(26 days)
DePuy Modular M Heads are indicated for use in total hip replacement procedures. Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Total hip replacement is indicated in the following conditions:
- A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
- Avascular necrosis of the femoral head.
- Acute traumatic fracture of the femoral head or neck.
- Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
- Certain cases of ankylosis.
The DePuy Modular M Heads are indicated for use with the Pinnacle® Acetabular Cup in cementless application.
The subject DePuy Modular M Heads are manufactured from wrought Co-Cr-Mo alloy and are available in:
- 40, 44, and 48 mm diameters with a 12/14 Articul/eze taper and -- 2, +1.5, +5, . +8.5. +12 and +15.5 mm neck lengths. All of the Articul/eze taper femoral heads have an internal taper that mate with a corresponding external taper on compatible cemented or cementless femoral stems (Exhibit III).
- 40 and 44 mm diameters with an 11/13 S-ROM taper and -3, +0, +3, +6, +9 . and +12 mm neck lengths. The 48 mm heads with the 11/13 S-ROM taper are available in +0, +3, +6, +9 and +12 mm neck lengths. All of the S-ROM taper femoral heads have an internal taper that mate with a corresponding external taper on compatible cemented or cementless femoral stems (Exhibit III).
The subject device is designed to articulate with the Pinnacle™ Marahon®" ES3 Liners (K033273) inside a Pinnacle™ Acetabular System shell (K033338) in cementless applications.
I am sorry, but the provided text is a 510(k) summary for a medical device (DePuy Modular M Heads), and it does not contain any information about acceptance criteria, device performance studies, or clinical trial data.
The document focuses on:
- Device Description and Intended Use: What the device is made of, its sizes, and what medical conditions it's used for.
- Classification and Product Codes: Regulatory categories.
- Substantial Equivalence: Comparing the new device to previously cleared devices.
- FDA Correspondence: The official letter from the FDA regarding the 510(k) clearance.
Therefore, I cannot extract the specific information you requested regarding acceptance criteria and study details (like sample size, ground truth, expert qualifications, adjudication methods, or MRMC studies) because that information is not present in the provided text. This type of detailed study data is typically found in the full 510(k) submission, not in the public summary.
§ 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.