# K181639: Panta 2 Arthrodesis Nail System

- Pathway: 510(k) (Special)
- Applicant: Integra LifeSciences Corporation
- Decided: Nov 2, 2018 after 134 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K982953 (1998). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091788: Panta Nail (Dia. 10MM), Panta Nail XL, Newdeal Sas (2009) Summary page 4.

## Indications for use
The Panta 2 Nail Arthrodesis System is intended for use in tibiotalocalcaneal arthrodesis and treatment of trauma to the hindfoot and distal tibia. Indications include: • Post-traumatic and degenerative arthritis involving both ankle and subtalar joints • Rheumatoid arthritis • Revision of failed ankle arthrodesis with subtalar involvement or with insufficient talar body • Revision of failed total ankle arthroplasty with subtalar intrusion • Talar deficiency conditions (requiring a tibiocalcaneal arthrodesis) • Avascular necrosis of the talus • Neuroarthropathy or neuropathic ankle deformity • Severe deformity as a result of talipes equinovarus, cerebral vascular accident, paralysis or other neuromuscular disease • Severe pilon fractures with trauma to the subtalar joint.

Source page: https://510kreport.com/device/K181639
Methodology: https://510kreport.com/methodology