(75 days)
The acetabular cup is intended for cemented use in skeletally mature individuals undergoing primary or revision surgery for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (NIDJ) or its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fuscd hip, fracture of the pelvis, and diastrophic variant.
The ZCA Snap-In Cup is a single unit manufactured from ultra-high molecular weight polyethylene (UHMWPE). The interior of the cup is designed to allow snap fitting of a 32 mm head into the articular surface through matcrial interference around the inner diameter rim. The ZCA Snap-In Cup is designed with a neutral face and is provided in outer diameter sizes ranging from 49 to 61 mm in 2 mm increments to fit varying anatomical requirements. The ZCA Snap-In Cup is hemispherical in shape and has four press-fit PMMA cement spacers affixed to the outer diameter to centralize the cup and help maintain a uniform 3 mm cement mantle. Radiopaque stainless steel wires at the dome and equator are used to determine the location and orientation of the component radiographically. Grooves and scallops on the outer surface are used for optimal cement interdigitation.
The provided text is related to a 510(k) premarket notification for a medical device: the ZCA All-Poly Acetabular Cup, Snap-In. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving the safety and effectiveness of a novel device through clinical trials and rigorous acceptance criteria studies as might be seen for entirely new technologies, especially those involving AI or imaging.
Therefore, the document does not contain the requested information regarding acceptance criteria studies, device performance tables, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details.
The document primarily focuses on:
- Device Description: A physical description and materials of the acetabular cup.
- Intended Use/Indications for Use: The medical conditions the device is designed to address.
- Predicate Devices: A list of existing, legally marketed devices to which the ZCA Snap-In Cup is being compared for substantial equivalence.
- Substantial Equivalence Statement: The FDA's determination that the new device is substantially equivalent to predicate devices.
In the context of this 510(k) summary, the "acceptance criteria" for the device are largely implied by its substantial equivalence to predicate devices, meaning it performs as safely and effectively as already approved devices for the stated indications. Performance data typically involves mechanical testing or material characterization, but explicit details of such studies are not provided in this summary.
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.