(338 days)
CranioMaxillofacial Fixation (CMF) System - CMF Visionare is intended for use in selective trauma of the midface, maxillofacial surgery, reconstructive procedures, and selective orthognathic surgery of the maxilla, mandible and chin.
The subject device is a fixation system consisting of plates and screws in a variety of shapes and sizes. All plates are made of commercially pure titanium conforming to ASTM F67, and all screws are made of Ti-6Al-4V alloy conforming to ASTM F136. The subject device includes the following groups: 1.5 System Plate, 2.0 System Plates, 2.4 System Plates, Orthognathic Plates, Blocking Screws (for intermaxillary fixation, 2.0 mm diameter), and screws for use with the various plates ranging in diameter from 1.5 mm to 2.7 mm.
It looks like the provided text is a 510(k) Summary for a CranioMaxillofacial Fixation (CMF) System, which is a medical device. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study.
Therefore, the input request asking for:
- A table of acceptance criteria and reported device performance
- Sample sizes for test set and data provenance
- Number and qualifications of experts for ground truth
- Adjudication method
- MRMC comparative effectiveness study results
- Standalone performance
- Type of ground truth
- Sample size for training set
- How ground truth for training set was established
cannot be fully answered from the provided text. The document describes non-clinical data (mechanical testing, dimensional analysis, biocompatibility) to show equivalence, not clinical study results with acceptance criteria.
Here's what can be extracted and inferred from the text:
1. A table of acceptance criteria and the reported device performance
There isn't a table of "acceptance criteria" for clinical performance. The "performance data" reported in the document is non-clinical, demonstrating mechanical and material properties. The acceptance criterion for the 510(k) submission itself is "substantial equivalence" to predicate devices.
Non-clinical Performance Data Reported:
| Test Method | Device Performance |
|---|---|
| Sterilization validation (ANSI/AAMI/ISO 17665-1, 14937) | Demonstrated. (Implied: meets standards) |
| Biocompatibility testing (ISO 10993-5, 10993-12) | Cytotoxicity testing supported. (Implied: meets standards, materials are biocompatible) |
| Dimensional analysis | Subject device plates compared favorably to predicate/reference devices in an engineering analysis of cross-sectional dimensions and bending moments of inertia (Ix, Iv). (Implied: dimensions are comparable and within acceptable ranges for intended function compared to predicates). |
| Mechanical testing (ASTM F382) | Single cycle bending fatigue (Implied: meets standards or performs similarly to predicates). |
| Mechanical testing (ASTM F543) | Torsional properties, driving torque, axial pullout, self-tapping performance. (Implied: meets standards or performs similarly to predicates). |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided as the submission relies on non-clinical engineering and laboratory testing, not a clinical test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable/not provided as there was no clinical test set requiring expert ground truth for performance evaluation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/not provided for the same reason as above.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable/not provided. The device is not an AI-assisted diagnostic tool; it's a physical fixation system. No clinical comparative effectiveness study is mentioned, particularly an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable/not provided. The device is not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the non-clinical tests, the "ground truth" implicitly refers to established engineering standards (ASTM, ISO) for mechanical properties, material composition, and sterilization. For the comparison to predicate devices, the "ground truth" is the design and performance characteristics of the legally marketed predicate devices.
8. The sample size for the training set
This information is not applicable/not provided as the device is not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established
This information is not applicable/not provided for the same reason as above.
Summary of what the document focuses on instead:
The document describes a substantial equivalence claim for the CranioMaxillofacial Fixation (CMF) System - CMF Visionare. This means the manufacturer is asserting their device is as safe and effective as a legally marketed predicate device, and does not raise new questions of safety or effectiveness. This is primarily established through:
- Comparison of Indications for Use: The indications for use are reported as "identical" to the primary predicate device (K102641), with the only difference being the device names.
- Comparison of Technological Characteristics: Detailed tables (Tables 1-6) are provided comparing the subject device's plates (1.5 System, 2.0 System, 2.4 System, Orthognathic) and screws (Blocking, other screws) to those of the primary predicate device and several reference devices. These comparisons cover plate designs, dimensions (thickness, overall sizes, hole configurations), screw dimensions (diameter, threaded length), and material composition.
- Non-clinical Performance Data:
- Sterilization validation: Conformed to ANSI/AAMI/ISO 17665-1 and ANSI/AAMI/ISO 14937.
- Biocompatibility testing: Conformed to ISO 10993-5 and ISO 10993-12 (cytotoxicity testing).
- Dimensional analysis: Engineering analysis of cross-sectional dimensions and bending moments of inertia "compared favorably" to predicate/reference devices.
- Mechanical testing: Performed according to ASTM F382 (single cycle bending fatigue) and ASTM F543 (torsional properties, driving torque, axial pullout, self-tapping performance). The implication is that these tests demonstrate performance comparable to predicate devices.
- Material Equivalence: All subject device plates are CP titanium, and all screws are Ti-6Al-4V alloy, which are stated to be substantially equivalent to the materials of the primary predicate and most reference devices. A minor difference in screw alloy (Ti-6Al-7Nb) for some reference devices is identified but deemed not to affect intended use or raise new safety/effectiveness questions.
In essence, the study presented is a design and performance comparison against existing, cleared devices and recognized standards, rather than a clinical trial with specific performance acceptance criteria.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December, 28, 2018
Visionare LLC % Kevin Thomas, Ph.D Vice President and Director of Regulatory Affairs PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130
Re: K180204
Trade/Device Name: CranioMaxillofacial Fixation (CMF) System - CMF Visionare Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: Class II Product Code: JEY, DZL Dated: November 26, 2018 Received: November 27, 2018
Dear Kevin Thomas:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Digitally signed by Mary S. Mary S. Runner -S3 Runner -S3 Date: 2018.12.28
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name
CranioMaxillofacial Fixation (CMF) System - CMF Visionare
Indications for Use (Describe)
CranioMaxillofacial Fixation (CMF) System - CMF Visionare is intended for use in selective trauma of the midface, maxillofacial surgery, reconstructive procedures, and selective orthognathic surgery of the maxilla, mandible and chin.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary K180204 CranioMaxillofacial Fixation (CMF) System – CMF Visionare Visionare LLC
November 26, 2018
ADMINISTRATIVE INFORMATION
| Manufacturer Name | Visionare LLC12251 Towne Lake DriveFort Meyers, FL 33913Telephone +1 239-244-2973 |
|---|---|
| Official Contact | Mariana de Oliveira QuinzaniRegulatory Affairs |
| Representative/Consultant | Kevin A. Thomas, PhDFloyd G. Larson, MS, MBAPaxMed International, LLC12264 El Camino Real, Suite 400San Diego, CA 92130Telephone: +1 858-792-1235Fax: +1 858-792-1236Email: kthomas@paxmed.com |
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name | CranioMaxillofacial Fixation (CMF) System - CMF Visionare |
|---|---|
| Common Names | Bone plate; Fixation screws |
| Primary Classification Name | Bone Plate |
| Primary Classification Regulation | 21 CFR 872.4760, Class II |
| Primary Product Code | JEY |
| Secondary Classification Name | Intraosseous fixation screw or wire |
| Secondary Classification Regulation | 21 CFR 872.4880, Class II |
| Secondary Product Code | DZL |
| Classification Panel | Dental Products Panel |
| Reviewing Branch | Dental Devices Branch |
PREDICATE DEVICE INFORMATION
Primary Predicate K102641, Mini and Micro Fragments Reconstruction System - NEOFACE, NEOORTHO Produtos Ortopédicos S/A
Reference Devices K021642, Synthes Craniofacial Plates, Synthes (USA) K050934, MODUS® Titanium Osteosynthesis System, Medartis, Inc. K033065, 2.0 mm Craniofacial Locking Plates, Synthes (USA)
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K972322, Lorenz 1.5mm Neuro Pack/Lorenz 2.0 FT Plates (sterile version), Walter Lorenz Surgical, Inc. K080694, OsteoMed Modular Locking Fixation System, OsteoMed LP
K091144, Synthes MatrixMANDIBLE Preformed Reconstruction Plates, Synthes USA
K992682. MODUS 2.5 Mandibular Reconstruction Set. Medartis
K063052, Mandibular Fracture/Reconstruction Devices and Pre-Bent Plates, Walter Lorenz Surgical, Incorporated
K980199, Synthes® (USA) 1.5mm/2.0mm Orthognathic Maxillary Plates and Screws, Synthes® (USA) K031708, Osteomed Maxillary/LeFort III Distraction System, OsteoMed L.P.
K944565, KLS-Martin Micro Osteosynthesis System (1.5 mm), KLS-Martin L.P.
K052061, MODUS IMF SCREWS 2.0, Medartis, Inc.
INDICATIONS FOR USE STATEMENT
CranioMaxillofacial Fixation (CMF) System – CMF Visionare is intended for use in selective trauma of the midface, maxillofacial surgery, reconstructive procedures, and selective orthognathic surgery of the maxilla, mandible and chin.
SUBJECT DEVICE DESCRIPTION
The subject device is a fixation system consisting of plates and screws in a variety of shapes and sizes. All plates are made of commercially pure titanium conforming to ASTM F67, and all screws are made of Ti-6Al-4V alloy conforming to ASTM F136. The subject device includes the following groups: 1.5 System Plate, 2.0 System Plates, 2.4 System Plates, Orthognathic Plates, Blocking Screws (for intermaxillary fixation, 2.0 mm diameter), and screws for use with the various plates ranging in diameter from 1.5 mm to 2.7 mm. The dimensions of the plates are provided in the comparison tables in this summary.
PERFORMANCE DATA
Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence included: sterilization validation according to ANSI/AAMI/ISO 17665-1 and ANSI/AAMI/ISO 14937; biocompatibility testing according to ISO 10993-5 and ISO 10993-12; dimensional analysis; engineering analysis; mechanical testing to ASTM F382 (single cycle bending fatigue) and ASTM F543 (torsional properties, driving torque, axial pullout, self-tapping performance). No clinical data were included in this submission.
EQUIVALENCE TO MARKETED DEVICE
Visionare LLC submits the information in this Premarket Notification to demonstrate that, for the purposes of FDA's regulation of medical devices, the subject device is substantially equivalent in indications and design principles to the following legally marketed devices cited above.
The subject device is substantially equivalent to the primary predicate device K102641 in intended use, Indications for Use, designs, materials, and function. The Indications for Use statement for the subject device is identical to that of the primary predicate K102641 except for the names of the devices. A comparison of the Indications for Use Statements and technological characteristics of the subject device, the primary predicate device, and the reference devices is provided in the following tables. Differences in the design features between the subject device and the primary predicate device K102641 are addressed by comparison to the reference devices as listed below.
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Table 1 – Substantial Equivalence 1.5 System Plates
| Subject Device | Primary Predicate Device | Reference Device | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Comparisons | K180204Mini and Micro Fragments Reconstruction System - CMF VisionareVisionare LLC | K102641Mini and Micro Fragments Reconstruction System - NEOFACENEOORTHO Produtos Ortopédicos S/A | K021642Synthes Craniofacial PlatesSynthes (USA) | |||||||
| Indications for UseStatement | CranioMaxillofacial Fixation (CMF) System - CMF Visionare is intended for use inselective trauma of the midface, maxillofacial surgery, reconstructive procedures,and selective orthognathic surgery of the maxilla, mandible and chin. | Mini and Micro Fragments Reconstruction System - NEOFACE is intendedfor use in selective trauma of the midface, maxillofacial surgery,reconstructive procedures, and selective orthognathic surgery of the maxilla,mandible and chin. | The Synthes Craniofacial Plates are intended for use in selectthe midface and craniofacial skeleton; craniofacial surgery reprocedures; and selective orthognathic surgery of the maxilla | |||||||
| Plate Designs forComparison | 1.5 Straight Plates1.5 Rectangular Plates1.5 T Plates1.5 Y Plates1.5 Double Y Plates1.5 L Plates1.5 L 110° Plates1.5 H Plates1.5 X Plates1.5 Z Plates1.5 Orbital Plates1.5 Orbital Floor Plates | Straight PlatesRectangular PlatesT PlatesY PlatesDouble Y PlatesL PlatesL 110° PlatesH PlatesX PlatesZ PlatesOrbital Plates | Rectangular PlatesY PlatesDouble Y PlatesL PlatesH PlatesZ PlatesOrbital Plates | |||||||
| Comparison of Designs | Thickness (mm) | Overall Sizes (mm) | Thickness (mm) | Overall Sizes (mm) | Thickness (mm) | Overall Sizes (mm) | ||||
| 1.5 Straight Plates | 1.5 Straight Plates | 0.7 | 8.8 - 79.2 | Straight Plates | 0.7 | 10.3 - 79.2 | ||||
| 1.5 Rectangular Plates | 1.5 Rectangular Plates | 0.7 | Rectangular Plates | 0.7 | Rectangular Plates(Box Plates) | 0.7 | ||||
| 2x2 hole | (7.2 - 10.3) x 10.3 | 2x2 hole | 11.7 x 11.7 | 2x2 (holes) | (5.0) | |||||
| 2x3 hole | 17.4 x 10.3 | 2x3 hole | 17.4 x 10.3 | |||||||
| 2x4 hole | 24.4 x 10.3 | 2x4 hole | 24.5 x 10.3 | |||||||
| 1.5 T Plates | 1.5 T Plates | 0.7 | T Plates | 0.7 | ||||||
| 3x2 hole | (11.2 - 15.7) x 11.2 | None | ||||||||
| 3x3 hole | (15.2 - 19.7) x 11.2 | 3x3 hole | 15.2 x 11.2 | |||||||
| 3x4 hole | (19.2 - 23.7) x 11.2 | 7x7 hole | 31.2 x 27.2 | |||||||
| 1.5 Y Plates | 1.5 Y Plates | 0.7 | Y Plates | 0.7 | Y Plates | 0.6 | ||||
| 3x3 hole | (18.0 - 22.5) x 8.9 | 3x2 hole | (15.6 - 18.5) x 8.9 | 3x3 hole | 22.0 | |||||
| 5x4 hole | (24.9 - 29.4) x 14.5 | None | ||||||||
| 1.5 Double Y Plates | 1.5 Double Y Plates | 0.7 | Double Y Plates | 0.7 | Double Y Plates | |||||
| 3x3 hole | (13.1 - 17.4) x 8.9 | 3x3 hole | (14.5-17.4) x 8.9 | |||||||
| 5x5 hole | (18.5 - 23.0) x 14.5 | None | 0.6 | (18.0) | ||||||
| 1.5 L Plates | 1.5 L Plates | 0.7 | L Plates | 0.7 | ||||||
| 2x2 hole | (11.4 - 15.7) x 7.2 | 2x2 hole | (12.8-15.7) x 7.2 | |||||||
| 1.5 L 110° Plates | 1.5 L 110° Plates | 0.7 | L 110° Plates | 0.7 | L Oblique Plates | 0.6 | ||||
| 3x3 hole | (18.1 - 22.4) x 11.2 | 3x3 hole | (19.7-21.0) x 11.2 | 2x3 hole | 22.0 | |||||
| 3x4 hole | (22.1 - 26.4) x 11.2 | None | 3x4 hole | 27.0 | ||||||
| 1.5 H Plates | 1.5 H Plates | 0.7 | 16.7 x 15.2 | H Plates | 0.7 | 20.4 x 19.2 | H Plates | 0.5 | 19.0 | |
| 1.5 X Plates | 1.5 X Plates | 0.7 | 11.2 x 11.2 | X Plates | 0.7 | 11.2 x 11.2 | ||||
| 1.5 Z Plates | 1.5 Z Plates | 0.7 | (10.5 - 13.4) x 11.2 | Z Plates | 0.7 | (11.7-14.6) x 11.1 | Z Plates | 0.6 | (10.9-1 | |
| Subject Device | Primary Predicate Device | Reference Device | Reference Device | |||||||
| Comparisons | K180204Mini and Micro Fragments Reconstruction System - CMF VisionareVisionare LLC | K102641Mini and Micro Fragments Reconstruction System – NEOFACENEOORTHO Produtos Ortopédicos S/A | K021642Synthes Craniofacial PlatesSynthes (USA) | K050934MODUS® Titanium Osteosynthesis SystemMedartis, Inc. | ||||||
| 1.5 Orbital Plates | 1.5 Orbital Plates | 0.7 | Orbital Plates | 0.7 | Orbital Plates | 0.6 | ||||
| 6 hole | 23.0 - 27.3 | 6 hole | 23.0 | 6 hole | 34.0 | |||||
| 8 hole | 30.6 - 34.8 | 8 hole | 30.6 | 8 hole | 41.0 | |||||
| 10 hole | 37.9 - 41.9 | 10 hole | 37.9 | 10 hole | 49.0 | |||||
| 1.5 Orbital Floor Plates | 1.5 Orbital Floor Plates | 0.3 | Orbital Floor Plates | 0.3 | Orbital Floor Plates | |||||
| Orbital Floor Plate, T 0.3 mm | 59.7 x 36.8 x 0.30 mm | Orbital Floor Plate | (0.2 - 0.4) | 62.2 x 38.5 | ||||||
| Regular Anatomical Orbital FloorPlate, T 0.3 mm | 29.0 x 17.0 x 0.30 mm | Small | 0.3 | 21.0 x 13.3 | ||||||
| Medium Anatomical Orbital FloorPlate, T 0.3 mm | 47.7 x 39.6 x 0.30 mm | Medium | 0.3 | 30.6 x 26.6 | ||||||
| Wide Medium Anatomical OrbitalFloor Plate, T 0.3 mm | 53.1 x 39.6 x 0.30 mm | Large | 0.3 | 41.3 x 34.6 | ||||||
| Large Anatomical Orbital FloorPlate, T 0.3 mm | 61.1 x 53.5 x 0.30 mm | |||||||||
| Universal Orbital Floor Plate,T 0.3 mm | 58.1 x 52.1 x 0.30 mm | Orbital Floor Plate | 56.7 x 49.9 | |||||||
| Plate Material | CP Titanium | CP Titanium | CP Titanium | CP Titanium |
| Reference Device | |||
|---|---|---|---|
| K050934MODUS® Titanium Osteosynthesis SystemMedartis, Inc. | |||
| The MODUS® Titanium Osteosynthesis System is intended for osteotomies and fractures involving any part of the craniofacial skeleton and requiring positional and functional stability. Indications include fixation in the nasoethmoidal, intraorbital, and frontal sinus areas; fixation of comminuted fractures of maxillo-facial and craniofacial areas; tumor surgery for defect bridging; reconstruction of bony structures by means of mesh materials; coverings for burr holes in the skull; trauma of nasal bones; surgical correction of dentofacial deformations; and reconstruction after tumor surgery. | |||
| T PlatesY PlatesL 110° Plates | |||
| Overall Sizes (mm) | Thickness (mm) | Overall Sizes (mm) | |
| (8.0 - 10.0) x 10 | |||
| T Plates3x2 hole3x3 hole3x4 hole | 0.6 | 12.0 x 12.017.0 x 12.021.0 x 12.0 | |
| (8.0 x 11.0 | Y Plates3x2 hole5x4 hole | 0.60.7 | (16.0 - 20.0) x 10.0(25.0 - 30.0) x 16.0 |
| (18.0 - 21.0) x 11.4 | |||
| (8.0 x 9.0(8.0 x 13.0 | L 110° Plates2x2 hole | 0.6 | (18.0 - 21.0) x 8.0 |
| (8.0 x 13.0 | |||
| (10.9-14.7) x 15 |
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Table 1 – Substantial Equivalence 1.5 System Plates
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Table 2 – Substantial Equivalence 2.0 System Plates
| Subject Device | Primary Predicate Device | Reference Device | Reference Device | Reference Device | Reference Device | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Comparison | K180204Mini and Micro FragmentsReconstruction System – CMFVisionareVisionare LLC | K102641Mini and Micro FragmentsReconstruction System – NEOFACENEOORTHO Produtos Ortopédicos S/A | K021642Synthes Craniofacial PlatesSynthes (USA) | K0330652.0 mm Craniofacial Locking PlatesSynthes (USA) | K972322Lorenz 1.5mm Neuro Pack/Lorenz 2.0FT Plates (sterile version)Walter Lorenz Surgical, Inc. | K050934MODUS® Titanium OsteosynthesisSystemMedartis, Inc. | K080694OsteoMed Modular Locking FixationSystemOsteoMed LP | |||||||
| Indications for UseStatement | CranioMaxillofacial Fixation (CMF)System - CMF Visionare is intended foruse in selective trauma of the midface,maxillofacial surgery, reconstructiveprocedures, and selective orthognathicsurgery of the maxilla, mandible and chin. | Mini and Micro Fragments ReconstructionSystem - NEOFACE is intended for use inselective trauma of the midface, maxillofacialsurgery, reconstructive procedures, andselective orthognathic surgery of the maxilla,mandible and chin. | The Synthes Craniofacial Plates areintended for use in selective trauma of themidface and craniofacial skeleton;craniofacial surgery; reconstructiveprocedures; and selective orthognathicsurgery of the maxilla and chin. | Synthes 2.0 mm Craniofacial LockingPlates are indicated for selective trauma ofthe midface and craniofacial skeleton;craniofacial surgery; reconstructiveprocedures; and selective orthognathicsurgery of the maxilla and chin. | Rigid fixation of cranio, facial andneurological bone. | The MODUS® Titanium OsteosynthesisSystem is intended for osteotomies andfractures involving any part of thecraniofacial skeleton and requiring positionaland functional stability. Indications includefixation in the nasoethmoidal, intraorbital,and frontal sinus areas; fixation ofcomminuted fractures of maxillo-facial andcraniofacial areas; tumor surgery for defectbridging; reconstruction of bony structures bymeans of mesh materials; coverings for burrholes in the skull; trauma of nasal bones;surgical correction of dentofacialdeformations; and reconstruction after tumorsurgery. | The OsteoMed Modular Locking FixationSystem is intended for fracture fixation incranio-maxillofacial trauma reconstruction,mandibular reconstruction and orthognathicreconstruction.The OsteoMed Modular Locking FixationSystem implants and drills are intended forsingle use only. | |||||||
| Plate Designs forComparison | 2.0 Straight Plates2.0 Rectangular Plates2.0 T Plates2.0 Y Plates2.0 Double Y Plates2.0 L Plates2.0 L 110° Plates2.0 H Plates2.0 I Plates2.0 X Plates2.0 Z Plates2.0 Orbital Plates2.0 Straight Locking Plates2.0 Rectangular Locking Plates | Straight PlatesT PlatesY PlatesDouble Y PlatesL PlatesZ PlatesOrbital PlatesStraight Locking Plates | Straight PlatesRectangular PlatesY PlatesDouble Y PlatesL 110° PlatesH PlatesX Plates | Straight Locking PlatesRectangular Locking Plates | Z PlatesOrbital Plates | Rectangular PlatesT PlatesL 100° PlatesI PlatesOrbital PlatesStraight Locking Plates | Y Plates | |||||||
| Comparison of Designs | Thickness (mm)/Features | Overall Sizes(mm) | Thickness (mm)/Features | Overall Sizes(mm) | Thickness (mm)/Features | Overall Sizes(mm) | Thickness (mm)/Features | Overall Sizes(mm) | Thickness (mm)/Features | Overall Sizes(mm) | Thickness (mm)/Features | Overall Sizes(mm) | Thickness (mm)/Features | Overall Sizes(mm) |
| 2.0 Straight Plates | 1.0 mm | 14.0 – 126.1 | 1.0 | 14.0 – 100.5 | 0.9 mm | 24.0 – 193.0 | ||||||||
| 2.0 Rectangular Plates | 1.0 mm2x2 hole2x3 hole | (10.9 – 17) x 1729.5 x 17 | 0.9 mm2x2 hole2x3 hole | (5x10) – (15x15)25x15 | 1.0 mm2x2 holes2x3 hole2x4 hole | (10-13) x 1322 x 1331 x 13 | ||||||||
| 2.0 T Plates | 1.0 mm3x2 hole | (17.3-26.4) x 17.3 | 1.0 mm3x2 hole | (23.4-26.4) x 17.3 | 1.0 mm3x2 hole | (17-20) x 17 | ||||||||
| 2.0 Y Plates | 1.0 mm3x3 hole5x4 hole | (28.2-37.3) x 13.539.2 x 22.6 | 1.0 mm3x2 hole | (21.8-27.9)x13.6 | 0.9 mm2x3 hole4x4 hole | 24.0 x 12.032.0 x 19.0 | 1.0 mm6x6 hole | 36.0 x 21.0 |
{8}------------------------------------------------
Table 2 – Substantial Equivalence 2.0 System Plates
| Subject Device | Primary Predicate Device | Reference Device | Reference Device | Reference Device | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| K180204 | K102641 | K021642 | K033065 | K972322 | |||||||
| Comparison | Mini and Micro FragmentsReconstruction System - CMF | Mini and Micro FragmentsReconstruction System - NEOFACE | Synthes Craniofacial Plates | 2.0 mm Craniofacial Locking Plates | Lorenz 1.5mm Neuro Pack/Lorenz 2.0FT Plates (sterile version) | ||||||
| VisionareVisionare LLC | NEOORTHO Produtos Ortopédicos S/A | Synthes (USA) | Synthes (USA) | Walter Lorenz Surgical, Inc. | |||||||
| 2.0 Double Y Plates | 1.0 mm | 3x3 hole5x5 hole | 1.0 mm | 3x3 hole | 0.9 mm | 2x3 | 24.0 x 12.0 | ||||
| (20.0-29.1) x 13.5(29.0-32.1) x 22.6 | (20.0-26.1)x13.6 | 4x4 | 32.0 x 19.0 | ||||||||
| 2.0 L Plates | 1.0 mm | 2x2 hole | 1.0 mm | 2x2 hole | |||||||
| (17.3-26.4) x 10.9 | (17.3-26.4) x 10.9 | ||||||||||
| 2.0 L 110° Plates | 1.0 mm | 3x3 hole | 0.9 mm | 2.0 ObliqueL-Plates | |||||||
| (23.7-32.8) x 17.3 | 2x3 hole | 25.0 x 10.0 | |||||||||
| 3x4 hole4x6 hole | (25.0-31.0) x(10.0-15.0)41.0 x 20.0 | ||||||||||
| (30.1-39.2) x 11.242.9 x 23.7 | 3x4 hole4x6 hole | ||||||||||
| 2.0 H Plates | 1.0 mm | 8 hole9 hole | 0.9 mm | 23.0 x 22.0 | |||||||
| 26.1 x 23.726.1 x 23.7 | |||||||||||
| 2.0 I Plates | 1.0 mm | 4 hole | |||||||||
| (14.0-20.0) x 10.9 | |||||||||||
| 2.0 X Plates | 1.0 mm | 0.9 mm | 18.0 x 18.0 | ||||||||
| 17.3 x 17.3 | |||||||||||
| 2.0 Z Plates | 1.0 mm | 1.0 mm | 0.6 mm | ||||||||
| (14.0-20.0) x 20.2 | (13.1-19.2) x 17.1 | (19.1 - 22.9) x 20.4 | |||||||||
| 2.0 Orbital Plates | 1.0 mm | 6 hole8 hole | 1.0 mm | 8 hole | 1.0 mm | 6 hole8 hole | |||||
| Lengths35.6 - 43.846.9 - 54.2 | Lengths40.7 | Length42.0 mm54.7 mm | |||||||||
| 2.0 StraightLocking Plates | 1.0 mm | 1.0 mm | 1.0 mm | ||||||||
| Lengths11.9 - 85.0 | Lengths15.5 - 53.4 | Lengths24.5 - 100.0 | |||||||||
| 1.5 mm | 1.3 mm | 1.25 mm | |||||||||
| Lengths30.5 - 102.0 | Lengths30.5 - 54.0 | Lengths40.4 - 70.5 | |||||||||
| 2.0 RectangularLocking Plates | 1.0 mm | 2x2 hole2x2 / 2x2 hole | 1.0 mm | 2x2 hole2x2 / 2x2 hole | |||||||
| 10.9 x 10.935.2 x 10.9 | 12.3 x 12.333.0 x 12.3 | ||||||||||
| Plate Material | CP Titanium | CP Titanium | CP Titanium | CP Titanium | CP Titanium |
| Reference Device | Reference Device | ||
|---|---|---|---|
| 50934MODUS® Titanium OsteosynthesisSystem | K080694OsteoMed Modular Locking FixationSystem | ||
| Medartis, Inc. | OsteoMed LP | ||
| mm | 2.0 L 110° Plates | ||
| 3 hole | 34.0 x 17.0 | ||
| mm | (17.0-23.0) x 11.0 | ||
| mm | Length | ||
| hole | 35.0 mm | ||
| hole | 47.0 mm | ||
| mm | Lengths | ||
| 34.0 - 142.0 | |||
| Titanium | CP Titanium; Ti-6Al-4V alloy |
{9}------------------------------------------------
Table 3 – Substantial Equivalence 2.4 System Plates
| Subject Device | Primary Predicate Device | Reference Device | Reference Device | |||||||
|---|---|---|---|---|---|---|---|---|---|---|
| K180204Mini and Micro Fragments Reconstruction System –CMF VisionareVisionare LLC | K102641Mini and Micro Fragments Reconstruction System –NEOFACE | K091144Synthes MatrixMANDIBLE Preformed ReconstructionPlates | K992682MODUS 2.5 Mandibular Reconstruction Set | K063052Mandibular Fracture/Reconstruction Devices andPre-Bent Plates | ||||||
| Comparison | NEOORTHO Produtos Ortopédicos S/A | Synthes USA | Medartis | |||||||
| Indication for UseStatement | CranioMaxillofacial Fixation (CMF) System - CMF Visionareis intended for use in selective trauma of the midface,maxillofacial surgery, reconstructive procedures, and selectiveorthognathic surgery of the maxilla, mandible and chin. | Mini and Micro Fragments Reconstruction System -NEOFACE is intended for use in selective trauma of themidface, maxillofacial surgery, reconstructive procedures, andselective orthognathic surgery of the maxilla, mandible andchin. | The Synthes MatrixMANDIBLE Preformed ReconstructionPlates are intended for use in oral and maxillofacial surgery,trauma and reconstructive surgery. This includes primarymandibular reconstruction, comminuted fractures andtemporary bridging pending delayed secondary reconstruction,including fractures of edentulous and/or atrophic mandibles, aswell as unstable fractures. | The indications for use of the MODUS® 2.5 Reconstruction Setinclude use in reconstruction surgery, including bone graftingand bridging defects in the mandible after tumor resection orsevere infection. It is also indicated for use in mandibulartrauma, e.g. unstable, comminuted mandibular fractures andbone loss. | Intended for use in the stabilization and fixation of mandibularfractures and mandibular reconstructive surgical procedures. | |||||
| Plate Designs forComparison | 2.4 Straight Reconstruction Plates2.4 Anatomic Reconstruction Plates2.4 Angled Reconstruction Plates2.4 Double Angled Reconstruction Plates | Straight Reconstruction PlatesAnatomic Reconstruction PlatesDouble Angled Reconstruction Plates | Straight Reconstruction PlatesAnatomic Reconstruction PlatesAngled Reconstruction PlatesDouble Angled Reconstruction Plates | Anatomic Reconstruction PlatesAngled Reconstruction PlatesDouble Angled Reconstruction Plates | Straight Reconstruction PlatesAnatomic Reconstruction Plates | |||||
| Comparison of Designs | Thickness (mm)/Features | Lengths orOverall Sizes (mm) | Thickness (mm)/Features | Lengths orOverall Sizes (mm) | Thickness (mm)/Features | Lengths orOverall Sizes (mm) | Thickness (mm)/Features | Lengths orOverall Sizes (mm) | Thickness (mm)/Features | Lengths orOverall Sizes (mm) |
| 2.4 StraightReconstruction Plates | 2.0 mm | 2.0 mm | 82.8 - 139.2 | 1.8 mm | 39.0 - 141.8 | |||||
| 4-12 hole | 38.0 - 118.0 | |||||||||
| 2.54 mm | 2.54 mm | 58.0 - 78.0 | 2.5 mm | 81.9 - 192.0 | ||||||
| 6-12 hole | 58 - 118 | |||||||||
| 2.4 AnatomicReconstruction Plates | 2.0 mm | 1.6 mm | 72.0 - 139.0 | 1.8 mm | 55.1 | |||||
| 6-14 hole | 57.9 - 135.9 | |||||||||
| 2.54 mm | 57.9 - 164.9 | 2.54 mm | 58.0 - 78.0(straight plates) | 2.5 mm | 81.9 - 192.0(straight plates) | |||||
| 6-17 hole | ||||||||||
| 2.4 AngledReconstruction Plates | 2.0 mm | 2.0 mm | 1.6 mm | |||||||
| 2x2 hole | 23.4 x 23.4 | 2x2 | 19.0 x 19.0 | |||||||
| 3x3 hole | 33.4 x 33.4 | 3x3 | 28.0 x 28.0 | |||||||
| 4x4 hole | 43.4 x 43.4 | 4x4 | 37.0 x 37.0 | |||||||
| 4x17 hole | 168.2 x 42.5 | 6x21 hole | 168.0 x 46.1 | |||||||
| 5x17 hole | 167.7 x 53.1 | 6x21 hole | 168.0 x 46.1 | |||||||
| 2.54 mm | 2.5 mm | |||||||||
| 3x3 hole | 33.4 x 33.4 | 3x3 hole | 32.5 x 32.5 | |||||||
| 4x4 hole | 43.4 x 43.4 | 4x4 hole | 42.1 x 42.1 | |||||||
| 4x17 hole | 168.2 x 42.5 | 6x21 | 170.0 x 50.0 | |||||||
| 5x17 hole | 167.7 x 53.1 | 6x21 | 170.0 x 50.0 | |||||||
{10}------------------------------------------------
Table 3 – Substantial Equivalence 2.4 System Plates
| Subject Device | Primary Predicate Device | Reference Device | Reference Device | Reference Device | |
|---|---|---|---|---|---|
| Comparison | K180204Mini and Micro Fragments Reconstruction System -CMF VisionareVisionare LLC | K102641Mini and Micro Fragments Reconstruction System -NEOFACENEOORTHO Produtos Ortopédicos S/A | K091144Synthes MatrixMANDIBLE Preformed ReconstructionPlatesSynthes USA | K992682MODUS 2.5 Mandibular Reconstruction SetMedartis | K063052Mandibular Fracture/Reconstruction Devices andPre-Bent PlatesWalter Lorenz Surgical, Incorporated |
| 2.4 Double AngledReconstruction Plates | |||||
| 2.0 mm | 2.0 mm | ||||
| 4x17x4 hole | 5x22x5 | 40.9 x 181.5 x 40.9 | |||
| 42.9 x 174.5 x 42.9 | |||||
| 4x20x4 hole | 6x24x6 | 48.7 x 197.6 x 48.7 | |||
| 43.2 x 201.2 x 43.2 | |||||
| 2.54 mm | |||||
| 4x17x4 hole | 2.54 mm | ||||
| 42.9 x 174.5 x 42.9 | 4x17x4 | ||||
| 42.5 x 172.4 x 42.5 | 2.5 mm | ||||
| 4x20x4 hole | 5x22x5 | (28.7-41.1) x(177.1-250.1) x(28.7-41.1) | |||
| 43.2 x 201.2 x 43.2 | |||||
| 5x17x5 hole | 4x17x4 | ||||
| 53.0 x 174.5 x 53.0 | 49.0 x 176.0 x 49.0 | ||||
| 5x20x5 hole | 5x19x5 | ||||
| 53.2 x 201.2 x 53.2 | 60.0 x 198.0 x 60.0 | ||||
| Plate Material | CP Titanium | CP Titanium | CP Titanium | CP Titanium | CP Titanium |
{11}------------------------------------------------
Table 4 – Substantial Equivalence Orthognathic Plates
| Subject Device | Primary Predicate Device | Reference Device | Reference Device | Reference Device | Reference Device | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Comparison | K180204Mini and Micro Fragments ReconstructionSystem – CMF VisionareVisionare LLC | K102641Mini and Micro Fragments ReconstructionSystem – NEOFACENEOORTHO Produtos Ortopédicos S/A | K980199Synthes® (USA) 1.5mm/2.0mmOrthognathic Maxillary Plates and ScrewsSynthes® (USA) | K031708Osteomed Maxillary/LeFort III DistractionSystem | K944565KLS-Martin Micro Osteosynthesis System(1.5 mm) | K050934MODUS® Titanium Osteosynthesis System | ||||||
| OsteoMed L.P. | KLS-Martin L.P. | Medartis, Inc. | ||||||||||
| Indication for UseStatement | CranioMaxillofacial Fixation (CMF) System - CMFVisionare is intended for use in selective trauma of themidface, maxillofacial surgery, reconstructiveprocedures, and selective orthognathic surgery of themaxilla, mandible and chin. | Mini and Micro Fragments ReconstructionSystem - NEOFACE is intended for use inselective trauma of the midface, maxillofacialsurgery, reconstructive procedures, and selectiveorthognathic surgery of the maxilla, mandibleand chin. | Synthes 1.5 mm / 2.0 mm OrthognathicMaxillary Plates and Screws are generallyintended for a variety of pan facial indications.Specifically, they are intended for selectivetrauma of the midface and craniofacial skeleton;craniofacial surgery; reconstructive procedures;and selective orthognathic surgery of the maxillaand chin. | Intended for use in the treatment of cranial ormidface conditions for which reconstructiveosteotomy and segment advancement areindicated. This includes conditions such as,syndromic craniosynostosis, midfacialretrusion, hemifacial microsomia, andmicrognathia. The OsteoMed Maxillary /LeFort III Distraction device is intended toprovide temporary stabilization and gradual | Not available on FDA 510(k) database webpage | The MODUS® Titanium Osteosynthesis System isintended for osteotomies and fractures involvingany part of the craniofacial skeleton and requiringpositional and functional stability. Indicationsinclude fixation in the nasoethmoidal, intraorbitaland frontal sinus areas; fixation of comminutedfractures of maxillo-facial and craniofacial areas;tumor surgery for defect bridging; reconstructionof bony structures by means of mesh materials; | ||||||
| lengthening of the cranial or midfacial bones.The OsteoMed Maxillary / LeFort IllDistraction System is intended for single patientuse only. | coverings for burr holes in the skull; trauma ofnasal bones; surgical correction of dentofacialdeformations; and reconstruction after tumorsurgery. | |||||||||||
| Plate Designs for Comparison | Orthognathic L PlatesOrthognathic Y PlatesOrthognathic Canine Pillar PlatesOrthognathic Zygomatic Pillar PlatesOrthognathic Le Fort PlatesOrthognathic Chin PlatesOrthognathic Paulus PlatesOrthognathic Straight Sagittal PlatesOrthognathic Straight Adjustable Sagittal PlatesOrthognathic Y Adjustable Sagittal PlatesOrthognathic Locking Straight Sagittal PlatesOrthognathic Locking Straight AdjustableSagittal PlatesOrthognathic Locking Y Adjustable SagittalPlates | Orthognathic L PlatesOrthognathic Y PlatesOrthognathic Le Fort PlatesOrthognathic Chin PlatesOrthognathic Paulus PlatesOrthognathic Straight Sagittal PlatesOrthognathic Locking Straight SagittalPlates | Orthognathic L PlatesOrthognathic Y PlatesOrthognathic Zygomatic Pillar PlatesOrthognathic Y Adjustable Sagittal PlatesOrthognathic Locking Y Adjustable SagittalPlates | Orthognathic Y PlatesOrthognathic Le Fort Plates | Orthognathic Le Fort Plates | Orthognathic L PlatesOrthognathic Y PlatesOrthognathic Canine Pillar PlatesOrthognathic Zygomatic Pillar PlatesOrthognathic Le Fort PlatesOrthognathic Chin PlatesOrthognathic Paulus PlatesOrthognathic Straight Sagittal PlatesOrthognathic Straight Adjustable SagittalPlatesOrthognathic Y Adjustable Sagittal PlatesOrthognathic Locking Straight SagittalPlatesOrthognathic Locking Straight AdjustableSagittal PlatesOrthognathic Locking Y Adjustable SagittalPlates | ||||||
| Comparison of Designs | Thickness (mm)/Features | Lengths orOverall Sizes (mm) | Thickness (mm)/Features | Lengths orOverall Sizes (mm) | Thickness (mm)/Features | Lengths orOverall Sizes (mm) | Thickness (mm)/Features | Lengths orOverall Sizes (mm) | Thickness (mm)/Features | Lengths orOverall Sizes (mm) | Thickness (mm)/Features | Lengths orOverall Sizes (mm) |
| Orthognathic L Plates | 0.7 mm | (12.8 - 15.7) x 7.2 | 0.7 | (12.8 - 15.7) x 7.2 | ||||||||
| 1.0 mm | (20.4 - 26.4) x 10.9 | 1.0 | (17.3 - 26.4) x 10.9 | |||||||||
| Orthognathic L Plates with offset | 0.7 mm | 13.9 x 7.2 (2 -11 offset) | 0.7 | (12.8-15.7) x 7.2 | ||||||||
| 1.0 mm | 19.1 x 10.9 (2 -11 offset) | 1.0 | (17.3 - 26.4) x 10.9 | |||||||||
| Orthognathic 110° L Plates | 0.7 mm | (19.5 - 22.4) x 11.2 | 0.7 mm | (19.7 - 21.0) x 11.2 | ||||||||
| 3x3 hole | 3x3 hole | |||||||||||
| 1.0 mm | (26.8 - 32.8) x 17.3 | 0.5 - 0.7 | (23.0 - 27.0) x 17.0 | 1.0 mm | 34.0 x 17.0 | |||||||
| 3x3 hole | 4x3 hole | 3x3 hole | ||||||||||
| Orthognathic Y Plates | 0.7 mm | 0.7 mm | 0.7 mm | |||||||||
| 3x3 hole | (18.2 - 22.5) x 8.9 | 3x2 hole | (15.6 - 18.5) x 8.9 | 3x3 hole | (16.0 - 30.0) x (10.0 -16.0) | |||||||
| 5x4 hole | (25.1 - 29.4) x 14.5 | 5x4 holes | (25.0 - 30.0) x 16.0 | |||||||||
| 1.0 mm | 1.0 mm | 1.0 mm | 1.0 mm | |||||||||
| 3x3 hole | (28.2 - 37.3) x 13.6 | 3x2 hole | (21.8 - 27.9) x 13.6 | 4x4 hole | 32.0 x 19.0 | 6x6 hole | 36.0 x 21.0 | |||||
| K080694 (See Table for 2.0 System) | ||||||||||||
| 1.0 mm | ||||||||||||
| 6x6 hole | 36.0 x 21.0 | |||||||||||
| 1.0 mm | 39.2 x 22.6 | |||||||||||
| 5x4 hole | ||||||||||||
| Subject Device | Primary Predicate Device | Reference Device | Reference Device | Reference Device | Reference Device | |||||||
| Comparison | K180204Mini and Micro Fragments ReconstructionSystem - CMF VisionareVisionare LLC | K102641Mini and Micro Fragments ReconstructionSystem – NEOFACE | K980199Synthes® (USA) 1.5mm/2.0mmOrthognathic Maxillary Plates and Screws | K031708Osteomed Maxillary/LeFort III DistractionSystem | K944565KLS-Martin Micro Osteosynthesis System(1.5 mm) | K050934MODUS® Titanium Osteosynthesis System | ||||||
| NEOORTHO Produtos Ortopédicos S/A | Synthes® (USA) | OsteoMed L.P. | KLS-Martin L.P. | Medartis, Inc. | ||||||||
| Orthognathic Canine Pillar Plates | 0.7 mm | 0.7 mm | ||||||||||
| 3x3 hole | (16.7 - 19.6) x 11.2 | 2x2 | (17.0 -19.0) x 8.0 | |||||||||
| 3x2 | 26.0 x 8.0 | |||||||||||
| 3x3 | (26.0 - 31.0) x 13.0 | |||||||||||
| 1.0 mm | ||||||||||||
| 3x3 hole | (26.5 - 32.2) x 17.3 | 3x3 | (26.0 - 31.0) x 13.0 | |||||||||
| Orthognathic Zygomatic Pillar Plates | 0.7 mm | (15.8 - 18.3) x 11.2 | 0.7 mm | (22.0 - 31.0) x 12.0 | 0.7 mm | |||||||
| 2x2 hole | 17.0 x 8.0 | |||||||||||
| 3x3 hole | (25.0 - 31.0) x (15.0 -16.0) | |||||||||||
| 1.0 mm | (23.9 - 28.3) x 17.3 | 0.8 mm | (23.8 - 34.3) x 13.5 | 0.7 mm3x3 hole | (25.0 - 31.0) x (15.0 -16.0) | |||||||
| Orthognathic Le Fort Plates | 0.7 mm | 29.0 x 23.2(0 -10 offset) | 0.7 mm | 33.8 x 25.2(2 -11 offset) | 0.7 mm | 25.5 x 23.8(2-12 offset) | 1.0 mm | 29.5 x 21.5(0-11 offset) | 0.7 mm | (23.0 - 31.0) x 25.0(0 - 11 offset) | ||
| Orthognathic Chin Plates | 0.7 mm | 15.0 x 11.9(0 -16 offset) | 1.0 | 15.0 x 11.9(2.5 -16 offset) | 0.6 mm | (19.0 - 24.0) x (16.0 -21.0)(0 - 11 offset) | ||||||
| Orthognathic Paulus Plates | 0.7 mm | 15.0 x 13.9(0 -16 offset) | 1.0 | 15.0 x 14.0(2 -16 offset) | 0.6 mm | (19.0 - 24.0) x (16.0 -21.0)(0 - 11 offset) | ||||||
| Orthognathic Straight Sagittal Plates | 1.0 mm | 21.6 - 36.6 | 1.0 mm | 25.2 - 34.2 | 1.0 mm | 27.0 - 49.0 | ||||||
| Orthognathic Straight AdjustableSagittal Plates | 1.0 mm | 26.6 - 41.6 | 0.7 mm | 33.0 - 40.0 | 0.7 / 0.8 mm | 27.0 - 47.0 | ||||||
| Orthognathic Y Adjustable SagittalPlates | 1.0 mm | 26.2 - 41.7 | 1.0 mm | 23.5 - 30.0 | 0.7 / 0.8 mm(Straight) | 27.0 - 47.0 | ||||||
| Orthognathic Locking StraightSagittal Plates | 1.0 mm | 22.3 - 37.3 | 1.0 | 25.2 - 34.2 | 1.0 mm | 27.0 - 49.0 | ||||||
| Orthognathic Locking StraightAdjustable Sagittal Plates | 1.0 mm | 26.6 - 41.6 | 0.7 / 0.8 mm | 27.0 - 47.0 | ||||||||
| Orthognathic Locking Y AdjustableSagittal Plates | 1.0 mm | 28.1 - 43.1 | 1.0 mm | 23.5 – 30.0 | 0.7 / 0.8 mm(Straight) | 27.0 - 47.0 | ||||||
| Plate Material | CP Titanium | CP Titanium | CP Titanium | CP Titanium | CP Titanium | CP Titanium | ||||||
{12}------------------------------------------------
Table 4 – Substantial Equivalence Orthognathic Plates
{13}------------------------------------------------
Table 5 – Substantial Equivalence Blocking Screws
| Subject Device | Primary Predicate Device | ||
|---|---|---|---|
| Comparison | K180204Mini and Micro Fragments Reconstruction System – CMF VisionareVisionare LLC | K102641Mini and Micro Fragments Reconstruction System – NEOFACENEOORTHO Produtos Ortopédicos S/A | K052061MODUSMedartis |
| Indications for UseStatement | CranioMaxillofacial Fixation (CMF) System - CMF Visionare is intended for use inselective trauma of the midface, maxillofacial surgery, reconstructive procedures, andselective orthognathic surgery of the maxilla, mandible and chin. | Mini and Micro Fragments Reconstruction System - NEOFACE is intended for use in selectivetrauma of the midface, maxillofacial surgery, reconstructive procedures, and selective orthognathicsurgery of the maxilla, mandible and chin. | MODUSmethod incondylarprocedure |
| Screw Designs | 2.0 Blocking screw series2.0 SW3 Blocking screw seriesSelf-drilling thread design | 2.0 Blocking screw series2.0 SH Blocking screw seriesSelf-drilling thread design | 2.0 IMFSelf-drilli |
| Screw diameter | 2.0 mm | 2.0 mm | 2.0 mm |
| Screw threaded length | 5 mm - 14 mm (in 1 mm increments) | 5, 7, 9 mm | 8, 11, 14 mm |
| Screw material | Ti-6Al-4V alloy | Ti-6Al-4V alloy | Ti-6Al-4V alloy |
Reference Device DUS IMF SCREWS 2.0 lartis, Inc. DUS IMF Screws 2.0 are indicated for temporary use as a supplementary hod in reduction and fixation of dislocated or fractured bone fragments, dylar fractures and restoration of occlusion in orthognathic or orthodontic cedures. IMF series -drilling thread design 1, 14 mm
6Al-4V alloy
{14}------------------------------------------------
Table 6 – Substantial Equivalence Screws
| Subject Device | Primary Predicate Device | Reference Device | Reference Device | ||||||
|---|---|---|---|---|---|---|---|---|---|
| K180204 | K102641 | K980199 | K972322 | ||||||
| Comparison | Mini and Micro Fragments Reconstruction System –CMF VisionareVisionare LLC | Mini and Micro Fragments Reconstruction System –NEOFACENEOORTHO Produtos Ortopédicos S/A | Synthes (USA) 1.5mm/2.0mm Orthognathic Maxillary plates and ScrewsSynthes (USA) | Lorenz 1.5mm Neuro Pack/Lorenz(sterile version)Walter Lorenz Surgical, Inc. | |||||
| Indications for UseStatement | CranioMaxillofacial Fixation (CMF) System - CMF Visionareis intended for use in selective trauma of the midface,maxillofacial surgery, reconstructive procedures, and selectiveorthognathic surgery of the maxilla, mandible and chin. | Mini and Micro Fragments Reconstruction System -NEOFACE is intended for use in selective trauma of themidface, maxillofacial surgery, reconstructive procedures, andselective orthognathic surgery of the maxilla, mandible andchin. | Synthes 1.5 mm / 2.0 mm Orthognathic Maxillary plates andScrews are generally intended for a variety of pan facialindications. Specifically, they are intended for selectivetrauma of the midface and craniofacial skeleton; craniofacialsurgery; reconstructive procedures; and selective orthognathicsurgery of the maxilla and chin. | Rigid fixation of cranio, facial and neck | |||||
| Comparison ofScrew Designs | Thread Diameter | Lengths | Thread Diameter | Lengths | Thread Diameter | Lengths | Thread Diameter | Lengths | |
| Non-locking Screws | |||||||||
| Self-Drilling | 1.5 mm | 4 mm - 9 mm | 1.5 mm | 4 mm - 9 mm | |||||
| Self-Tapping | 1.5 mm | 4 mm - 16 mm | 1.5 mm | 2.5 mm -16 mm | |||||
| Emergency Self-Tapping | 1.8 mm | 4 mm - 16 mm | 1.8 mm | 3.5 mm - 7 mm | 1.85 mm | 4 mm - 18 mm | |||
| Self-Drilling | 2.0 mm | 5 mm - 11 mm | 2.0 mm | 4 mm - 25 mm | |||||
| Self-Tapping | 2.0 mm | 4 mm - 19 mm | 2.0 mm | 4 mm – 19 mm | |||||
| Emergency Self-Tapping | 2.3 mm | 4 mm – 18 mm | 2.3 mm | 3.5 mm - 11 mm | 2.3 mm | 5 mm | |||
| Self-Tapping | 2.4 mm | 8 mm - 20 mm | 2.4 mm | 6 mm - 18 mm | |||||
| Emergency Self-Tapping | 2.7 mm | 8 mm - 18 mm | 2.7 mm | 6 mm - 18 mm | |||||
| Locking Screws | |||||||||
| Self-Tapping Locking | 2.0 mm | 5 mm - 19 mm | 2.0 mm | 5 mm - 19 mm | |||||
| Self-Tapping Locking | 2.4 mm | 8 mm - 20 mm | 2.4 mm | 6 mm - 18 mm | |||||
| Self-Tapping Locking | 2.7 mm | 8 mm - 18 mm | 2.7 mm | 6 mm - 18 mm | |||||
| Insertion Screws | |||||||||
| For Locking plates | Threads M2.8x0.4, 1.9 mm L, cruciform head,2.0 mm ØThreads M4.0x0.5, 2.5 mm L, cruciform head,2.4 mm Ø | Threads M2.8x0.4, 1.9 mm L, cruciform head,2.0 mm ØThreads M4.0x0.5, 2.5 mm L, cruciform head,2.4 mm Ø | |||||||
| Screw Material | Ti-6Al-4V alloy | Ti-6Al-4V alloy | Ti-6Al-7Nb alloy | Ti-6Al-4V alloy |
| Device | Reference Device | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| mz 2.0 FT plates | K091144Synthes MatrixMANDIBLE Preformed Reconstruction platesSynthes USA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| eurological bone. | The 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. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| gths | Thread DiameterLengthsm - 18 mm2.4 mm5 mm – 40 mm2.4 mm8 mm – 24 mm | Thread Diameter | Lengths | m - 18 mm | 2.4 mm | 5 mm – 40 mm | 2.4 mm | 8 mm – 24 mm | |||||||||||||||||||||||||||||||||||||||||||||||||
| Thread Diameter | Lengths | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| m - 18 mm | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 2.4 mm | 5 mm – 40 mm | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 2.4 mm | 8 mm – 24 mm | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Ti-6Al-7Nb alloy |
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The subject device 1.5 System plates are substantially equivalent to the primary predicate device K102641, or the reference devices K021624 and K050934, in designs and the range of dimensions. The reference device K021642 is for substantial equivalence of overall sizes not encompassed by the primary predicate device for the 1.5 Rectangular, Y, Double Y, L Oblique, H, Z, Orbital, and Orbital Floor Plates. The reference device K0050934 is for substantial equivalence of overall sizes not encompassed by the primary predicate device for the 1.5 T, Y, and L 110º plates.
The subject device 2.0 System plates are substantially equivalent to the primary predicate device K102641, or the reference devices K021642, K033065, K972322, K050934, and K080694, in designs and the range of dimensions. The reference device K021642 is for substantial equivalence of the ranges of overall sizes not encompassed by the primary predicate device for the 2.0 Straight, Rectangular, Y , Double Y, L 110°, H, and X plates. The reference device K033065 is for substantial equivalence of the ranges of overall sizes not encompassed by the primary predicate device for the 2.0 Straight Locking and Rectangular Locking plates. The reference device K972322 is for substantial equivalence of the ranges of overall sizes not encompassed by the primary predicate device for the 2.0 Z and Orbital plates. The reference device K050934 is for substantial equivalence of overall sizes not encompassed by the primary predicate device for the 2.0 Rectangular, T, L 110°, I, Orbital, and Straight Locking plates. The reference device K080694 is for substantial equivalence of the ranges of overall sizes not encompassed by the primary predicate device for the 2.0 Y plates.
The subject device 2.4 System plates are substantially equivalent to the primary predicate device K102641, or the reference devices K091144, K992682, and K063052, in designs and the range of dimensions. The reference device K091144 is for substantial equivalence of the ranges of overall sizes not encompassed by the primary predicate device for the 2.4 Straight Reconstruction, Anatomic Reconstruction, Angled Reconstruction, and Double Angled Reconstruction plates. The reference device K 992682 is for substantial equivalence of the ranges of overall sizes not encompassed by the primary predicate device for the 2.4 Anatomic Reconstruction, Angled Reconstruction, and Double Angled Reconstruction plates. The reference device K063052 is for substantial equivalence of the ranges of overall sizes not encompassed by the primary predicate device for the 2.4 Straight Reconstruction and Anatomic Reconstruction plates.
The subject device Orthognathic plates are substantially equivalent to the primary predicate device K102641, or the reference devices K980199, K031708. K944565, and K050934, in designs and the range of dimensions. The reference device K980199 is for substantial equivalence of overall sizes not encompassed by the primary predicate device for the Orthognathic 110º L, Y, Zygomatic Pillar, Straight Adjustable Sagittal, Y Adjustable Sagittal, and Locking Y Adjustable Sagittal plates. The reference device K031708 is for substantial equivalence of overall sizes not encompassed by the primary predicate device for the Orthognathic Y and Le Fort plates. The reference device K944565 is for substantial equivalence of the ranges of overall sizes not encompassed by the primary predicate device for the Orthognathic Le Fort plates. The reference device K050934 is for substantial equivalence of the ranges of overall sizes not encompassed by the primary predicate device for the Orthognathic 110° L, Y, Canine Pillar, Zygomatic Pillar, Le Fort, Chin, Paulus, Straight Sagittal, Straight Adjustable Sagittal, Y Adjustable Sagittal, Locking Straight Sagittal, Locking Straight Adjustable Sagittal, and Locking Y Adjustable Sagittal plates.
The subject device Blocking Screws are substantially equivalent to the primary predicate device K102641, or the reference devices K052061 in designs and the range of dimensions. The reference device K052061 is for substantial equivalence of the screw lengths not included in K102641. The subject device
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blocking screws and the blocking screws from K102641 and K052061 have the same intended use for intermaxillary fixation.
The subject device Screws are substantially equivalent to the primary predicate device K102641, or the reference devices K980199, K972322, and K091144 in designs and the range of dimensions. The following subject device screws are substantially equivalent to the primary predicate device K102641 in designs and the ranges of dimensions: 1.5 mm diameter (Ø) self-drilling screws; 1.5 mm Ø self-tapping screws; 2.0 mm Ø self-drilling screws; 2.0 mm Ø self-tapping screws; 2.7 mm Ø self-tapping screws; 2.0 mm Ø self-tapping locking screws; and 2.7 mm Ø self-tapping locking screws. The reference device K980199 is for substantial equivalence of the 1.8 mm Ø self-tapping screw lengths up to 16 mm not included in K102641. The reference device K972322 is for substantial equivalence of the 2.3 mm Ø selftapping screw lengths up to 18 mm not included in K102641. The reference device K091144 is for substantial equivalence of the 2.4 mm Ø self-tapping screws screws screw lengths up to 20 mm not included in K102641. The reference device K091144 also is for substantial equivalence of the 2.4 mm Ø self-tapping locking screw lengths up to 20 mm not included in K102641. The subject device insertion screws (for use with locking plates) are substantially equivalent to insertion screws in the primary predicate device K102641 in design and dimensions.
All subject device plates are manufactured from commercially pure (CP) titanium and all subject device screws are manufactured from titanium alloy (Ti-6Al-4V); these materials are substantially equivalent to the materials of the primary predicate device K102641. All reference device plates also are manufactured from CP titanium (or Ti-6A1-4V alloy, K080694). The screws from the subject device, the primary predicate K102641, and reference device K972322 screws are manufactured from Ti-6Al-4V alloy. The screws in the reference devices K980199 and K091144 are made of a slightly different Ti-6A1-7Nb alloy; this difference does not affect the intended use or raise different questions of safety or effectiveness. Biocompatibility of the subject device materials was supported by cytotoxicity testing to according to ISO 10993-5 and ISO 10993-12.
Performance data provided to demonstrate substantial equivalence included detailed dimensional analysis of the subject device and predicate/reference device designs, engineering analysis, and mechanical testing of the subject device according to ASTM F382 (single cycle bending fatigue) and ASTM F543 (torsional properties, driving torque, axial pullout, self-tapping performance). Comparisons of the cross-sectional dimensions and calculation of the bending moments of inertia (Ix, Iv) were performed on critical regions of minimum material cross section subject to bending. The moment of inertia calculations take into consideration the geometry and provide an assessment of the worst-case scenario for the subject and predicate constructs. In this engineering analysis the subject device plates compared favorably to the predicate/reference devices.
CONCLUSION
The subject device, the primary predicate device, and the reference devices have the same intended use, have similar technological characteristics, and are made of similar materials. The subject device, the primary predicate device, and the reference devices encompass the same range of physical dimensions, are provided non-sterile, and are to be sterilized by using moist heat (steam) sterilization. The data included in this submission demonstrate substantial equivalence to the predicate devices listed above.
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.