# K081243: Biomet Phoenix Ankle Nail System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Trauma
- Decided: Jun 27, 2008 after 57 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: 2 generations back to K982953 (1998). 5 ancestors in all.
18 later devices descend from it; 3 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)
- K070955: Acid Etched Lag Screws, Biomet Orthopedics, Inc. (2007) Summary page 1.
- K063570: Biomet Tibial Locking Nail System, Biomet Manufacturing Corp (2007) Summary page 1.
- K021786: Titanium Ankle Arthrodesis Nail, Biomet, Inc. (2002) Summary page 1.
- K991790: Ultimax Ankle Fusion Rod System, Encore Orthopedics, Inc. (1999) Summary page 1.

## 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

## Indications for use
The Biomet Phoenix TM Ankle Nail System is 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

Source page: https://510kreport.com/device/K081243
Methodology: https://510kreport.com/methodology