# K102641: Mini and  Micro Fragments Reconstruction System-Neoface

- Pathway: 510(k) (Traditional)
- Applicant: Neoortho Produtos Ortopedicos S/A
- Decided: Dec 20, 2010 after 98 days
- Product code: JEY (Plate, Bone)
- Device class: 2
- Regulation: 21 CFR 872.4760
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K980512 (1998). 9 ancestors in all.
12 later devices descend from it; 2 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050608: Synthes Carniofacial Plate and Screw System, Synthes (Usa) (2005) Summary page 2.
- K080331: Synthes Craniofacial Plate and Screw System, Synthes (Usa) (2008) Summary page 2.
- K083388: Synthes Matrixorthognathis Fixation System, Synthes (Usa) (2009) Summary page 2.
- K091144: Synthes Matrixmandible Preformed Reconstruction Plates, Synthes (Usa) (2009) Summary page 2.
- K081067: Fracture/Reconstruction System (Traumaone), Biomet Microfixation, Inc. (2008) Summary page 2.
- K063052: Lorenz Titanium Fracture / Reconstruction Devices and Pre-Bent Plates, Walter Lorenz Surgical, Inc. (2007) Summary page 2.
- K972322: Lorenz 1.5 MM Neuro Pack/Lorenz 2.0 FT Plates, Walter Lorenz Surgical, Inc. (1997) Summary page 2.

## Most influential descendants
- K142419: Mini and Micro Fragments Reconstruction System-NEOFIX (2014), 8 descendants of its own
- 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
- K180204: CranioMaxillofacial Fixation (CMF) System - CMF Visionare (2018), 2 descendants of its own

## Indications for use
Mini and Micro Fragments Reconstruction System - NEOFACE is intended for use in selective trauma of the muidface, maxillofacial surgery, reconstructive procedures, and selective orthognathic Surgery of the maxilla, mandible and chin.

Source page: https://510kreport.com/device/K102641
Methodology: https://510kreport.com/methodology