510(k) · Cleared
ClearedMyShoulder Placement Guides
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medacta International S.A. · PHX Shoulder Prosthesis, Reverse Configuration
Cleared on Dec 13, 2019 as substantially equivalent to K143374 (Tornier S.A.S., 2015) after a 266-day review. Its family tree reaches back 10 generations to 1991. 4 later devices descend from it.
- Decided
- Dec 13, 2019
- Review
- 266 days
- Class
- Class II
- Product code
- PHX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K905070 (1991). 98 ancestors in all, the oldest K800494 (1980). 4 later devices descend from it, 2 citing it directly.
- Root · 10 generations backK905070 VistarPhilips Medical Systems (Cleveland), Inc. · 1991
- 6 generations between
- 3 generations backK111863 Signature Planner,Signature GuidesMaterialise NV · 2012
- 2 generations backK130126 Signature Personalized Patient Care System - Glenoid Guide SystemBiomet, Inc. · 2013
- 1 generation backK143374 BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2015
- This deviceK190738 MyShoulder Placement GuidesMedacta International S.A. · 2019
- Descendant · cites it directly · 2 of its ownK233992 Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd. · 2024
- Descendant · 2 generations on · 1 of its ownK243955 Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd. · 2025
- Descendant · 3 generations on · 0 of its ownK251558 Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK243509 Archer PSI System3D-Side · 2025
Show all 10 generations
- Root · 10 generations backK905070 VistarPhilips Medical Systems (Cleveland), Inc. · 1991
- 9 generations backK961168 ViewpointPhilips Medical Systems (Cleveland), Inc. · 1996
- 8 generations backK963221 Optical Digitizer Option for View PointPhilips Medical Systems (Cleveland), Inc. · 1997
- 7 generations backK970604 Viewpoint - 3.0 SoftwarePhilips Medical Systems (Cleveland), Inc. · 1997
- 6 generations backK984298 Z Kat Flurotactic Guidance System MkiZ-Kat, Inc. · 1999
- 5 generations backK013025 Modification to Flourolab PlusZ-Kat, Inc. · 2001
- 4 generations backK031454 Acumen Surgical Navigation SystemBiomet, Inc. · 2004
- 3 generations backK111863 Signature Planner,Signature GuidesMaterialise NV · 2012
- 2 generations backK130126 Signature Personalized Patient Care System - Glenoid Guide SystemBiomet, Inc. · 2013
- 1 generation backK143374 BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2015
- This deviceK190738 MyShoulder Placement GuidesMedacta International S.A. · 2019
Most influential descendants
Showing 4 of 4 · See all- K233992Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd. · 2024 · cites it directly2descendants
- K243955Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd. · 2025 · 2 generations on1descendant
- K251558Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd. · 2026 · 3 generations on0descendants
- K243509Archer PSI System3D-Side · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K905070 | Vistar | Philips Medical Systems (Cleveland), Inc. | 1991 | — |
| −9 | K961168 | Viewpoint | Philips Medical Systems (Cleveland), Inc. | 1996 | — |
| −8 | K963221 | Optical Digitizer Option for View Point | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −7 | K970604 | Viewpoint - 3.0 Software | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −6 | K984298 | Z Kat Flurotactic Guidance System Mki | Z-Kat, Inc. | 1999 | — |
| −5 | K013025 | Modification to Flourolab Plus | Z-Kat, Inc. | 2001 | — |
| −4 | K031454 | Acumen Surgical Navigation System | Biomet, Inc. | 2004 | — |
| −3 | K111863 | Signature Planner,Signature Guides | Materialise NV | 2012 | — |
| −2 | K130126 | Signature Personalized Patient Care System - Glenoid Guide System | Biomet, Inc. | 2013 | — |
| −1 | K143374 | BLUEPRINT Patient Specific Instrumentation | Tornier S.A.S. | 2015 | — |
| 0 (this device) | K190738 | MyShoulder Placement Guides | Medacta International S.A. | 2019 | — |
| +1 | K233992 | Precision AI Surgical Planning System (PAI-SPS) | Precision AI Pty, Ltd. | 2024 | — |
| +2 | K243955 | Precision AI Surgical Planning System (PAI-SPS) | Precision AI Pty, Ltd. | 2025 | — |
| +3 | K251558 | Precision AI Surgical Planning System (PAI-SPS) | Precision AI Pty, Ltd. | 2026 | — |
| +1 | K243509 | Archer PSI System | 3D-Side | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 2 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 1 | 0 |
| 1993 | 3 | 0 |
| 1994 | 3 | 0 |
| 1995 | 3 | 0 |
| 1996 | 5 | 0 |
| 1997 | 3 | 0 |
| 1998 | 2 | 0 |
| 1999 | 6 | 0 |
| 2000 | 5 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 5 | 0 |
| 2004 | 8 | 0 |
| 2005 | 5 | 0 |
| 2006 | 6 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 5 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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 PHX? 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 PHX device
- #1 K212737 INHANCE™ Reverse Shoulder Systemscore 28.4 · 15 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 |
|---|---|---|---|
| * | K143374 | BLUEPRINT Patient Specific InstrumentationSummary page 4…Predicate Device Substantial equivalence is therefore claimed to the following devices: Primary Predicate: BLUEPRINT Patient Specific Instrumentation (K143374), Wright- Tornier Reference Device: Anatomic Shoulder Prosthesis (K170910), Medacta International… | 2015 |
| † | K170910 | Medacta Anatomic Shoulder Prosthesis | 2017 |
| † | K170452 | Medacta Shoulder System | 2017 |
| † | K132788 | Myspine Pedicle Screw Placement Guides | 2014 |
What descends from it? (4)
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 28 years and passes through 6 companies; a new generation was cleared every 2.3 years on median.
- 19 of the 98 ancestors have a recall of any class.
- Of its descendants, K233992 (Precision AI Pty, Ltd., 2024) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K143374.
How does its category compare?
All PHX devicesPHX Shoulder Prosthesis, Reverse Configuration: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · PHX
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PHX
72in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PHX
3in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PHX
2,848in 2025
MAUDE reports naming product code PHX, 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 | 5 | 97 | 0 | 0 |
| 2008 | 6 | 79 | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 8 | 124 | 0 | 0 |
| 2011 | 12 | 94 | 0 | 0 |
| 2012 | 12 | 114 | 0 | 0 |
| 2013 | 8 | 143 | 0 | 0 |
| 2014 | 12 | 110 | 0 | 0 |
| 2015 | 4 | 206 | 2 | 14 |
| 2016 | 4 | 132 | 0 | 5 |
| 2017 | 11 | 141 | 0 | 25 |
| 2018 | 14 | 127 | 1 | 323 |
| 2019 | 9 | 144 | 3 | 504 |
| 2020 | 13 | 143 | 3 | 986 |
| 2021 | 21 | 143 | 8 | 1,404 |
| 2022 | 9 | 198 | 0 | 1,342 |
| 2023 | 9 | 154 | 7 | 1,401 |
| 2024 | 9 | 139 | 1 | 2,142 |
| 2025 | 9 | 72 | 3 | 2,848 |
| 2026 | 18 | 130 | 7 | — |
What is it indicated for?
The MyShoulder guides are intended to be used as guides specifically designed for the anatomy of a single patient. The humeral guide is used to define the level and orientation of the humeral head resection cut. The glenoidal guide is used to position and orient the K-wire that will subsequently guide the glenoidal reaming.
Both anatomical and reverse total joint configurations are acceptable.
Both humeral and glenoid guides are suitable for a delto-pectoral approach only.
MyShoulder Patient-Matched Guides are intended for use with Medacta Shoulder System and its cleared indications for use.
MyShoulder Patient-Matched Guides are intended for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190738 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190738: MyShoulder Placement Guides.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190738
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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