# K090857: Valor Ankle Fusion Nail System

- Pathway: 510(k) (Traditional)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Jul 14, 2009 after 106 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
24 later devices descend from it; 7 cite it directly.
0 of 25 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
- K102413: Fuze: Intramedullary Internal Fixation Nail (2011), 7 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

## Recalls of this device
- Mar 14, 2018 · Class II · Z-1376-2018: Tow lot of VALOR(TM) Nail could potentially be missing the assembled compression screw.
- Mar 14, 2018 · Class II · Z-1375-2018: Tow lot of VALOR(TM) Nail could potentially be missing the assembled compression screw.
- Nov 8, 2016 · Class II · Z-0566-2020: The firm discovered a lack of adequate documentation confirming sterility on certain products.
- Apr 5, 2012 · Not classified · Z-1484-2012: The possibility exists that the handle of the targeting guide may rotate and/or break under normal usage.
- Apr 5, 2012 · Not classified · Z-1485-2012: The possibility exists that the handle of the targeting guide may rotate and/or break under normal usage.

## Indications for use
The VALORTM Ankle Fusion Nail System is intended to facilitate tibiotalocalcaneal arthrodesis to treat severe foot/ankle deformity, arthritis, instability, and skeletal defects after tumor resection. These include Neuro-osteoarthropathy,(Charcot's Foot), Avascular Necrosis of the talus, failed joint replacement, failed ankle fusion, distal tibia fracture non-unions, Osteoarthritis, Rheumatoid Arthritis, and Pseudoarthrosis.

Source page: https://510kreport.com/device/K090857
Methodology: https://510kreport.com/methodology