510(k) · Cleared
ClearedSmartBase for Arthrex 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 Feb 19, 2016 as substantially equivalent to K151500 (Custom Orthopaedic Solutions, 2015) after a 106-day review. Its family tree reaches back 9 generations to 1991.
- Decided
- Feb 19, 2016
- Review
- 106 days
- Class
- Class II
- Product code
- KWS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K911686 (1991). 31 ancestors in all, the oldest K800494 (1980). No later device cites it as a predicate yet.
- Root · 9 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 5 generations between
- 3 generations backK123122 Glenoid Intelligent Reusable Instrument System (Glenoid Iris)Cleveland Clinic · 2013
- 2 generations backK142072 Glenoid Intelligent Reusable Instrument System (Glenoid Iris)Custom Orthopaedic Solutions, Inc. · 2014
- 1 generation backK151500 Arthrex Glenoid Intelligent Reusable Instrument System (Arthrex…Custom Orthopaedic Solutions · 2015
- This deviceK153215 SmartBase for Arthrex Glenoid IRISCustom Orthopaedic Solutions, Inc. · 2016
Show all 9 generations
- Root · 9 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 8 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 7 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 6 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
- 5 generations backK062116 Delta Cta Reverse Shoulder System Humeral HeadsDePuy Orthopaedics, Inc. · 2006
- 4 generations backK062250 Delta Xtend Reverse Shoulder SystemDePuy Orthopaedics, Inc. · 2007 · Recalled
- 3 generations backK123122 Glenoid Intelligent Reusable Instrument System (Glenoid Iris)Cleveland Clinic · 2013
- 2 generations backK142072 Glenoid Intelligent Reusable Instrument System (Glenoid Iris)Custom Orthopaedic Solutions, Inc. · 2014
- 1 generation backK151500 Arthrex Glenoid Intelligent Reusable Instrument System (Arthrex…Custom Orthopaedic Solutions · 2015
- This deviceK153215 SmartBase for Arthrex Glenoid IRISCustom Orthopaedic Solutions, Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −8 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −7 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −6 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| −5 | K062116 | Delta Cta Reverse Shoulder System Humeral Heads | DePuy Orthopaedics, Inc. | 2006 | — |
| −4 | K062250 | Delta Xtend Reverse Shoulder System | DePuy Orthopaedics, Inc. | 2007 | 8 |
| −3 | K123122 | Glenoid Intelligent Reusable Instrument System (Glenoid Iris) | Cleveland Clinic | 2013 | — |
| −2 | 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 | — |
| 0 (this device) | K153215 | SmartBase for Arthrex Glenoid IRIS | Custom Orthopaedic Solutions, Inc. | 2016 | — |
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 |
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 |
|---|---|---|---|
| * | K151500 | Arthrex Glenoid Intelligent Reusable Instrument System (Arthrex Glenoid IRIS)Summary page 4…tal / polymer, cemented PREDICATE DEVICES: Arthrex Glenoid Intelligent Reusable Instrument System (Arthrex Glenoid IRIS) (K151500) DEVICE DESCRIPTION: The SmartBase is a reusable instrument that allows the IRI device from the Arthrex Glenoid IRIS system (K15… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
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 25 years and passes through 5 companies; a new generation was cleared every 1.6 years on median.
- 8 of the 31 ancestors have a recall of any class.
- 1 other device also cites its predicate K151500.
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. 2016, 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 Arthrex Glenoid IRIS is indicated for use with the Arthrex Univers II or…
Read the full statement (118 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 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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K153215 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153215: SmartBase for Arthrex 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/K153215
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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