510(k) · Cleared
ClearedDePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (USA) Products, LLC · GXN Plate, Cranioplasty, Preformed, Non-Alterable
Cleared on Sep 18, 2020 as substantially equivalent to K912932 (Synthes (Usa), 1991) and 16 other predicates after a 357-day review. Its family tree reaches back 3 generations to 2002. 1 of the 21 devices in its family, counting itself, has a Class I recall.
- Decided
- Sep 18, 2020
- Review
- 357 days
- Class
- Class II
- Product code
- GXN
- Recalls
- None
- Predicates
- 17
Its longest line of descent runs back 3 generations to K022012 (2002). 20 ancestors in all, the oldest K792561 (1979). No later device cites it as a predicate yet. 1 of the 21 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK022012 Synthes Low Profile Neuro SystemSynthes (Usa) · 2002
- 2 generations backK123723 Synthes Matrixneuro Cranial Plating SystemSynthes · 2013
- 1 generation backK140462 Matrixneuro Preformed Mesh (Part of the Matrixneuro Cranial Plating…Synthes (USA) Products, LLC · 2014
- This deviceK192702 DePuy Synthes Craniomaxillofacial Neuro Devices - MR ConditionalSynthes (USA) Products, LLC · 2020
Class I recalls in this family
- K060138 Synthes (Usa) Craniomaxillofacial Distraction…direct predicate · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K022012 | Synthes Low Profile Neuro System | Synthes (Usa) | 2002 | — |
| −2 | K123723 | Synthes Matrixneuro Cranial Plating System | Synthes | 2013 | — |
| −1 | K140462 | Matrixneuro Preformed Mesh (Part of the Matrixneuro Cranial Plating System) | Synthes (USA) Products, LLC | 2014 | — |
| 0 (this device) | K192702 | DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional | Synthes (USA) Products, LLC | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1991 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 3 | 0 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 1 |
| 2008 | 1 | 0 |
| 2017 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GXN device
- #1 K260709 ClearFit Ti Ring 14mm (171750);ClearFit Ti…score 13.7 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (17)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K912932 | Synthes Maxillofacial Titanium Micro SetSummary page 18…MR Conditional Classification Name(s): Plate, Bone Regulatory Class: Class II; 872.4760 Product Code(s): JEY 1.3 Predicate Device K912932 Synthes Maxillofacial Titanium Micro Set 1.4 Device Description The DePuy Synthes Maxillofacial Titanium Micro… | 1991 |
| * | K954385 | Synthes Mandibular Modular Fixation SystemSummary page 20…MR Conditional Classification Name(s): Plate, Bone Regulatory Class: Class II; 872.4760 Product Code(s): JEY 1.3 Predicate Device K954385 Synthes Mandibular Modular Fixation System 1.4 Device Description The DePuy Synthes Mandibular Modular Fixatio… | 1996 |
| * | K981075 | Synthes (Usa) (Synthes) Single Vector Distractor with Detachable FeetSummary page 22…on Name(s): External Mandibular Fixator And/Or Distractor Regulatory Class: Class II; 872.4760 Product Code(s): MQN 1.3 Predicate Device K981075 Synthes (USA) Single Vector Distractor with Detachable Feet 1.4 Device Description The DePuy Synthes Single Ve… | 1998 |
| * | K992000 | Synthes Cranial Flap Tube ClampSummary page 24…late, Cranioplasty, Preformed, Non-Alterable Regulatory Class: Class II, §882.5330 Product Code(s): GXN 1.3. Predicate Device K992000 Synthes Cranial Tube Clamp 1.4. Device Description The DePuy Synthes Cranial Flap Tube Clamp consists of tw… | 1999 |
| * | K022012 | Synthes Low Profile Neuro SystemSummary page 26…MR Conditional Classification Name(s): Plate, Bone Regulatory Class: Class II; 872.4760 Product Code(s): JEY 1.3 Predicate Device K022012 Synthes Low Profile Neuro System 1.4 Device Description The DePuy Synthes Low Profile Neuro System consists of… | 2002 |
| * | K031807 | Synthes Low Profile Neuro System - 3 MM ScrewsSummary page 28…Classification Name(s): Screw, Fixation, Intraosseous Regulatory Class: Class II; 872.4880 Product Code(s): DZL 1.3. Predicate Device K031807 Synthes Low Profile Neuro System - 3 mm Screws 1.4. Device Description Synthes ø1.6 mm Low Profile Neuro System… | 2003 |
| * | K033121 | 1.3 & 1.5MM Contourable Titanium (TI.) Mesh PlatesSummary page 30…Conditional Classification Name(s): Plate, Bone Regulatory Class: Class II; 872.4760 Product Code(s): JEY 1.3 Predicate Device K033121 1.3 & 1. 5MM Contourable Titanium (Ti.) Mesh Plates 1.4 Device Description The DePuy Synthes 1.3 & 1.5 mm Cont… | 2003 |
| * | K040083 | Synthes External Midface DistractorSummary page 32…on Name(s): External Mandibular Fixator And/Or Distractor Regulatory Class: Class II; 872.4760 Product Code(s): MQN 1.3. Predicate Device K040083 Synthes External Midface Distractor 1.4. Device Description The DePuy Synthes External Midface Distractor is an… | 2004 |
| * | K041887 | Synthes (Usa) 1.0/1.22 MM Craniofacial ScrewsSummary page 34…tion Name(s): Screw, Fixation, Intraosseous Regulatory Class: Class II; 872.4880 Product Code(s): DZL 1.3 Predicate Device K041887 Synthes (USA) 1.0/1.2 mm Craniofacial Screws 1.4 Device Description The DePuy Synthes 1.0/1.2 mm Craniof… | 2004 |
| * | K042365 | Synthes (Usa) Neuro Plate and Screw SystemSummary page 36…Classification Name(s): Plate, Bone Regulatory Class: Class II; 872.4760 Product Code(s): JEY 1.3 Predicate Device K042365 Synthes (USA) Neuro Plate and Screw System 1.4 Device Description DePuy Synthes Neuro Plate and Screw Sy… | 2004 |
| * | K042986 | Modification to Synthes (Usa) (Synthes) Low Profile Neuro SystemSummary page 38…Classification Name(s): Cover, Burr Hole Regulatory Class: Class II, §882.5250 Product Code(s): GXR 1.3. Predicate Device K042986 Modification to Synthes (USA) Low Profile Neuro System 1.4. Device Description The DePuy Synthes 1.6 mm bur… | 2004 |
| * | K050608 | Synthes Carniofacial Plate and Screw SystemSummary page 40…MR Conditional Classification Name(s): Plate, Bone Regulatory Class: Class II; 872.4760 Product Code(s): JEY 1.3 Predicate Device K050608 Synthes Craniofacial Plate and Screw System 1.4 Device Description The DePuy Synthes Craniofacial Plate and Sc… | 2005 |
| * | K060138 | Synthes (Usa) Craniomaxillofacial Distraction SystemSummary page 42…on Name(s): External Mandibular Fixator And/Or Distractor Regulatory Class: Class II; 872.4760 Product Code(s): MQN 1.3 Predicate Device K060138 Synthes (USA) Craniomaxillofacial Distraction System K170818 DePuy Synthes Craniomaxillofacial Distraction (CMFD) System Cr… | 2006 |
| * | K170818 | Craniomaxillofacial Distraction System (CMFD)Summary page 42…gulatory Class: Class II; 872.4760 Product Code(s): MQN 1.3 Predicate Device K060138 Synthes (USA) Craniomaxillofacial Distraction System K170818 DePuy Synthes Craniomaxillofacial Distraction (CMFD) System Cranial Indications 1.4 Device Description DePuy S… | 2017 |
| * | K080331 | Synthes Craniofacial Plate and Screw SystemSummary page 44…MR Conditional Classification Name(s): Plate, Bone Regulatory Class: Class II; 872.4760 Product Code(s): JEY 1.3 Predicate Device K080331 Synthes Craniofacial Plate and Screw System 1.4 Device Description The DePuy Synthes Orbital Plates, component… | 2008 |
| * | K123723 | Synthes Matrixneuro Cranial Plating SystemSummary page 46…): Plate, Cranioplasty, Preformed, Alterable Regulatory Class: Class II, §882.5320 Product Code(s): GWO 1.3. Predicate Device K123723 Synthes MatrixNEURO Cranial Plating System 1.4. Device Description The DePuy Synthes MatrixNEURO Cranial Pl… | 2013 |
| * | K140462 | Matrixneuro Preformed Mesh (Part of the Matrixneuro Cranial Plating System)Summary page 48…): Plate, Cranioplasty, Preformed, Alterable Regulatory Class: Class II, §882.5320 Product Code(s): GWO 1.3. Predicate Device K140462 MatrixNEURO Preformed Mesh (Part of the MatrixNEURO Cranial Plating System) 1.4. Device Description The DeP… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K060138Synthes (Usa) Craniomaxillofacial Distraction SystemSynthes (Usa) · 2006 · Direct predicate · ◆ in the 2006 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 6.3 years on median.
- 6 of the 20 ancestors have a recall of any class; 1 has a Class I recall.
- 7 other devices also cite its predicate K912932.
How does its category compare?
All GXN devicesGXN Plate, Cranioplasty, Preformed, Non-Alterable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · GXN
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GXN
69in 2021
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GXN
6in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GXN
24in 2025
MAUDE reports naming product code GXN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 3 |
| 2008 | 1 | — | 0 | 17 |
| 2009 | 0 | — | 0 | 17 |
| 2010 | 0 | — | 0 | 23 |
| 2011 | 2 | — | 0 | 20 |
| 2012 | 3 | 102 | 0 | 29 |
| 2013 | 1 | — | 0 | 57 |
| 2014 | 2 | — | 0 | 60 |
| 2015 | 2 | — | 0 | 47 |
| 2016 | 1 | — | 0 | 35 |
| 2017 | 2 | — | 0 | 74 |
| 2018 | 3 | 199 | 6 | 56 |
| 2019 | 0 | — | 0 | 54 |
| 2020 | 5 | 33 | 0 | 63 |
| 2021 | 3 | 69 | 0 | 63 |
| 2022 | 2 | — | 0 | 57 |
| 2023 | 1 | — | 0 | 32 |
| 2024 | 1 | — | 0 | 35 |
| 2025 | 2 | — | 0 | 24 |
| 2026 | 4 | 193 | 0 | — |
What is it indicated for?
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…
Read the full statement (858 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192702 · printed Nov 4, 2026
Cite this page
510(k) Report. “K192702: DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K192702
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026