Patient Specific Planning Solution 3D Bone Models

No FDA recalls found in the data synced 25 Oct 2026.

510(k) Number

K230540 ↗

FDA Product Code

LLZ

Device Class

Class II

Regulation

21 CFR Part 892.2050

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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See all devices from Biomet Manufacturing Corp →

• What is the primary purpose of the Patient Specific Planning Solution 3D Bone Models in a clinical setting?

  This device is designed to create three-dimensional printed physical models of a patient’s bone anatomy using their CT scan or other radiological images. The purpose is to assist surgeons and orthopedic teams in pre-operative planning and surgical preparation by providing a tangible, accurate representation of the patient’s anatomy for better visualization and strategy development.

• Are the 3D bone models intended for direct use on patients, or are they meant for planning purposes only?

  The models are explicitly cleared for use as a reusable planning tool and are not intended for direct patient use. They serve as a surgical aid in radiology settings to help clinicians prepare for procedures, rather than being implanted or applied to a patient.

• How are the 3D bone models supplied, and do they come in standardized sizes?

  The models are supplied as custom 3D-printed items generated from patient-specific imaging data, meaning each model’s size varies based on the anatomical requirements of the individual patient. While specific dimensions aren’t detailed in the regulatory filing, the variability ensures a precise fit for pre-surgical planning.

• Is sterility or single-use specified for these models, or are they intended for reuse?

  The FDA clearance does not designate the models as sterile or single-use. Instead, they are described as a reusable planning tool, implying they are meant for use in a controlled, non-patient-contact environment (e.g., surgical planning rooms) and can be reused for multiple cases as long as they remain intact and uncontaminated.

• What regulatory pathway was followed for clearance of this device, and who should buyers contact for further details?

  The device was cleared through the FDA 510(k) process (K230540), classified under Product Code LLZ (Radiology) with a Traditional review. For inquiries, buyers can contact Katherine Choi at Biomet Manufacturing Corp via the provided address: 56 E Bell Dr., Warsaw, IN 46581, US.