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 Oct 12, 2021 as substantially equivalent to K190595 (Orthosoft Inc (D/B/A Zimmer Cas), 2019) and 1 other predicate after a 60-day review. Its family tree reaches back 12 generations to 1991. 7 later devices descend from it.
- Decided
- Oct 12, 2021
- Review
- 60 days
- Class
- Class II
- Product code
- QHE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K905070 (1991). 68 ancestors in all, the oldest K800494 (1980). 7 later devices descend from it, 2 citing it directly.
- Root · 12 generations backK905070 VistarPhilips Medical Systems (Cleveland), Inc. · 1991
- 8 generations between
- 3 generations backK190595 Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas) · 2019
- 2 generations backK192074 Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas) · 2019
- 1 generation backK200615 Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas) · 2020
- This deviceK212560 Signature™ ONE SystemOrthosoft Inc (D/B/A Zimmer Cas) · 2021
- Descendant · cites it directly · 3 of its ownK222007 Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc. · 2023
- Descendant · cites it directly · 2 of its ownK232425 Signature™ ONE SystemOrthosoft Inc. (D/B/A) Zimmer Cas) · 2023
- Descendant · 2 generations on · 1 of its ownK260104 Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS · 2026
- Descendant · 2 generations on · 1 of its ownK230904 Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc. · 2023
- Descendant · 3 generations on · 0 of its ownK261510 Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS · 2026
Show all 12 generations
- Root · 12 generations backK905070 VistarPhilips Medical Systems (Cleveland), Inc. · 1991
- 11 generations backK961168 ViewpointPhilips Medical Systems (Cleveland), Inc. · 1996
- 10 generations backK963221 Optical Digitizer Option for View PointPhilips Medical Systems (Cleveland), Inc. · 1997
- 9 generations backK970604 Viewpoint - 3.0 SoftwarePhilips Medical Systems (Cleveland), Inc. · 1997
- 8 generations backK984298 Z Kat Flurotactic Guidance System MkiZ-Kat, Inc. · 1999
- 7 generations backK013025 Modification to Flourolab PlusZ-Kat, Inc. · 2001
- 6 generations backK031454 Acumen Surgical Navigation SystemBiomet, Inc. · 2004
- 5 generations backK111863 Signature Planner,Signature GuidesMaterialise NV · 2012
- 4 generations backK130126 Signature Personalized Patient Care System - Glenoid Guide SystemBiomet, Inc. · 2013
- 3 generations backK190595 Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas) · 2019
- 2 generations backK192074 Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas) · 2019
- 1 generation backK200615 Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas) · 2020
- This deviceK212560 Signature™ ONE SystemOrthosoft Inc (D/B/A Zimmer Cas) · 2021
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K222007Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc. · 2023 · cites it directly3descendants
- K232425Signature™ ONE SystemOrthosoft Inc. (D/B/A) Zimmer Cas) · 2023 · cites it directly2descendants
- K260104Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS · 2026 · 2 generations on1descendant
- K230904Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc. · 2023 · 2 generations on1descendant
- K261510Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K905070 | Vistar | Philips Medical Systems (Cleveland), Inc. | 1991 | — |
| −11 | K961168 | Viewpoint | Philips Medical Systems (Cleveland), Inc. | 1996 | — |
| −10 | K963221 | Optical Digitizer Option for View Point | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −9 | K970604 | Viewpoint - 3.0 Software | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −8 | K984298 | Z Kat Flurotactic Guidance System Mki | Z-Kat, Inc. | 1999 | — |
| −7 | K013025 | Modification to Flourolab Plus | Z-Kat, Inc. | 2001 | — |
| −6 | K031454 | Acumen Surgical Navigation System | Biomet, Inc. | 2004 | — |
| −5 | K111863 | Signature Planner,Signature Guides | Materialise NV | 2012 | — |
| −4 | K130126 | Signature Personalized Patient Care System - Glenoid Guide System | Biomet, Inc. | 2013 | — |
| −3 | K190595 | Signature ONE System | Orthosoft Inc (D/B/A Zimmer Cas) | 2019 | — |
| −2 | K192074 | Signature ONE System | Orthosoft Inc (D/B/A Zimmer Cas) | 2019 | — |
| −1 | K200615 | Signature ONE System | Orthosoft Inc (D/B/A Zimmer Cas) | 2020 | — |
| 0 (this device) | K212560 | Signature™ ONE System | Orthosoft Inc (D/B/A Zimmer Cas) | 2021 | — |
| +1 | K222007 | Arthrex Virtual Implant Positioning (VIP) System | Arthrex, Inc. | 2023 | — |
| +1 | K232425 | Signature™ ONE System | Orthosoft Inc. (D/B/A) Zimmer Cas) | 2023 | — |
| +2 | K260104 | Signature™ ONE System | Orthosoft Inc. (d/b/a) Zimmer CAS | 2026 | — |
| +2 | K230904 | Arthrex Virtual Implant Positioning (VIP) System | Arthrex, Inc. | 2023 | — |
| +3 | K261510 | Signature™ ONE System | Orthosoft Inc. (d/b/a) Zimmer CAS | 2026 | — |
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 |
|---|---|---|
| 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…R 888.3670) K212560 Page 1 of 4 Predicate Device(s): K190595 Signature™ ONE Zimmer CAS (Primary) System K200615 Signatu… | 2019 |
| * | K200615 | Signature ONE SystemSummary page 5…5 === Predicate Device(s): K190595 Signature™ ONE Zimmer CAS (Primary) System K200615 Signature™ ONE Zimmer CAS (Secondary) System Purpose and Device Description:… | 2020 |
What descends from it? (7)
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 30 years and passes through 5 companies; a new generation was cleared every 2.1 years on median.
- 15 of the 68 ancestors have a recall of any class.
- Of its descendants, K222007 (Arthrex, Inc., 2023) has gone furthest, with 3 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. 2021, 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/K212560 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212560: 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/K212560
Report an extraction error
Are you the manufacturer?
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