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The Apex Modular™ Hip Stem is intended for use as the femoral component of a primary 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 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. The modular heads are available in standard diameters so as to fit appropriate commercially available acetabular components of the surgeons' choosing. Several offset options are also available for the heads to allow further refinement of the lengths and offsets. The Apex Modular Hip Stem may be used in conjunction with the Link® SPII® Acetabular Cup for total hip arthroplasty.
The femoral stem and neck components are manufactured from titanium alloy, and the head components are manufactured from wrought cobalt chromium alloy, the same materials used to manufacture the predicate hip stems and heads, respectively. The proximal metaphyseal region of each size femoral stem is circumferentially coated with unalloyed titanium applied by plasma spray. The alignment pin in the femoral stem is manufactured from wrought cobalt chromium alloy.

The provided document is a 510(k) summary for the Apex Modular™ Hip Stem, a medical device. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a dedicated study with performance metrics.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not available in this document.

The document highlights the following:

• Intended Use: The Apex Modular Hip Stem is intended for use as the femoral component of a primary total hip replacement for conditions like non-inflammatory degenerative joint disease, rheumatoid arthritis, correction of functional deformity, congenital dislocation, revision procedures, and femoral neck and trochanteric fractures.
• Device Description: It consists of three modular components: a porous coated femoral stem, a modular neck, and a modular head. Materials are titanium alloy for stem and neck, and cobalt chromium alloy for the head. The proximal metaphyseal region of the femoral stem is circumferentially coated with unalloyed titanium applied by plasma spray.
• Predicate Device Comparison: Substantial equivalence is claimed to the S-ROM® Femoral Stem and the Biomet Modular Hip System. The document includes a table comparing design features and materials.
• Performance Testing Mentioned: "Performance testing of the modular stem has been completed as per the relevant FDA guidance documents, including assembly testing of the neck-stem modular connection and fatigue testing of the assembled device. Performance testing of the plasma sprayed unalloyed (CP) titanium coating was completed as per the relevant FDA guidance documents with data in the referenced Device Master File."

Missing Information:

The document does not provide:

• A table of acceptance criteria and reported device performance.
• Details of a specific study designed to prove the device meets acceptance criteria.
• Sample sizes for test or training sets.
• Data provenance.
• Number or qualifications of experts.
• Adjudication methods.
• Information on MRMC comparative effectiveness studies.
• Standalone performance data.
• Type of ground truth used or how it was established.

This type of 510(k) submission primarily relies on demonstrating that the new device has the same intended use and similar technological characteristics to a legally marketed predicate device, and that any differences do not raise new questions of safety and effectiveness, often supported by standard mechanical/material testing outlined in FDA guidance documents rather than clinical studies with human subjects.

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