# K043200: Sign Fin Nail

- Pathway: 510(k) (Traditional)
- Applicant: Surgical Implant Generation Network (Sign)
- Decided: Feb 3, 2005 after 77 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
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 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 its predicate without a number.
- (no number) SIGN HA Nail System: named in the summary without a submission number
- (no number) Howmedica Alta HA Rod System: named in the summary without a submission number
- (no number) Biomet Brooker Femoral nail: named in the summary without a submission number
- (no number) Encore True/Flex Upper Extremity Nail: named in the summary without a submission number

## Most influential descendants
- K083582: Sign Hip Construct (SHC), Model: 701 (2009), 2 descendants of its own
- K153759: SIGN Compression Screw System (2016), 0 descendants of its own
- K152757: SIGN Hip Construct (SHC) (2015), 0 descendants of its own
- K122823: Sign Pediatric Fin Nail (2013), 0 descendants of its own

## Indications for use
The SIGN Fin nail is indicated for internal fixation of stable fractures in the femur and humerus.

Source page: https://510kreport.com/device/K043200
Methodology: https://510kreport.com/methodology