Search Results

The OsteoMed Metatarsal Resurfacing Implant, a hemi-arthroplasty implant for the metatarsophalangeal (MTP) joint, is indicated for use in the treatment of patients with degenerative and post-traumatic arthritis in the MTP joint in the presence of good bone stock and integrity of the phalangeal base, along with the following clinical conditions; hallux limitus, hallux valgus, hallux rigidus, and an unstable or painful MTP joint.

The OsteoMed Metatarsal Resurfacing Implant is intended to be used with bone cement or press fit without bone cement.

The OsteoMed Metatarsal Resurfacing Implant is intended for single use only.

The OsteMed Metatarsal Resurfacing Implant is a one piece implant designed to replace the distal head of the metatarsal and provides a smooth articular surface for the adjacent phalangeal base. The implant is available in several sizes in direct proportion to the anatomic construct of the metatarsal head.

This 510(k) summary for the OsteoMed Metatarsal Resurfacing Implant System with Hydroxylapatite Coating (K081876) indicates that the device was found substantially equivalent to a predicate device (OsteoMed Metatarsal Resurfacing Implant System K073065). The summary does not contain any information about acceptance criteria, device performance metrics, or any studies conducted to prove the device meets specific performance criteria.

Therefore, I cannot provide the requested information. The document focuses on regulatory classification, indications for use, and substantial equivalence to a predicate device, rather than detailed performance data or a study report.

Ask a specific question about this device