Device Information
Indications
The Redemption Duo Hindfoot Nail System is intended for tibiotalocalcaneal arthrodesis (fusion) and is used in patients with previously infected arthrosis, revision ankle arthrodesis, failed total ankle arthroplasty, avascular necrosis of the talus, severe deformity or instability (as a result of talipes equivarus, cerebral vascular accident, paralysis or other neuromuscular disease), rheumatoid arthritis, osteoarthritis,pseudarthrosis, trauma (malunited tibial pilon fracture), Charcot foot, severe end stage degenerative arthritis, severe defects after tumor resection, pantalar arthrodesis, post-traumatic arthrosis, and neuroarthropathy.
- MedDRA Code: Post-traumatic arthritis: 10020720
Intended Use
This system is intended for use in patients requiring hindfoot fusion. This device should be used by trained orthopedic surgeons for patients requiring tibiotalocalcaneal fusion.
Availability
Prescription-only (21 CFR 801 Subpart D).
Contraindications
None specified.
Limitations
The device should be used only for qualified professionals’ intended medical indications. Pre-surgical sterilization of the device is necessary.
Study Results
This system passed several performance tests, including bending fatigue, static torsion, driving torque, and axial pullout strength. These results demonstrate that the device is as safe and effective as its predicate devices.
Regulatory Information
The device complies with FDA guidelines under 21 CFR Part 820 for design controls and good manufacturing practices. It is approved for marketing under 510(k) notification without the need for premarket approval (PMA).
Manufacturer Information
- Name: Vilex LLC
- Address: 111 Moffitt Street, McMinnville, Tennessee 37110
- Contact: Brock Johnson, President
Predicate Device Information
- Predicate Device Name: Biomet Phoenix Ankle Nail and Ankle Arthrodesis Nail
- K Number: K091976
- Is the predicate device an earlier version of the same device? No
- Difference: The Redemption Duo has minor dimensional differences, differences in raw materials, and sterilization method. These changes are considered minor and do not raise questions of safety or effectiveness. Substantial equivalence was demonstrated through testing.
Implications
The Redemption Duo Hindfoot Nail System provides an effective solution for patients with severe ankle and foot conditions requiring fusion. Its safety and performance align with previously approved devices.
References
- Redemption Duo Hindfoot Nail System. K231343. FDA summary link: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?id=K231343
- Vilex Redemption Duo Hindfoot Nail system. https://www.vilex.com
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