(84 days)
The Patient Matched Flanged Acetabular Component is indicated for use in patients requiring reconstruction of the hip joint due to disease, deformity or trauma. The device is intended for either cemented or cementless application for general use in skeletally mature individuals undergoing surgery for rehabilitating hip joints. The device is a single use implant. The device is to be used in conjunction with Biomet's RingLock Acetabular Liners. The device may be used in conjunction with any commercially available femoral component.
The Patient Matched Flanged Acetabular Component is an acetabular cup designed to match the natural geometry of an individual patient Matched Flanged Acefabular Component is matched to a particular patient, a specific device description is not possible.
This submission does not contain information about acceptance criteria, device performance, or a study proving that the device meets acceptance criteria. The provided text is a summary of safety and effectiveness, an FDA clearance letter for a 510(k) submission, and the indications for use for a "Patient Matched Flanged Acetabular Component."
Here's what can be extracted from the provided documents:
- Device Name: Patient Matched Flanged Acetabular Component
- Intended Use: Reconstruction of the hip joint due to disease, deformity, or trauma in skeletally mature individuals.
- Classification: Class II (Product Codes: LPH and JDI)
- Substantial Equivalence: Deemed substantially equivalent to predicate devices such as Healey™ Revision Acetabular Component, Recovery Protusio Cage, Universal® Acetabular Component, and Mallory-Head® Acetabular Component.
However, the documents do not include:
- A table of acceptance criteria and reported device performance.
- Details about a study (sample size, data provenance, expert ground truth, adjudication method, MRMC study, standalone performance, ground truth type for testing or training, training set size, or how training ground truth was established).
This type of information is typically found in premarket approval (PMA) applications, design validation reports, or specific performance studies, which are not part of a standard 510(k) summary document. A 510(k) primarily demonstrates substantial equivalence to a legally marketed predicate device, rather than providing detailed performance data against specific acceptance criteria.
§ 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.