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FDA 510(k)

AltiVate Anatomic Shoulder System

K-Number: K162024 · 2016-11-21

ApplicantEncore Medical L.P.
Decision Date2016-11-21
Product CodeKWS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AltiVate Anatomic Shoulder System is a medical device manufactured by Encore Medical L.P.. It received FDA 510(k) clearance on 2016-11-21 under approval number K162024. The device is classified under product code KWS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AltiVate Anatomic Shoulder System?

AltiVate Anatomic Shoulder System is a medical device that received FDA 510(k) clearance on 2016-11-21. It is manufactured by Encore Medical L.P.. The 510(k) number is K162024.

When was AltiVate Anatomic Shoulder System approved by the FDA?

AltiVate Anatomic Shoulder System received FDA 510(k) clearance on 2016-11-21, under approval number K162024.

What company makes AltiVate Anatomic Shoulder System?

AltiVate Anatomic Shoulder System is manufactured by Encore Medical L.P..

What is the FDA product code for AltiVate Anatomic Shoulder System?

The FDA product code for AltiVate Anatomic Shoulder System is KWS.

Related Clinical Trials

NCT04816825 Home-monitored Telerehabilitation in COPD Patients COMPLETED 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 NCT07421245 OsseoFit Stemless Shoulder System (Anatomic) NOT_YET_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 Encore Medical L.P.

K161610EXPRT Revision Hip System K161945EXPRT Revision Knee Femoral Augment(5mm), EXPRT Revision Knee Stem Extension (40mm) K160342EMPOWR PS Knee System K173073AltiVate Anatomic to Reverse Conversion Module K172651FMP Extended Liners K172351AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small Hemi-Adapter, AltiVate Reverse, Small Socket Insert

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Related Devices (Code: KWS)

K161789BLUEPRINT Patient Specific InstrumentationTornier S.A.S. K161863ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA), ReUnion Total Shoulder Arthroplasty (TSA)Stryker GmbH K161108Arthrex VaultLock GlenoidArthrex, Inc. K160975Aequalis PerFORM+ Shoulder SystemTornier, Inc. K160555BLUEPRINT Patient Specific InstrumentationTornier S.A.S. K153602Materialise Glenoid Positioning SystemMaterialise NV

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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