Knee System - India CDSCO Medical Device Registration

Knee System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000076_0fd2ba5dabd0832843ccf85d9aeffc94_6222f72cc8ffb2598071e47e7e00210d. This device is marketed under the brand name JOURNEY. The license holder is Smith & Nephew Healthcare Pvt. Ltd., and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered

Class Class C

Knee System

UID: IMP/MD/2018/000076_0fd2ba5dabd0832843ccf85d9aeffc94_6222f72cc8ffb2598071e47e7e00210d

Brand Name

JOURNEY

License Holder

Smith & Nephew Healthcare Pvt. Ltd.

Device Class

Class C

Approving Authority

CDSCO

Product Information

Rheumatoid arthritis.•Post-traumatic arthritis, osteoarthritis, or degenerative arthritis.•Failed osteotomies, unicompartmental replacement, or total knee replacement.•Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent, and the collateral ligaments remain intact.•Constrained knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (JOURNEY) are incompetent.•The device is indicated for use only in surgeries where the patella is resurfaced