# K163589: SIGN IM Nail

- Pathway: 510(k) (Traditional)
- Applicant: Sign Fracture Care International
- Decided: Jul 20, 2017 after 212 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: 13 generations back to K841189 (1984). 94 ancestors in all.
No later device cites it as a predicate yet.
0 of 95 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051590: T2 Ankle Arthrodesis Nail, Howmedica Osteonics Corp. (2005) Summary page 4.
- K022632: Sign IM Nail, Surgical Implant Generation Network (Sign) (2002) Summary page 4.
- K112982: Anatomic Ankle Arthrodesis Interlocking Nail (A3 Interlocking Nail ), Small Bone Innovations, Inc. (2012) Summary page 4.
- K123810: Piccolo Composite Ankle Arthrodesis Nailing System, CarboFix Orthopedics, Ltd. (2013) Summary page 4.

## Indications for use
The SIGN IM Nail System is indicated for tibiotalocalcaneal arthrodesis. Specific examples of indications include primary or post traumatic or previously infected arthrosis, failed ankle arthrodesis, failed total ankle replacement, avascular necrosis of the talus, neuromuscular deformity or instability of the ankle, osteoarthritis, nonunions or pseudarthrosis of hindfoot and distal tibia, malunited tibial pilon fracture, charcot foot, severe arthritis, severe defects after tumor resection, pantalar arthrodesis. IM Nail sizes recommended for these indications are 10-12mm diameter and 200-300mm in length.

Source page: https://510kreport.com/device/K163589
Methodology: https://510kreport.com/methodology