Search Results

Spider Frame Computer Assisted External Fixation system used as a temporary or permanent method of correction and stabilization of the extremity bones.

Indications are:

1. Post-Traumatic joint contracture which has resulted in loss of range of motion
2. Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction
3. Open and closed fracture fixation
4. Pseudoarthrosis of long bones
5. Limb lengthening by epiphyseal or metaphyseal distraction
6. Correction of bony or soft tissue deformities
7. Correction of segmental bony or soft tissue defects
8. Joint arthrodesis
9. Infected fractures or nonunions,

Not Found

I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria. The document is a 510(k) clearance letter from the FDA for a medical device called the "Spider Frame External Fixation System." It details the device's indications for use and regulatory information, but it does not include performance metrics, study details, or acceptance criteria like those typically found in clinical validation reports.

Ask a specific question about this device