Total Knee Replacement System - India CDSCO Medical Device Registration

Total Knee Replacement System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2021/000688_34c2e41e8e18584bcde6363d92a64ef3_57650375a637f908937e2cbbc3ccd835. This device is marketed under the brand name NexGen Complete Knee Solution-Tibial Component. The license holder is Zimmer India Private Limited, and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered

Class Class C

Total Knee Replacement System

UID: IMP/MD/2021/000688_34c2e41e8e18584bcde6363d92a64ef3_57650375a637f908937e2cbbc3ccd835

Brand Name

NexGen Complete Knee Solution-Tibial Component

License Holder

Zimmer India Private Limited

Device Class

Class C

Approving Authority

CDSCO

Product Information

This device is indicated for patients with severe knee pain and disability due to: – Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. – Collagen disorders, and/or avascular necrosis of the femoral condyle. – Post‑traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. – Moderate valgus, varus, or flexion deformities. – The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. • CR and LPS porous coated femoral and tibial baseplate components may be used cemented or uncemented (NexGen Complete Knee Solution-Tibial Component). The CR Hydroxyapatite/tricalcium phosphate [HA/TCP] coated femoral or tibial baseplate components may only be used uncemented. All other femoral, tibial baseplate and all‑polyethylene patella components are indicated for cemented use only. • NexGen Augments that may be used with cemented CR, CRA, PS, LPS, and LCCK femoral and tibial baseplate components are indicated for cemented use only

Class C

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Stryker India Pvt. Ltd.,

Class C

Brand: Lorenz® Surgical Instruments

Class B