(71 days)
The Osteolock™ Acetabular Shells are intended to be used to replace the bearing portion of the acetabulum in primary or revision total hip arthroplasty. These components are designed to be press fit into the acetabulum. They do not achieve fixation by biological ingrowth.
The Osteolock™ Acetabular Shells are available in outer diameters from 38-80mm in two millimeter increments. The shells are available in four styles: one with a north pole visualization hole, one without a north pole hole, one with screw holes, and one that is pre-assembled with the plastic inserts. The inner aspect of the shell has scalloped depressions which form part of the locking mechanism for the acetabular insert. All shells are manufactured from Titanium alloy conforming to ASTM-F136.
There is a Titanium plasma spray coating on the outer aspect of the shell to provide a roughened surface texture. This plasma spray coating is not a porous coating and, as such, this cup is intended to be press fit into the acetabulum.
There is an apical hole plug which may be used in the design with a north pole hole. This apical hole plug is press fit into the north pole hole after the acetabular cup has been seated. The apical hole plug is designed to close the north pole hole to reduce the possibility of polyethylene debris egress from this opening.
The provided text describes a 510(k) summary for the Osteolock™ Acetabular Shell System. It focuses on the device's design, materials, intended use, and substantial equivalence to previously marketed devices. However, it does not contain information regarding detailed acceptance criteria or a study proving the device meets specific performance criteria in the way a diagnostic AI device summary typically would.
Instead, the document highlights:
- Substantial Equivalence: The core of this 510(k) summary is establishing "substantial equivalence" to predicate devices based on intended use, materials, design, operational principles, and relative indications and contraindications. This is a regulatory pathway that generally relies on demonstrating similarity to already cleared devices rather than extensive novel performance studies.
- Assembly/Disassembly Testing and Plasma Spray Characterization: The only mention of any "testing" is for "Assembly/disassembly testing of the liner from the shell" and "characterization of the plasma spray coating." These are likely engineering and material characterization tests, not clinical performance studies with specific performance metrics such as sensitivity, specificity, or AUC.
- Postmarket Surveillance: The FDA letter explicitly requires postmarket surveillance studies under Section 522(a) of the Act, indicating that longer-term or real-world performance data would be collected after market clearance, not as part of the initial 510(k) submission to prove initial acceptance criteria.
Therefore, I cannot provide the requested information in the format of acceptance criteria and a study proving its fulfillment because such details are not present in the provided 510(k) summary for this type of medical device (an orthopedic implant). The focus for this device is on safety and effectiveness through substantial equivalence to existing devices, coupled with engineering and material specifications.
If this were an AI/diagnostic device, the summary would typically include detailed performance metrics and study designs as requested.
§ 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.