Search Results

The Vented Cement Restrictor is intended for use as a cement restrictor used in the treatment of the following:

• Total Hip Arthroplasty

• Total Knee Arthroplasty

• Total or Hemi Shoulder Arthroplasty

The device is not intended for use in spinal surgeries.

The Vented Cement Restrictor used in cemented applications for hip, knee and shoulder arthroplasty, is a polymeric component manufactured from either medical grade injection molded polyethylene (ASTM F639-98a) or from 70:30 Polylactic Acid (Poly (Llactide-co-D, L-lactide) amorphous (ASTM F1925-99e1).

Moreover, the subject Vented Cement Restrictor features a ball valve which safely vents air trapped distally to the stem, thus alleviating distal intra-medullary air pressure related embolisms.

The provided text does not contain information about acceptance criteria or a study that proves the device meets acceptance criteria.

The document is a 510(k) summary for the Amedica Corp. Vented Cement Restrictor. It focuses on:

• Device Description: What the device is made of and its function (venting air to alleviate distal intra-medullary air pressure related embolisms).
• Intended Use/Indications For Use: Specific orthopedic surgeries where it's used (Total Hip, Total Knee, Total or Hemi Shoulder Arthroplasty).
• Substantial Equivalence: A comparison to legally marketed predicate devices to show that the new device is as safe and effective as existing ones. This is the primary basis for 510(k) clearance.

Therefore, I cannot fill out the requested table or answer the questions regarding study details, sample sizes, ground truth, or expert involvement. These types of clinical or performance studies are generally not required for 510(k) submissions where substantial equivalence to a predicate device can be demonstrated through other means (e.g., material safety, dimensions, functional principles).

Ask a specific question about this device