(58 days)
This stem is intended to be used for primary or secondary reconstruction of the head and neck of the femur when sufficient, good quality bone stock is present. Use of this device is indicated for reconstruction of painful and/or severely disabled hip joints resulting from osteoarthritis, rheumatiod arthritis, post traumatic arthritis, avascular necrosis, subcaptital fracture, or in revision of a failed femoral prosthesis.
This femoral stem is intended to be used with Howmedica Osteonics femoral heads with a 2° 52' taper. The femoral stem can be used with Howmedica Osteonics bipolar or unipolar devices as an endoprosthesis, or can articulate with a Howmedica Osteonics acetabular cup prosthesis in total hip arthroplasty procedures.
The Precision® Osteolock Femoral Component with Pure-Fix™ HA Coating is designed to be used in a simple cementless press-fit mode.
The purpose of this premarket notification is to describe a modification to the Precision® Osteolock Femoral Stems with Hydroxyapatite Coating (previously determined substantially equivalent via 510(k) K912395). It is the intention of Howmedica Osteonics to change the hydroxyapatite coating on these femoral stems from the Low Pressure Plasma Spray (LPPS) HA coating described in K912395 to Howmedica Osteonics Pure-Fix™ HA coating. The Pure-Fix™ HA coating was originally determined substantially equivalent on the Osteonics® Omnifit® EPF Femoral Prosthesis in premarket notification K896047. This coating has been cleared for marketing on several other Osteonics® hip prostheses.
This femoral stem is intended to be used with Howmedica Osteonics femoral heads with a 2° 52' taper. The femoral stem can be used with Howmedica Osteonics bipolar or unipolar devices as an endoprosthesis, or can articulate with a Howmedica Osteonics acetabular cup prosthesis in total hip arthroplasty procedures.
The Precision® Osteolock Femoral Component with Pure-Fix™ HA Coating is designed to be used in a simple cementless press-fit mode.
The provided text is a 510(k) summary for the Precision® Osteolock Femoral Stems with Pure-Fix™ HA Coating, indicating its substantial equivalence to a previously cleared device. It describes the device, its intended use, and its classification. However, it does not contain information about acceptance criteria, device performance studies, or details specified in your request (like sample size, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies).
This type of submission focuses on demonstrating substantial equivalence to a predicate device, often relying on existing data and regulatory clearances for the components (in this case, the Pure-Fix™ HA coating) and the overall device design. It typically does not include new clinical study results or detailed performance data as would be expected for a novel device requiring extensive performance testing against predefined acceptance criteria.
Therefore, I cannot populate the table or answer the specific questions about the study that proves the device meets acceptance criteria based on 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.