(275 days)
General indications: Mobility-limiting diseases, fractures or defects which cannot be treated by conservative or osteosynthetic procedures. Indications: 1) Primary and secondary osteoarthritis 2) Rheumatoid arthritis 3) Correction of functional deformities 4) Avascular necrosis 5) Femoral neck fractures 6) Revision after implant loosening dependent on bone mass and quality The MobileLink Dual Mobility Insert is additionally indicated for: 7) Dislocation risks The MobileLink Acetabular Shells are intended for cementless fixation.
This 510k adds MobileLink TrabecuLink Acetabular Shells to the MobileLink Acetabular Cup System previously cleared in K182321, K192559, K200607. These shells are additively manufactured from Ti6Al4V alloy per ISO 5832-3 and feature a porous structure (TrabecuLink) on the bone interfacing surface for biologic fixation. The shells come in cluster-hole and in multi-hole patterns. mate with the same UHMWPE liners (in conventional PE and highly-crosslinked vitamin E PE) as previously cleared in K182321, and with the same Dual Mobility Inserts and Shell/Insert Adapters previously cleared in K200607. They can be used with the same bone screws cleared in K192559.
I am sorry, but the provided text does not contain the specific information required to complete your request. The document is a 510(k) premarket notification clearance letter from the FDA for a medical device (LINK MobileLink Acetabular Cup System). It discusses the device's substantial equivalence to predicate devices and lists non-clinical performance testing that was performed (e.g., acetabular deformation, fatigue testing, biocompatibility).
However, it does not include:
- A table of acceptance criteria and reported device performance.
- Details about sample size, data provenance, number or qualifications of experts, or adjudication methods for test sets.
- Information about multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes.
- Details about standalone algorithm performance.
- The type of ground truth used, training set sample size, or how ground truth for the training set was established.
The document explicitly states: "Clinical performance testing was not required to demonstrate the substantial equivalence of this device." This suggests that the clearance was based on non-clinical testing and comparison to predicate devices, rather than a clinical study with the detailed criteria you're asking for.
§ 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.