(124 days)
The DePuy Duraloc Acetabular Cup Liners are intended to be used with the Duraloc System Acetabular Cups to resurface the acetabular socket in cemented or cementless total hip arthroplasty.
The subject DePuy Duraloc Acetabular Cup Liners are polyethylene acetabular cup liners which are available with 28mm or 32mm inner diameters, and with a neutral or a 10° lip. The 28mm liners are available in sizes to fit Duraloc metal acctabular shells with outer diameters of 48-74mm. The 32mm liners are available in sizes to fit Duraloc metal acetabular shells with outer diameters of 52-74mm. The Duraloc polyethylene liners are locked into the Duraloc metal shells with a metal wire locking ring which is supplied with the metal shells. The subject polyethylene liners are identical in design to the acetabular cup liners cleared with the Modified DePuy Acetabular Cup System and the DePuy Modified AML+ Acetabular Cup System. The only difference between the subject Duraloc polyethylene liners and those that have been previously cleared by FDA is that the subject liners are manufactured from crosslinked polyethylene which has physical and mechanical properties that are similar to those of standard UHMWPE but has increased resistance to oxidation compared to gamma radiation sterilized standard UHMWPE.
The provided text does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.
The document is a 510(k) premarket notification letter from the FDA to DePuy Inc. regarding their Duraloc® Acetabular Cup System. It confirms that the device is substantially equivalent to previously marketed devices and can be brought to market.
The information provided includes:
- Device name and intended use.
- Company contact information.
- Regulatory classification and product codes.
- A brief description of the device's design and its manufacturing from crosslinked polyethylene.
- The FDA's finding of substantial equivalence based on the provided submission.
However, it does not include any details on:
- A table of acceptance criteria and reported device performance.
- Sample sizes, data provenance, number of experts, qualifications of experts, or adjudication methods for a test set.
- Whether a multi-reader, multi-case comparative effectiveness study was done, or any effect sizes of human readers with/without AI assistance.
- Whether a standalone algorithm performance study was done.
- The type of ground truth used.
- Sample size for the training set or how ground truth for the training set was established.
This type of information is typically found in design validation reports or clinical study summaries, which are not part of this particular FDA correspondence. The 510(k) process primarily focuses on demonstrating substantial equivalence to a predicate device, rather than requiring extensive performance studies in all cases.
§ 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.