# K192702: DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (USA) Products, LLC
- Decided: Sep 18, 2020 after 357 days
- Product code: GXN (Plate, Cranioplasty, Preformed, Non-Alterable)
- Device class: 2
- Regulation: 21 CFR 882.5330
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K022012 (2002). 20 ancestors in all.
No later device cites it as a predicate yet.
1 of 21 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K912932: Synthes Maxillofacial Titanium Micro Set, Synthes (Usa) (1991) Summary page 18.
- K954385: Synthes Mandibular Modular Fixation System, Synthes (Usa) (1996) Summary page 20.
- K981075: Synthes (Usa) (Synthes) Single Vector Distractor with Detachable Feet, Synthes (Usa) (1998) Summary page 22.
- K992000: Synthes Cranial Flap Tube Clamp, Synthes (Usa) (1999) Summary page 24.
- K022012: Synthes Low Profile Neuro System, Synthes (Usa) (2002) Summary page 26.
- K031807: Synthes Low Profile Neuro System - 3 MM Screws, Synthes (Usa) (2003) Summary page 28.
- K033121: 1.3 & 1.5MM Contourable Titanium (TI.) Mesh Plates, Synthes (Usa) (2003) Summary page 30.
- K040083: Synthes External Midface Distractor, Synthes (Usa) (2004) Summary page 32.
- K041887: Synthes (Usa) 1.0/1.22 MM Craniofacial Screws, Synthes (Usa) (2004) Summary page 34.
- K042365: Synthes (Usa) Neuro Plate and Screw System, Synthes (Usa) (2004) Summary page 36.
- K042986: Modification to Synthes (Usa) (Synthes) Low Profile Neuro System, Synthes (Usa) (2004) Summary page 38.
- K050608: Synthes Carniofacial Plate and Screw System, Synthes (Usa) (2005) Summary page 40.
- K060138: Synthes (Usa) Craniomaxillofacial Distraction System, Synthes (Usa) (2006) Summary page 42.
- K170818: Craniomaxillofacial Distraction System (CMFD), Synthes USA Products, LLC (2017) Summary page 42.
- K080331: Synthes Craniofacial Plate and Screw System, Synthes (Usa) (2008) Summary page 44.
- K123723: Synthes Matrixneuro Cranial Plating System, Synthes (2013) Summary page 46.
- K140462: Matrixneuro Preformed Mesh (Part of the Matrixneuro Cranial Plating System), Synthes (USA) Products, LLC (2014) Summary page 48.

## Indications for use
Neuro: • Neurosurgery • Nasoethmoidal fractures • Infraorbital area fractures • Frontal sinus wall Fractures • Infant craniofacial surgery Dental: • Maxillofacial surgery 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 • Neurosurgery: osteosynthesis of the cranial bones. Dental: The DePuy Synthes Single Vector Distractor with Detachable Feet is intended for use as a bone stabilizer and lengthener for conditions such as mandibular hypoplasia or posttraumatic defects of the mandible, where gradual bone distraction is required. The device is ideal for treating fonns of clefts of the lip and palate, and congenital mandibular hypoplasia, such as Hemifacial Microsomia, Treacher Collins Syndrome, Nagers Syndrome, Pierre Robin Syndrome, Goldenhar Syndrome, Apert Syndrome, and Crouzon Syndrome. The DePuy Synthes Single Vector Distractor with Detachable Feet is also ideal for treating hypoplasias of an acquired origin such as from post‐traumatic growth disorders associated with injury to the temporomandibular joint, temporomandibular ankylosis, and segmental loss of bone. Neuro: The DePuy Synthes Single Vector Distractor with Detachable Feet can be used for stabilization and advancement of the mid‐face, in which a deficiency of mid‐facial bone requires gradual bone distraction. Such deficiencies include, but are not limited to Plagiocephaly, Trigonocephaly, Scaphocephaly, and Brachycephaly. The DePuy Synthes Cranial Tube Clamp is intended to reattach a cranial bone flap to the surrounding cranium after a craniotomy procedure. Dental: 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. Neuro: The DePuy Synthes Low Profile Neuro System is intended for cranial closure and/or bone fixation, craniotomies, cranial trauma repair and reconstruction. Dental: 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. Neuro: The DePuy Synthes Low Profile Neuro System is intended for cranial closure and/or bone fixation, craniotomies, cranial trauma repair and reconstruction. Dental: 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. Neuro: The DePuy Synthes 1.3 & 1.5 mm Contourable Titanium (Ti.) Mesh Plates are intended for use in selective trauma of the craniofacial skeleton and craniofacial surgery. Dental: The DePuy Synthes External Midface 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, the midface utilizing a LeFort II or III osteotomy in adult and pediatric populations where gradual bone distraction is required. Neuro: The DePuy Synthes External Midface Distractor is intended for use in craniofacial surgery and reconstructive procedures. Specifically, it is intended for distraction of the cranium utilizing a monobloc osteotomy in adult and pediatric populations where gradual bone distration is required. The DePuy Synthes 1.0/1.2 mm Craniofacial Screws are intended for use as follows: Neuro: • Nasoethmoidal fractures • Infraorbital area fractures • Frontal sinus wall fractures • Infant craniofacial surgery Dental: • Maxillofacial surgery Dental: 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. Neuro: DePuy Synthes Neuro Plate and Screw System is intended for use in fixation of the cranial bones in procedures such as reconstruction, fracture repair, craniotomies, and osteotomies. Dental: 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. Neuro: The DePuy Synthes Low Profile Neuro System is intended for cranial closure and/or bone fixation, craniotomies, cranial trauma repair and reconstruction. Dental: 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. Neuro: The DePuy Synthes Craniofacial Plate and Screw System is intended for use in selective trauma of the craniofacial skeleton and craniofacial surgery. The DePuy Synthes CMF Distraction System is intended for use as a bone stabilizer and lengthening (and/or transport) device. The DePuy Synthes CMF Distraction System is indicated for correction of congenital deficiencies or post‐traumatic defects of the cranium, where gradual bone distraction is required in adults and pediatric patients. Cranium The 1.5 mm and 2.0 mm mesh and cloverleaf footplates and screws are intended for infants, children, adolescents, and adults. The DePuy Synthes MatrixNEURO Cranial Plating System is intended for use in fixation of the cranial bones in procedures such as reconstruction, fracture repair, craniotomies, and osteotomies. The DePuy Synthes MatrixNEURO Preformed Mesh is intended for use in fixation of the cranial bones in procedures such as reconstruction, fracture repair, craniotomies, and osteotomies.

Source page: https://510kreport.com/device/K192702
Methodology: https://510kreport.com/methodology