# K983358: G/K SFN and STN Locking Nails

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica, Inc.
- Decided: Nov 18, 1998 after 55 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.
36 later devices descend from it; 1 cites it directly.
0 of 37 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) Synthes’ Universal Femoral Nail: named in the summary without a submission number
- (no number) Synthes’ Unreamed Tibial Nail: named in the summary without a submission number
- (no number) Orthofix’s Tibial Nailing System: named in the summary without a submission number
- (no number) Orthofix’s Femoral Nailing System: named in the summary without a submission number

## Most influential descendants
- K010322: Iskd (Intramedullary Skeletal Kinetic Distractor) (2001), 35 descendants of its own
- K031219: Modification to Iskd (Intramedullary Skeletal Kinetic Distractor) (2003), 30 descendants of its own
- K101997: Ellipse Intramedullary Limb Lengthening System (2011), 29 descendants of its own
- K131677: Precice Intramedullary Limb Lengthening System (2013), 21 descendants of its own
- K133289: Precice Intramedullary Limb Lengthening System (2013), 19 descendants of its own

## Indications for use
The G/K Locking Nail System is a family of intramedullary rods intended to provide temporary stabilization of various types of fractures, osteotomies, malunions and nonunions of the femur and tibia. Other types of procedures include reconstruction, bone lengthening/shortening, prophylactic nailing of impending fractures and fusions.

Source page: https://510kreport.com/device/K983358
Methodology: https://510kreport.com/methodology