restor3d Reverse Total Shoulder Arthroplasty System
K-Number: K243643 · 2025-05-19
ApplicantRestor3D
Decision Date2025-05-19
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
restor3d Reverse Total Shoulder Arthroplasty System is a medical device manufactured by Restor3D. It received FDA 510(k) clearance on 2025-05-19 under approval number K243643. The device is classified under product code PHX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the restor3d Reverse Total Shoulder Arthroplasty System?
restor3d Reverse Total Shoulder Arthroplasty System is a medical device that received FDA 510(k) clearance on 2025-05-19. It is manufactured by Restor3D. The 510(k) number is K243643.
When was restor3d Reverse Total Shoulder Arthroplasty System approved by the FDA?
restor3d Reverse Total Shoulder Arthroplasty System received FDA 510(k) clearance on 2025-05-19, under approval number K243643.
What company makes restor3d Reverse Total Shoulder Arthroplasty System?
restor3d Reverse Total Shoulder Arthroplasty System is manufactured by Restor3D.
What is the FDA product code for restor3d Reverse Total Shoulder Arthroplasty System?
The FDA product code for restor3d Reverse Total Shoulder Arthroplasty System is PHX.
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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 Restor3D
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K152966Aequalis Fx2Tornier S.A.S.
K173073AltiVate Anatomic to Reverse Conversion ModuleEncore Medical L.P.
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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.