# K192655: Depuy Synthes Maxillofacial Portfolio - MR Conditional

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (USA) Products, LLC
- Decided: Dec 30, 2019 after 96 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: 6 generations back to K820944 (1982). 42 ancestors in all.
No later device cites it as a predicate yet.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141165: Matrixwave MMF System, Synthes (USA) Products, LLC (2014) Summary page 3.
- K121574: Synthes Matrixmadible Plate and Screw System, Synthes, Inc. (2012) Summary page 4.
- K113567: Synthes Matrixmadible Plate and Screw System, Synthes, Inc. (2012) Summary page 5.
- K102656: Synthes Dentoalveolar Bone Fixation System, Synthes (Usa) (2010) Summary page 6.
- K091233: Synthes Matrixmandible Subcondylar Plates, Synthes (Usa) (2009) Summary page 7.
- K091144: Synthes Matrixmandible Preformed Reconstruction Plates, Synthes (Usa) (2009) Summary page 8.
- K083388: Synthes Matrixorthognathis Fixation System, Synthes (Usa) (2009) Summary page 9.
- K082335: Synthes Matrixmandible Plate and Screw System, Synthes (Usa) (2008) Summary page 10.
- K080331: Synthes Craniofacial Plate and Screw System, Synthes (Usa) (2008) Summary page 11.
- K063790: The Synthes Matrixmandible Plate and Screw System, Synthes (Usa) (2007) Summary page 12.
- K050608: Synthes Carniofacial Plate and Screw System, Synthes (Usa) (2005) Summary page 13.
- K042365: Synthes (Usa) Neuro Plate and Screw System, Synthes (Usa) (2004) Summary page 14.
- K033121: 1.3 & 1.5MM Contourable Titanium (TI.) Mesh Plates, Synthes (Usa) (2003) Summary page 15.
- K031761: Synthes (Usa) New/Sterial Orbital Plates, Synthes (Usa) (2003) Summary page 16.
- K022012: Synthes Low Profile Neuro System, Synthes (Usa) (2002) Summary page 17.
- K022005: Synthes Midface Distractor, Synthes (Usa) (2002) Summary page 18.
- K020505: Synthes Translating Maxillary Distractor, Synthes (Usa) (2002) Summary page 19.
- K010499: Synthes (Usa) Midface Distractor, Synthes (Usa) (2001) Summary page 20.
- K003393: Maxillary Distractor, Synthes (Usa) (2001) Summary page 21.
- K001311: Synthes (Usa) Oribital Mesh Plates, Synthes (Usa) (2000) Summary page 22.
- K974555: Synthes 2.0 MM Locking Plate System (2.0 LPS), Synthes (Usa) (1998) Summary page 23.
- K961421: Synthes 2.4 MM Universal Locking Plate System, Synthes (Usa) (1996) Summary page 24.
- K954385: Synthes Mandibular Modular Fixation System, Synthes (Usa) (1996) Summary page 25.
- K912932: Synthes Maxillofacial Titanium Micro Set, Synthes (Usa) (1991) Summary page 26.

## Indications for use
The DePuy Synthes MatrixWAVE MMF System is indicated for the temporary treatment of mandibular and maxillary fractures and osteotomies in adults and adolescents (age 12 and higher) in whom permanent teeth have erupted. The DePuy Synthes MatrixMANDIBLE Plate and Screw System is intended for oral, maxillofacial surgery: • Trauma • Reconstructive surgery • Orthognathic surgery (surgical correction of dentofacial deformities) The DePuy Synthes MatrixMANDIBLE Plate and Screw System is intended for oral, maxillofacial surgery: • Trauma • Reconstructive surgery • Orthognathic surgery (surgical correction of dentofacial deformities) The DePuy Synthes Dentoalveolar Bone Fixation System is intended for use in non-load bearing applications for maintaining the relative position of and/or containing bony fragments, bone grafts (autograft or allograft), or bone graft substitutes in reconstruction of maxillary and/or mandibular areas, including the dentoalveolar ridge. The DePuy Synthes MatrixMANDIBLE Subcondylar Plates are intended for oral, maxillofacial surgery; trauma and reconstructive surgery, specifically for fractures of the subcondylar region of the mandible and fractures of the condylar basis region of the mandible. The DePuy Synthes MatrixMANDIBLE Preformed Reconstruction Plates are intended for use in oral and maxillofacial surgery, trauma and reconstructive surgery. This includes primary mandibular reconstruction, comminuted fractures and temporary bridging pending delayed secondary reconstruction, including fractures of edentulous and/or atrophic mandibles, as well as unstable fractures. The DePuy Synthes MatrixORTHOGNATHIC Plating System consists of a variety of plates that come in a variety of shapes and sizes to meet the anatomical needs of the patient. This system is designed for use with Synthes Matrix screws. System components are manufactured in either titanium or titanium alloy and are intended for single use only. The Synthes MatrixORTHOGNATHIC Plating System is intended for use in selective trauma of the midface and maxillofacial skeleton; maxillofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla, mandible and chin in adolescents (greater than 12 to 21 years of age) and adults. Specific Indications for Use: • Fractures of the midface and maxillofacial skeleton • LeFort I osteotomies, sagittal split osteotomies and genioplasties • Orthognathic surgery including reconstructive procedures The DePuy Synthes MatrixMANDIBLE Plate and Screw System is intended for oral, maxillofacial surgery; trauma; reconstructive surgery; and orthognathic surgery (surgical correction of dentofacial deformities). The DePuy Synthes Craniofacial Plate and Screw System is intended for use in selective trauma of the midface and maxillofacial skeleton, maxillofacial surgery, reconstructive procedures and selective orthognathic surgery of the maxilla and chin. The DePuy Synthes MatrixMANDIBLE Plate and Screw System is intended for oral, maxillofacial surgery; trauma; reconstructive surgery; and orthognathic surgery (surgical correction of dentofacial deformities). The DePuy Synthes Craniofacial Plate and Screw System is intended for use in selective trauma of the midface and maxillofacial skeleton; maxillofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin. The DePuy Synthes Neuro Plate and Screw System is intended for use in selective trauma of the midface and maxillofacial skeleton; maxillofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin. The DePuy Synthes 1.3 & 1.5 mm Contourable Titanium (Ti.) Mesh Plates are intended for use in selective trauma of the midface and maxillofacial skeleton; maxillofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin. The DePuy Synthes Orbital Plates are intended for use in selective trauma of the midface and maxillofacial skeleton; maxillofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin. The DePuy Synthes Low Profile Neuro System is intended for use in selective trauma of the midface and maxillofacial skeleton; maxillofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin. The DePuy Synthes Midface Distractor is intended for use in adult and pediatric populations for the treatment of midface conditions for which reconstructive osteotomy and segment advancement are indicated. This includes conditions such as midfacial retrusion. The device is intended to provide temporary stabilization and gradual lengthening of the midfacial bones. The DePuy Synthes Translating Maxillary Distractor is intended for use in maxillofacial surgery, reconstructive procedures, and selective orthognathic surgery of the maxilla. Specifically it is intended for distraction of the maxilla utilizing a LeFort I osteotomy in adult and pediatric populations. The DePuy Synthes Midface Distractor is intended for use in adult and pediatric populations for the treatment of midface conditions for which reconstructive osteotomy and segment advancement are indicated. This includes conditions such as midfacial retrusion. The device is intended to provide temporary stabilization and gradual lengthening of the midfacial bones. The DePuy Synthes Maxillary Distractor is intended for use in maxillofacial surgery, reconstructive procedures, and selective orthognathic surgery of the maxilla. Specifically it is intended for distraction of the maxilla utilizing a LeFort I osteotomy in adult and pediatric populations. The DePuy Synthes Orbital Mesh Plates for the Midfacial System are indicated for selective trauma of the midface and maxillofacial skeleton; maxillofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin. The DePuy Synthes 2.0 LPS is intended for oral, maxillofacial surgery: trauma; reconstructive surgery; and orthognathic surgery (surgical correction of dentofacial deformities). The DePuy Synthes 2.4 mm Universal Locking Plate System is a plate and screw system, that is intended for mandible trauma and reconstruction procedures. The DePuy Synthes Mandibular Modular Fixation System is a plate and screw system, manufactured from commercially pure titanium, and is intended for use in: • Oral, maxillofacial surgery: trauma; surgical correction of dentofacial deformities; reconstructive surgery; and maxillofacial surgery General indications: - Maxillofacial surgery

Source page: https://510kreport.com/device/K192655
Methodology: https://510kreport.com/methodology