# K161904: GEO Bone Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Gramercy Extremity Orthopeidics, LLC
- Decided: Jan 18, 2017 after 191 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: 12 generations back to K962616 (1996). 108 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 113 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991151: Vilex Cannulated Bone Screw, Duval Cannulated Bone Screw, Orthex Cannulated Bone Screw, Vilex, Inc. (1999) Summary page 4.
- K991197: Vilex/Duval/Orthex Cannulated Bone Screw, Models P222-XX, S25-XX, P227-XX, S30-XX, P235-XX, S35-XX, P240-XX, S40-XX, P24, Vilex, Inc. (1999) Summary page 4.
- K042310: Ortho-Pro Cannulated Bone Screws, Ortho-Pro, LLC (2004) Summary page 4.
- K143460: Cannulated Screw System, Wrightmedicaltechnologyinc (2015) Summary page 4.
- K150693: PHIN-FX Cannulated Lag Screw System, Ascent Medical, LLC (2015) Summary page 4.

## Most influential descendants
- K202817: GEO Bone Screw System (2020), 1 descendant of its own
- K201430: InFrame™ Cannulated Fixation System (2020), 1 descendant of its own
- K230946: Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression Screw System-Medium Product Code ACC-M; Accelerate Compression Screw System-Large Product Code ACC-L (2023), 0 descendants of its own
- K220892: ExsoMed INnate NanoTM Lag Screw System (2022), 0 descendants of its own

## Indications for use
The GEO Bone Screw System is indicated for bone fractures, osteotomies, arthrodesis, osteochondritis, and tendon reattachment.

Source page: https://510kreport.com/device/K161904
Methodology: https://510kreport.com/methodology