510(k) · Cleared
ClearedBLUEPRINT™ Patient Specific Instrumentation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tornier S.A.S. · PHX Shoulder Prosthesis, Reverse Configuration
Cleared on Feb 21, 2024 as substantially equivalent to K211359 (Tornier, Inc., 2021) and 1 other predicate after a 205-day review. Its family tree reaches back 14 generations to 1991. 3 later devices descend from it.
- Decided
- Feb 21, 2024
- Review
- 205 days
- Class
- Class II
- Product code
- PHX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 14 generations to K905070 (1991). 109 ancestors in all, the oldest K800494 (1980). 3 later devices descend from it, 2 citing it directly.
- Root · 14 generations backK905070 VistarPhilips Medical Systems (Cleveland), Inc. · 1991
- 10 generations between
- 3 generations backK162800 BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2017
- 2 generations backK203315 BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S. · 2021
- 1 generation backK211359 Tornier Perform™ Patient-Matched Primary Reversed Glenoid and…Tornier, Inc. · 2021 · Recalled
- This deviceK232265 BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S. · 2024
- Descendant · cites it directly · 1 of its ownK241491 Blueprint Patient-Specific Instrumentation; Shoulder iD Primary…Stryker Corporation (Tornier, S.A.S.) · 2024
- Descendant · 2 generations on · 0 of its ownK253674 Blueprint Patient-Specific InstrumentationStryker Corporation (Tornier, S.A.S.) · 2026
- Descendant · cites it directly · 0 of its ownK241097 Arthrex Virtual Implant Positioning (VIP) System SoftwareArthrex, Inc. · 2024
Show all 14 generations
- Root · 14 generations backK905070 VistarPhilips Medical Systems (Cleveland), Inc. · 1991
- 13 generations backK961168 ViewpointPhilips Medical Systems (Cleveland), Inc. · 1996
- 12 generations backK963221 Optical Digitizer Option for View PointPhilips Medical Systems (Cleveland), Inc. · 1997
- 11 generations backK970604 Viewpoint - 3.0 SoftwarePhilips Medical Systems (Cleveland), Inc. · 1997
- 10 generations backK984298 Z Kat Flurotactic Guidance System MkiZ-Kat, Inc. · 1999
- 9 generations backK013025 Modification to Flourolab PlusZ-Kat, Inc. · 2001
- 8 generations backK031454 Acumen Surgical Navigation SystemBiomet, Inc. · 2004
- 7 generations backK111863 Signature Planner,Signature GuidesMaterialise NV · 2012
- 6 generations backK130126 Signature Personalized Patient Care System - Glenoid Guide SystemBiomet, Inc. · 2013
- 5 generations backK143374 BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2015
- 4 generations backK160555 BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2016
- 3 generations backK162800 BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2017
- 2 generations backK203315 BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S. · 2021
- 1 generation backK211359 Tornier Perform™ Patient-Matched Primary Reversed Glenoid and…Tornier, Inc. · 2021 · Recalled
- This deviceK232265 BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S. · 2024
Most influential descendants
Showing 3 of 3 · See all- K241491Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed GlenoidStryker Corporation (Tornier, S.A.S.) · 2024 · cites it directly1descendant
- K253674Blueprint Patient-Specific InstrumentationStryker Corporation (Tornier, S.A.S.) · 2026 · 2 generations on0descendants
- K241097Arthrex Virtual Implant Positioning (VIP) System SoftwareArthrex, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K905070 | Vistar | Philips Medical Systems (Cleveland), Inc. | 1991 | — |
| −13 | K961168 | Viewpoint | Philips Medical Systems (Cleveland), Inc. | 1996 | — |
| −12 | K963221 | Optical Digitizer Option for View Point | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −11 | K970604 | Viewpoint - 3.0 Software | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −10 | K984298 | Z Kat Flurotactic Guidance System Mki | Z-Kat, Inc. | 1999 | — |
| −9 | K013025 | Modification to Flourolab Plus | Z-Kat, Inc. | 2001 | — |
| −8 | K031454 | Acumen Surgical Navigation System | Biomet, Inc. | 2004 | — |
| −7 | K111863 | Signature Planner,Signature Guides | Materialise NV | 2012 | — |
| −6 | K130126 | Signature Personalized Patient Care System - Glenoid Guide System | Biomet, Inc. | 2013 | — |
| −5 | K143374 | BLUEPRINT Patient Specific Instrumentation | Tornier S.A.S. | 2015 | — |
| −4 | K160555 | BLUEPRINT Patient Specific Instrumentation | Tornier S.A.S. | 2016 | — |
| −3 | K162800 | BLUEPRINT Patient Specific Instrumentation | Tornier S.A.S. | 2017 | — |
| −2 | K203315 | BLUEPRINT™ Patient Specific Instrumentation | Tornier S.A.S. | 2021 | — |
| −1 | K211359 | Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™… | Tornier, Inc. | 2021 | 2 |
| 0 (this device) | K232265 | BLUEPRINT™ Patient Specific Instrumentation | Tornier S.A.S. | 2024 | — |
| +1 | K241491 | Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed Glenoid | Stryker Corporation (Tornier, S.A.S.) | 2024 | — |
| +2 | K253674 | Blueprint Patient-Specific Instrumentation | Stryker Corporation (Tornier, S.A.S.) | 2026 | — |
| +1 | K241097 | Arthrex Virtual Implant Positioning (VIP) System Software | Arthrex, Inc. | 2024 | — |
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 | 5 | 0 |
| 2002 | 2 | 0 |
| 2003 | 5 | 0 |
| 2004 | 10 | 0 |
| 2005 | 6 | 0 |
| 2006 | 7 | 0 |
| 2007 | 2 | 0 |
| 2008 | 4 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 5 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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? (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 |
|---|---|---|---|
| * | K211359 | Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient…Summary page 4…Trade name 510(k) Decision date Applicant Number BLUEPRINT™ Patient Specific K211359 November 12, 2021 TORNIER Instrumentation (PRIMARY)… | 2021 |
| * | K203315 | BLUEPRINT™ Patient Specific InstrumentationSummary page 4…12, 2021 TORNIER Instrumentation (PRIMARY) SAS BLUEPRINT™ Patient Specific K203315 April 15, 2021 TORNIER Instrumentation (Additional)… | 2021 |
What descends from it? (3)
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 33 years and passes through 6 companies; a new generation was cleared every 2.1 years on median.
- 21 of the 109 ancestors have a recall of any class.
- Of its descendants, K241491 (Stryker Corporation (Tornier, S.A.S.), 2024) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K211359.
How does its category compare?
All PHX devicesPHX Shoulder Prosthesis, Reverse Configuration: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?
Hardware The BLUEPRINT™ Glenoid Guides are patient-specific drill guides. They have been specially designed to assist in the intraoperative positioning of glenoid components used with total anatomic or reversed shoulder arthroplasty procedures using anatomic landmarks that are identifiable on patient-specific preoperative CT scans. Software Blueprint® is a medical device for surgeons. Blueprint® is intended to be used as a pre-surgical planner for…
Read the full statement (176 words)
Hardware
The BLUEPRINT™ Glenoid Guides are patient-specific drill guides. They have been specially designed to assist in the intraoperative positioning of glenoid components used with total anatomic or reversed shoulder arthroplasty procedures using anatomic landmarks that are identifiable on patient-specific preoperative CT scans.
Software
Blueprint® is a medical device for surgeons.
Blueprint® is intended to be used as a pre-surgical planner for shoulder replacement surgery.
Blueprint® requires CT scan images showing the anatomical shoulder structure in a DICOM format.
Blueprint® allows surgeons to visualize, measure, reconstruct, and annotate anatomic data.
Blueprint® allows surgeons to design patient specific components (patient-specific instruments and Tornier Perform patient-matched primary reversed glenoid*) based on the pre-surgical plan.
Blueprint® leads to the generation of a planning report.
Blueprint® is to be used for adult men and women patients only whose bone maturity is reached and should not be used for diagnostic purpose.
Note:
Measures and patient specific guide design are provided depending on the case profiles.
*Only if patient-specific instruments or Tornier Perform patient-matched primary reversed glenoid are available in your geography.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232265 · printed Nov 4, 2026
Cite this page
510(k) Report. “K232265: BLUEPRINT™ Patient Specific Instrumentation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K232265
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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