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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Restor3D. It received FDA 510(k) clearance on 2025-05-19 under 510(k) 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. The listed applicant is Restor3D. The 510(k) number is K243643.

When did restor3d Reverse Total Shoulder Arthroplasty System receive FDA 510(k) clearance?

restor3d Reverse Total Shoulder Arthroplasty System received FDA 510(k) clearance on 2025-05-19, under 510(k) number K243643.

Who is the listed applicant for restor3d Reverse Total Shoulder Arthroplasty System?

The FDA 510(k) record lists Restor3D as the applicant. This does not by itself establish the device manufacturer.

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.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07563803The restor3d Outcomes RegistryNOT_YET_RECRUITINGNCT01480440Outcomes Study of the Trabecular Metal (TM) Reverse Shoulder SystemACTIVE_NOT_RECRUITINGNCT03726554Post-Market Study of Comprehensive Reverse Augmented Glenoid and Mini Humeral Tray in Total Shoulder ArthroplastyACTIVE_NOT_RECRUITINGNCT05339815S-33 SMR Shoulder HP Reverse GlenosphereCOMPLETEDNCT06371833PRIMA EU Retrospective & ProspectiveRECRUITINGNCT07464977EMG and Delta Function in Standard RTSA vs LateralizationNOT_YET_RECRUITING

Other records listing Restor3D as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260556Veritas Shoulder SystemK253992Veritas Reverse Total Shoulder SystemK252067Velora Acetabular SystemK252454Kinos Total Ankle SystemK243768iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement SystemK242356TIDAL Fusion Cage System

View all 19 devices →

Related Devices (Code: PHX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260556Veritas Shoulder SystemRestor3DK261683Augment Off-Axis Instrument SystemZimmer, Inc.K260102Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder SystemStryker Corporation (Tornier, Inc.)K261016MSS - Humeral reverse liners extensionMedacta International, SAK253992Veritas Reverse Total Shoulder SystemRestor3DK252404Comprehensive Reverse Shoulder - HA Glenosphere BaseplatesBiomet Orthopedics

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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