(13 days)
EMPHASYS Femoral Stems are intended for use in total and partial hip arthroplasty. The stems are intended only for uncemented use.
Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.
Partial hip arthroplasty (hip hemiarthroplasty) is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of a satisfactory natural acetabulum and sufficient femoral bone to seat and support the femoral stem.
EMPHASYS Femoral Stems are intended for single use only.
Total hip replacement is indicated in the following conditions:
- A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
- Avascular necrosis of the femoral head.
- Acute traumatic fracture of the femoral head or neck.
- Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
- Certain cases of ankylosis.
Partial hip replacement is indicated in the following conditions:
- Acute fracture of the femoral head or neck that cannot be appropriately reduced and treated with internal fixation.
- Fracture dislocation of the hip that cannot be appropriately reduced and treated with internal fixation.
- Avascular necrosis of the femoral head.
- Non-union of femoral neck fractures.
- Certain high subcapital and femoral neck fractures in the elderly.
- Degenerative arthritis involving only the femoral head in which the acetabulum does not require replacement.
- Pathology involving only the femoral head/neck and/or proximal femur that can be adequately treated by hip hemiarthroplasty.
The EMPHASYS Femoral Stems are indicated for cementless use only.
The EMPHASYS Femoral Stems include HA-coated femoral stems in standard and high offsets and in collared and collarless configurations.
The stems are manufactured from titanium alloy forgings per ASTM F620-20 and coated with a layer of plasma-sprayed HA per ASTM F1185-14 and ISO 13779-6: 2015.
The provided FDA 510(k) summary (K233233) describes an application for an extension of the shelf life of the EMPHASYS Femoral Stems from 5 years to 10 years, not a new device or an AI/software-based device.
Therefore, the requested information regarding acceptance criteria for device performance, sample size for test sets, expert ground truth establishment, MRMC studies, standalone algorithm performance, and training set details are not applicable to this submission. This document focuses on the equivalence of properties related to an extended shelf life.
However, I can extract and present the acceptance criteria and reported device performance related to the shelf-life extension from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Related to Shelf-Life Extension) | Reported Device Performance (for 10 years shelf life) |
|---|---|
| Maintenance of HA coating properties (Crystallinity, Foreign Phases, CaP ratio) as per ISO-13779-3 for aged products. | HA coating properties on aged products were tested and confirmed to maintain specifications. |
| Maintenance of HA coating thickness as per ASTM F1854 for aged products. | HA coating thickness on aged products was tested and confirmed to maintain specifications. |
| Maintenance of HA coating porosity as per ASTM E2109 for aged products. | HA coating porosity on aged products was tested and confirmed to maintain specifications. |
| Packaging integrity and sterility validation for 10 years. | Packaging shelf-life validation has been carried out to confirm a shelf-life of 10 years. |
The submission explicitly states:
- No clinical tests were conducted to demonstrate substantial equivalence for this shelf-life extension.
- The shelf life extension will not impact the fit, form, or function of these components as they are manufactured to the same specifications and utilize the same materials as the predicate devices.
- The nonclinical tests reviewed as part of K211657 and K203167 (previous clearances for the device and a predicate) remain current.
Given that this is a 510(k) for a shelf-life extension of an existing medical device, rather than the initial clearance of a device that relies on complex performance metrics or AI, the detailed performance study requirements (like those for AI/software devices) are not relevant here.
§ 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.