# K162800: BLUEPRINT Patient Specific Instrumentation

- Pathway: 510(k) (Traditional)
- Applicant: Tornier S.A.S.
- Decided: Feb 22, 2017 after 140 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: 11 generations back to K905070 (1991). 99 ancestors in all.
23 later devices descend from it; 2 cite it directly.
0 of 123 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160555: BLUEPRINT Patient Specific Instrumentation, Tornier S.A.S. (2016) Summary page 5.

## Most influential descendants
- K203315: BLUEPRINT™ Patient Specific Instrumentation (2021), 18 descendants of its own
- 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

## 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™ 3D Planning Software is a medical device for surgeon composed of one software component. It is intended to be used as a pre-surgical planner for shoulder orthopedic surgery. BLUEPRINT™ 3D Planning Software runs on standard personal and business computers running Microsoft Windows or Mac OS operating systems. The software supports DICOM standard to import the CT scan (Computed Tomography) images of the patient. Only CT scan modality can be loaded with BLUEPRINT™ 3D Planning Software. BLUEPRINT™ 3D Planning Software allows surgeon to visualize, measure, reconstruct, annotate and edit anatomic data. It allows surgeon to design glenoid patient-specific guides based on the pre-surgical plan. The software leads to the generation of a surgery report along with a 3D file of the glenoid patient-specific guide. BLUEPRINT™ 3D Planning Software does not include any system to manufacture the glenoid patient-specific guide. BLUEPRINT™ 3D Planning Software is to be used for adult patients only and should not be used for diagnostic purpose.

Source page: https://510kreport.com/device/K162800
Methodology: https://510kreport.com/methodology