(73 days)
The Apex Hip System K1™ Hip Stem is intended for use as the femoral component of a primary or revision total hip replacement when used with the Apex Interface™ Acetabular System. The Apex Interface™ Acetabular System articulates with the Apex Modular Femoral Head (Cobalt Chromium or Ceramic). The femoral hip stem is intended for uncemented fixation and single use implantation. These prosthesis may be used for hip arthroplasty to treat 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 Hip System K1 Femoral Stem is also intended for use in hemiarthroplasty when used with the Apex Bipolar Head.
The Apex Hip System Bipolar Head is intended for use in combination with an Apex Hip System femoral stem for uncemented primary or revision hemiarthroplasty of the hip. This prosthesis may be used for the following conditions, as appropriate:
• Femoral neck and trochanteric fractures of the proximal femur;
• Osteonecrosis of the femoral head;
• Revision procedures where other treatments or devices for these indications have failed.
The Apex K1™ Hip Stems are rectangular in cross-section and tapered in the proximal-to-distal direction. The K1 Hip Stem is offered in 12 sizes and two neck offsets for each size. Standard necks have a 135 degree angle and lateralized (Lat) necks have a 130 degree angle. Sizes 7 to 12 also offer a Lat + offset with a 127 degree angle.
The provided text is a 510(k) Summary for the Apex K1™ Hip System, a medical device for hip replacement. It outlines the device's characteristics, intended use, and a comparison to a predicate device. However, it explicitly states: "No clinical studies were performed."
Therefore, it is impossible to provide the requested information about acceptance criteria, device performance, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, or ground truth, as no clinical study was conducted for this device.
The document indicates that the device's substantial equivalence to a legally marketed predicate device (K060072 - Apex K1™ Hip Stem) was established through non-clinical testing.
Here's a summary based on the provided text, highlighting the absence of clinical study data:
Absence of Clinical Study Data:
The provided 510(k) Summary explicitly states: "No clinical studies were performed." Therefore, the device performance against acceptance criteria, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment, which are typically derived from clinical studies, cannot be detailed.
Instead, the device's substantial equivalence was demonstrated through non-clinical testing and comparison to an existing predicate device.
Non-Clinical Test Summary:
The following non-clinical tests were conducted:
- Fatigue Strength Testing: Performed according to ISO 7206-6, ISO-7206-4, ISO 7206-8, and ASTM 2068-09.
- ROM (Range of Motion) evaluation: Performed per ISO 21535.
Predicate Device Comparison:
The Apex K1™ Hip Stem (subject device, sizes 0, 0 Lat, 1, 1 Lat, and 7 thru 12 Lat +) was found to be substantially equivalent to the predicate device (Apex K1™ Hip Stem, Sz 2 to 12, K060072) based on the following:
| Characteristic | Apex K1 Hip Stem (Subject Device) | Apex K1 Hip Stem (Predicate Device, K060072) |
|---|---|---|
| Intended Use | Yes (for primary and revision total hip replacement) | Yes (for primary and revision total hip replacement) |
| Stem Design | Identical to K060072 | Rectangular in cross-section and tapered in the proximal-to-distal direction |
| Materials (K1 Stem) | Identical to K060072 | Ti6Al4V per ASTMF136 |
| Plasma spray Titanium coating | Identical to K060072 | Ti Coating per ASTM F1580 |
| Sterilization | Identical to K060072 | Ethylene oxide |
| SAL (Sterility Assurance Level) | Identical to K060072 | 10^-6^ |
| Packaging | Identical to K060072 | Paper Board Box, Double Tyvek inner pouch |
Since no clinical studies were performed, the specific details requested for clinical performance acceptance criteria, study design, and ground truth establishment cannot be provided from this document. The basis for acceptance for this device was its substantial equivalence to a previously cleared predicate device, supported by the mentioned non-clinical engineering and material testing.
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.