# K021786: Titanium Ankle Arthrodesis Nail

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Aug 26, 2002 after 88 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K982953 (1998). 1 ancestor in all.
27 later devices descend from it; 5 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982953: Titanium Intramedullary Nails-Various Styles, Biomet, Inc. (1998) Summary page 1.

## Most influential descendants
- K081243: Biomet Phoenix Ankle Nail System (2008), 18 descendants of its own
- K050882: Newdeal Ankle Nail (2005), 15 descendants of its own
- K123810: Piccolo Composite Ankle Arthrodesis Nailing System (2013), 14 descendants of its own
- K091788: Panta Nail (Dia. 10MM), Panta Nail XL (2009), 14 descendants of its own
- K120419: Dyna Locking Ankle Nail (2012), 9 descendants of its own

## Recalls of this device
- Mar 16, 2005 · Not classified · Z-0916-05: The wire appears to be soft and the wire bent during insertion. This causes kinks in which the reamer could not pass over the bent/kinked wire.

## Indications for use
The Titanium Ankle Arthrodesis Nail is intended for tibiotalocalcaneal arthrodesis (fusion). The process of tibiotalocalcaneal arthrodesis using an intramedullary nail usually involves an ankle arthrotomy, preparation of the joint surfaces, and then placement of the nail through a plantar incision. Screws are placed proximally into the tibia in a standard fashion and, after compression, the nail can be locked distally with screws into the calcaneus and the talus. The indications for tibiotalocalcaneal arthrodesis include: 1. Avascular necrosis of the talus 2. Failed total ankle arthroplasty 3. Trauma (malunited tibial pilon fracture) 4. Severe deformity or instability as a result of talipes equinovarus, cerebral vascular accident, paralysis or other neuromuscular disease 5. Revision ankle arthrodesis 6. Neuroarthropathy 7. Rheumatoid arthritis 8. Osteoarthritis 9. Pseudoarthrosis

Source page: https://510kreport.com/device/K021786
Methodology: https://510kreport.com/methodology