# K253992: Veritas Reverse Total Shoulder System

- Pathway: 510(k) (Traditional)
- Applicant: Restor3D
- Decided: May 7, 2026 after 146 days
- Product code: PHX (Shoulder Prosthesis, Reverse Configuration)
- Device class: 2
- Regulation: 21 CFR 888.3660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K911686 (1991). 80 ancestors in all.
No later device cites it as a predicate yet.
1 of 81 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K243643: restor3d Reverse Total Shoulder Arthroplasty System, Restor3D (2025) Summary page 5.

## Indications for use
The Veritas Reverse Total Shoulder 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 patient must be anatomically and structurally suited to receive the implants, and a functional deltoid muscle is necessary. The Veritas Reverse Total Shoulder System standard components are indicated for primary, fracture and revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency. The system's patient specific components are only indicated for primary total shoulder replacement. Glenoid components with porous surface are indicated for uncemented application with the addition of screw fixation. Humeral components with porous surface are indicated for either cemented or uncemented applications. Note: A CT scan is used to create the Veritas TM patient specific components.

Source page: https://510kreport.com/device/K253992
Methodology: https://510kreport.com/methodology