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) · KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
Cleared on Jun 5, 2019 as substantially equivalent to K150730 (Zimmer, 2015) and 1 other predicate after a 90-day review. Its family tree reaches back 9 generations to 1991. 10 later devices descend from it.
- Decided
- Jun 5, 2019
- Review
- 90 days
- Class
- Class II
- Product code
- KWT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K905070 (1991). 65 ancestors in all, the oldest K800494 (1980). 10 later devices descend from it, 3 citing it directly.
- Root · 9 generations backK905070 VistarPhilips Medical Systems (Cleveland), Inc. · 1991
- 5 generations between
- 3 generations backK031454 Acumen Surgical Navigation SystemBiomet, Inc. · 2004
- 2 generations backK111863 Signature Planner,Signature GuidesMaterialise NV · 2012
- 1 generation backK130126 Signature Personalized Patient Care System - Glenoid Guide SystemBiomet, Inc. · 2013
- This deviceK190595 Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas) · 2019
- Descendant · cites it directly · 9 of its ownK192074 Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas) · 2019
- Descendant · cites it directly · 8 of its ownK200615 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
Show all 9 generations
- Root · 9 generations backK905070 VistarPhilips Medical Systems (Cleveland), Inc. · 1991
- 8 generations backK961168 ViewpointPhilips Medical Systems (Cleveland), Inc. · 1996
- 7 generations backK963221 Optical Digitizer Option for View PointPhilips Medical Systems (Cleveland), Inc. · 1997
- 6 generations backK970604 Viewpoint - 3.0 SoftwarePhilips Medical Systems (Cleveland), Inc. · 1997
- 5 generations backK984298 Z Kat Flurotactic Guidance System MkiZ-Kat, Inc. · 1999
- 4 generations backK013025 Modification to Flourolab PlusZ-Kat, Inc. · 2001
- 3 generations backK031454 Acumen Surgical Navigation SystemBiomet, Inc. · 2004
- 2 generations backK111863 Signature Planner,Signature GuidesMaterialise NV · 2012
- 1 generation backK130126 Signature Personalized Patient Care System - Glenoid Guide SystemBiomet, Inc. · 2013
- This deviceK190595 Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas) · 2019
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K192074Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas) · 2019 · cites it directly9descendants
- K200615Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas) · 2020 · cites it directly8descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K905070 | Vistar | Philips Medical Systems (Cleveland), Inc. | 1991 | — |
| −8 | K961168 | Viewpoint | Philips Medical Systems (Cleveland), Inc. | 1996 | — |
| −7 | K963221 | Optical Digitizer Option for View Point | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −6 | K970604 | Viewpoint - 3.0 Software | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −5 | K984298 | Z Kat Flurotactic Guidance System Mki | Z-Kat, Inc. | 1999 | — |
| −4 | K013025 | Modification to Flourolab Plus | Z-Kat, Inc. | 2001 | — |
| −3 | K031454 | Acumen Surgical Navigation System | Biomet, Inc. | 2004 | — |
| −2 | K111863 | Signature Planner,Signature Guides | Materialise NV | 2012 | — |
| −1 | K130126 | Signature Personalized Patient Care System - Glenoid Guide System | Biomet, Inc. | 2013 | — |
| 0 (this device) | 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 | — |
| +1 | 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 | — |
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 |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 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 KWT? 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 KWT device
- #1 K231657 AGILON® XO Shoulder Replacement Systemscore 17.7 · 17 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 |
|---|---|---|---|
| * | K150730 | Zimmer PSI Shoulder SystemSummary page 5…K190595 Page 2/5 Predicate Device(s): Manufacturer Device Name 510(k) Number Zimmer CAS Zimmer PSI K150730 Shoulder *Primary Biomet Signature K130126 Personaliz… | 2015 |
| * | K130126 | Signature Personalized Patient Care System - Glenoid Guide SystemSummary page 5…me 510(k) Number Zimmer CAS Zimmer PSI K150730 Shoulder *Primary Biomet Signature K130126 Personalized Patient Care System- Glenoid Guide… | 2013 |
| † | K131409 | Cas Psi Knee System | 2013 |
What descends from it? (10)
3 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 28 years and passes through 5 companies; a new generation was cleared every 2.3 years on median.
- 15 of the 65 ancestors have a recall of any class.
- Of its descendants, K192074 (Orthosoft Inc (D/B/A Zimmer Cas), 2019) has gone furthest, with 9 descendants of its own.
How does its category compare?
All KWT devicesKWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · KWT
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWT
242in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWT
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWT
749in 2025
MAUDE reports naming product code KWT, 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 | 1 | — | 0 | 32 |
| 2008 | 0 | — | 1 | 48 |
| 2009 | 0 | — | 0 | 58 |
| 2010 | 1 | — | 7 | 71 |
| 2011 | 5 | 165 | 0 | 112 |
| 2012 | 1 | — | 2 | 83 |
| 2013 | 1 | — | 1 | 113 |
| 2014 | 1 | — | 0 | 168 |
| 2015 | 2 | — | 0 | 176 |
| 2016 | 2 | — | 1 | 445 |
| 2017 | 1 | — | 1 | 560 |
| 2018 | 2 | — | 1 | 480 |
| 2019 | 4 | 91 | 3 | 419 |
| 2020 | 1 | — | 0 | 215 |
| 2021 | 1 | — | 0 | 228 |
| 2022 | 1 | — | 0 | 273 |
| 2023 | 1 | — | 1 | 361 |
| 2024 | 1 | — | 0 | 601 |
| 2025 | 4 | 242 | 0 | 749 |
| 2026 | 1 | — | 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 (97 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 and Comprehensive® Reverse Augmented Baseplates.
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/K190595 · printed Nov 5, 2026
Cite this page
510(k) Report. “K190595: Signature ONE System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K190595
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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