DISTAL FEMORAL GROWING PROSTHESIS - India CDSCO Medical Device Registration

DISTAL FEMORAL GROWING PROSTHESIS is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000496_928862ab80f1616460513e616710ebd8_48d89fe613d0be82ea00f765ccdee0a5. This device is marketed under the brand name Femoral Stems. The license holder is M/s Stryker India Private Ltd.,, and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered

Class Class C

DISTAL FEMORAL GROWING PROSTHESIS

UID: IMP/MD/2019/000496_928862ab80f1616460513e616710ebd8_48d89fe613d0be82ea00f765ccdee0a5

Brand Name

Femoral Stems

License Holder

M/s Stryker India Private Ltd.,

Device Class

Class C

Approving Authority

CDSCO

Product Information

The Stryker Distal Femoral Growing Prosthesis is indicated for pediatric patients who have not achieved full skeletal maturity (Femoral Stems), where radical resection and replacement of the distal femur and or/proximal tibia is required with the following conditions: • Oncology indications • Severe trauma • Non-inflammatory degenerative joint disease including osteoarthritis • Correction of functional deformity • Rheumatoid arthritis • Revision procedures where other treatments or devices have failed • The devices are single use implants intended only for implantation with bone cement. • The HMRS System is intended for use in patients requiring extensive reconstruction of the hip joint and/or knee joint, including knee fusions, necessitated by extensive bone loss due to trauma, failed previous prosthesis and/or tumor resection