restor3d Reverse Total Shoulder Arthroplasty System— 510(k) K243643

Clearance details

Applicant

Restor3D

Product code

Code PHX

Device class

Class 2

Regulation

21 CFR 888.3660

Advisory panel

Orthopedic

Date received

2024-11-26

Decision date

2025-05-19

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Durham, NC, US

• 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
• K261016 — MSS - Humeral reverse liners extension2026-06-10
• K253992 — Veritas Reverse Total Shoulder System2026-05-07

• K252454 — Kinos Total Ankle System2025-09-03
• K242868 — Kinos Total Ankle System2024-10-18
• K241482 — Kinos Total Ankle System2024-07-22
• K234087 — restor3d TIDAL Lumbar Interbody Fusion System2024-01-22
• K232595 — Kinos Axiom Total Ankle System2023-11-28

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 →

• Z-2987-2026 — Brand Name: Veritas Standard Reverse Total Shoulder Product Name: Veritas Standard Glenoid Baseplate Model/Catalog Number: 1500-1030; 1500-1035 Software Version: N/A - off-the-shelf hardware product Product Description: The restor3d Reverse Total Shoulder Arthroplasty System is intended for patients requiring a reverse shoulder replacement for patients with a functional deltoid muscle and with a deficient rotator cuff. The restor3d Reverse Total Shoulder Arthroplasty System consists of the glenoid baseplate, glenosphere intraoperatively affixed to the baseplate, humeral stem, and polymer bearing component affixed to the humeral stem. Additionally, the system includes supporting standard instrument trays and all required accessories (e.g., security screws, peripheral screws). The restor3d rTSA System is indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The Veritas standard glenoid baseplate is the only component within scope of this field action. The patient-specific baseplate is unaffected by this defect and therefore not in scope. Component: Reverse Total ShoulderClass II·Ongoing·restor3d Inc.·20260630

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K243643.