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510(k) Data Aggregation
K Number
K241491Device Name
Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed Glenoid
Manufacturer
Stryker Corporation (Tornier, S.A.S.)
Date Cleared
2024-10-10
(139 days)
Product Code
PHX, KWS, QHE
Regulation Number
888.3660Why did this record match?
Applicant Name (Manufacturer) :
Stryker Corporation (Tornier, S.A.S.)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
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 Shoulder iD™ 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 Shoulder iD™ Primary Reversed Glenoid are available in your geography.
The Shoulder iD™ Primary Reversed Glenoid implant is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle and with massive and non-repairable rotator cuff-tear with pain disabled by:
· Rheumatoid arthritis
- · Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)
- · Correction of functional deformity
- · Fractures of the humeral head
- · Traumatic arthritis
- · Revision of glenohumeral joint if sufficient native glenoid bone remains
All components are single use.
The Shoulder iD™ Primary Reversed Glenoid implant is anchored to the bone with screws and is for non-cemented fixation.
Note: A CT Scan is used to create the Shoulder iD™ Primary Reversed Glenoid implant
Device Description
BLUEPRINT™ Patient Specific Instrumentation
Blueprint Patient Specific Instrumentation is composed of two components: Blueprint Glenoid Guides (hardware) and Blueprint Planning Software (software)
Blueprint™ Glenoid Guides
The Blueprint Glenoid Guides are patients specially designed to facilitate the implantation of Wright-Tornier glenoid prostheses.
The Blueprint Glenoid Guides are designed and manufactured based on a pre-operated only by the software Blueprint Planning Software.
Blueprint™ Planning Software
Blueprint Planning Software is a software connected to an Online Management System (OMS). The user interface software is installed on a computer and is intended to be used by orthopedic surgeons, as a preoperative planning software for shoulder arthroplasty surgery (anatomic and reversed).
It is intended to help to plan an operation by allowing surgeons to:
- · Plan for shoulder arthroplasty cases
- · Position and select glenoid and humeral implants,
- · Simulate the prosthetic range of motion,
- · Interact with implants and different computed measurements
- · Generate information required to design a patient-specific glenoid component when appropriate.
Shoulder iD™ Primary Reversed Glenoid
The Shoulder iD Primary Reversed Glenoid implant (Shoulder iD) is intended to replace the native glenoid surface of the scapulohumeral joint as part of a reverse shoulder prosthesis.
The glenoid implant is composed of a baseplate with a press-fit post, peripheral anchoring screws, and a glenosphere. Ancillary instruments are also provided for the implantation of the prosthesis.
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