# K243643: restor3d Reverse Total Shoulder Arthroplasty System

- Pathway: 510(k) (Traditional)
- Applicant: Restor3D
- Decided: May 19, 2025 after 174 days
- Product code: PHX (Shoulder Prosthesis, Reverse Configuration)
- Device class: 2
- Regulation: 21 CFR 888.3660
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K911686 (1991). 79 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 81 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193373: Comprehensive® Reverse Shoulder, Biomet, Inc. (2020) Summary page 6.

## Most influential descendants
- K253992: Veritas Reverse Total Shoulder System (2026), 0 descendants of its own

## Recalls of this device
- Jun 30, 2026 · Class II · Z-2987-2026: Due to incorrect machining of peripheral screw hole resulting in potential for improper engagement of the peripheral screws.

## Indications for use
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 patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. The restor3d rTSA System is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency. Glenoid component with porous surface is indicated for uncemented biological fixation application only. The restor3d rTSA System glenoid baseplate components are intended for cementless application with the addition of screw fixation. Humeral components with porous surface are indicated for either cemented or uncemented applications.

Source page: https://510kreport.com/device/K243643
Methodology: https://510kreport.com/methodology