510(k) · Cleared
ClearedDepuy Synthes Maxillofacial Portfolio - MR Conditional
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (USA) Products, LLC · JEY Plate, Bone
Cleared on Dec 30, 2019 as substantially equivalent to K141165 (Synthes (USA) Products, LLC, 2014) and 23 other predicates after a 96-day review. Its family tree reaches back 6 generations to 1982.
- Decided
- Dec 30, 2019
- Review
- 96 days
- Class
- Class II
- Product code
- JEY
- Recalls
- None
- Predicates
- 24
Its longest line of descent runs back 6 generations to K820944 (1982). 42 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK820944 Dental Arch BarUnisplint Corp. · 1982
- 5 generations backK991004 Synthes Quick Lock Imf SystemSynthes (Usa) · 1999
- 4 generations backK031207 Safety Release Arch Bar KitCasey Surgical, LLC · 2003
- 3 generations backK061271 Erch Arch Bar, Model 38-690-00KLS-Martin L.P. · 2006
- 2 generations backK122313 Stryker Universal Smartlock Hybrid MMF SystemStryker · 2012
- 1 generation backK141165 Matrixwave MMF SystemSynthes (USA) Products, LLC · 2014
- This deviceK192655 Depuy Synthes Maxillofacial Portfolio - MR ConditionalSynthes (USA) Products, LLC · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K820944 | Dental Arch Bar | Unisplint Corp. | 1982 | — |
| −5 | K991004 | Synthes Quick Lock Imf System | Synthes (Usa) | 1999 | — |
| −4 | K031207 | Safety Release Arch Bar Kit | Casey Surgical, LLC | 2003 | — |
| −3 | K061271 | Erch Arch Bar, Model 38-690-00 | KLS-Martin L.P. | 2006 | — |
| −2 | K122313 | Stryker Universal Smartlock Hybrid MMF System | Stryker | 2012 | — |
| −1 | K141165 | Matrixwave MMF System | Synthes (USA) Products, LLC | 2014 | — |
| 0 (this device) | K192655 | Depuy Synthes Maxillofacial Portfolio - MR Conditional | Synthes (USA) Products, LLC | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 2 | 0 |
| 1996 | 5 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 5 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2012 | 2 | 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.
Planning a device in JEY? 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 JEY device
- #1 K252246 Leforte MMF Systemscore 15.6 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (24)
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 |
|---|---|---|---|
| * | K141165 | Matrixwave MMF SystemSummary page 3…K192655 Device Name DePuy Synthes Maxillofacial Portfolio – MR Conditional Indications for Use (Describe) DePuy Synthes MatrixWAVE MMF System (originally cleared per K141165) The DePuy Synthes MatrixWAVE MMF System is indicated for the temporary treatment of mandibular and maxillary fractures and oste… | 2014 |
| * | K121574 | Synthes Matrixmadible Plate and Screw SystemSummary page 4…Name DePuy Synthes Maxillofacial Portfolio – MR Conditional Indications for Use (Describe) DePuy Synthes MatrixMANDIBLE Plate and Screw System (originally cleared per K121574) The DePuy Synthes MatrixMANDIBLE Plate and Screw System is intended for oral, maxillofacial surgery: • Trauma • Reconstructive… | 2012 |
| * | K113567 | Synthes Matrixmadible Plate and Screw SystemSummary page 5…Name DePuy Synthes Maxillofacial Portfolio – MR Conditional Indications for Use (Describe) DePuy Synthes MatrixMANDIBLE Plate and Screw System (originally cleared per K113567) The DePuy Synthes MatrixMANDIBLE Plate and Screw System is intended for oral, maxillofacial surgery: • Trauma • Reconstructive… | 2012 |
| * | K102656 | Synthes Dentoalveolar Bone Fixation SystemSummary page 6…ice Name DePuy Synthes Maxillofacial Portfolio – MR Conditional Indications for Use (Describe) DePuy Synthes Dentoalveolar Bone Fixation System (originally cleared per K102656) The DePuy Synthes Dentoalveolar Bone Fixation System is intended for use in non-load bearing applications for maintaining the r… | 2010 |
| * | K091233 | Synthes Matrixmandible Subcondylar PlatesSummary page 7…vice Name DePuy Synthes Maxillofacial Portfolio – MR Conditional Indications for Use (Describe) DePuy Synthes MatrixMANDIBLE Subcondylar Plates (originally cleared per K091233) The DePuy Synthes MatrixMANDIBLE Subcondylar Plates are intended for oral, maxillofacial surgery; trauma and reconstructive sur… | 2009 |
| * | K091144 | Synthes Matrixmandible Preformed Reconstruction PlatesSummary page 8…uy Synthes Maxillofacial Portfolio – MR Conditional Indications for Use (Describe) DePuy Synthes MatrixMANDIBLE Preformed Reconstruction Plates (originally cleared per K091144) The DePuy Synthes MatrixMANDIBLE Preformed Reconstruction Plates are intended for use in oral and maxillofacial surgery, trauma… | 2009 |
| * | K083388 | Synthes Matrixorthognathis Fixation SystemSummary page 9…vice Name DePuy Synthes Maxillofacial Portfolio – MR Conditional Indications for Use (Describe) DePuy Synthes MatrixORTHOGNATHIC Plating System (originally cleared per K083388) The DePuy Synthes MatrixORTHOGNATHIC Plating System consists of a variety of plates that come in a variety of shapes and sizes… | 2009 |
| * | K082335 | Synthes Matrixmandible Plate and Screw SystemSummary page 10…Name DePuy Synthes Maxillofacial Portfolio – MR Conditional Indications for Use (Describe) DePuy Synthes MatrixMANDIBLE Plate and Screw System (originally cleared per K082335) The DePuy Synthes MatrixMANDIBLE Plate and Screw System is intended for oral, maxillofacial surgery; trauma; reconstructive sur… | 2008 |
| * | K080331 | Synthes Craniofacial Plate and Screw SystemSummary page 11…ce Name DePuy Synthes Maxillofacial Portfolio – MR Conditional Indications for Use (Describe) DePuy Synthes Craniofacial Plate and Screw System (originally cleared per K080331) The DePuy Synthes Craniofacial Plate and Screw System is intended for use in selective trauma of the midface and maxillofacial… | 2008 |
| * | K063790 | The Synthes Matrixmandible Plate and Screw SystemSummary page 12…Name DePuy Synthes Maxillofacial Portfolio – MR Conditional Indications for Use (Describe) DePuy Synthes MatrixMANDIBLE Plate and Screw System (originally cleared per K063790) The DePuy Synthes MatrixMANDIBLE Plate and Screw System is intended for oral, maxillofacial surgery; trauma; reconstructive sur… | 2007 |
| * | K050608 | Synthes Carniofacial Plate and Screw SystemSummary page 13…ce Name DePuy Synthes Maxillofacial Portfolio – MR Conditional Indications for Use (Describe) DePuy Synthes Craniofacial Plate and Screw System (originally cleared per K050608) The DePuy Synthes Craniofacial Plate and Screw System is intended for use in selective trauma of the midface and maxillofacial… | 2005 |
| * | K042365 | Synthes (Usa) Neuro Plate and Screw SystemSummary page 14…5 Device Name DePuy Synthes Maxillofacial Portfolio – MR Conditional Indications for Use (Describe) DePuy Synthes Neuro Plate and Screw System (originally cleared per K042365) The DePuy Synthes Neuro Plate and Screw System is intended for use in selective trauma of the midface and maxillofacial skeleto… | 2004 |
| * | K033121 | 1.3 & 1.5MM Contourable Titanium (TI.) Mesh PlatesSummary page 15…nthes Maxillofacial Portfolio – MR Conditional Indications for Use (Describe) DePuy Synthes 1.3 & 1.5 mm Contourable Titanium (Ti.) Mesh Plates (originally cleared per K033121) The DePuy Synthes 1.3 & 1.5 mm Contourable Titanium (Ti.) Mesh Plates are intended for use in selective trauma of the midface a… | 2003 |
| * | K031761 | Synthes (Usa) New/Sterial Orbital PlatesSummary page 16…known) K192655 Device Name DePuy Synthes Maxillofacial Portfolio – MR Conditional Indications for Use (Describe) DePuy Synthes Orbital Plates (originally cleared per K031761) The DePuy Synthes Orbital Plates are intended for use in selective trauma of the midface and maxillofacial skeleton; maxillofac… | 2003 |
| * | K022012 | Synthes Low Profile Neuro SystemSummary page 17…92655 Device Name DePuy Synthes Maxillofacial Portfolio – MR Conditional Indications for Use (Describe) DePuy Synthes Low Profile Neuro System (originally cleared per K022012) The DePuy Synthes Low Profile Neuro System is intended for use in selective trauma of the midface and maxillofacial skeleton; m… | 2002 |
| * | K022005 | Synthes Midface DistractorSummary page 18…wn) K192655 Device Name DePuy Synthes Maxillofacial Portfolio – MR Conditional Indications for Use (Describe) DePuy Synthes Midface Distractor (Originally cleared per K022005) The DePuy Synthes Midface Distractor is intended for use in adult and pediatric populations for the treatment of midface condit… | 2002 |
| * | K020505 | Synthes Translating Maxillary DistractorSummary page 19…evice Name DePuy Synthes Maxillofacial Portfolio – MR Conditional Indications for Use (Describe) DePuy Synthes Translating Maxillary Distractor (Originally cleared per K020505) The DePuy Synthes Translating Maxillary Distractor is intended for use in maxillofacial surgery, reconstructive procedures, and… | 2002 |
| * | K010499 | Synthes (Usa) Midface DistractorSummary page 20…wn) K192655 Device Name DePuy Synthes Maxillofacial Portfolio – MR Conditional Indications for Use (Describe) DePuy Synthes Midface Distractor (Originally cleared per K010499) The DePuy Synthes Midface Distractor is intended for use in adult and pediatric populations for the treatment of midface condit… | 2001 |
| * | K003393 | Maxillary DistractorSummary page 21…) K192655 Device Name DePuy Synthes Maxillofacial Portfolio – MR Conditional Indications for Use (Describe) DePuy Synthes Maxillary Distractor (Originally cleared per K003393) The DePuy Synthes Maxillary Distractor is intended for use in maxillofacial surgery, reconstructive procedures, and selective o… | 2001 |
| * | K001311 | Synthes (Usa) Oribital Mesh PlatesSummary page 22…n) K192655 Device Name DePuy Synthes Maxillofacial Portfolio - MR Conditional Indications for Use (Describe) DePuy Synthes Orbital Mesh Plates (Originally cleared per K001311) The DePuy Synthes Orbital Mesh Plates for the Midfacial System are indicated for selective trauma of the midface and maxillofac… | 2000 |
| * | K974555 | Synthes 2.0 MM Locking Plate System (2.0 LPS)Summary page 23…Name DePuy Synthes Maxillofacial Portfolio – MR Conditional Indications for Use (Describe) DePuy Synthes 2.0 mm Locking Plate System (2.0 LPS) (originally cleared per K974555) The DePuy Synthes 2.0 LPS is intended for oral, maxillofacial surgery: trauma; reconstructive surgery; and orthognathic surgery… | 1998 |
| * | K961421 | Synthes 2.4 MM Universal Locking Plate SystemSummary page 24…Name DePuy Synthes Maxillofacial Portfolio – MR Conditional Indications for Use (Describe) DePuy Synthes 2.4 mm Universal Locking Plate System (originally cleared per K961421) The DePuy Synthes 2.4 mm Universal Locking Plate System is a plate and screw system, that is intended for mandible trauma and r… | 1996 |
| * | K954385 | Synthes Mandibular Modular Fixation SystemSummary page 25…ice Name DePuy Synthes Maxillofacial Portfolio – MR Conditional Indications for Use (Describe) DePuy Synthes Mandibular Modular Fixation System (originally cleared per K954385) The DePuy Synthes Mandibular Modular Fixation System is a plate and screw system, manufactured from commercially pure titanium,… | 1996 |
| * | K912932 | Synthes Maxillofacial Titanium Micro SetSummary page 26…evice Name DePuy Synthes Maxillofacial Portfolio – MR Conditional Indications for Use (Describe) DePuy Synthes Maxillofacial Titanium Micro Set (originally cleared per K912932) General indications: - Maxillofacial surgery Type of Use (Select one or both, as applicable) Prescriptio… | 1991 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 37 years and passes through 6 companies; a new generation was cleared every 5.2 years on median.
- 5 of the 42 ancestors have a recall of any class.
- 1 other device also cites its predicate K141165.
How does its category compare?
All JEY devicesJEY Plate, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · JEY
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JEY
159in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JEY
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JEY
1,003in 2025
MAUDE reports naming product code JEY, 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 | 9 | 115 | 0 | 29 |
| 2008 | 7 | 84 | 3 | 24 |
| 2009 | 4 | 121 | 6 | 93 |
| 2010 | 6 | 199 | 85 | 215 |
| 2011 | 5 | 75 | 0 | 241 |
| 2012 | 10 | 194 | 0 | 428 |
| 2013 | 8 | 126 | 1 | 766 |
| 2014 | 6 | 223 | 0 | 616 |
| 2015 | 7 | 160 | 0 | 767 |
| 2016 | 1 | — | 0 | 558 |
| 2017 | 5 | 190 | 0 | 568 |
| 2018 | 7 | 255 | 0 | 608 |
| 2019 | 6 | 163 | 0 | 595 |
| 2020 | 6 | 198 | 1 | 680 |
| 2021 | 4 | 299 | 0 | 451 |
| 2022 | 5 | 135 | 0 | 344 |
| 2023 | 2 | — | 0 | 495 |
| 2024 | 5 | 159 | 0 | 696 |
| 2025 | 2 | — | 0 | 1,003 |
| 2026 | 3 | 258 | 0 | — |
What is it indicated for?
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…
Read the full statement (902 words)
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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192655 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192655: Depuy Synthes Maxillofacial Portfolio - MR Conditional.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192655
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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