Intuitive Orthotic System Receives FDA Clearance

09/01/2021 by No Comments

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In2Bones, Inc. , the developer of Intuitive Orthotic® Orthotic System, announced receipt of a 510(k) clearance from the US Food and Drug Administration (FDA) in March 2016 for its pre-surgery cutting guide system, Intuitive Orthotic System. Intuitive Orthotic System delivers the unique ability to control the position and orientation of a cutting tool in an orthotic appliance, which provides an alternative to the “surgical plan” method of treatment options for an individual with limited- or no-option knee surgery or congenital malformations. The Intuitive Orthotic System is now available for all customers who purchased Intuitive Orthotic System during the first three quarters of 2016. Based on the 510(k) clearance, the company will begin providing In2Bones® cutting guides for the Intuitive Orthotic System to the US, starting with the FDA-cleared orthotic systems.

For decades, orthopedic surgeons have been attempting to provide the individual with limited and no-option surgery and associated orthotic or arthritic treatment option the option of complete knee joint replacement (KJR) or a prosthetic knee with the goal of maintaining or improving the patient’s ability to perform a full range of joint and muscle movements. However, with the limitations of available knee surgery options for the general public, there is a growing community of patients with significant health problems who do not have the means to pursue surgical relief of their pain and functional limitations related to the knee joint. 1 These patients include patients with severe arthritis due to the development of malignant or malformed tumors, congenital defects, and limb deformities, where the orthopedic surgeon is unable or unwilling to meet the strict requirements of a KJR.

FDA clearance of the Total Ankle System and patient-specific software for In2Bones and 3D Printed cutting guides & figures.

Total Ankle System: FDA clearance of the Total Ankle System and patient-specific software for In2Bones and 3D Printed cutting guides & figures.

BACKGROUND: Footwear in the office is most commonly designed through a series of drawings, sketches, models, prototypes, or digital models that are then translated into an in-the-pocket product. This process is labor intensive and expensive. One process that can simplify the design process is to construct a cutting guide for each patient-specific design on the form, which is then printed on a 3D Printer.

The goal of this study is to compare the results of using 3D printed cutting guides with cutting guides manufactured with In2Bones and In2Bones Surgical Inc. (In2Bones) for a common foot-ankle deformity. The cutting guides manufactured by In2Bones are designed to mimic the cutting guides manufactured by the surgeon and are based on the manufacturing drawings and specifications. The study design is hypothesis-driven and involves an initial feasibility study.

RESULTS: A total of 20 patients (12 men and 8 women) with a history of Charcot-Marie-Tooth disease were included in this study. The subjects were evenly divided into 2 groups: those treated with the Total Ankle System and those treated with In2Bones. This study was performed in a retrospective cohort design. There were no significant differences between the 2 groups with respect to age, height, or body mass. The mean age of the In2Bones group was 42. 5 years, and the mean age of the Total Ankle group was 42.

The mean BMI was 26. The mean length of the upper and lower tibial incisions was 8. 2 cm respectively. At the conclusion of the in-the-pocket design design, the mean length of the upper and lower tibial incisions in the In2Bones group was 4. 5 cm, while their respective values in the Total Ankle group were 8.

The QUANTUM Total Ankle System.

The QUANTUM Total Ankle System.

The QUANTUM Total Ankle System.

Description: The QUANTUM Total Ankle System (hereinafter abbreviated as QUANTUM TA) is a software package for the measurement and control of the knee extension under load, such as a computer software program being used to measure the movement or force of the patella and the tibial component under load. The goal of this software program is to enable an individual to assess and control the amount of the tibia and patella flexion/extension under load.

Information on this website is provided for informational purposes only and is not intended to substitute for medical advice. You should not use the information contained herein for diagnosing or treating a health problem or disease, or prescribing any medication. You should read carefully all product packaging and labels. Bedding, mattresses and other goods are sold without any warranty. You should verify that the product being purchased has the ingredients and materials specified and are not sold under any other warranty. If you have any concerns regarding this project you should contact the manufacturer directly.

By clicking Submit, I acknowledge that I am 12 years of age or older, and that the information I provide is accurate. I understand that this information may not be the most current version of the product. I consent to receive the information in an e-mail and text message from SPS, Inc.

Bedding, mattresses and other goods are sold without any warranty. You should verify that the product being purchased has the ingredients and materials specified and are not sold under any other warranty. If you have any concerns regarding this project you should contact the manufacturer directly.

How to read the above-referenced terms: * The QUANTUM TA System is intended to be used as a stand-alone software program (i. , there is no need for any other programs or resources from SPS, Inc. to operate the system) to assist individuals in performing tasks, such as the assessment of knee extension, the measurement of the amount of flexion and extension. By using the system, the users define the amount of flexion and extension to that would be determined by the software.

In2Bones.com : Safe-Harbor Medical Devices & Services.

In2Bones.com : Safe-Harbor Medical Devices & Services.

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