# K153215: SmartBase for Arthrex Glenoid IRIS

- Pathway: 510(k) (Traditional)
- Applicant: Custom Orthopaedic Solutions, Inc.
- Decided: Feb 19, 2016 after 106 days
- Product code: KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented)
- 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: 9 generations back to K911686 (1991). 31 ancestors in all.
No later device cites it as a predicate yet.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151500: Arthrex Glenoid Intelligent Reusable Instrument System (Arthrex Glenoid IRIS), Custom Orthopaedic Solutions (2015) Summary page 4.

## Indications for use
The Glenoid Intelligent Reusable Instrument System (“Glenoid IRIS”) is a patient specific manual instrument system intended to facilitate preoperative planning and intraoperative placement of the central glenoid guide pin used in the preparation of the glenoid in total shoulder systems that utilize a central guide pin for preparing the glenoid to receive the glenoid implant. The Arthrex Glenoid IRIS is indicated for use with the Arthrex Univers II or Arthrex Univers Apex, Keeled or Pegged Glenoid components as well as the Univers Revers Baseplate component. The indications for use of the Arthrex shoulder systems with which the Arthex Glenoid IRIS is intended to be used are the same as those described in the labeling for these shoulder systems.

Source page: https://510kreport.com/device/K153215
Methodology: https://510kreport.com/methodology