# K142072: Glenoid Intelligent Reusable Instrument System (Glenoid Iris)

- Pathway: 510(k) (Traditional)
- Applicant: Custom Orthopaedic Solutions, Inc.
- Decided: Nov 24, 2014 after 124 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: 7 generations back to K911686 (1991). 29 ancestors in all.
10 later devices descend from it; 3 cite it directly.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123122: Glenoid Intelligent Reusable Instrument System (Glenoid Iris), Cleveland Clinic (2013) Summary page 5.

## Most influential descendants
- K151500: Arthrex Glenoid Intelligent Reusable Instrument System (Arthrex Glenoid IRIS) (2015), 7 descendants of its own
- K151501: OrthoVis Web Portal (2015), 7 descendants of its own
- K162697: Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex OrthoVis Preoperative Plan, SmartBase for Arthrex Glenoid IRIS, ArthrexVIP Web Portal (2017), 5 descendants of its own
- K222007: Arthrex Virtual Implant Positioning (VIP) System (2023), 3 descendants of its own
- K230904: Arthrex Virtual Implant Positioning (VIP) System (2023), 1 descendant of its own

## 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 Glenoid IRIS is indicated for use in planning and placing the central glenoid guide pin for the DePuy Global AP Shoulder glenoid component, Global Shoulder StepTech Anchor Peg glenoid component, or Delta Xtend Reverse Shoulder metaglene component as an alternative to the standard instruments provided for placing the guide pin with these implant systems. The indications for use of the DePuy shoulder systems with which the Glenoid IRIS is intended to be used are the same as those described in the labeling for these shoulder systems except that the Glenoid IRIS is not intended for use in hemi-shoulder replacement. The Indications for Use of these DePuy shoulder systems are: DePuy Global AP Shoulder System and Global StepTech Anchor Peg Glenoid The DePuy Global AP Shoulder System and Global StepTech Anchor Peg Glenoid are indicated for use in total shoulder replacement surgery for patients suffering from: • A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis. • Fracture-dislocation of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon’s experience dictates that alternative methods of treatment are unsatisfactory. • Other difficult clinical problems where shoulder surgery arthrodesis or resection arthroplasty are not acceptable (e.g., revision of a failed primary component). The Global AP Glenoid and StepTech glenoid components are indicated only for use with bone cement. DePuy Delta Xtend Reverse Shoulder System • The Delta Xtend Reverse Shoulder prosthesis is intended for use as total shoulder or hemi-shoulder replacement. • The Delta Xtend Reverse Shoulder prosthesis is indicated for use in a grossly efficient rotator cuff joint with severe arthropathy or a previous failed joint replacement with a grossly deficient rotator cuff joint. • The patient’s joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device. • In cases of bone defects in the proximal humerus, the monoblock implant should be used and then only in cases where the residual bone permits firm fixation of this implant. • Delta Xtend hemi-shoulder replacement is also indicated for hemi-arthroplasty if the glenoid is fractured intraoperatively. • The metaglene component is HA coated and is intended for cementless use with the addition of screws for fixation. All other components are for cemented use only.

Source page: https://510kreport.com/device/K142072
Methodology: https://510kreport.com/methodology