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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 the device name listed in this FDA 510(k) record. The listed applicant is Zimmer, Inc.. It received FDA 510(k) clearance on 2024-12-11 under 510(k) 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. The listed applicant is Zimmer, Inc.. The 510(k) number is K241873.

When did OsseoFit Stemless Shoulder System receive FDA 510(k) clearance?

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

Who is the listed applicant for OsseoFit Stemless Shoulder System?

The FDA 510(k) record lists Zimmer, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07421245OsseoFit Stemless Shoulder System (Anatomic)NOT_YET_RECRUITING

Other records listing Zimmer, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

PMA P060037Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearingK261683Augment Off-Axis Instrument SystemK260831Z1 Hip SystemK251840Zimmer® Persona® Personalized Knee SystemK260182Avenir® Müller Stem; Avenir Complete™ Hip SystemK253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter)

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Related Devices (Code: PKC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254154FX V135 EASYTECH® Shoulder SystemFX Shoulder Solutions, Inc.K252129AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.K243248INHANCE INTACT™Depuy Ireland UCK240716AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.K221758SMR Stemless AnatomicLima Corporate S.P.A.K220418Tornier Perform Humeral System – StemlessTornier, 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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