510(k) · Cleared
ClearedSignature ONE System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthosoft Inc (D/B/A Zimmer Cas) · QHE Shoulder Arthroplasty Implantation System
Cleared on Jun 5, 2020 as substantially equivalent to K190595 (Orthosoft Inc (D/B/A Zimmer Cas), 2019) and 1 other predicate after an 88-day review. Its family tree reaches back 11 generations to 1991. 8 later devices descend from it.
- Decided
- Jun 5, 2020
- Review
- 88 days
- Class
- Class II
- Product code
- QHE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K905070 (1991). 67 ancestors in all, the oldest K800494 (1980). 8 later devices descend from it, 1 citing it directly.
- Root · 11 generations backK905070 VistarPhilips Medical Systems (Cleveland), Inc. · 1991
- 7 generations between
- 3 generations backK130126 Signature Personalized Patient Care System - Glenoid Guide SystemBiomet, Inc. · 2013
- 2 generations backK190595 Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas) · 2019
- 1 generation backK192074 Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas) · 2019
- This deviceK200615 Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas) · 2020
- Descendant · cites it directly · 7 of its ownK212560 Signature™ ONE SystemOrthosoft Inc (D/B/A Zimmer Cas) · 2021
- Descendant · 2 generations on · 3 of its ownK222007 Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc. · 2023
- Descendant · 2 generations on · 2 of its ownK232425 Signature™ ONE SystemOrthosoft Inc. (D/B/A) Zimmer Cas) · 2023
- Descendant · 3 generations on · 1 of its ownK260104 Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS · 2026
- Descendant · 3 generations on · 1 of its ownK230904 Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc. · 2023
Show all 11 generations
- Root · 11 generations backK905070 VistarPhilips Medical Systems (Cleveland), Inc. · 1991
- 10 generations backK961168 ViewpointPhilips Medical Systems (Cleveland), Inc. · 1996
- 9 generations backK963221 Optical Digitizer Option for View PointPhilips Medical Systems (Cleveland), Inc. · 1997
- 8 generations backK970604 Viewpoint - 3.0 SoftwarePhilips Medical Systems (Cleveland), Inc. · 1997
- 7 generations backK984298 Z Kat Flurotactic Guidance System MkiZ-Kat, Inc. · 1999
- 6 generations backK013025 Modification to Flourolab PlusZ-Kat, Inc. · 2001
- 5 generations backK031454 Acumen Surgical Navigation SystemBiomet, Inc. · 2004
- 4 generations backK111863 Signature Planner,Signature GuidesMaterialise NV · 2012
- 3 generations backK130126 Signature Personalized Patient Care System - Glenoid Guide SystemBiomet, Inc. · 2013
- 2 generations backK190595 Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas) · 2019
- 1 generation backK192074 Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas) · 2019
- This deviceK200615 Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas) · 2020
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K212560Signature™ ONE SystemOrthosoft Inc (D/B/A Zimmer Cas) · 2021 · cites it directly7descendants
- K222007Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc. · 2023 · 2 generations on3descendants
- K232425Signature™ ONE SystemOrthosoft Inc. (D/B/A) Zimmer Cas) · 2023 · 2 generations on2descendants
- K260104Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS · 2026 · 3 generations on1descendant
- 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 |
|---|---|---|---|---|---|
| −11 | K905070 | Vistar | Philips Medical Systems (Cleveland), Inc. | 1991 | — |
| −10 | K961168 | Viewpoint | Philips Medical Systems (Cleveland), Inc. | 1996 | — |
| −9 | K963221 | Optical Digitizer Option for View Point | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −8 | K970604 | Viewpoint - 3.0 Software | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −7 | K984298 | Z Kat Flurotactic Guidance System Mki | Z-Kat, Inc. | 1999 | — |
| −6 | K013025 | Modification to Flourolab Plus | Z-Kat, Inc. | 2001 | — |
| −5 | K031454 | Acumen Surgical Navigation System | Biomet, Inc. | 2004 | — |
| −4 | K111863 | Signature Planner,Signature Guides | Materialise NV | 2012 | — |
| −3 | K130126 | Signature Personalized Patient Care System - Glenoid Guide System | Biomet, Inc. | 2013 | — |
| −2 | K190595 | Signature ONE System | Orthosoft Inc (D/B/A Zimmer Cas) | 2019 | — |
| −1 | K192074 | Signature ONE System | Orthosoft Inc (D/B/A Zimmer Cas) | 2019 | — |
| 0 (this device) | 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 | — |
| +2 | K222007 | Arthrex Virtual Implant Positioning (VIP) System | Arthrex, Inc. | 2023 | — |
| +2 | K232425 | Signature™ ONE System | Orthosoft Inc. (D/B/A) Zimmer Cas) | 2023 | — |
| +3 | K260104 | Signature™ ONE System | Orthosoft Inc. (d/b/a) Zimmer CAS | 2026 | — |
| +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 |
| 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 | 2 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K190595 | Signature ONE SystemSummary page 5…888.3670) Page 1 of 4 K200615 Predicate Device(s): K190595 Signature™ ONE Zimmer CAS (Primary) System K192074 Signatu… | 2019 |
| * | K192074 | Signature ONE SystemSummary page 5…5 === Predicate Device(s): K190595 Signature™ ONE Zimmer CAS (Primary) System K192074 Signature™ ONE Zimmer CAS (Secondary) System Purpose and Device Description:… | 2019 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K212560 | Signature™ ONE System | 2021 | 7 |
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 29 years and passes through 5 companies; a new generation was cleared every 2.1 years on median.
- 15 of the 67 ancestors have a recall of any class.
- Of its descendants, K212560 (Orthosoft Inc (D/B/A Zimmer Cas), 2021) has gone furthest, with 7 descendants of its own.
- 2 other devices also cite its predicate K190595.
How does its category compare?
All QHE devicesQHE Shoulder Arthroplasty Implantation System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 Signature™ ONE System is indicated, based on patient-specific radiological images with identifiable placement anatomical landmarks, to assist in pre-operative planning and/or intra-operative guiding of surgical instruments for shoulder replacement surgical procedures on patients not precluded from being radiologically scanned. The Signature™ ONE System is to be used with the glenoid components of the following shoulder implant systems in accordance…
Read the full statement (100 words)
The Signature™ ONE System is indicated, based on patient-specific radiological images with identifiable placement anatomical landmarks, to assist in pre-operative planning and/or intra-operative guiding of surgical instruments for shoulder replacement surgical procedures on patients not precluded from being radiologically scanned.
The Signature™ ONE System is to be used with the glenoid components of the following shoulder implant systems in accordance with their indications and contraindications: Zimmer® Trabecular Metal™ Reverse Plus Shoulder, Comprehensive® Total Shoulder System, Comprehensive® Reverse Shoulder System, Comprehensive® Reverse Augmented Baseplates and Alliance™ Glenoid System.
The Signature™ ONE Guides and bone models are intended for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200615 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200615: Signature ONE System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200615
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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