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FDA 510(k)

ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA), ReUnion Total Shoulder Arthroplasty (TSA)

K-Number: K161863 · 2016-11-23

ApplicantStryker GmbH
Decision Date2016-11-23
Product CodeKWS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA), ReUnion Total Shoulder Arthroplasty (TSA) is a medical device manufactured by Stryker GmbH. It received FDA 510(k) clearance on 2016-11-23 under approval number K161863. 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 ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA), ReUnion Total Shoulder Arthroplasty (TSA)?

ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA), ReUnion Total Shoulder Arthroplasty (TSA) is a medical device that received FDA 510(k) clearance on 2016-11-23. It is manufactured by Stryker GmbH. The 510(k) number is K161863.

When was ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA), ReUnion Total Shoulder Arthroplasty (TSA) approved by the FDA?

ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA), ReUnion Total Shoulder Arthroplasty (TSA) received FDA 510(k) clearance on 2016-11-23, under approval number K161863.

What company makes ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA), ReUnion Total Shoulder Arthroplasty (TSA)?

ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA), ReUnion Total Shoulder Arthroplasty (TSA) is manufactured by Stryker GmbH.

What is the FDA product code for ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA), ReUnion Total Shoulder Arthroplasty (TSA)?

The FDA product code for ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA), ReUnion Total Shoulder Arthroplasty (TSA) is KWS.

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 NCT07613203 Forced-Air Warming for Preventing Perioperative Hypothermia During Total Knee Arthroplasty COMPLETED NCT05016219 Phase 2 - Rhythmic Light Therapy for Alzheimer's Disease Patients RECRUITING NCT05391828 Persona MC vs PS RCT With ROSA RECRUITING NCT06019832 Analysis of Varus Collapse in Obese Patients With Stem and Non-Stem Tibial Components Following Primary Total Knee Arthroplasty ACTIVE_NOT_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: 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) PMID: 40025985 Patient-reported outcome measures offer little additional value two years after arthroplasty : a systematic review and meta-analysis. The bone & joint journal (2025)

Other Devices by Stryker GmbH

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Related Devices (Code: KWS)

K161789BLUEPRINT Patient Specific InstrumentationTornier S.A.S. K162024AltiVate Anatomic Shoulder SystemEncore Medical L.P. 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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