510(k) · Cleared
ClearedZimmer PSI Shoulder System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer · KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
Cleared on Jun 16, 2015 as substantially equivalent to K131129 (Zimmer Cas, 2013) after an 88-day review. Its family tree reaches back 8 generations to 1991. 11 later devices descend from it.
- Decided
- Jun 16, 2015
- Review
- 88 days
- Class
- Class II
- Product code
- KWT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K911686 (1991). 42 ancestors in all, the oldest K800494 (1980). 11 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 7 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 6 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 5 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
- 4 generations backK062116 Delta Cta Reverse Shoulder System Humeral HeadsDePuy Orthopaedics, Inc. · 2006
- 3 generations backK062250 Delta Xtend Reverse Shoulder SystemDePuy Orthopaedics, Inc. · 2007 · Recalled
- 2 generations backK123122 Glenoid Intelligent Reusable Instrument System (Glenoid Iris)Cleveland Clinic · 2013
- 1 generation backK131129 Cas Psi ShoulderZimmer Cas · 2013
- This deviceK150730 Zimmer PSI Shoulder SystemZimmer · 2015
- Descendant · cites it directly · 10 of its ownK190595 Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas) · 2019
- Descendant · 2 generations on · 9 of its ownK192074 Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas) · 2019
- Descendant · 2 generations on · 8 of its ownK200615 Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas) · 2020
- Descendant · 2 generations on · 7 of its ownK212560 Signature™ ONE SystemOrthosoft Inc (D/B/A Zimmer Cas) · 2021
- Descendant · 3 generations on · 3 of its ownK222007 Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc. · 2023
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K190595Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas) · 2019 · cites it directly10descendants
- K192074Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas) · 2019 · 2 generations on9descendants
- K200615Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas) · 2020 · 2 generations on8descendants
- K212560Signature™ ONE SystemOrthosoft Inc (D/B/A Zimmer Cas) · 2021 · 2 generations on7descendants
- K222007Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc. · 2023 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −7 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −6 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −5 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| −4 | K062116 | Delta Cta Reverse Shoulder System Humeral Heads | DePuy Orthopaedics, Inc. | 2006 | — |
| −3 | K062250 | Delta Xtend Reverse Shoulder System | DePuy Orthopaedics, Inc. | 2007 | 8 |
| −2 | K123122 | Glenoid Intelligent Reusable Instrument System (Glenoid Iris) | Cleveland Clinic | 2013 | — |
| −1 | K131129 | Cas Psi Shoulder | Zimmer Cas | 2013 | — |
| 0 (this device) | K150730 | Zimmer PSI Shoulder System | Zimmer | 2015 | — |
| +1 | 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 | — |
| +2 | K200615 | Signature ONE System | Orthosoft Inc (D/B/A Zimmer Cas) | 2020 | — |
| +2 | K212560 | Signature™ ONE System | Orthosoft Inc (D/B/A Zimmer Cas) | 2021 | — |
| +3 | K222007 | 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 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 2 | 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? (1)
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 |
|---|---|---|---|
| * | K131129 | Cas Psi ShoulderSummary page 4…ation 21 CFR § 888.3650 (Shoulder joint metal/polymer non- constrained cemented prosthesis) Predicate Devices: CAS PSI Shoulder System, from Zimmer CAS, 510(k) # K131129, cleared Aug. 20th, 2013 Device Description: The Zimmer PSI Shoulder System is an orthopedic instrument syste… | 2013 |
What descends from it? (11)
See all 111 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K190595 | Signature ONE System | 2019 | 10 |
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 24 years and passes through 5 companies; a new generation was cleared every 2.7 years on median.
- 12 of the 42 ancestors have a recall of any class.
- Of its descendants, K190595 (Orthosoft Inc (D/B/A Zimmer Cas), 2019) has gone furthest, with 10 descendants of its own.
- 1 other device also cites its predicate K131129.
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. 2015, 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 Zimmer® PSI Shoulder 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 Zimmer® PSI Shoulder is to be used with the glenoid components of the following shoulder implant systems in accordance…
Read the full statement (95 words)
The Zimmer® PSI Shoulder 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 Zimmer® PSI Shoulder is to be used with the glenoid components of the following shoulder implant systems in accordance with their indications and contraindications: Zimmer® Bigliani/Flatow® Complete Shoulder Solution, Zimmer® Trabecular Metal™ Glenoid, and Zimmer® Trabecular Metal™ Reverse Shoulder.
The Zimmer® PSI Shoulder instrument guides and bone model are intended for single use only.
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/K150730 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150730: Zimmer PSI Shoulder System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150730
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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