# K143374: BLUEPRINT Patient Specific Instrumentation

- Pathway: 510(k) (Traditional)
- Applicant: Tornier S.A.S.
- Decided: Apr 8, 2015 after 134 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: 9 generations back to K905070 (1991). 97 ancestors in all.
31 later devices descend from it; 3 cite it directly.
0 of 129 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131129: Cas Psi Shoulder, Zimmer Cas (2013) Summary page 4.
- K112389: Surgicase Connect, Surgicase Guide, Materialise NV (2012) Summary page 4.
- K130126: Signature Personalized Patient Care System - Glenoid Guide System, Biomet, Inc. (2013) Summary page 4.
- K131559: Match Point System (TM), Surgicase Connect, Match Point System (TM) Guides, Materialise NV (2013) Summary page 4.
- K111902: Aequalis Shoulder System, Tornier (2011) Summary page 4.
- K101342: Osirix MD, Pixmeo Sarl (2010) Summary page 4.

## Most influential descendants
- K160555: BLUEPRINT Patient Specific Instrumentation (2016), 25 descendants of its own
- K162800: BLUEPRINT Patient Specific Instrumentation (2017), 23 descendants of its own
- 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

## Indications for use
The hardware The Aequalis 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 shoulder arthroplasty procedures using anatomic landmarks that are identifiable on patient-specific preoperative CT-scans. Aequalis PerFORM Anatomic Glenoid Guide is used by surgeons to facilitate the placement of the Aequalis PerFORM glenoids. The software The 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 BLUEPRINT3D planning software. BLUEPRINT 3D planning software allows surgeon to visualize, measure, reconstruct, and annotate anatomic data. It allows surgeon to design patient specific guides based on the presurgical plan. This device is intended for use provided anatomic reference points necessary for positioning of the guide are present on the CT scan. The software leads to the generation of a surgery report along with a 3D file of the patient-specific guide. BLUEPRINT 3D planning software does not include any system to manufacture the 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/K143374
Methodology: https://510kreport.com/methodology