Veritas Reverse Total Shoulder System— 510(k) K253992

Name: FDA 510(k) clearance K253992
Creator: U.S. Food and Drug Administration
Published: 2026-05-07

Substantially Equivalent

Restor3D

FDA 510(k) clearance K253992 for Veritas Reverse Total Shoulder System, Substantially Equivalent on 2026-05-07. Applicant: Restor3D. Device class: 2.

Summary

Restor3D's Veritas Reverse Total Shoulder System is filed under PHX, reverse configuration shoulder prostheses.

Class II, 21 CFR 888.3660. Orthopedic is both the classification panel and the review panel, and the submission was a Traditional 510(k).

Restor3D filed from Durham, North Carolina. Review took 146 calendar days (December 12, 2025 to May 7, 2026).

Clearance details

Applicant: Restor3D
Product code: Product code PHX
Device class: Class 2
Regulation: 21 CFR 888.3660
Advisory panel: Orthopedic
Date received: 2025-12-12
Decision date: 2026-05-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Durham, NC, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code PHX

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K263421 — Veritas Shoulder System2026-10-22
K263086 — AltiVate Reverse® Glenosphere with RAVN Technology2026-10-02
K260556 — Veritas Shoulder System2026-07-01
K261683 — Augment Off-Axis Instrument System2026-06-16
K260102 — Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder System2026-06-12

More clearances from Restor3D

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K252454 — Kinos Total Ankle System2025-09-03
K243643 — restor3d Reverse Total Shoulder Arthroplasty System2025-05-19
K242868 — Kinos Total Ankle System2024-10-18
K241482 — Kinos Total Ankle System2024-07-22
K234087 — restor3d TIDAL Lumbar Interbody Fusion System2024-01-22

Adverse events under product code PHX

product code PHX

Death: 10
Injury: 9,705
Malfunction: 1,252
Total: 10,967

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.