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The Mpact 3D Metal implants are designed for cementless use in total hip arthroplasty in primary or revision surgery.

The patient should be skeletally mature.

The patient's condition should be due to one or more of:

• Severely painful and/or disabled joint: as a result of osteoarthritis, post-traumatic arthritis, rheumatoid arthritis or psoriatic arthritis, congenital hip dysplasia, ankylosing spondylitis.
• Avascular necrosis of the femoral head.
• Acute traumatic fracture of the femoral head or neck.
• Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement where sufficient bone stock is present.

The Mpact 3D Metal Implants Extension - DMLS Technology are a line extension to the Mpact 3D Metal Acetabular Shells and 3D Metal Augments (K171966, K202568) and to the Mpact Acetabular Systems Shells (K103721, K122641, K132879 and K230011) and are designed to be used with the Medacta Total Hip Prosthesis System. Specifically, the devices subject of this submission are:

• Acetabular shell size Ø44 Two-holes;
• Acetabular shell size Ø44 Multi-holes thin;
• Acetabular shells sizes from Ø42T to Ø58T of both Two-holes and Multi-holes Thin designs, allowing to be coupled with an increase size of liner.

The subject implants are intended to be used during Total Hip Arthroplasty to replace the acetabulum and they are provided individually packed, sterile and single-use. Similarly to the predicate devices, the subject acetabular shells are manufactured using a Direct Metal Laser Sintering (DMLS) process with titanium alloy powder according to ASTM F2924-14.

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