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
Custom Orthopaedic Solutions, Inc. · KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Cleared on Nov 24, 2014 as substantially equivalent to K123122 (Cleveland Clinic, 2013) after a 124-day review. Its family tree reaches back 7 generations to 1991. 10 later devices descend from it.
- Decided
- Nov 24, 2014
- Review
- 124 days
- Class
- Class II
- Product code
- KWS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K911686 (1991). 29 ancestors in all, the oldest K800494 (1980). 10 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 6 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 5 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 4 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
- 3 generations backK062116 Delta Cta Reverse Shoulder System Humeral HeadsDePuy Orthopaedics, Inc. · 2006
- 2 generations backK062250 Delta Xtend Reverse Shoulder SystemDePuy Orthopaedics, Inc. · 2007 · Recalled
- 1 generation backK123122 Glenoid Intelligent Reusable Instrument System (Glenoid Iris)Cleveland Clinic · 2013
- This deviceK142072 Glenoid Intelligent Reusable Instrument System (Glenoid Iris)Custom Orthopaedic Solutions, Inc. · 2014
- Descendant · cites it directly · 7 of its ownK151500 Arthrex Glenoid Intelligent Reusable Instrument System (Arthrex…Custom Orthopaedic Solutions · 2015
- Descendant · cites it directly · 7 of its ownK151501 OrthoVis Web PortalCustom Orthopaedic Solutions, Inc. · 2015
- Descendant · cites it directly · 5 of its ownK162697 Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex…Custom Orthopaedic Solutions, Inc. · 2017
- Descendant · 2 generations on · 3 of its ownK222007 Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc. · 2023
- Descendant · 3 generations on · 1 of its ownK230904 Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc. · 2023
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K151500Arthrex Glenoid Intelligent Reusable Instrument System (Arthrex Glenoid IRIS)Custom Orthopaedic Solutions · 2015 · cites it directly7descendants
- K151501OrthoVis Web PortalCustom Orthopaedic Solutions, Inc. · 2015 · cites it directly7descendants
- K162697Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex OrthoVis Preoperative…Custom Orthopaedic Solutions, Inc. · 2017 · cites it directly5descendants
- K222007Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc. · 2023 · 2 generations on3descendants
- K230904Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc. · 2023 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −6 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −5 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −4 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| −3 | K062116 | Delta Cta Reverse Shoulder System Humeral Heads | DePuy Orthopaedics, Inc. | 2006 | — |
| −2 | K062250 | Delta Xtend Reverse Shoulder System | DePuy Orthopaedics, Inc. | 2007 | 8 |
| −1 | K123122 | Glenoid Intelligent Reusable Instrument System (Glenoid Iris) | Cleveland Clinic | 2013 | — |
| 0 (this device) | K142072 | Glenoid Intelligent Reusable Instrument System (Glenoid Iris) | Custom Orthopaedic Solutions, Inc. | 2014 | — |
| +1 | K151500 | Arthrex Glenoid Intelligent Reusable Instrument System (Arthrex Glenoid IRIS) | Custom Orthopaedic Solutions | 2015 | — |
| +1 | K151501 | OrthoVis Web Portal | Custom Orthopaedic Solutions, Inc. | 2015 | — |
| +1 | K162697 | Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex OrthoVis… | Custom Orthopaedic Solutions, Inc. | 2017 | — |
| +2 | K222007 | Arthrex Virtual Implant Positioning (VIP) System | Arthrex, Inc. | 2023 | — |
| +3 | K230904 | Arthrex Virtual Implant Positioning (VIP) System | Arthrex, Inc. | 2023 | — |
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 |
|---|---|---|
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 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? (1)
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 |
|---|---|---|---|
| * | K123122 | Glenoid Intelligent Reusable Instrument System (Glenoid Iris)Summary page 5…constrained metal / (Glenoid IRIS) polymer, cemented PREDICATE DEVICES: Glenoid Intelligent Reusable Instrument System (Glenoid IRIS)(K123122) DEVICE DESCRIPTION: The Glenoid Intelligent Reusable Instrument System described in this submission is identical to the Glenoi… | 2013 |
What descends from it? (10)
3 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 23 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
- 8 of the 29 ancestors have a recall of any class.
- Of its descendants, K151500 (Custom Orthopaedic Solutions, 2015) has gone furthest, with 7 descendants of its own.
- 3 other devices also cite its predicate K123122.
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. 2014, 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 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…
Read the full statement (443 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142072 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142072: Glenoid Intelligent Reusable Instrument System (Glenoid Iris).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142072
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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