(76 days)
The EcoFit® Hip System is indicated for use as a total hip replacement in cases of:
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
- Rheumatoid arthritis;
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable by other techniques; and
- Revision of previously failed total hip arthroplasty.
The EcoFit® Acetabular Cup is intended for uncemented, press-fit fixation.
The MUTARS® Proximal Femur Replacement System is a modular hip replacement system offering various components that can be combined to replace the hip joint and address major bone defects with various options depending upon the size and location of the defects of each patient.
The MUTARS® Proximal Femur System is intended for uncemented use in total hip arthroplasty or hemiarthroplasty for the following indications:
- Proximal femur replacement in oncology cases where radical resection and replacement of bone is required.
- Limb salvage procedures including surgical intervention for severe trauma, failed previous prosthesis, and/or oncology indications, where radical resection and replacement of the bone is required.
The MUTARS® ic-Bipolar Head System is intended for uncemented use in hemiarthroplasty, where the femoral head requires replacement but the acetabulum does not, in conjunction with the EcoFit® Hip System and MUTARS® Proximal Femur Replacement System for the following indications:
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
- Rheumatoid arthritis
- Correction of functional deformity
- Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
The purpose of this Traditional 510(k) is to expand the existing EcoFit® Hip System portfolio with a line extension inclusive of additional acetabular inserts and cementless femoral stems.
The provided text is a 510(k) summary for a medical device (EcoFit® Hip System). It describes the device, its indications for use, and declares substantial equivalence to predicate devices, but it does not contain a study that proves the device meets specific acceptance criteria through performance metrics.
Instead, it states that "All necessary testing has been performed for the 'worst case' components of the line extension of the EcoFit® Hip System to assure substantial equivalence to its predicates and to demonstrate the subject devices perform as intended." It then lists the types of tests performed.
Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document, nor can I answer the questions related to sample size, data provenance, ground truth establishment, or clinical study specifics like MRMC effect size or standalone performance, as this information is not present.
The document indicates that the following types of performance tests were conducted:
- Fatigue Testing (ISO 7206-4 and ISO 7206-6)
- Impingement Testing (ASTM F2582-14)
- Liner Disassembly Testing (ASTM F1820)
- Range of Motion
Without the actual test reports, specific acceptance criteria (e.g., minimum cycles for fatigue, maximum force for impingement) and the results demonstrating compliance cannot be extracted.
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.