# K253674: Blueprint Patient-Specific Instrumentation

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Corporation (Tornier, S.A.S.)
- Decided: Apr 3, 2026 after 133 days
- Product code: PHX (Shoulder Prosthesis, Reverse Configuration)
- Device class: 2
- Regulation: 21 CFR 888.3660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K905070 (1991). 114 ancestors in all.
No later device cites it as a predicate yet.
0 of 115 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241491: Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed Glenoid, Stryker Corporation (Tornier, S.A.S.) (2024) Summary page 5.
- K222987: Akunah REFLECT, Akunah Pty, Ltd. (2023) Summary page 5.

## Indications for use
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.

Source page: https://510kreport.com/device/K253674
Methodology: https://510kreport.com/methodology