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The MBAResorb Implant is indicated as an internal support to primary surgical interventions in the treatment of flat foot, providing structural support at minimum during the first three months of healing.

The MBAResorb Implant consists of a soft-threaded implant designed to be inserted between the posterior and middle facets of the subtalar joint and corresponding instrumentation to facilitate insertion. The design differs from the predicate Subtalar MBA device only in that the material is reabsorbed into the body.

This document describes a 510(k) premarket notification for a medical device called the MBAResorb Implant. It is not a study proving the device meets acceptance criteria. The document is an application to the FDA seeking clearance to market the device based on its substantial equivalence to previously cleared devices.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies cannot be extracted from the provided text. These elements are typically found in clinical study reports or detailed performance data submissions, which are not present here.

Summary of what can be extracted related to the device and its intended use:

• Device Name: MBAResorb Implant
• Intended Use: "The MBAResorb Implant is indicated as an internal support to primary surgical interventions in the treatment of flat foot, providing structural support at minimum during the first three months of healing."
• Material: Poly L-Lactide (PLLA), described as bioresorbable.
• Predicate Device: KMI Subtalar MBA Orthopedic Foot Implant (K960692), cleared Jul 23, 1996.
• Regulatory Clearance: The FDA letter (SEP - 6 2005) indicates that the device was deemed substantially equivalent to a legally marketed predicate device, allowing it to proceed to market. This is a regulatory clearance, not a performance study outcome.

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