# K202817: GEO Bone Screw System

- Pathway: 510(k) (Special)
- Applicant: Gramercy Extremity Orthopedics, LLC
- Decided: Oct 22, 2020 after 28 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: 14 generations back to K962616 (1996). 209 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 211 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161904: GEO Bone Screw System, Gramercy Extremity Orthopeidics, LLC (2017) Summary page 4.
- K153154: Asnis JFX System, Stryker Trauma AG (2015) Summary page 4.
- K190586: Monster® Screw System, Paragon 28, Inc. (2019). Our reading of the summary gave K190686, FDA’s number for Optilite IgM CSF Kit (The Binding Site Group, Ltd.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Paragon 28 Monster Screw System”.
- K191289: Bone Screw Line Addition, Vilex IN Tennessee, Inc. (2019) Summary page 4.
- K180377: Fracture and Correction System, In2bones USA, LLC (2018) Summary page 4.

## Most influential descendants
- 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

## Indications for use
The GEO Bone Screw System is indicated for bone fractures, osteotomies, arthrodesis, osteochondritis, and tendon reattachment. Surgical indications include fixation of malunion and nonunion, acute fractures, repetitive stress fractures, malleolar, talus, and greater tuberosity fractures, Jones fracture and 5th metatarsal fracture fixation and bone reconstruction where appropriate for the size of the device.

Source page: https://510kreport.com/device/K202817
Methodology: https://510kreport.com/methodology