(75 days)
The Smith & Nephew Modular Femoral Heads are indicated for the following:
- Noninflammatory degenerative joint disease including osteoarthritis, osteonecrosis, avascular . necrosis and post traumatic arthritis;
- . rheumatoid arthritis;
- arthritis secondary to a variety of diseases :: nd anomalies and correction of functional deformity . such as congenital hip dysplasia or ankylosing spondylitis;
- revision procedures where other freatments: have failed; and .
- treatment of proximal femoral non-union, fe moral neck fracture, and trochanteric fractures of the . proximal femur with head involvement.
The modular femoral heads are for single use only and are intended to be used as part of a hemi-hip replacement system when articulating against the natural acetabulum.
New cobalt chrome (CoCr) modular femoral heads have been designed and developed by Smith & Nephew Orthopaedics. The subject devices are offiered in sizes ranging from 38-58mm and feature a 12/14 taper interface to allow the components to be used in conjunction with existing Smith & Nephew femoral components. The overall designs of the components are based upon existing Uni-polar implants subject of K896580.
The provided text is a 510(k) summary for the Smith & Nephew Modular Femoral Heads. This is a premarket notification for a medical device that aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving new safety and effectiveness through clinical studies and acceptance criteria.
Therefore, the document does not contain the information requested regarding acceptance criteria, device performance, study details (sample sizes, data provenance, expert involvement, adjudication, MRMC, standalone performance), or training set information.
The 510(k) process primarily relies on demonstrating that a new device is as safe and effective as (substantially equivalent to) an existing, legally marketed device. It typically involves:
- Device Description: What the device is and how it works.
- Intended Use: The medical conditions the device is designed to treat.
- Substantial Equivalence Information: Comparison to predicate devices regarding design, intended use, and materials. This may include bench testing, and sometimes animal studies, but generally not human clinical trials with specific performance criteria for the new device as would be seen in a PMA application.
In summary, none of the requested information (table of acceptance criteria and performance, sample sizes, data provenance, expert details, adjudication, MRMC, standalone performance, ground truth types, or training set info) is present in this 510(k) summary because it's not the type of document that would typically include such data.
§ 888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.(b)
Classification. Class II.