Knee Replacement System - Femoral - India CDSCO Medical Device Registration

Knee Replacement System - Femoral is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000347_d47ea46ed5b0ee75eb125a3c891196e6_d7c9b4888a5954b34acc8331c202b245. This device is marketed under the brand name C-Stem. 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 - Femoral

UID: IMP/MD/2018/000347_d47ea46ed5b0ee75eb125a3c891196e6_d7c9b4888a5954b34acc8331c202b245

Brand Name

C-Stem

License Holder

Johnson & Johnson Private Limited

Device Class

Class D

Approving Authority

CDSCO

Product Information

With Cement: The LCS® Complete – PFC Σ RP Mobile Bearing Total Knee System is indicated for cemented use in cases of osteoarthritis and rheumatoid arthritis. The rotating platform prosthesis and modular revision components are indicated for revision of failed knee prostheses. Without Cement: The porous coated components within 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 (C-Stem) 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. The PFC Σ RP Curved bearings when used with the PFC Σ Cruciate Retaining Femoral Component can be used in posterior cruciate ligament retaining procedures. In addition, Titanium Alloy components, coated with Titanium-Nitride are available and may be selected where patient metal sensitivity to Co-Cr is suspected

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Void Centraliser

Brand: C-Stem

Johnson & Johnson Private Limited

Class C

Void Centrailser-Centraliser

Brand: C-Stem

Johnson & Johnson Private Limited

Knee Replacement System - Femoral - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

Product Information

DJ Fang

Void Centraliser

Void Centrailser-Centraliser

Knee Replacement System - Femoral

Hip System - Heads

Knee Replacement System- Tibial Tray

Hip System - Cups

Hip Prosthesis

Modular Femoral Heads

Modular Femoral Heads

Knee Replacement System - Femoral

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NON ABSORBABLE SURGICAL SUTURE U. S. P.

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