Search Results

The Mpact 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, rheumatic 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, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement where sufficient bone stock is present

The Mpact Extension implants are a line extension to Medacta's Mpact (K103721) and Mpact Extensions (K122641, K132879, K183582 and K200391) Systems and are designed to be used with the Medacta Total Hip Prosthesis System. Specifically, the devices subject of this submission are: - Liners sizes 22/A and 28/A of each design type (flat, hooded, offset +4mm and face changing . +10°); - Acetabular Shells size Ø44 of each design type (No-hole, Two-holes and Multi-holes); ● - Acetabular Shells sizes from Ø42T to Ø58T of each design type (No-hole, Two-holes and Multi-● holes) allowing to be coupled with an increase size of liner. The Mpact Extension implants are sterile implantable devices intended to be used during Total Hip Arthroplasty: the acetabular shells together with their respective liners are used to replace the acetabulum. Analogously to the predicate devices, the subject acetabular shells are made of Ti6Al4V according to ASTM F136-13 and Ti coated according to ASTM F1580-18, while the subject liners are made of High-Cross ultra-high molecular weight polyethylene (UHMWPE).

The hip prosthesis AMIS-K Long is designed for cemented use in total or partial hip arthroplasty in primary or revision surgery. Total hip replacement is indicated in the following cases: · Severely painful and/or disabled joint as a result of arthritis, rheumatoid polyarthritis or congenital hip dysplasia - Avascular necrosis of the femoral head - · Acute traumatic fracture of the femoral head or neck · Failure of previous hip surgery: joint reconstruction, arthrodesis, partial hip arthroplasty, hip resurfacing replacement, or total hip arthroplasty. Partial hip arthroplasty is indicated in the following cases: · Acute traumatic fracture of the femoral head or neck - · Non-union of femoral neck fracture - · Avascular necrosis of the femoral head. - · Primary pathology involving the femoral head but with a non-deformed acetabulum.

The AMIS-K Long cemented stem is designed for cemented use in total or partial hip arthroplasty in primary or revision surgery. The AMIS-K Long is a straight, double-tapered cemented stem whose primary stability is ensured by bone cement. The AMIS-K Long implants in this submission are comprised of the following size: from #2 to #5 with 2 different stem body size for #2, #3 and #4, 1 different stem body size for #5. Stem length: 200 - 250 - 300 mm (for each size). The AMIS-K Long implants are part of the Medacta Total Hip Prosthesis system. The Medacta Total Hip Prosthesis system consists of femoral stemoral heads, and acetabular components. The AMIS-K Long are cemented stems manufactured from high nitrogen stainless steel (ISO 5832-9) with a mirror polished surface. The acetabular components consist of metal cups and liners made of ultra-high molecular weight polyethylene (UHMWPE), or Highcross highly crosslinked ultra-high polyethylene (HXUHMWE). Acetabular components include the Mpact DM (K143453), VersafitCup (K083116 and K092265), VersafitCup CC Trio (K103352, K120531 and K122911), Mpact (K103721 and K132879), Mpact 3D Metal (K171966), and Medacta Bipolar Head (K091967). The AMIS-K Long implants can be combined with the CoCr Ball Heads (K072857 and K080885). Endo Head (K111145), or MectaCer BIOLOX® Forte (K073337) or MectaCer BIOLOX® Delta Femoral Heads (K112115).

The MectaLIF implants in combination with supplemental fixation are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 - S1 whose condition requires the use of interbody fusion. Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of non-operative treatment prior to treatment with the devices.

The subject MectaLIF Extension implants are a line extension to the MectaLIF Oblique and Posterior PEEK implants (K110927, K131671 and K181970) and MectaLIF Oblique and Posterior TiPEEK implants (K133192 and K181970). MectaLIF implants are used to replace a degenerative disc in order to restore the height of the spinal column structure. The devices are not intended to be coupled with other implants but are intended to be used with supplemental fixation and autogenous bone graft. The subject MectaLIF Extension includes various sizes of MectaLIF Oblique and MectaLIF Posterior implants with different widths, lengths, heights, and lordosis angles. The implants are made of implant grade Polyetherketone and have markers made of Tantalum. The devices are available both uncoated or coated with commercially pure titanium coating.