510(k) · Cleared
ClearedArthrex Virtual Implant Positioning (VIP) System
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 Mar 8, 2023 as substantially equivalent to K162697 (Custom Orthopaedic Solutions, Inc., 2017) and 1 other predicate after a 244-day review. Its family tree reaches back 13 generations to 1991. 3 later devices descend from it.
- Decided
- Mar 8, 2023
- Review
- 244 days
- Class
- Class II
- Product code
- QHE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 13 generations to K905070 (1991). 75 ancestors in all, the oldest K800494 (1980). 3 later devices descend from it, 2 citing it directly.
- Root · 13 generations backK905070 VistarPhilips Medical Systems (Cleveland), Inc. · 1991
- 9 generations between
- 3 generations backK192074 Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas) · 2019
- 2 generations backK200615 Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas) · 2020
- 1 generation backK212560 Signature™ ONE SystemOrthosoft Inc (D/B/A Zimmer Cas) · 2021
- This deviceK222007 Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc. · 2023
- Descendant · cites it directly · 1 of its ownK230904 Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK241470 CORE Shoulder SystemLinkBio Corp. · 2025 · Recalled
- Descendant · 2 generations on · 0 of its ownK241097 Arthrex Virtual Implant Positioning (VIP) System SoftwareArthrex, Inc. · 2024
Show all 13 generations
- Root · 13 generations backK905070 VistarPhilips Medical Systems (Cleveland), Inc. · 1991
- 12 generations backK961168 ViewpointPhilips Medical Systems (Cleveland), Inc. · 1996
- 11 generations backK963221 Optical Digitizer Option for View PointPhilips Medical Systems (Cleveland), Inc. · 1997
- 10 generations backK970604 Viewpoint - 3.0 SoftwarePhilips Medical Systems (Cleveland), Inc. · 1997
- 9 generations backK984298 Z Kat Flurotactic Guidance System MkiZ-Kat, Inc. · 1999
- 8 generations backK013025 Modification to Flourolab PlusZ-Kat, Inc. · 2001
- 7 generations backK031454 Acumen Surgical Navigation SystemBiomet, Inc. · 2004
- 6 generations backK111863 Signature Planner,Signature GuidesMaterialise NV · 2012
- 5 generations backK130126 Signature Personalized Patient Care System - Glenoid Guide SystemBiomet, Inc. · 2013
- 4 generations backK190595 Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas) · 2019
- 3 generations backK192074 Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas) · 2019
- 2 generations backK200615 Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas) · 2020
- 1 generation backK212560 Signature™ ONE SystemOrthosoft Inc (D/B/A Zimmer Cas) · 2021
- This deviceK222007 Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc. · 2023
Most influential descendants
Showing 3 of 3 · See all- K230904Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc. · 2023 · cites it directly1descendant
- K241470CORE Shoulder SystemLinkBio Corp. · 2025 · cites it directly0descendants
- K241097Arthrex Virtual Implant Positioning (VIP) System SoftwareArthrex, Inc. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K905070 | Vistar | Philips Medical Systems (Cleveland), Inc. | 1991 | — |
| −12 | K961168 | Viewpoint | Philips Medical Systems (Cleveland), Inc. | 1996 | — |
| −11 | K963221 | Optical Digitizer Option for View Point | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −10 | K970604 | Viewpoint - 3.0 Software | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −9 | K984298 | Z Kat Flurotactic Guidance System Mki | Z-Kat, Inc. | 1999 | — |
| −8 | K013025 | Modification to Flourolab Plus | Z-Kat, Inc. | 2001 | — |
| −7 | K031454 | Acumen Surgical Navigation System | Biomet, Inc. | 2004 | — |
| −6 | K111863 | Signature Planner,Signature Guides | Materialise NV | 2012 | — |
| −5 | K130126 | Signature Personalized Patient Care System - Glenoid Guide System | Biomet, Inc. | 2013 | — |
| −4 | K190595 | Signature ONE System | Orthosoft Inc (D/B/A Zimmer Cas) | 2019 | — |
| −3 | K192074 | Signature ONE System | Orthosoft Inc (D/B/A Zimmer Cas) | 2019 | — |
| −2 | K200615 | Signature ONE System | Orthosoft Inc (D/B/A Zimmer Cas) | 2020 | — |
| −1 | K212560 | Signature™ ONE System | Orthosoft Inc (D/B/A Zimmer Cas) | 2021 | — |
| 0 (this device) | K222007 | Arthrex Virtual Implant Positioning (VIP) System | Arthrex, Inc. | 2023 | — |
| +1 | K230904 | Arthrex Virtual Implant Positioning (VIP) System | Arthrex, Inc. | 2023 | — |
| +1 | K241470 | CORE Shoulder System | LinkBio Corp. | 2025 | 1 |
| +2 | 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 |
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 3 | 0 |
| 1998 | 2 | 0 |
| 1999 | 6 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 4 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 4 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 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 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 |
|---|---|---|---|
| * | K162697 | Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex OrthoVis Preoperative…Summary page 6…S, PHX, LLZ Classification Name 21 CFR 888.3660: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class II Primary Predicate K162697: Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex OrthoVis Preoperative Plan, SmartBase fo… | 2017 |
| * | K212560 | Signature™ ONE SystemSummary page 6…eusable Instrument System, Arthrex OrthoVis Preoperative Plan, SmartBase for Arthrex Glenoid Iris, Arthrex VIP Web Portal Secondary Predicate K212560: Signature™ ONE System Reference Device K193523: Arthrex VIP Web Portal Purpose of Submission This traditional 510(k) pr… | 2021 |
| † | K193523 | ArthrexVIP Web Portal | 2020 |
What descends from it? (3)
2 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 32 years and passes through 6 companies; a new generation was cleared every 1.4 years on median.
- 15 of the 75 ancestors have a recall of any class.
- Of its descendants, K230904 (Arthrex, Inc., 2023) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K162697.
How does its category compare?
All QHE devicesQHE Shoulder Arthroplasty Implantation System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
The VIP Glenoid Targeter is a 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 VIP Glenoid Targeter is indicated for use with the Univers™ II and Univers™ Apex total shoulder systems, keeled or pegged glenoid…
Read the full statement (434 words)
The VIP Glenoid Targeter is a 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 VIP Glenoid Targeter is indicated for use with the Univers™ II and Univers™ Apex total shoulder systems, keeled or pegged glenoid components, the Univers VaultLock® glenoid component, as well as the Univers Revers™ baseplate component (Universal Glenoid) and Univers Revers™ modular glenoid system (MGS) baseplates.
The VIP Glenoid Reamer is intended for use with the VIP Glenoid Targeter in total shoulder systems that utilize a central guide pin for preparing the glenoid to receive the glenoid implant. The VIP Glenoid Reamer is indicated for use with the Univers VaultLock® glenoid component and the Univers Revers™ modular glenoid system (MGS) baseplates.
The indications for use of the Arthrex shoulder systems with which the VIP glenoid instrumentation is intended to be used are the same as those described in the labeling for these shoulder systems.
The OrthoVis preoperative plan is a preoperative plan created via the OrthoVis software that facilitates accurate preoperative planning and intraoperative placement of the glenoid component in total shoulder replacement.
The VIP Glenoid Targeter is indicated for use with the Univers™ II and Univers™ Apex total shoulder systems, keeled or pegged glenoid components, the Univers VaultLock® glenoid component, as well as the Univers Revers™ baseplate component (Universal Glenoid) and Univers Revers™ modular glenoid system (MGS) baseplates. The VIP Glenoid Reamer is indicated for use with the Univers VaultLock® glenoid component and the Univers Revers™ 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.
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 glenoid implant lines: Univers™ II and Univers™ Apex total shoulder systems, keeled or pegged glenoid components, the Univers VaultLock® glenoid component, as well as the Univers Revers™ baseplate component (Universal Glenoid) and Univers Revers™ modular glenoid system (MGS) baseplates.
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/K222007 · printed Nov 3, 2026
Cite this page
510(k) Report. “K222007: Arthrex Virtual Implant Positioning (VIP) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K222007
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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