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FDA 510(k)

Shoulder Innovations Total Shoulder System

K-Number: K213615 · 2022-03-11

ApplicantShoulder Innovations, Inc.
Decision Date2022-03-11
Product CodePKC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Shoulder Innovations Total Shoulder System is a medical device manufactured by Shoulder Innovations, Inc.. It received FDA 510(k) clearance on 2022-03-11 under approval number K213615. 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 Shoulder Innovations Total Shoulder System?

Shoulder Innovations Total Shoulder System is a medical device that received FDA 510(k) clearance on 2022-03-11. It is manufactured by Shoulder Innovations, Inc.. The 510(k) number is K213615.

When was Shoulder Innovations Total Shoulder System approved by the FDA?

Shoulder Innovations Total Shoulder System received FDA 510(k) clearance on 2022-03-11, under approval number K213615.

What company makes Shoulder Innovations Total Shoulder System?

Shoulder Innovations Total Shoulder System is manufactured by Shoulder Innovations, Inc..

What is the FDA product code for Shoulder Innovations Total Shoulder System?

The FDA product code for Shoulder Innovations Total Shoulder System is PKC.

Related Clinical Trials

NCT07191067 Pivotal Study on the NOVABLOC System for Patients Undergoing Primary Total Knee Arthroplasty RECRUITING NCT06727942 Virtual Reality-Infused Treadmill Training on Aging-Related Outcomes RECRUITING NCT05016219 Phase 2 - Rhythmic Light Therapy for Alzheimer's Disease Patients RECRUITING NCT05391828 Persona MC vs PS RCT With ROSA RECRUITING NCT04325022 Safety and Effectiveness Study of OR3O™ Dual Mobility System in THA ACTIVE_NOT_RECRUITING NCT00453505 Modulation of Motor Function by Stimulation of the Central and Peripheral Nervous System COMPLETED

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: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026)

Other Devices by Shoulder Innovations, Inc.

K173824Humeral Short Stem System K192365Shoulder Innovations Total Shoulder System K210533Inset Reverse Total Shoulder System K252221Inset Reverse Total Shoulder System K241817InSet Total Shoulder System K254128InSet Reverse Total Shoulder System

View all 8 devices →

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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