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The InterMoore Fracture Hip Stem is intended for prosthetic replacement of the proximal portion of the femur in hip replacements (i.e., total hip replacement or hemi-arthroplasty).

The InterMoore Fracture Hip Stem is intended for prosthetic replacement of the proximal portion of the femur in hip replacements (i.e., total hip replacement or hemi-arthroplasty). This device will be manufactured from either cast, forged, or wrought Cobalt-Chromium (CoCr) alloy conforming to ASTM Standards F75, F799, and F1537, respectively. This straight stem is offered in a variety of sizes to allow the surgeon to replicate the natural anatomy of the hip joint as closely as possible when performing a femoral replacement. In addition, the InterMoore Fracture Hip Stem:

• i has a broad collar which wraps around the anterior, medial, and posterior sides.
• I incorporates a stem-neck angle which replicates natural anatomy.
• E is available in a fenestrated design for press-fit applications and a solid design for press-fit and cemented applications.
• 트 has a 12/14 Morse-type male taper making it compatible with any Intermedics Orthopedics, Inc. 12/14 metal femoral head (e.g., modular femoral head, unipolar) or bipolar component which utilizes a 12/14 modular femoral head.
• 트 provides lateral offsets ranging from 32 to 49mm.
• 부 incorporates I-beam grooves along the anterior and posterior surfaces to increase rotational stability in vivo.
• 트 has a roughened/grit-blasted surface below the collar, to enhance fixation in vivo.
• 트 will incorporate a proximal, lateral fin to the fenestrated design. This fin will increase the rotational stability of the implant in vivo.

The provided text is a 510(k) Summary for a medical device (InterMoore Fracture Hip Stem), which is a premarket notification to demonstrate that the device is as safe and effective as a legally marketed predicate device. This type of regulatory submission does not contain information on acceptance criteria or studies that prove a device meets performance acceptance criteria in the way that would typically be seen for an AI/ML medical device, diagnostic test, or clinical trial for a pharmaceutical product.

Instead, the 510(k) submission focuses on demonstrating substantial equivalence to predicate devices. This involves comparing the new device's technological characteristics and indications for use to those of devices already on the market.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth methods because this type of information is not typically part of a 510(k) summary for a mechanical orthopedic implant. The summary focuses on product description and comparison to existing, legally marketed devices.

If this were an AI/ML device, the requested information would be crucial. However, for a hip stem from 1996, the "proof" is generally based on:

• Material properties: Conformance to ASTM standards (e.g., F75, F799, F1537 for CoCr alloy).
• Design similarities: Comparison of features (collar, stem-neck angle, taper, offsets, I-beam grooves, roughened surface, fin) to predicate devices.
• Intended use: Matching the specified prosthetic replacement of the proximal femur for total hip replacement or hemi-arthroplasty.

The summary explicitly states the device is "substantially equivalent to the Apollo Hip Stem™ offered by Intermedics Orthopedics, Inc., the Modular Austin Moore Hip Stem offered by Zimmer, Inc., the Bio-Moore II Stem offered by Biomet, Inc. and the Hip Fracture Stem offered by Howmedica, Inc." This is the core of the "proof" for a 510(k) submission for this type of device.

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