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Knee Replacement System-Sleeve - India CDSCO Medical Device Registration

Knee Replacement System-Sleeve is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000029_b423bce59fc8676ebd54723f8e7aa253_7e533b47b8a372be0a08044166a4ccbe. This device is marketed under the brand name LPS. The license holder is Johnson & Johnson Private Limited, and it is classified as Device Class Class D. The approving authority is CDSCO.

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CDSCO Registered
Class Class D
Knee Replacement System-Sleeve
UID: IMP/MD/2019/000029_b423bce59fc8676ebd54723f8e7aa253_7e533b47b8a372be0a08044166a4ccbe

Brand Name

LPS

Device Class

Class D

Approving Authority

CDSCO

Product Information

The Mobile Bearing Total Knee System is indicated for cemented use in cases of osteoarthritis and rheumatoid arthritis. The RPF and RPS inserts and femoral components are indicated where a higher than normal degree of post-operative flexion is required. The rotating platform prosthesis and modular revision components are indicated for revision of failed knee prostheses. The porous coated Keeled and Non Keeled M.B.T (LPS) Tray configurations of the LCS Total Knee System are indicated for noncemented use in skeletally mature individuals undergoing primary surgery for reconstructing knees damaged as a result of noninflammatory degenerative joint disease (LPS) or either of its composite diagnoses of osteoarthritis and post-traumatic arthritis pathologies. The Rotating Platform device configuration is indicated for use in knees whose anterior and posterior cruciate ligaments are absent or are in such condition as to justify their sacrifice

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