# K091976: Biomet Phoenix Ankle Nail and Ankle Arthrodesis Nail

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Trauma
- Decided: Aug 17, 2009 after 47 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
23 later devices descend from it; 6 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K123810: Piccolo Composite Ankle Arthrodesis Nailing System (2013), 14 descendants of its own
- K182307: Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail System (2019), 8 descendants of its own
- K192163: TTC Phantom® Intramedullary Nail System (2020), 6 descendants of its own
- K191782: TTC Phantom Intramedullary Nail System (2019), 6 descendants of its own
- K201227: Phantom® Hindfoot TTC/TC Nail System (2020), 5 descendants of its own

## Recalls of this device
- Mar 12, 2018 · Class II · Z-1236-2018: Certain lots of the Phoenix Tibia Nail 3.5mm Inserter instruments are being recalled due to reports of fracturing and remaining in the device implant.
- Apr 1, 2016 · Class II · Z-1819-2016: Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the product becomes non

## Indications for use
The Biomet Phoenix Ankle Nail System and the Biomet® Ankle Arthrodesis Nail are indicated for tibiotalocalcaneal arthrodesis (fusion). Specific indications 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 10. Post-traumatic arthrosis 11. Previously infected arthrosis 12. Charcot foot 13. Severe endstage degenerative arthritis 14. Severe defects after tumor resection 15. Pantalar arthrodesis

Source page: https://510kreport.com/device/K091976
Methodology: https://510kreport.com/methodology