# K123122: Glenoid Intelligent Reusable Instrument System (Glenoid Iris)

- Pathway: 510(k) (Traditional)
- Applicant: Cleveland Clinic
- Decided: Apr 5, 2013 after 183 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: 6 generations back to K911686 (1991). 28 ancestors in all.
56 later devices descend from it; 4 cite it directly.
0 of 85 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060874: Depuy Global AP Shoulder System, DePuy Orthopaedics, Inc. (2006) Summary page 1.
- K981487: Depuy Global Shoulder Glenoid, DePuy Orthopaedics, Inc. (1998) Summary page 1.
- K092122: Global Shoulder Steptech Anchor Peg Glenoid, DePuy Orthopaedics, Inc. (2009) Summary page 1.
- K062250: Delta Xtend Reverse Shoulder System, DePuy Orthopaedics, Inc. (2007) Summary page 1.

## Most influential descendants
- K131129: Cas Psi Shoulder (2013), 39 descendants of its own
- K143374: BLUEPRINT Patient Specific Instrumentation (2015), 31 descendants of its own
- K160555: BLUEPRINT Patient Specific Instrumentation (2016), 25 descendants of its own
- K162800: BLUEPRINT Patient Specific Instrumentation (2017), 23 descendants of its own
- K133367: Orthovis Preoperative Plan (2013), 23 descendants of its own

## Indications for use
The Glenaid 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 Anchor Peg Glenoid (APG) component of the DePuy AP Shoulder System, the DePuy Global StepTech Glenoid component, or the DePuy Delta Xtend Reverse Shoulder metaglene component as an alternative to the standard instruments provided for placing the guide pin with these implant systems. The Glenoid IRIS is not indicated for use in hemi-shoulder arthroplasty. The labeling and indications for use for each of these DePuy shoulder systems remain the same as described in DePuy's labeling.

Source page: https://510kreport.com/device/K123122
Methodology: https://510kreport.com/methodology