440 Outcomes Study of the Trabecular Metal (TM) Reverse Shoulder System ACTIVE_NOT_RECRUITING NCT07550543 PEMF Therapy in Shoulder Tendinopathy 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)

Other Devices by Zimmer, Inc.

K161830Zimmer M/L Taper Hip Prosthesis K151716Cable-Ready Cable Grip System: Cable-Ready Bone Plate System K151848Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle System K172767Zimmer Trabecular Metal Reverse Shoulder System, Mini Glenoid K172114Zimmer Natural Nail System K181761Zimmer Biomet Select Ceramic Heads

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Related Devices (Code: PKC)

K171858Sidus Stem-Free ShoulderZimmer GmbH K173388Exactech Equinoxe Stemless ShoulderExactech, Inc. K182516Comprehensive Nano Stemless ShoulderBiomet Manufacturing Corp K203100Arthrex Eclipse Titanium Humeral HeadArthrex, Inc. K201542Arthrex Eclipse Shoulder Prosthesis SystemArthrex, Inc. K193226AltiVate Anatomic Canal-Sparing (CS) ShoulderEncore Medical L.P.

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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