# K242939: ARTFX Trauma Bone Plate and Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Artfx Medical
- Decided: Dec 23, 2024 after 89 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K000684 (2000). 287 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 290 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191793: Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand of DHS Plating System, Nebula Surgical Private Limited (2019) Summary page 8.
- K171808: TDM Plate and Screw System, Tdm Co., Ltd. (2018) Summary page 8.
- K161894: SurgTech Trauma System, Surgtech, Inc. (2017) Summary page 8.
- K171904: Tandry Locking Plate System, Microware Precision Co., Ltd. (2018) Summary page 8.
- K163383: GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND Of DHS/Dynamic Condylar Plate Plating System, Greens Surgicals Pvt., Ltd. (2017) Summary page 8.
- K142419: Mini and Micro Fragments Reconstruction System-NEOFIX, Neoortho Productos Orthopedicos S/A (2014) Summary page 9.

## Most influential descendants
- K261830: FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See Catalog);FRAXION Mini Plate System (Various - See Catalog);FRAXION Bone Screw System (Various - See Catalog) (2026), 0 descendants of its own
- K260277: Mikron Trauma Bone Plate& Screw System (2026), 0 descendants of its own

## Indications for use
The ARTFX Trauma Bone Plate and Screw System is indicated for fixation of upper extremity (humerus, olecranon, radius, ulna, metacarpals, phalanges), lower extremity (femur, tibia, fibula, tarsals, metatarsals, phalanges), pelvis, and clavicle fractures, fusions, osteotomies, non-unions, malunions and reconstructions. The ARTFX Trauma Bone Plate and Screw System is not intended for use in the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine, nor for fixation of the sacroiliac joint. The system is intended for single use and for adult patients only. The ARTFX 3.5 System is indicated for the fixation of upper extremity (humerus, olecranon, radius, ulna, metacarpal, phalangeal), fibula, foot (tarsal, metatarsal, phalangeal), pelvis, and clavicle fractures, fusions, osteotomies, non-unions, malunions and reconstructions. The ARTFX 4.5 System is indicated for fixation of lower extremity (femur, tibia, fibula) and foot (tarsal, metatarsal, phalangeal) fractures, fusions, osteotomies, non-unions, malunions and reconstructions. The ARTFX Mini-Plate System is indicated for fixation of hand (metacarpal, phalangeal) and foot (tarsal, metatarsal, phalangeal) fractures, fusions, osteotomies, non-unions, malunions and reconstructions.

Source page: https://510kreport.com/device/K242939
Methodology: https://510kreport.com/methodology