AL-2 MP-1 (Polyimide) Acetabular Liner
AL-2 MP-1 (Polyimide) Acetabular Liner
M.M.A.TECH Ltd. product is an Acetabular Liner Family produced of an advanced polyimide -
 MP-1™.

 M.M.A.TECH Ltd. produces the Liners according to EN ISO 13485:2012 approved manufacturing
 process and supplies them to the customer.

 The aim of this study is to evaluate, in the frame of PMCF, the safety and performance of
 using AL-X MP1 Polyimide Acetabular liners in Total Hip Replacement surgery by clinical
 following up of patients for a period of 2 years .
The procedure involves removal of the diseased parts of the joint, that is the damaged
 cartilage and adjacent bone, and replacing them with artificial parts which closely resemble
 in structure and/or function the removed native parts.

 The artificial parts fit onto the reshaped bone and are fixed either with bone cement (e.g.,
 polymethylmethacrylate) and press fit of the part(cemented), or by self-anchorage with bone
 ingrowth to its porous surface(cementless).

 The design of the artificial parts may include a stem, a keel or pegs, which fit onto the
 medullary canal of the bone or into a hole pre-prepared in the bone. An artificial part may
 fit loosely and be fixed with bone cement, press-fit for self- anchorage or include
 extendible anchors which are retracted upon placement and extended thereafter so as to secure
 the implant in place.

 Following fixation of the components, the joint is reduced and the soft tissue tension is
 appropriately checked to reassure stability of the joint.

 The MP-1™ acetabular liner will be tapper locked in acetabular metal shells to resurface the
 acetabular socket in cementless total hip replacement.

 MMaTech Ltd will manufacture the liners to perfectly fit into the external metallic shell of
 the following sizes (mm):

 LINER CUP SIZE LINER SIZE HEAD Liner thickness AL-2MP132040 44-48 32 ID 40 OD 32 4 mm
 AL-2MP136044 50-54 36 ID 44 OD 36 4mm AL-2MP136048 56-66 36 ID 48 OD 36 6mm AL-2MP140048
 56-66 40 ID 48 OD 40 4mm

 The MP-1™ Acteabular liners are intended to be used only against ceramic femoral heads-
 Biolox Delta
Inclusion Criteria:

 The inclusion criteria for subject participation in the study are:

 (Patient must meet all of the following characteristics to be enrolled in the study):

 -  Males and females, 21 to 90 years of age, inclusive;

 -  Primary diagnosis of non-inflammatory arthritis (osteoarthritis) or inflammatory
 arthritis (rheumatoid arthritis), or patients requiring a revision as specified
 previously;

 -  The patient or his/her legal guardian is willing to consent to participate in the
 study by signing and dating the approved consent form;

 -  The patient will be available for follow-up through at least two years postoperative;

 -  The patient has met an acceptable preoperative medical clearance and is free or
 treated for cardiac, pulmonary, hematological, etc., conditions that would pose
 excessive operative risk (FDA requirement);

 -  The patient has a total Harris Hip Score of less than or equal to 60 (FDA
 requirement);

 -  The patient meets none of the exclusion criteria.

 Exclusion Criteria:

 with any of the following characteristics must be excluded from the study):

 -  Patients known to have insufficient quantity or quality of bone support resulting from
 Conditions such as cancer, femoral osteotomy, Girdlestone resection, significant
 osteoporosis or metabolic disorders of calcified tissues. Patients with physical
 conditions tending to place extreme loads on implants such as morbid obesity (> 100
 pounds over desirable body weight), Charcot joints, muscle deficiencies, or multiple
 joint disabilities;

 -  Patients with active localized or systemic infection;

 -  Patients who have not reached full skeletal maturity;

 -  Patient has had a total knee arthroplasty of either leg

 -  Patient psychological or neurological conditions which tend to preempt the patient's
 ability or willingness to restrict activities or follow medical advice, especially
 during the postoperative period, e.g.: drug or alcohol abuse, serious mental illness
 or retardation, or general neurological conditions;

 -  The patient is participating in any other pharmaceutical, biologic or medical device
 clinical investigation;

 -  Immunosuppressive disorders - immunosuppressive disorders are chronic conditions
 characterized by markedly inhibited ability to respond to antigenic stimuli. Examples
 of such conditions include patients who are on immunosuppressive therapy
 (corticosteroid hormones in large amounts, cytotoxic drugs, antilymphocytic serum or
 irradiation in large doses), patients receiving therapy to prevent homograft
 rejection, patients who have acquired immunodeficiency syndrome (AIDS), or auto-immune
 diseases (except rheumatoid arthritis).

 -  Pregnancy.

 -  Patients with known sensitivity to materials in the device.