# K260556: Veritas Shoulder System

- Pathway: 510(k) (Traditional)
- Applicant: Restor3D
- Decided: Jul 1, 2026 after 132 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: 14 generations back to K911686 (1991). 72 ancestors in all.
No later device cites it as a predicate yet.
1 of 73 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193099: Anatomical Shoulder System, Zimmer GmbH (2020) Summary page 6.

## Indications for use
Reverse Application of the Veritas Shoulder System: The Veritas 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, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency. The Veritas system’s patient specific components are only indicated for primary total shoulder replacement. Glenoid component with porous surface is indicated for uncemented application with the addition of screw fixation. Note: A CT scan is used to create the Veritas patient specific components Hemiarthroplasty Application of the Veritas Shoulder System: The Veritas Shoulder System is indicated for: Advanced wear and tear of the shoulder joint resulting from degenerative, post-traumatic, or rheumatoid arthritis if adequate bone stock is present. Avascular Necrosis Conditions consequent to earlier operations Humeral components with porous surface are indicated for either cemented or uncemented applications.

Source page: https://510kreport.com/device/K260556
Methodology: https://510kreport.com/methodology