510(k) · Cleared
ClearedMini and Micro Fragments Reconstruction System-Neoface
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neoortho Produtos Ortopedicos S/A · JEY Plate, Bone
Cleared on Dec 20, 2010 as substantially equivalent to K050608 (Synthes (Usa), 2005) and 6 other predicates after a 98-day review. Its family tree reaches back 2 generations to 1998. 12 later devices descend from it.
- Decided
- Dec 20, 2010
- Review
- 98 days
- Class
- Class II
- Product code
- JEY
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 2 generations to K980512 (1998). 9 ancestors in all, the oldest K972322 (1997). 12 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK980512 Lorenz Reconstruction System with Modular ScrewWalter Lorenz Surgical, Inc. · 1998
- 1 generation backK063052 Lorenz Titanium Fracture / Reconstruction Devices and Pre-Bent PlatesWalter Lorenz Surgical, Inc. · 2007
- This deviceK102641 Mini and Micro Fragments Reconstruction System-NeofaceNeoortho Produtos Ortopedicos S/A · 2010
- Descendant · cites it directly · 8 of its ownK142419 Mini and Micro Fragments Reconstruction System-NEOFIXNeoortho Productos Orthopedicos S/A · 2014
- Descendant · 2 generations on · 4 of its ownK182718 Mini and Micro Fragments Reconstruction System – GMReisGm Dos Reis Industria E Comerico Ltda. · 2019
- Descendant · 2 generations on · 2 of its ownK242939 ARTFX Trauma Bone Plate and Screw SystemArtfx Medical · 2024
- Descendant · 2 generations on · 2 of its ownK242596 Versalock Mini and Micro Plating SystemGM Dos Reis Industria e Comercio Ltda. · 2024
- Descendant · cites it directly · 2 of its ownK180204 CranioMaxillofacial Fixation (CMF) System - CMF VisionareVisionare, LLC · 2018
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K142419Mini and Micro Fragments Reconstruction System-NEOFIXNeoortho Productos Orthopedicos S/A · 2014 · cites it directly8descendants
- K182718Mini and Micro Fragments Reconstruction System – GMReisGm Dos Reis Industria E Comerico Ltda. · 2019 · 2 generations on4descendants
- K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical · 2024 · 2 generations on2descendants
- K242596Versalock Mini and Micro Plating SystemGM Dos Reis Industria e Comercio Ltda. · 2024 · 2 generations on2descendants
- K180204CranioMaxillofacial Fixation (CMF) System - CMF VisionareVisionare, LLC · 2018 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K980512 | Lorenz Reconstruction System with Modular Screw | Walter Lorenz Surgical, Inc. | 1998 | — |
| −1 | K063052 | Lorenz Titanium Fracture / Reconstruction Devices and Pre-Bent Plates | Walter Lorenz Surgical, Inc. | 2007 | — |
| 0 (this device) | K102641 | Mini and Micro Fragments Reconstruction System-Neoface | Neoortho Produtos Ortopedicos S/A | 2010 | — |
| +1 | K142419 | Mini and Micro Fragments Reconstruction System-NEOFIX | Neoortho Productos Orthopedicos S/A | 2014 | — |
| +2 | K182718 | Mini and Micro Fragments Reconstruction System – GMReis | Gm Dos Reis Industria E Comerico Ltda. | 2019 | — |
| +2 | K242939 | ARTFX Trauma Bone Plate and Screw System | Artfx Medical | 2024 | — |
| +2 | K242596 | Versalock Mini and Micro Plating System | GM Dos Reis Industria e Comercio Ltda. | 2024 | — |
| +1 | K180204 | CranioMaxillofacial Fixation (CMF) System - CMF Visionare | Visionare, LLC | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2024 | 3 | 0 |
| 2026 | 4 | 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? (7)
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 |
|---|---|---|---|
| * | K050608 | Synthes Carniofacial Plate and Screw SystemSummary page 2…es, each of which has been determined by FDA to be substantially equivalent to pre-amendment devices: Synthes (USA) Craniofacial Plate and Screw System cleared under K050608, Synthes Orbital Plates cleared under K08033 1, Synthes MatrixORTHOGNATHIC Plating System cleared under K0833 88, Syn… | 2005 |
| * | K080331 | Synthes Craniofacial Plate and Screw SystemSummary page 2…substantially equivalent to pre-amendment devices: Synthes (USA) Craniofacial Plate and Screw System cleared under K050608, Synthes Orbital Plates cleared under K08033 1, Synthes MatrixORTHOGNATHIC Plating System cleared under K0833 88, Synthes MatrixMANDIBLE Preformed Reconstruction Plates… | 2008 |
| * | K083388 | Synthes Matrixorthognathis Fixation SystemSummary page 2…Craniofacial Plate and Screw System cleared under K050608, Synthes Orbital Plates cleared under K08033 1, Synthes MatrixORTHOGNATHIC Plating System cleared under K0833 88, Synthes MatrixMANDIBLE Preformed Reconstruction Plates cleared under K091 144, Biomnet Mandibular Fracture / Reconstruct… | 2009 |
| * | K091144 | Synthes Matrixmandible Preformed Reconstruction PlatesSummary page 2…es cleared under K08033 1, Synthes MatrixORTHOGNATHIC Plating System cleared under K0833 88, Synthes MatrixMANDIBLE Preformed Reconstruction Plates cleared under K091 144, Biomnet Mandibular Fracture / Reconstruction Devices (TraumnaOne) cleared under K08 1067, Walter Lorenz Surgical Mandibu… | 2009 |
| * | K081067 | Fracture/Reconstruction System (Traumaone)Summary page 2…8, Synthes MatrixMANDIBLE Preformed Reconstruction Plates cleared under K091 144, Biomnet Mandibular Fracture / Reconstruction Devices (TraumnaOne) cleared under K08 1067, Walter Lorenz Surgical Mandibular Fracture / Reconstruction Devices and Pre-bent Plates cleared under K063052, and L… | 2008 |
| * | K063052 | Lorenz Titanium Fracture / Reconstruction Devices and Pre-Bent PlatesSummary page 2…Reconstruction Devices (TraumnaOne) cleared under K08 1067, Walter Lorenz Surgical Mandibular Fracture / Reconstruction Devices and Pre-bent Plates cleared under K063052, and Lorenz Sterile Bone Plates and Bone Screws cleared under K972322. The subject device and the predicate devices have the… | 2007 |
| * | K972322 | Lorenz 1.5 MM Neuro Pack/Lorenz 2.0 FT PlatesSummary page 2…enz Surgical Mandibular Fracture / Reconstruction Devices and Pre-bent Plates cleared under K063052, and Lorenz Sterile Bone Plates and Bone Screws cleared under K972322. The subject device and the predicate devices have the same intended use and have the same technological characteristics. The su… | 1997 |
What descends from it? (12)
See all 122 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 12 years and passes through 2 companies; a new generation was cleared every 8.7 years on median.
- 4 of the 9 ancestors have a recall of any class.
- Of its descendants, K142419 (Neoortho Productos Orthopedicos S/A, 2014) has gone furthest, with 8 descendants of its own.
- 4 other devices also cite its predicate K050608.
How does its category compare?
All JEY devicesJEY Plate, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
Mini and Micro Fragments Reconstruction System - NEOFACE is intended for use in selective trauma of the muidface, maxillofacial surgery, reconstructive procedures, and selective orthognathic Surgery of the maxilla, mandible and chin.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102641 · printed Nov 5, 2026
Cite this page
510(k) Report. “K102641: Mini and Micro Fragments Reconstruction System-Neoface.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K102641
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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