# K142419: Mini and Micro Fragments Reconstruction System-NEOFIX

- Pathway: 510(k) (Traditional)
- Applicant: Neoortho Productos Orthopedicos S/A
- Decided: Dec 16, 2014 after 110 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: 6 generations back to K981372 (1998). 63 ancestors in all.
8 later devices descend from it; 4 cite it directly.
0 of 72 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090047: Synthes (Usa) 1.5MM Mini Fragment LCP System, Synthes (Usa) (2009) Summary page 5.
- K063049: Synthes (Usa) Modular Mini Fragment LCP System, Synthes (Usa) (2006) Summary page 5.
- K102694: 2.4MM VA-LCP Dorsal Distal Radius Plates, Synthes (Usa) (2010) Summary page 6.
- K071184: Synthes (Usa) Variable Angle-Locking Compression Plate (VA-LCP) Distal Radius System, Synthes (Usa) (2007) Summary page 6.
- K083694: Synthes (Usa) 2.4 MM VA-LCP Two Column Volar Distal Radius Plates, Synthes (Usa) (2009) Summary page 6.
- K091644: Synthes (Usa) 2.4MM LCP Volar Column Distal Radius Plates, Synthes (Usa) (2009) Summary page 6.
- K092556: Synthes (Usa) 2.4MM VA-LCP Two-Column Narrow Volar Distal Radius, Synthes (Usa) (2009) Summary page 6.
- K012114: Synthes Locking Distal Radius Plating System, Synthes (Usa) (2001) Summary page 6.
- K102641: Mini and  Micro Fragments Reconstruction System-Neoface, Neoortho Produtos Ortopedicos S/A (2010) Summary page 6.
- K982732: Synthes (Usa) Distal Radius Plate System (DRPS), Synthes (1998) Summary page 6.
- K113733: Small and Large Fragments Osteosynthesis System Neofix, Neoortho Produtos Ortopedicos S/A (2012) Summary page 6.

## Most influential descendants
- K182718: Mini and Micro Fragments Reconstruction System – GMReis (2019), 4 descendants of its own
- K242939: ARTFX Trauma Bone Plate and Screw System (2024), 2 descendants of its own
- K242596: Versalock Mini and Micro Plating System (2024), 2 descendants of its own
- K260390: Super Upper Limbs Versalock Plating System (2026), 1 descendant of its own
- 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

## Indications for use
Mini and Micro Fragments Reconstruction System – NEOFIX is intended for small bone fracture fixation, arthrodesis, reconstruction, and osteotomy fixation. Examples include small bones of the hand, wrist, foot and ankle. The use of locking plate/screw systems is suited for treatment of fractures in osteopenic bone.

Source page: https://510kreport.com/device/K142419
Methodology: https://510kreport.com/methodology