Search Results
Found 1 results
510(k) Data Aggregation
(90 days)
INFINITY Total Ankle System, INBONE Total Ankle System
The INBONE Total Ankle System and INFINITY Total Ankle System are indicated for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis.
The INBONE Total Ankle System and INFINITY Total Ankle System are additionally indicated for patients with a failed previous ankle surgery.
CAUTION: In the United States, the ankle prosthesis is intended for cement use only.
The subject INBONE™ and INFINITY™ Total Ankle Systems are fixed-bearing, bone-sparing ankle replacement prostheses that restore mobility to a failing ankle joint. Both the INFINITY and INBONE systems include three components (tibial trays with or without stems, poly inserts, and talar domes) that are assembled together to create the two-piece prosthesis.
This is a 510(k) premarket notification for a medical device (INFINITY and INBONE Total Ankle Systems) and does not contain the detailed information typically found in a study proving a device meets specific acceptance criteria in the context of AI/ML or diagnostic performance. Instead, it demonstrates substantial equivalence to predicate devices, focusing on design, materials, and non-clinical performance.
Therefore, many of the requested points cannot be answered from the provided text. I will address the points that can be inferred or directly stated.
1. A table of acceptance criteria and the reported device performance
The document does not present acceptance criteria or reported device performance in the form of a table with numerical values for metrics like sensitivity, specificity, or image quality, as would be expected for a diagnostic or AI-driven device. Instead, it lists non-clinical tests performed to demonstrate substantial equivalence to predicate devices.
| Acceptance Criteria (Non-Clinical Tests) | Reported Device Performance (as demonstrated by testing) |
|---|---|
| Chemical Analysis | Demonstrated equivalence to predicate devices |
| Compressive Strength | Demonstrated equivalence to predicate devices |
| Shear and Tensile Strength | Demonstrated equivalence to predicate devices |
| MRI Safety Analysis | Minimal risk to patients in an MR environment (MR Conditional) |
| Direct Metal Laser Sintering (DMLS) Process Validation | Demonstrated equivalence to predicate devices (Performance Qualification, Mechanical validation, Microstructure, Powder Bed Position Validation) |
| Endotoxin ( |
Ask a specific question about this device
Page 1 of 1