# K183113: DePuy Synthes Maxillofacial Portfolio - MR Conditional

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (USA) Products, LLC
- Decided: Mar 13, 2019 after 124 days
- Product code: MQN (External Mandibular Fixator And/Or Distractor)
- 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: 8 generations back to K792561 (1979). 55 ancestors in all.
No later device cites it as a predicate yet.
1 of 56 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010527: Synthes (Usa) Imf Screws, Synthes (Usa) (2001) Summary page 3.
- K010690: Synthes Titanium Multi-Vector Distractor, Synthes (Usa) (2001) Summary page 4.
- K031807: Synthes Low Profile Neuro System - 3 MM Screws, Synthes (Usa) (2003) Summary page 5.
- K040083: Synthes External Midface Distractor, Synthes (Usa) (2004) Summary page 6.
- K041887: Synthes (Usa) 1.0/1.22 MM Craniofacial Screws, Synthes (Usa) (2004) Summary page 7.
- K043555: Synthes 9USA) Alveolar Ridge Distractor, Synthes (Usa) (2005) Summary page 8.
- K060138: Synthes (Usa) Craniomaxillofacial Distraction System, Synthes (Usa) (2006) Summary page 9.
- K063181: Synthes (Usa) Condylar Head Add-on System, Synthes (Usa) (2007) Summary page 10.
- K080153: Synthes (Usa) Curvilinear Distraction System, Synthes (Usa) (2008) Summary page 11.
- K081747: Modification to Synthes (Usa) Condylar Head Add-on System, Synthes (Usa) (2008) Summary page 12.
- K093299: Synthes Orthodontic Bone Anchor System, Synthes (Usa) (2010) Summary page 13.
- K121502: Synthes Curvilinear Distraction System, Synthes, Inc. (2012) Summary page 14.
- K962272: Synthes Mandible Distractor, Synthes (Usa) (1996) Summary page 15.
- K964261: SMF Stainless Steel Bone Screws, Synthes (Usa) (1997) Summary page 16.
- K980199: Synthes 1.5MM/2.0MM Orthognathic Maxillary Plates and Screws, Synthes (Usa) (1998) Summary page 17.
- K981075: Synthes (Usa) (Synthes) Single Vector Distractor with Detachable Feet, Synthes (Usa) (1998) Summary page 18.
- K981362: Synthes (Usa) External Multi Vector Mandible Distractor, Synthes (Usa) (1998) Summary page 19.
- K990637: Synthes Locking Reconstruction Plate (LRP) with Condylar Head, Synthes (Usa) (1999) Summary page 20.
- K092530: Sprytie, Models ST001, ST002 and ST003, Russell B. Walther (2010) Summary page 70.

## Indications for use
The DePuy Synthes IMF Screws are intended to provide indirect stabilization of the maxilla and mandible following maxillofacial and mandibular trauma or reconstruction. The DePuy Synthes Titanium Multi-Vector Distractor is intended for use in mandibular bone lengthening for conditions such as mandibular hypoplasia or post-traumatic defects such as tumor resections, severe trauma, bone grafting defects, severe open mandible fractures where gradual distraction is required. Where bone loss is a result of the condition, bone transport can be performed as an alternative to free flaps or bone grafts. The DePuy Synthes Low Profile Neuro System - 3 mm Screws 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 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 and/or the midface utilizing a LeFort II or III osteotomy in adult and pediatric populations where gradual bone distraction is required. The DePuy Synthes 1.0/1.2 mm Craniofacial Screws are intended for use as follows: General Indications: • Maxillofacial surgery The DePuy Synthes Alveolar Distractor is intended for vertical bone lengthening of the alveolar ridge in the mandible and the maxilla where gradual bone distraction is required, including deficiency in bone height as a result of trauma, resorption after dental extraction, periodontal disease, tumor resection, and congenital deformity. The DePuy Synthes Craniomaxillofacial Distraction System (CMF Distraction System) is intended for use as a bone stabilizer and lengthening (and/or transport) device for correction of congenital deficiencies or post-traumatic defects of the mandibular body and ramus where gradual bone distraction is required. The DePuy Synthes CMF Distraction System is intended for single use only. The DePuy Synthes Pediatric CMF Distraction System is intended for use as a bone stabilizer and lengthening (and/or transport) device for correction of congenital deficiencies or post-traumatic defects of the mandibular body and ramus where gradual bone distraction is required in children under the age of 12 months. The DePuy Synthes Pediatric CMF Distraction System is intended for single use only. The DePuy Synthes Condylar Head Add-On System is intended for temporary reconstruction in patients undergoing ablative tumor surgery requiring the removal of the mandibular condyle. This device is not for permanent implantation, for patients with TMJ or traumatic injuries, or for treatment of temporomandibular joint disease (TMD). The DePuy Synthes Curvilinear Distraction System is intended for use as a bone stabilizer and lengthening (and/or transport) device for correction of congenital deficiencies or post-traumatic defects of the mandibular body and ramus where gradual bone distraction is required. This system is intended for use in either adults or pediatric patients over 1 year old. The DePuy Synthes Curvilinear Distraction System is intended for single use only. The DePuy Synthes Condylar Head Add-On System Intended for temporary reconstruction in patients undergoing ablative tumor surgery requiring the removal of the mandibular condyle. This device is not for permanent implantation, for patients with TMJ or traumatic injuries, or for treatment of temporomandibular joint disease (TMD). The DePuy Synthes Orthodontic Bone Anchor (OBA) System screw anchors are intended to be implanted intraorally and used as an anchor for orthodontic procedures in adolescents greater than age 12 and adults. The DePuy Synthes Orthodontic Bone Anchor (OBA) System plate anchors are intended to be implanted intraorally and used as an anchor for orthodontic procedures in adults. The DePuy Synthes Curvilinear Distraction System is intended for use as a bone stabilizer and lengthening (and/or transport) device. The DePuy Synthes Curvilinear Distraction System is indicated for correction of congenital deficiencies or posttraumatic defects of the mandibular body and ramus where gradual bone distraction is required. The 2.0 mm Curvilinear Distractor is intended for use in adult and pediatric patients more than 1 year old. The 1.3 mm Curvilinear Distractor is intended for use in pediatric patients 4 years of age and younger. The DePuy Synthes Curvilinear Distraction System is intended for single use only. The DePuy Synthes Mandible Distractor is intended to be used in the mandible for conditions such as mandibular deficiency or post-traumatic effects of the mandible, where gradual bone distraction is required. The DePuy Synthes SMF Stainless Steel Bone Screws are intended for maxillofacial and mandibular trauma and reconstruction. The longer screw lengths (24-38mm) are specifically intended for symphysial fractures, parasymphyseal fractures, and angle fractures where the lag screw technique is being followed. The lag screw technique involves overdrilling the near cortex, thus the screw glides through the near cortical and cancellous bone and purchases only into the far cancellous and cortical bone. The DePuy Synthes 1.5 mm/2.0 mm Orthognathic Maxillary Plates and Screws are generally intended for a variety of pan facial indications. Specifically, it is intended 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 Single Vector Distractor with Detachable Feet is intended for use as a bone stabilizer and lengthener for conditions such as mandibular hypoplasia or post-traumatic defects of the mandible, where gradual bone distraction is required. The device is ideal for treating forms 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. The DePuy Synthes External Multi Vector Mandible Distractor (MVMD) 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 any form of 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 External MVMD 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. The DePuy Synthes Locking Reconstruction Plate with Condylar Head is intended for temporary reconstruction in patients undergoing ablative tumor surgery requiring the removal of the mandibular condyle. This device is not for permanent implantation, for patients with TMJ or traumatic injuries, or for treatment of temporomandibular joint disease (TMD). The DePuy Synthes Cerclage Wires are indicated for use in the jaws in adults and children to directly wire bony segments together, for the fixation of arch bars or splints to the teeth, for stabilization of bony segments, or for wiring the teeth together maxillomandibular fixation).

Source page: https://510kreport.com/device/K183113
Methodology: https://510kreport.com/methodology