# K232265: BLUEPRINT™ Patient Specific Instrumentation

- Pathway: 510(k) (Traditional)
- Applicant: Tornier S.A.S.
- Decided: Feb 21, 2024 after 205 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: 14 generations back to K905070 (1991). 109 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 113 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211359: Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient Specific Instrumentation, Tornier, Inc. (2021) Summary page 4.
- K203315: BLUEPRINT™ Patient Specific Instrumentation, Tornier S.A.S. (2021) Summary page 4.

## Most influential descendants
- K241491: Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed Glenoid (2024), 1 descendant of its own
- K253674: Blueprint Patient-Specific Instrumentation (2026), 0 descendants of its own
- K241097: Arthrex Virtual Implant Positioning (VIP) System Software (2024), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K232265
Methodology: https://510kreport.com/methodology