Intended Use

Blueprint Patient Specific Instrumentation assists in the intraoperative positioning of glenoid components for total anatomic or reversed shoulder arthroplasty using patient-specific landmarks from preoperative CT scans. Blueprint software serves as a pre-surgical planner for shoulder replacement surgery, visualizing and measuring anatomical shoulder data for adult patients and enabling design of patient-specific instruments and implants. The Shoulder iD Primary Reversed Glenoid implant replaces the native glenoid for patients with functional deltoid muscle and serious shoulder conditions.

Technology

The system comprises Blueprint Glenoid Guides (hardware) designed from preoperative CT-based planning by Blueprint Planning Software. The software connects to an Online Management System and assists surgeons in planning shoulder arthroplasty by allowing implant positioning, simulation, and design of patient-specific implants. The Shoulder iD Primary Reversed Glenoid implant includes a baseplate, screws, and glenosphere for non-cemented fixation. Both hardware and software have similar technological features as predicate devices, with differences addressed by performance testing.

Performance

The patient-specific instrumentation was validated by dimensional and cadaveric tests demonstrating equivalence to predicate devices. Software verification and validation confirmed the operating principle is consistent with predicate software. The Shoulder iD implant underwent non-clinical loosening testing confirming substantial equivalence. No clinical studies were performed.

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    5/24/2024

    4 months
  • 2

    FDA Approval

    10/10/2024

Other devices from Stryker Corporation (Tornier, S.A.S.)

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