Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Anatomical Shoulder System, Anatomical Shoulder Domelock System, Anatomical Shoulder Fracture System

K-Number: K160085 · 2016-03-08

ApplicantZimmer GmbH
Decision Date2016-03-08
Product CodeKWS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Anatomical Shoulder System, Anatomical Shoulder Domelock System, Anatomical Shoulder Fracture System is a medical device manufactured by Zimmer GmbH. It received FDA 510(k) clearance on 2016-03-08 under approval number K160085. 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 Anatomical Shoulder System, Anatomical Shoulder Domelock System, Anatomical Shoulder Fracture System?

Anatomical Shoulder System, Anatomical Shoulder Domelock System, Anatomical Shoulder Fracture System is a medical device that received FDA 510(k) clearance on 2016-03-08. It is manufactured by Zimmer GmbH. The 510(k) number is K160085.

When was Anatomical Shoulder System, Anatomical Shoulder Domelock System, Anatomical Shoulder Fracture System approved by the FDA?

Anatomical Shoulder System, Anatomical Shoulder Domelock System, Anatomical Shoulder Fracture System received FDA 510(k) clearance on 2016-03-08, under approval number K160085.

What company makes Anatomical Shoulder System, Anatomical Shoulder Domelock System, Anatomical Shoulder Fracture System?

Anatomical Shoulder System, Anatomical Shoulder Domelock System, Anatomical Shoulder Fracture System is manufactured by Zimmer GmbH.

What is the FDA product code for Anatomical Shoulder System, Anatomical Shoulder Domelock System, Anatomical Shoulder Fracture System?

The FDA product code for Anatomical Shoulder System, Anatomical Shoulder Domelock System, Anatomical Shoulder Fracture System is KWS.

Related Clinical Trials

NCT05225935 Computed Tomography-Guided Catheter Ablation for Ventricular Tachycardia COMPLETED NCT06808217 A Registry on the FARAVIEW Technology of the OPAL HDx Mapping System When Used With the FARAWAVE NAV Ablation Catheter in the Treatment of Atrial Fibrillation ACTIVE_NOT_RECRUITING NCT07492797 Accessible Remote Rehabilitation System for Real-Time Biomechanical Monitoring NOT_YET_RECRUITING NCT04816825 Home-monitored Telerehabilitation in COPD Patients COMPLETED NCT07210151 Anatomical Navigation for Guided Electrophysiology in AFL and AFib RECRUITING NCT07572318 Pilot Study on the Feasibility of High-energy Collimation With Optimized Geometry on a VERITON™ CZT Camera 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) PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025)

Other Devices by Zimmer GmbH

K161620Anatomical Shoulder Domelock Dome centric K161192Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® System K171858Sidus Stem-Free Shoulder K170711ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined System K170072Fitmore® Hip Stem K181827Affixus Natural Nail System Humeral Nail

View all 19 devices →

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 K162024AltiVate Anatomic Shoulder SystemEncore Medical L.P. K161108Arthrex VaultLock GlenoidArthrex, Inc. K160975Aequalis PerFORM+ Shoulder SystemTornier, Inc. K160555BLUEPRINT Patient Specific InstrumentationTornier S.A.S.

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.

↑