510(k) · Cleared
ClearedGlenoid Intelligent Reusable Instrument System (Glenoid Iris)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cleveland Clinic · KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Cleared on Apr 5, 2013 as substantially equivalent to K060874 (DePuy Orthopaedics, Inc., 2006) and 3 other predicates after a 183-day review. Its family tree reaches back 6 generations to 1991. 56 later devices descend from it.
- Decided
- Apr 5, 2013
- Review
- 183 days
- Class
- Class II
- Product code
- KWS
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K911686 (1991). 28 ancestors in all, the oldest K800494 (1980). 56 later devices descend from it, 4 citing it directly.
- Root · 6 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 5 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 4 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 3 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
- 2 generations backK062116 Delta Cta Reverse Shoulder System Humeral HeadsDePuy Orthopaedics, Inc. · 2006
- 1 generation backK062250 Delta Xtend Reverse Shoulder SystemDePuy Orthopaedics, Inc. · 2007 · Recalled
- This deviceK123122 Glenoid Intelligent Reusable Instrument System (Glenoid Iris)Cleveland Clinic · 2013
- Descendant · cites it directly · 39 of its ownK131129 Cas Psi ShoulderZimmer Cas · 2013
- Descendant · 2 generations on · 31 of its ownK143374 BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2015
- Descendant · 3 generations on · 25 of its ownK160555 BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2016
- Descendant · 4 generations on · 23 of its ownK162800 BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2017
- Descendant · cites it directly · 23 of its ownK133367 Orthovis Preoperative PlanCustom Orthopaedic Solutions · 2013
Showing 5 of 56 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 56 · See all- K131129Cas Psi ShoulderZimmer Cas · 2013 · cites it directly39descendants
- K143374BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2015 · 2 generations on31descendants
- K160555BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2016 · 3 generations on25descendants
- K162800BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2017 · 4 generations on23descendants
- K133367Orthovis Preoperative PlanCustom Orthopaedic Solutions · 2013 · cites it directly23descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −5 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −4 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −3 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| −2 | K062116 | Delta Cta Reverse Shoulder System Humeral Heads | DePuy Orthopaedics, Inc. | 2006 | — |
| −1 | K062250 | Delta Xtend Reverse Shoulder System | DePuy Orthopaedics, Inc. | 2007 | 8 |
| 0 (this device) | K123122 | Glenoid Intelligent Reusable Instrument System (Glenoid Iris) | Cleveland Clinic | 2013 | — |
| +1 | K131129 | Cas Psi Shoulder | Zimmer Cas | 2013 | — |
| +2 | K143374 | BLUEPRINT Patient Specific Instrumentation | Tornier S.A.S. | 2015 | — |
| +3 | K160555 | BLUEPRINT Patient Specific Instrumentation | Tornier S.A.S. | 2016 | — |
| +4 | K162800 | BLUEPRINT Patient Specific Instrumentation | Tornier S.A.S. | 2017 | — |
| +1 | K133367 | Orthovis Preoperative Plan | Custom Orthopaedic Solutions | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 5 | 0 |
| 2016 | 4 | 0 |
| 2017 | 4 | 0 |
| 2019 | 4 | 0 |
| 2020 | 3 | 0 |
| 2021 | 5 | 0 |
| 2022 | 2 | 0 |
| 2023 | 6 | 0 |
| 2024 | 5 | 0 |
| 2025 | 8 | 0 |
| 2026 | 7 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KWS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KWS device
- #1 K220847 AETOS Shoulder Systemscore 21.1 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K060874 | Depuy Global AP Shoulder SystemSummary page 1…constrained metal polymer, cemented PREDICATE DEVICES: DePuy Global Shoulder AP Shoulder System (K(060874 DePuy Global Shoulder Glenoid (K98 1487) DePuy Global StepTech Anchor Peg Glenoid (K092122) DePuy Delta Xtend Reverse Shoulder Sy… | 2006 |
| * | K981487 | Depuy Global Shoulder GlenoidSummary page 1…polymer, cemented PREDICATE DEVICES: DePuy Global Shoulder AP Shoulder System (K(060874 DePuy Global Shoulder Glenoid (K98 1487) DePuy Global StepTech Anchor Peg Glenoid (K092122) DePuy Delta Xtend Reverse Shoulder System (062250) DEVICE DESCRIPTION: The… | 1998 |
| * | K092122 | Global Shoulder Steptech Anchor Peg GlenoidSummary page 1…mer, cemented PREDICATE DEVICES: DePuy Global Shoulder AP Shoulder System (K(060874 DePuy Global Shoulder Glenoid (K98 1487) DePuy Global StepTech Anchor Peg Glenoid (K092122) DePuy Delta Xtend Reverse Shoulder System (062250) DEVICE DESCRIPTION: The Glenoid Intelligent Reusable Instrument System isco… | 2009 |
| * | K062250 | Delta Xtend Reverse Shoulder SystemSummary page 1…ulder AP Shoulder System (K(060874 DePuy Global Shoulder Glenoid (K98 1487) DePuy Global StepTech Anchor Peg Glenoid (K092122) DePuy Delta Xtend Reverse Shoulder System (062250) DEVICE DESCRIPTION: The Glenoid Intelligent Reusable Instrument System iscomposed of two (2) manual instruments intended for u… | 2007 |
What descends from it? (56)
See all 564 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 3 companies; a new generation was cleared every 4.4 years on median.
- 8 of the 28 ancestors have a recall of any class.
- Of its descendants, K131129 (Zimmer Cas, 2013) has gone furthest, with 39 descendants of its own.
- 6 other devices also cite its predicate K060874.
How does its category compare?
All KWS devicesKWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · KWS
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWS
97in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWS
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWS
2,281in 2025
MAUDE reports naming product code KWS, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 21 | 158 |
| 2008 | 4 | 37 | 29 | 238 |
| 2009 | 4 | 108 | 0 | 294 |
| 2010 | 7 | 33 | 10 | 393 |
| 2011 | 11 | 90 | 11 | 486 |
| 2012 | 7 | 86 | 10 | 542 |
| 2013 | 12 | 120 | 0 | 818 |
| 2014 | 7 | 89 | 1 | 1,066 |
| 2015 | 8 | 129 | 0 | 1,170 |
| 2016 | 10 | 114 | 1 | 970 |
| 2017 | 7 | 120 | 4 | 1,681 |
| 2018 | 4 | 152 | 1 | 1,545 |
| 2019 | 9 | 106 | 2 | 1,728 |
| 2020 | 3 | 98 | 5 | 1,567 |
| 2021 | 5 | 151 | 0 | 1,358 |
| 2022 | 5 | 158 | 0 | 1,268 |
| 2023 | 4 | 250 | 2 | 1,750 |
| 2024 | 2 | — | 0 | 2,122 |
| 2025 | 3 | 97 | 0 | 2,281 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
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…
Read the full statement (149 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123122 · printed Nov 4, 2026
Cite this page
510(k) Report. “K123122: Glenoid Intelligent Reusable Instrument System (Glenoid Iris).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K123122
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026