# K063589: Gso Bone Fixation Fasteners

- Pathway: 510(k) (Traditional)
- Applicant: Gold Standard Orthopaedics, LLC
- Decided: Jan 31, 2007 after 61 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K761228 (1976). 37 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960385: Sterile Kirschner Wires and Steinmann Pins, Depuy, Inc. (1996) Summary page 2.
- K011719: Plus Cancellous Bone Screws, Plus Orthopedics (2001) Summary page 1.
- K972403: Bti Cortical Bone Screws, Biodynamic Technologies, Inc. (1997) Summary page 2.
- K061620: Ifs Cannulated Bone Screw, Internal Fixation Systems, Inc. (2006) Summary page 2.
- K023260: 1.2MM Osteomed Auto-Drive Screw System, Osteomed Corp. (2002) Summary page 2.

## Most influential descendants
- K071035: Ifs Bone Fixation Devices (2007), 3 descendants of its own
- K130613: Cannulated Screw and Kirschner (Kwire) System (2014), 1 descendant of its own
- K252758: Cannulated Screw and Kirschner (K wire) System (2025), 0 descendants of its own
- K140216: Orthopedic Fixation Systems (2014), 0 descendants of its own

## Indications for use
The GSO Bone Fixation Fasteners are indicated for use in fixation of bone fractures, for bone reconstructions, as guide pins for insertion of other implants or implantation through the skin so that traction may be applied to the skeletal system. Warning: GSO Bone Fixation Devices are not indicated for spinal fixation.

Source page: https://510kreport.com/device/K063589
Methodology: https://510kreport.com/methodology