510(k) · Cleared
ClearedArthrex Virtual Implant Positioning (VIP) System Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrex, Inc. · QHE Shoulder Arthroplasty Implantation System
Cleared on Oct 2, 2024 as substantially equivalent to K230904 (Arthrex, Inc., 2023) and 1 other predicate after a 163-day review. Its family tree reaches back 15 generations to 1991.
- Decided
- Oct 2, 2024
- Review
- 163 days
- Class
- Class II
- Product code
- QHE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 15 generations to K905070 (1991). 145 ancestors in all, the oldest K800494 (1980). No later device cites it as a predicate yet.
- Root · 15 generations backK905070 VistarPhilips Medical Systems (Cleveland), Inc. · 1991
- 11 generations between
- 3 generations backK203315 BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S. · 2021
- 2 generations backK213546 ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho · 2022 · Recalled
- 1 generation backK230904 Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc. · 2023
- This deviceK241097 Arthrex Virtual Implant Positioning (VIP) System SoftwareArthrex, Inc. · 2024
Show all 15 generations
- Root · 15 generations backK905070 VistarPhilips Medical Systems (Cleveland), Inc. · 1991
- 14 generations backK961168 ViewpointPhilips Medical Systems (Cleveland), Inc. · 1996
- 13 generations backK963221 Optical Digitizer Option for View PointPhilips Medical Systems (Cleveland), Inc. · 1997
- 12 generations backK970604 Viewpoint - 3.0 SoftwarePhilips Medical Systems (Cleveland), Inc. · 1997
- 11 generations backK984298 Z Kat Flurotactic Guidance System MkiZ-Kat, Inc. · 1999
- 10 generations backK013025 Modification to Flourolab PlusZ-Kat, Inc. · 2001
- 9 generations backK031454 Acumen Surgical Navigation SystemBiomet, Inc. · 2004
- 8 generations backK111863 Signature Planner,Signature GuidesMaterialise NV · 2012
- 7 generations backK130126 Signature Personalized Patient Care System - Glenoid Guide SystemBiomet, Inc. · 2013
- 6 generations backK143374 BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2015
- 5 generations backK160555 BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2016
- 4 generations backK162800 BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2017
- 3 generations backK203315 BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S. · 2021
- 2 generations backK213546 ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho · 2022 · Recalled
- 1 generation backK230904 Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc. · 2023
- This deviceK241097 Arthrex Virtual Implant Positioning (VIP) System SoftwareArthrex, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K905070 | Vistar | Philips Medical Systems (Cleveland), Inc. | 1991 | — |
| −14 | K961168 | Viewpoint | Philips Medical Systems (Cleveland), Inc. | 1996 | — |
| −13 | K963221 | Optical Digitizer Option for View Point | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −12 | K970604 | Viewpoint - 3.0 Software | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −11 | K984298 | Z Kat Flurotactic Guidance System Mki | Z-Kat, Inc. | 1999 | — |
| −10 | K013025 | Modification to Flourolab Plus | Z-Kat, Inc. | 2001 | — |
| −9 | K031454 | Acumen Surgical Navigation System | Biomet, Inc. | 2004 | — |
| −8 | K111863 | Signature Planner,Signature Guides | Materialise NV | 2012 | — |
| −7 | K130126 | Signature Personalized Patient Care System - Glenoid Guide System | Biomet, Inc. | 2013 | — |
| −6 | K143374 | BLUEPRINT Patient Specific Instrumentation | Tornier S.A.S. | 2015 | — |
| −5 | K160555 | BLUEPRINT Patient Specific Instrumentation | Tornier S.A.S. | 2016 | — |
| −4 | K162800 | BLUEPRINT Patient Specific Instrumentation | Tornier S.A.S. | 2017 | — |
| −3 | K203315 | BLUEPRINT™ Patient Specific Instrumentation | Tornier S.A.S. | 2021 | — |
| −2 | K213546 | ExactechGPS Total Shoulder Application, Equinoxe Planning Software | Blue Ortho | 2022 | 1 |
| −1 | K230904 | Arthrex Virtual Implant Positioning (VIP) System | Arthrex, Inc. | 2023 | — |
| 0 (this device) | K241097 | Arthrex Virtual Implant Positioning (VIP) System Software | Arthrex, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 2 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 1 | 0 |
| 1993 | 3 | 0 |
| 1994 | 3 | 0 |
| 1995 | 3 | 0 |
| 1996 | 5 | 0 |
| 1997 | 3 | 0 |
| 1998 | 2 | 0 |
| 1999 | 7 | 0 |
| 2000 | 7 | 0 |
| 2001 | 8 | 0 |
| 2002 | 6 | 0 |
| 2003 | 6 | 0 |
| 2004 | 10 | 0 |
| 2005 | 8 | 0 |
| 2006 | 10 | 0 |
| 2007 | 3 | 0 |
| 2008 | 4 | 0 |
| 2009 | 2 | 0 |
| 2010 | 4 | 0 |
| 2011 | 5 | 0 |
| 2012 | 2 | 0 |
| 2013 | 4 | 0 |
| 2014 | 1 | 0 |
| 2015 | 4 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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 QHE? 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 QHE device
- #1 K242813 Materialise Shoulder System™, Materialise…score 19.0 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K230904 | Arthrex Virtual Implant Positioning (VIP) SystemSummary page 5…QHE Classification Name 21 CFR 888.3660: Shoulder joint metal/polymer semi‐constrained cemented prosthesis Regulatory Class II Primary Predicate K230904: Arthrex Virtual Implant Positioning (VIP) System software (VIP Web Portal and OrthoVis Preoperative Plan… | 2023 |
| * | K232265 | BLUEPRINT™ Patient Specific InstrumentationSummary page 5…K230904: Arthrex Virtual Implant Positioning (VIP) System software (VIP Web Portal and OrthoVis Preoperative Plan) Additional Predicate K232265: Blueprint Patient Specific Instrumentation (Tornier SAS) Purpose of Submission This Traditional 510(k) premarket notification… | 2024 |
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 33 years and passes through 7 companies; a new generation was cleared every 1.5 years on median.
- 28 of the 145 ancestors have a recall of any class.
How does its category compare?
All QHE devicesQHE Shoulder Arthroplasty Implantation System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · QHE
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QHE
181in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QHE
No recall names QHE since 2007.
Adverse event reports per year · QHE
1in 2025
MAUDE reports naming product code QHE, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 3 | 88 | 0 | 0 |
| 2021 | 2 | — | 0 | 0 |
| 2022 | 3 | 149 | 0 | 0 |
| 2023 | 6 | 103 | 0 | 0 |
| 2024 | 4 | 97 | 0 | 5 |
| 2025 | 3 | 181 | 0 | 1 |
| 2026 | 4 | 59 | 0 | — |
What is it indicated for?
VIP Web Portal: The VIP 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 Arthrex technicians. The VIP Web Portal is intended for use with the VIP glenoid instrumentation and with the OrthoVis…
Read the full statement (276 words)
VIP Web Portal:
The VIP 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 Arthrex technicians.
The VIP Web Portal is intended for use with the VIP glenoid instrumentation and with the OrthoVis preoperative plan. It is indicated for use with the following implant lines: Univers T II and UniversTM Apex total shoulder systems, keeled or pegged glenoid components, the Univers VaultLock® glenoid component, as well as the Univers ReversT" baseplate component (Universal Glenoid), Univers ReversTM modular glenoid system (MGS) baseplates, and Arthrex humeral implants compatible with these implant lines.
OrthoVis Preoperative Plan:
The OrthoVis Preoperative Plan is a preoperative plan created via the OrthoVis software that facilitates accurate preoperative planning of glenoid and humeral components in total shoulder replacement, and intraoperative placement of the glenoid component in total shoulder replacement.
The VIP Glenoid Targeter is indicated for use with the Univers TM 11 and Univers T Apex total shoulder systems, keeled or pegged glenoid components, the Univers VaultLock® glenoid component, as well as the Univers ReversTM baseplate component (Universal Glenoid) and Univers ReversTr modular glenoid system (MGS) baseplates.
The VIP Glenoid Reamer is indicated for use with the Univers VaultLock® glenoid component and the Univers ReversTr modular glenoid system (MGS) baseplates.
The indications for use of the Arthrex shoulder systems with which the OrthoVis Preoperative Plan is intended to be used are the same as those described in the labeling for these shoulder systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241097 · printed Nov 5, 2026
Cite this page
510(k) Report. “K241097: Arthrex Virtual Implant Positioning (VIP) System Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K241097
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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