(89 days)
The Apex Modular™ Alumina Femoral Head is intended for use in combination with the Apex Modular Hip Stem as the femoral component in total hip replacement procedures. This ceramic head is intended to articulate with a polyethylene or metal-backed polyethylene acetabular cup component. This prosthesis is intended for single use implantation, and may be used for the following conditions, as appropriate:
- Non-inflammatory degenerative joint disease, including osteoarthritis and . avascular necrosis;
- Rheumatoid arthritis; .
- Correction of functional deformity; .
- Congenital dislocation; .
- Revision procedures where other treatments or devices have failed; .
- Femoral neck and trochanteric fractures of the proximal femur. ●
The Apex Modular™ Alumina Heads are manufactured of Biolox® forte alumina (high purity aluminum oxide ceramic) by CeramTec AG (Biolox® is a registered trademark of CeramTec AG). The bore on this ball was designed and tested for compatibility with the neck taper on the Apex Modular Hip Stem (K000788). These modular heads are available in 28 mm and 32 mm diameters, with three offset options for each head size: -3.5, 0, and +3.5 mm (28 mm diameter heads) and -4, 0, and +4 mm (32 mm diameter heads).
The provided document is a 510(k) premarket notification for a medical device, specifically the Apex Modular™ Alumina Femoral Head. It describes the device, its intended use, and compares it to predicate devices to establish substantial equivalence.
However, this document does not contain information about acceptance criteria for device performance, nor does it describe a study proving the device meets such criteria in terms of clinical or diagnostic performance.
The document focuses on demonstrating substantial equivalence to existing legally marketed devices (Smith & Nephew Biolox Alumina Ceramic Heads and Plus Orthopedics Biolox® forte Alumina Ceramic Heads) for regulatory approval. This is typically done by showing that the new device has the same intended use, similar technological characteristics, and performs as safely and effectively as the predicate devices.
The only "testing" mentioned is:
- "Burst and fatigue testing of these alumina heads on the Apex Modular 12/14 taper have been completed as per the relevant FDA guidance document."
This refers to mechanical engineering tests to ensure the physical integrity and durability of the ceramic head, not studies related to diagnostic accuracy, clinical outcomes, or human reader performance.
Therefore, I cannot fulfill the request for a table of acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment as these details are not present in the provided text.
§ 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.