510(k) · Cleared
ClearedBlueprint Patient-Specific Instrumentation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Corporation (Tornier, S.A.S.) · PHX Shoulder Prosthesis, Reverse Configuration
Cleared on Apr 3, 2026 as substantially equivalent to K241491 (Stryker Corporation (Tornier, S.A.S.), 2024) and 1 other predicate after a 133-day review. Its family tree reaches back 16 generations to 1991.
- Decided
- Apr 3, 2026
- Review
- 133 days
- Class
- Class II
- Product code
- PHX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 16 generations to K905070 (1991). 114 ancestors in all, the oldest K800494 (1980). No later device cites it as a predicate yet.
- Root · 16 generations backK905070 VistarPhilips Medical Systems (Cleveland), Inc. · 1991
- 12 generations between
- 3 generations backK211359 Tornier Perform™ Patient-Matched Primary Reversed Glenoid and…Tornier, Inc. · 2021 · Recalled
- 2 generations backK232265 BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S. · 2024
- 1 generation backK241491 Blueprint Patient-Specific Instrumentation; Shoulder iD Primary…Stryker Corporation (Tornier, S.A.S.) · 2024
- This deviceK253674 Blueprint Patient-Specific InstrumentationStryker Corporation (Tornier, S.A.S.) · 2026
Show all 16 generations
- Root · 16 generations backK905070 VistarPhilips Medical Systems (Cleveland), Inc. · 1991
- 15 generations backK961168 ViewpointPhilips Medical Systems (Cleveland), Inc. · 1996
- 14 generations backK963221 Optical Digitizer Option for View PointPhilips Medical Systems (Cleveland), Inc. · 1997
- 13 generations backK970604 Viewpoint - 3.0 SoftwarePhilips Medical Systems (Cleveland), Inc. · 1997
- 12 generations backK984298 Z Kat Flurotactic Guidance System MkiZ-Kat, Inc. · 1999
- 11 generations backK013025 Modification to Flourolab PlusZ-Kat, Inc. · 2001
- 10 generations backK031454 Acumen Surgical Navigation SystemBiomet, Inc. · 2004
- 9 generations backK111863 Signature Planner,Signature GuidesMaterialise NV · 2012
- 8 generations backK130126 Signature Personalized Patient Care System - Glenoid Guide SystemBiomet, Inc. · 2013
- 7 generations backK143374 BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2015
- 6 generations backK160555 BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2016
- 5 generations backK162800 BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2017
- 4 generations backK203315 BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S. · 2021
- 3 generations backK211359 Tornier Perform™ Patient-Matched Primary Reversed Glenoid and…Tornier, Inc. · 2021 · Recalled
- 2 generations backK232265 BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S. · 2024
- 1 generation backK241491 Blueprint Patient-Specific Instrumentation; Shoulder iD Primary…Stryker Corporation (Tornier, S.A.S.) · 2024
- This deviceK253674 Blueprint Patient-Specific InstrumentationStryker Corporation (Tornier, S.A.S.) · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K905070 | Vistar | Philips Medical Systems (Cleveland), Inc. | 1991 | — |
| −15 | K961168 | Viewpoint | Philips Medical Systems (Cleveland), Inc. | 1996 | — |
| −14 | K963221 | Optical Digitizer Option for View Point | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −13 | K970604 | Viewpoint - 3.0 Software | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −12 | K984298 | Z Kat Flurotactic Guidance System Mki | Z-Kat, Inc. | 1999 | — |
| −11 | K013025 | Modification to Flourolab Plus | Z-Kat, Inc. | 2001 | — |
| −10 | K031454 | Acumen Surgical Navigation System | Biomet, Inc. | 2004 | — |
| −9 | K111863 | Signature Planner,Signature Guides | Materialise NV | 2012 | — |
| −8 | K130126 | Signature Personalized Patient Care System - Glenoid Guide System | Biomet, Inc. | 2013 | — |
| −7 | K143374 | BLUEPRINT Patient Specific Instrumentation | Tornier S.A.S. | 2015 | — |
| −6 | K160555 | BLUEPRINT Patient Specific Instrumentation | Tornier S.A.S. | 2016 | — |
| −5 | K162800 | BLUEPRINT Patient Specific Instrumentation | Tornier S.A.S. | 2017 | — |
| −4 | K203315 | BLUEPRINT™ Patient Specific Instrumentation | Tornier S.A.S. | 2021 | — |
| −3 | K211359 | Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™… | Tornier, Inc. | 2021 | 2 |
| −2 | 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 | — |
| 0 (this device) | K253674 | Blueprint Patient-Specific Instrumentation | Stryker Corporation (Tornier, S.A.S.) | 2026 | — |
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 | 5 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 5 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K241491 | Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed GlenoidSummary page 5…Product Code(s) PHX, KWS, QHE I Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K241491 BLUEPRINT™ Patient Specific Instrumentation PHX K222987 Akunah REFLECT LLZ Device Description Summary 21 CFR 807.92(a)(4) BLUEPR… | 2024 |
| * | K222987 | Akunah REFLECTSummary page 5…ate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K241491 BLUEPRINT™ Patient Specific Instrumentation PHX K222987 Akunah REFLECT LLZ Device Description Summary 21 CFR 807.92(a)(4) BLUEPRINT™ Patient Specific Instrumentation Blueprint Patient… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
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 35 years and passes through 7 companies; a new generation was cleared every 1.7 years on median.
- 21 of the 114 ancestors have a recall of any class.
How does its category compare?
All PHX devicesPHX Shoulder Prosthesis, Reverse Configuration: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?
Blueprint is a medical device for surgeons. Blueprint is intended to be used as a pre-surgical planner for shoulder replacement surgery or shoulder instability treatment of cases with anterior glenoid bone loss. 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…
Read the full statement (165 words)
Blueprint is a medical device for surgeons.
Blueprint is intended to be used as a pre-surgical planner for shoulder replacement surgery or shoulder instability treatment of cases with anterior glenoid bone loss.
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 Shoulder iD Primary Reversed Glenoid*) based on the pre-surgical plan.
Blueprint generates a planning report.
Blueprint arthroplasty planning is to be used for adult men and women patients only whose bone maturity is reached and should not be used for diagnostic purpose.
Blueprint instability planning is to be used for 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 Shoulder iD Primary Reversed Glenoid are available in your geography.
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/K253674 · printed Nov 4, 2026
Cite this page
510(k) Report. “K253674: 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/K253674
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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