(92 days)
- noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
- rheumatoid arthritis;
- correction of functional deformity;
- revision procedures where other treatments or devices have failed; and,
- treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
The EXETER Centralizer is intended to be used to centralize the femoral stem within the intramedullary canal and is intended to be used with bone cement.
The EXETER 2.5mm Intramedullary Bone Plug is intended to restrict the migration of bone cement down the femoral canal and permit cement pressurization during total hip arthroplasty and is intended to be used with bone cement.
The subject devices, EXETER Centralizer and EXETER 2.5mm Intramedullary Plug, are a modified version of the predicate EXETER Centralizer and EXETER 2.5mm Intramedullary Plug. The subject devices are identical to the predicate devices in design and geometry. The subject centralizers and plugs will be manufactured from Acrylic Resin Colacry1® TS2270, an alternate PMMA material.
The labeling for the modified devices is being updated to add MR Conditional labeling. This labeling was previously cleared in K171768.
The provided text describes a 510(k) premarket notification for two devices: the EXETER Centralizer and the EXETER 2.5mm Intramedullary Plug. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving device performance against specific clinical acceptance criteria through a study with experts and ground truth.
Therefore, the input text does not contain the information requested in points 1-9 of your prompt regarding acceptance criteria, study design, expert involvement, or ground truth establishment in a diagnostic or clinical performance study. The 510(k) summary explicitly states: "Clinical testing was not required as a basis for substantial equivalence."
Instead, the submission relies on:
- Comparison to predicate devices: The subject devices are stated to be identical to predicate devices in intended use, indications, design, and operational principles.
- Material change: The primary difference is a change in the PMMA material used for manufacturing.
- Non-clinical testing: This testing was performed to evaluate the new material and device mechanics, not to establish clinical performance in a human study.
The non-clinical testing performed includes:
- Biological Evaluation per ISO 10993-1: 2018
- IM Plug Off-Axis Impaction testing
- Centralizer Insertion (fracture) testing
- Centralizer retention (pull-out) testing
- Centralizer wing flexibility testing
- Material Characterization (Tensile Modulus, Ultimate Tensile Strength, Elongation at Break, Flexural Modulus, Flexural Strength, Izod Impact Strength)
- MRI Analysis
Since no clinical study with human data, expert evaluation, or ground truth establishment was conducted for this 510(k) submission, I cannot provide the requested information for points 1-9.
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.