510(k) · Cleared
ClearedArthrexVIP Web Portal
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Custom Orthopaedic Solutions, Inc. · LLZ System, Image Processing, Radiological
Cleared on Mar 15, 2016 as substantially equivalent to K151501 (Custom Orthopaedic Solutions, Inc., 2015) after an 89-day review. Its family tree reaches back 9 generations to 1991.
- Decided
- Mar 15, 2016
- Review
- 89 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K911686 (1991). 37 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 backK133367 Orthovis Preoperative PlanCustom Orthopaedic Solutions · 2013
- 1 generation backK151501 OrthoVis Web PortalCustom Orthopaedic Solutions, Inc. · 2015
- This deviceK153612 ArthrexVIP Web PortalCustom 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 backK133367 Orthovis Preoperative PlanCustom Orthopaedic Solutions · 2013
- 1 generation backK151501 OrthoVis Web PortalCustom Orthopaedic Solutions, Inc. · 2015
- This deviceK153612 ArthrexVIP Web PortalCustom 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 | K133367 | Orthovis Preoperative Plan | Custom Orthopaedic Solutions | 2013 | — |
| −1 | K151501 | OrthoVis Web Portal | Custom Orthopaedic Solutions, Inc. | 2015 | — |
| 0 (this device) | K153612 | ArthrexVIP Web Portal | 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 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2014 | 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 LLZ? 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 LLZ device
- #1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K151501 | OrthoVis Web Portal | 2015 |
| Kept off the family tree | K151568 | FDA’s K151568 is Arthrex OrthoVis Preoperative Plan Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2015 |
| Kept off the family tree | K151500 | FDA’s K151500 is Arthrex Glenoid Intelligent Reusable Instrument System (Arthrex Glenoid IRIS) Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 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 1.8 years on median.
- 8 of the 37 ancestors have a recall of any class.
- 1 other device also cites its predicate K151501.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, 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 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
The ArthrexVIP Web Portal is intended for use as a software interface and for the transfer of imaging information from a medical scanner such as a CT scanner. It is also intended as software for displaying/editing implant placement and surgical treatment options that were generated in the OrthoVis Desktop Software by trained COS technicians. The ArthrexVIP Web Portal is intended for use with the Arthrex Glenoid Intelligent Reusable Instrument System (Arthrex Glenoid IRIS) and with the Arthrex OrthoVis Preoperative Plan. It is indicated for use with the following glenoid implant lines: Arthrex Univers Apex, Arthrex Univers II, and Arthrex Univers Revers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153612 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153612: ArthrexVIP Web Portal.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153612
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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