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The Apex Modular™ HA Hip Stem is intended for use as the femoral component of a primary or revision total hip replacement. This femoral hip stem is intended for uncemented fixation and single use implantation. This prosthesis 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™ HA Hip Stem consists of three modular components, with various sizes available for each component: the porous coated femoral stem, a modular neck that connects to the proximal end of the femoral stem, and a modular head that connects to the tapered trunion on the neck. This configuration allows the user to choose a combination of stem, neck, and head components to appropriately fit the anatomy of the patient. The various neck sizes allow for several length and lateral offset options for a given stem size. Several offset options are also available for the heads to allow further refinement of the lengths and offsets. The Apex Modular HA Hip Stem may be used in conjunction with the Apex Modular Acetabular Cup (K031110) for total hip arthroplasty. The femoral stems (and modular necks) are manufactured from titanium alloy. The Apex Modular HA stems can be used with the cobalt chromium alloy heads and the alumina ceramic heads that are part of the Apex Modular and Apex K2 hip systems. The proximal metaphyseal region of each size femoral stem is circumferentially coated with unalloyed titanium applied by plasma spray, with an optional hydroxyapatite (HA) coating on top of the titanium coating. As in the predicate Apex Modular stem, the alignment pin in the stem is manufactured from wrought cobalt chromium alloy.

The provided document is a 510(k) premarket notification for the Apex Modular™ HA Hip Stem. It describes the device, its intended use, and compares it to predicate devices to establish substantial equivalence.

However, this document does not contain information on acceptance criteria, a study proving the device meets those criteria, or any of the detailed study parameters requested in the prompt (e.g., sample sizes for training/test sets, ground truth establishment, expert qualifications, MRMC studies, standalone performance).

The 510(k) process for this type of medical device (hip prosthesis) primarily relies on demonstrating substantial equivalence to already legally marketed predicate devices, rather than conducting new clinical trials or performance studies with specific quantitative acceptance criteria in the manner requested for AI/software devices. The "study" mentioned here is the comparison to predicate devices, and the "acceptance criteria" is essentially the demonstration of substantial equivalence.

Therefore, I cannot fulfill your request for a detailed table and description of the study and its parameters because the necessary information is not present in the provided text. The document focuses on regulatory approval through substantial equivalence, not on the quantitative performance validation typical for AI/software.

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