# K203315: BLUEPRINT™ Patient Specific Instrumentation

- Pathway: 510(k) (Traditional)
- Applicant: Tornier S.A.S.
- Decided: Apr 15, 2021 after 156 days
- Product code: KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented)
- 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: 12 generations back to K905070 (1991). 100 ancestors in all.
18 later devices descend from it; 4 cite it directly.
0 of 119 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162800: BLUEPRINT Patient Specific Instrumentation, Tornier S.A.S. (2017) Summary page 4.

## Most influential descendants
- K213546: ExactechGPS Total Shoulder Application, Equinoxe Planning Software (2022), 8 descendants of its own
- K211359: Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient Specific Instrumentation (2021), 8 descendants of its own
- K232265: BLUEPRINT™ Patient Specific Instrumentation (2024), 3 descendants of its own
- K233199: ROSA® Shoulder System (2024), 3 descendants of its own
- K232425: Signature™ ONE System (2023), 2 descendants of its own

## Indications for use
Hardware The BLUEPRINT m 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 BLUEPRINTTm 3D Planning Software is a medical device for surgeons. BLUEPRINT m 3D Planning Software is intended to be used as a pre-surgical planner for shoulder orthopedic surgery. BLUEPRINTIM 3D Planning Software requires CT scan images showing the anatomical shoulder structure in a DICOM format. BLUEPRINTM 3D Planning Software allows surgeons to visualize, measure, reconstruct, and annotate anatomic data. BLUEPRINTIM 3D Planning Software allows surgeons to design patient specific guides based on the pre-surgical plan. BLUEPRINTTm 3D Planning Software leads to the generation of a planning report. BLUEPRINTM 3D Planning Software is to be used for adult men and women 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.

Source page: https://510kreport.com/device/K203315
Methodology: https://510kreport.com/methodology