(338 days)
No
The device description and performance studies focus on the mechanical properties and materials of plates and screws for fixation, with no mention of AI or ML.
Yes
The device is used for fixation in surgical procedures for trauma, reconstructive procedures, and orthognathic surgery, which are all intended to treat or alleviate a medical condition.
No
Explanation: The device description states it is a "fixation system consisting of plates and screws." The intended use describes its application in surgical procedures for trauma and reconstructive procedures, consistent with a surgical implant/fixation device, not a diagnostic device.
No
The device description explicitly states it is a "fixation system consisting of plates and screws" made of titanium alloys, which are hardware components. The performance studies also focus on mechanical testing of these physical components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "fixation" in surgical procedures involving the craniofacial skeleton. This is a therapeutic and structural function, not a diagnostic one.
- Device Description: The device is described as a "fixation system consisting of plates and screws." These are physical implants used to stabilize bone fragments.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze samples (blood, tissue, etc.) or provide information about a patient's health status through in vitro testing.
- Performance Studies: The performance studies focus on mechanical properties, sterilization, and biocompatibility – all relevant to a surgical implant, not an IVD.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
JEY, DZL
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Midface, maxillofacial region, maxilla, mandible, chin, craniofacial skeleton, nasoethmoidal, intraorbital, frontal sinus areas, nasal bones, mandibular bony structures, cranial bones.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K021642, K050934, K033065, K972322, K080694, K091144, K992682, K063052, K980199, K031708, K944565, K052061
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
1
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
2
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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3
510(k) Summary K180204 CranioMaxillofacial Fixation (CMF) System – CMF Visionare Visionare LLC
November 26, 2018
ADMINISTRATIVE INFORMATION
| Manufacturer Name | Visionare LLC
12251 Towne Lake Drive
Fort Meyers, FL 33913
Telephone +1 239-244-2973 |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact | Mariana de Oliveira Quinzani
Regulatory Affairs |
| Representative/Consultant | Kevin A. Thomas, PhD
Floyd G. Larson, MS, MBA
PaxMed International, LLC
12264 El Camino Real, Suite 400
San Diego, CA 92130
Telephone: +1 858-792-1235
Fax: +1 858-792-1236
Email: 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)
4
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.
5
Table 1 – Substantial Equivalence 1.5 System Plates
| Subject Device | Primary Predicate Device | Reference Device | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Comparisons | K180204 | |||||||||
| Mini and Micro Fragments Reconstruction System - CMF Visionare | ||||||||||
| Visionare LLC | K102641 | |||||||||
| Mini and Micro Fragments Reconstruction System - NEOFACE | ||||||||||
| NEOORTHO Produtos Ortopédicos S/A | K021642 | |||||||||
| Synthes Craniofacial Plates | ||||||||||
| Synthes (USA) | ||||||||||
| 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. | Mini and Micro Fragments Reconstruction System - NEOFACE 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 Synthes Craniofacial Plates are intended for use in select | |||||||||
| the midface and craniofacial skeleton; craniofacial surgery re | ||||||||||
| procedures; and selective orthognathic surgery of the maxilla | ||||||||||
| Plate Designs for | ||||||||||
| Comparison | 1.5 Straight Plates | |||||||||
| 1.5 Rectangular Plates | ||||||||||
| 1.5 T Plates | ||||||||||
| 1.5 Y Plates | ||||||||||
| 1.5 Double Y Plates | ||||||||||
| 1.5 L Plates | ||||||||||
| 1.5 L 110° Plates | ||||||||||
| 1.5 H Plates | ||||||||||
| 1.5 X Plates | ||||||||||
| 1.5 Z Plates | ||||||||||
| 1.5 Orbital Plates | ||||||||||
| 1.5 Orbital Floor Plates | Straight Plates | |||||||||
| Rectangular Plates | ||||||||||
| T Plates | ||||||||||
| Y Plates | ||||||||||
| Double Y Plates | ||||||||||
| L Plates | ||||||||||
| L 110° Plates | ||||||||||
| H Plates | ||||||||||
| X Plates | ||||||||||
| Z Plates | ||||||||||
| Orbital Plates | Rectangular Plates | |||||||||
| Y Plates | ||||||||||
| Double Y Plates | ||||||||||
| L Plates | ||||||||||
| H Plates | ||||||||||
| Z Plates | ||||||||||
| Orbital 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 | K180204 | |||||||||
| Mini and Micro Fragments Reconstruction System - CMF Visionare | ||||||||||
| Visionare LLC | K102641 | |||||||||
| Mini and Micro Fragments Reconstruction System – NEOFACE | ||||||||||
| NEOORTHO Produtos Ortopédicos S/A | K021642 | |||||||||
| Synthes Craniofacial Plates | ||||||||||
| Synthes (USA) | K050934 | |||||||||
| MODUS® Titanium Osteosynthesis System | ||||||||||
| Medartis, 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 Floor | ||||||||||
| Plate, T 0.3 mm | 29.0 x 17.0 x 0.30 mm | Small | 0.3 | 21.0 x 13.3 | ||||||
| Medium Anatomical Orbital Floor | ||||||||||
| Plate, T 0.3 mm | 47.7 x 39.6 x 0.30 mm | Medium | 0.3 | 30.6 x 26.6 | ||||||
| Wide Medium Anatomical Orbital | ||||||||||
| Floor 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 Floor | ||||||||||
| Plate, 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 | |||
|---|---|---|---|
| K050934 | |||
| MODUS® Titanium Osteosynthesis System | |||
| Medartis, 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 Plates | |||
| Y Plates | |||
| L 110° Plates | |||
| Overall Sizes (mm) | Thickness (mm) | Overall Sizes (mm) | |
| (8.0 - 10.0) x 10 | |||
| T Plates | |||
| 3x2 hole | |||
| 3x3 hole | |||
| 3x4 hole | 0.6 | 12.0 x 12.0 | |
| 17.0 x 12.0 | |||
| 21.0 x 12.0 | |||
| (8.0 x 11.0 | Y Plates | ||
| 3x2 hole | |||
| 5x4 hole | 0.6 | ||
| 0.7 | (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° Plates | ||
| 2x2 hole | 0.6 | (18.0 - 21.0) x 8.0 | |
| (8.0 x 13.0 | |||
| (10.9-14.7) x 15 |
6
Table 1 – Substantial Equivalence 1.5 System Plates
7
Table 2 – Substantial Equivalence 2.0 System Plates
| Subject Device | Primary Predicate Device | Reference Device | Reference Device | Reference Device | Reference Device | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Comparison | K180204 | |||||||||||||
| Mini and Micro Fragments | ||||||||||||||
| Reconstruction System – CMF | ||||||||||||||
| Visionare | ||||||||||||||
| Visionare LLC | K102641 | |||||||||||||
| Mini and Micro Fragments | ||||||||||||||
| Reconstruction System – NEOFACE | ||||||||||||||
| NEOORTHO Produtos Ortopédicos S/A | K021642 | |||||||||||||
| Synthes Craniofacial Plates | ||||||||||||||
| Synthes (USA) | K033065 | |||||||||||||
| 2.0 mm Craniofacial Locking Plates | ||||||||||||||
| Synthes (USA) | K972322 | |||||||||||||
| Lorenz 1.5mm Neuro Pack/Lorenz 2.0 | ||||||||||||||
| FT Plates (sterile version) | ||||||||||||||
| Walter Lorenz Surgical, Inc. | K050934 | |||||||||||||
| MODUS® Titanium Osteosynthesis | ||||||||||||||
| System | ||||||||||||||
| Medartis, Inc. | K080694 | |||||||||||||
| OsteoMed Modular Locking Fixation | ||||||||||||||
| System | ||||||||||||||
| OsteoMed LP | ||||||||||||||
| 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. | Mini and Micro Fragments Reconstruction | |||||||||||||
| System - NEOFACE 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 Synthes Craniofacial Plates are | |||||||||||||
| intended for use in selective trauma of the | ||||||||||||||
| midface and craniofacial skeleton; | ||||||||||||||
| craniofacial surgery; reconstructive | ||||||||||||||
| procedures; and selective orthognathic | ||||||||||||||
| surgery of the maxilla and chin. | Synthes 2.0 mm Craniofacial Locking | |||||||||||||
| Plates are indicated for selective trauma of | ||||||||||||||
| the midface and craniofacial skeleton; | ||||||||||||||
| craniofacial surgery; reconstructive | ||||||||||||||
| procedures; and selective orthognathic | ||||||||||||||
| surgery of the maxilla and chin. | Rigid fixation of cranio, facial and | |||||||||||||
| neurological bone. | 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. | The OsteoMed Modular Locking Fixation | |||||||||||||
| System is intended for fracture fixation in | ||||||||||||||
| cranio-maxillofacial trauma reconstruction, | ||||||||||||||
| mandibular reconstruction and orthognathic | ||||||||||||||
| reconstruction. | ||||||||||||||
| The OsteoMed Modular Locking Fixation | ||||||||||||||
| System implants and drills are intended for | ||||||||||||||
| single use only. | ||||||||||||||
| Plate Designs for | ||||||||||||||
| Comparison | 2.0 Straight Plates | |||||||||||||
| 2.0 Rectangular Plates | ||||||||||||||
| 2.0 T Plates | ||||||||||||||
| 2.0 Y Plates | ||||||||||||||
| 2.0 Double Y Plates | ||||||||||||||
| 2.0 L Plates | ||||||||||||||
| 2.0 L 110° Plates | ||||||||||||||
| 2.0 H Plates | ||||||||||||||
| 2.0 I Plates | ||||||||||||||
| 2.0 X Plates | ||||||||||||||
| 2.0 Z Plates | ||||||||||||||
| 2.0 Orbital Plates | ||||||||||||||
| 2.0 Straight Locking Plates | ||||||||||||||
| 2.0 Rectangular Locking Plates | Straight Plates | |||||||||||||
| T Plates | ||||||||||||||
| Y Plates | ||||||||||||||
| Double Y Plates | ||||||||||||||
| L Plates | ||||||||||||||
| Z Plates | ||||||||||||||
| Orbital Plates | ||||||||||||||
| Straight Locking Plates | Straight Plates | |||||||||||||
| Rectangular Plates | ||||||||||||||
| Y Plates | ||||||||||||||
| Double Y Plates | ||||||||||||||
| L 110° Plates | ||||||||||||||
| H Plates | ||||||||||||||
| X Plates | Straight Locking Plates | |||||||||||||
| Rectangular Locking Plates | Z Plates | |||||||||||||
| Orbital Plates | Rectangular Plates | |||||||||||||
| T Plates | ||||||||||||||
| L 100° Plates | ||||||||||||||
| I Plates | ||||||||||||||
| Orbital Plates | ||||||||||||||
| Straight 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 mm | |||||||||||||
| 2x2 hole | ||||||||||||||
| 2x3 hole | (10.9 – 17) x 17 | |||||||||||||
| 29.5 x 17 | 0.9 mm | |||||||||||||
| 2x2 hole | ||||||||||||||
| 2x3 hole | (5x10) – (15x15) | |||||||||||||
| 25x15 | 1.0 mm | |||||||||||||
| 2x2 holes | ||||||||||||||
| 2x3 hole | ||||||||||||||
| 2x4 hole | (10-13) x 13 | |||||||||||||
| 22 x 13 | ||||||||||||||
| 31 x 13 | ||||||||||||||
| 2.0 T Plates | 1.0 mm | |||||||||||||
| 3x2 hole | (17.3-26.4) x 17.3 | 1.0 mm | ||||||||||||
| 3x2 hole | (23.4-26.4) x 17.3 | 1.0 mm | ||||||||||||
| 3x2 hole | (17-20) x 17 | |||||||||||||
| 2.0 Y Plates | 1.0 mm | |||||||||||||
| 3x3 hole | ||||||||||||||
| 5x4 hole | (28.2-37.3) x 13.5 | |||||||||||||
| 39.2 x 22.6 | 1.0 mm | |||||||||||||
| 3x2 hole | (21.8-27.9)x13.6 | 0.9 mm | ||||||||||||
| 2x3 hole | ||||||||||||||
| 4x4 hole | 24.0 x 12.0 | |||||||||||||
| 32.0 x 19.0 | 1.0 mm | |||||||||||||
| 6x6 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 Fragments | ||||||||||
| Reconstruction System - CMF | Mini and Micro Fragments | ||||||||||
| Reconstruction System - NEOFACE | Synthes Craniofacial Plates | 2.0 mm Craniofacial Locking Plates | Lorenz 1.5mm Neuro Pack/Lorenz 2.0 | ||||||||
| FT Plates (sterile version) | |||||||||||
| Visionare | |||||||||||
| Visionare LLC | NEOORTHO Produtos Ortopédicos S/A | Synthes (USA) | Synthes (USA) | Walter Lorenz Surgical, Inc. | |||||||
| 2.0 Double Y Plates | 1.0 mm | 3x3 hole | |||||||||
| 5x5 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 Oblique | |||||||
| L-Plates | |||||||||||
| (23.7-32.8) x 17.3 | 2x3 hole | 25.0 x 10.0 | |||||||||
| 3x4 hole | |||||||||||
| 4x6 hole | (25.0-31.0) x | ||||||||||
| (10.0-15.0) | |||||||||||
| 41.0 x 20.0 | |||||||||||
| (30.1-39.2) x 11.2 | |||||||||||
| 42.9 x 23.7 | 3x4 hole | ||||||||||
| 4x6 hole | |||||||||||
| 2.0 H Plates | 1.0 mm | 8 hole | |||||||||
| 9 hole | 0.9 mm | 23.0 x 22.0 | |||||||||
| 26.1 x 23.7 | |||||||||||
| 26.1 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 hole | |||||||||
| 8 hole | 1.0 mm | 8 hole | 1.0 mm | 6 hole | |||||||
| 8 hole | |||||||||||
| Lengths | |||||||||||
| 35.6 - 43.8 | |||||||||||
| 46.9 - 54.2 | Lengths | ||||||||||
| 40.7 | Length | ||||||||||
| 42.0 mm | |||||||||||
| 54.7 mm | |||||||||||
| 2.0 Straight | |||||||||||
| Locking Plates | 1.0 mm | 1.0 mm | 1.0 mm | ||||||||
| Lengths | |||||||||||
| 11.9 - 85.0 | Lengths | ||||||||||
| 15.5 - 53.4 | Lengths | ||||||||||
| 24.5 - 100.0 | |||||||||||
| 1.5 mm | 1.3 mm | 1.25 mm | |||||||||
| Lengths | |||||||||||
| 30.5 - 102.0 | Lengths | ||||||||||
| 30.5 - 54.0 | Lengths | ||||||||||
| 40.4 - 70.5 | |||||||||||
| 2.0 Rectangular | |||||||||||
| Locking Plates | 1.0 mm | 2x2 hole | |||||||||
| 2x2 / 2x2 hole | 1.0 mm | 2x2 hole | |||||||||
| 2x2 / 2x2 hole | |||||||||||
| 10.9 x 10.9 | |||||||||||
| 35.2 x 10.9 | 12.3 x 12.3 | ||||||||||
| 33.0 x 12.3 | |||||||||||
| Plate Material | CP Titanium | CP Titanium | CP Titanium | CP Titanium | CP Titanium |
| Reference Device | Reference Device | ||
|---|---|---|---|
| 50934 | |||
| MODUS® Titanium Osteosynthesis | |||
| System | K080694 | ||
| OsteoMed Modular Locking Fixation | |||
| System | |||
| 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 | |||||||
|---|---|---|---|---|---|---|---|---|---|---|
| K180204 | ||||||||||
| Mini and Micro Fragments Reconstruction System – | ||||||||||
| CMF Visionare | ||||||||||
| Visionare LLC | K102641 | |||||||||
| Mini and Micro Fragments Reconstruction System – | ||||||||||
| NEOFACE | K091144 | |||||||||
| Synthes MatrixMANDIBLE Preformed Reconstruction | ||||||||||
| Plates | K992682 | |||||||||
| MODUS 2.5 Mandibular Reconstruction Set | K063052 | |||||||||
| Mandibular Fracture/Reconstruction Devices and | ||||||||||
| Pre-Bent Plates | ||||||||||
| Comparison | NEOORTHO Produtos Ortopédicos S/A | Synthes USA | Medartis | |||||||
| Indication 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. | Mini and Micro Fragments Reconstruction System - | |||||||||
| NEOFACE 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 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 indications for use of the MODUS® 2.5 Reconstruction Set | |||||||||
| include use in reconstruction surgery, including bone grafting | ||||||||||
| and bridging defects in the mandible after tumor resection or | ||||||||||
| severe infection. It is also indicated for use in mandibular | ||||||||||
| trauma, e.g. unstable, comminuted mandibular fractures and | ||||||||||
| bone loss. | Intended for use in the stabilization and fixation of mandibular | |||||||||
| fractures and mandibular reconstructive surgical procedures. | ||||||||||
| Plate Designs for | ||||||||||
| Comparison | 2.4 Straight Reconstruction Plates | |||||||||
| 2.4 Anatomic Reconstruction Plates | ||||||||||
| 2.4 Angled Reconstruction Plates | ||||||||||
| 2.4 Double Angled Reconstruction Plates | Straight Reconstruction Plates | |||||||||
| Anatomic Reconstruction Plates | ||||||||||
| Double Angled Reconstruction Plates | Straight Reconstruction Plates | |||||||||
| Anatomic Reconstruction Plates | ||||||||||
| Angled Reconstruction Plates | ||||||||||
| Double Angled Reconstruction Plates | Anatomic Reconstruction Plates | |||||||||
| Angled Reconstruction Plates | ||||||||||
| Double Angled Reconstruction Plates | Straight Reconstruction Plates | |||||||||
| Anatomic Reconstruction Plates | ||||||||||
| Comparison of Designs | Thickness (mm)/ | |||||||||
| Features | Lengths or | |||||||||
| Overall Sizes (mm) | Thickness (mm)/ | |||||||||
| Features | Lengths or | |||||||||
| Overall Sizes (mm) | Thickness (mm)/ | |||||||||
| Features | Lengths or | |||||||||
| Overall Sizes (mm) | Thickness (mm)/ | |||||||||
| Features | Lengths or | |||||||||
| Overall Sizes (mm) | Thickness (mm)/ | |||||||||
| Features | Lengths or | |||||||||
| Overall Sizes (mm) | ||||||||||
| 2.4 Straight | ||||||||||
| Reconstruction 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 Anatomic | ||||||||||
| Reconstruction 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 Angled | ||||||||||
| Reconstruction 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 | K180204 | ||||
| Mini and Micro Fragments Reconstruction System - | |||||
| CMF Visionare | |||||
| Visionare LLC | K102641 | ||||
| Mini and Micro Fragments Reconstruction System - | |||||
| NEOFACE | |||||
| NEOORTHO Produtos Ortopédicos S/A | 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 | |||||
| 2.4 Double Angled | |||||
| Reconstruction 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 | K180204 | |||||||||||
| Mini and Micro Fragments Reconstruction | ||||||||||||
| System – CMF Visionare | ||||||||||||
| Visionare LLC | K102641 | |||||||||||
| Mini and Micro Fragments Reconstruction | ||||||||||||
| System – NEOFACE | ||||||||||||
| NEOORTHO Produtos Ortopédicos S/A | K980199 | |||||||||||
| Synthes® (USA) 1.5mm/2.0mm | ||||||||||||
| Orthognathic Maxillary Plates and Screws | ||||||||||||
| Synthes® (USA) | K031708 | |||||||||||
| Osteomed Maxillary/LeFort III Distraction | ||||||||||||
| System | K944565 | |||||||||||
| KLS-Martin Micro Osteosynthesis System | ||||||||||||
| (1.5 mm) | K050934 | |||||||||||
| MODUS® Titanium Osteosynthesis System | ||||||||||||
| OsteoMed L.P. | KLS-Martin L.P. | Medartis, Inc. | ||||||||||
| Indication 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. | Mini and Micro Fragments Reconstruction | |||||||||||
| System - NEOFACE is intended for use in | ||||||||||||
| selective trauma of the midface, maxillofacial | ||||||||||||
| surgery, reconstructive procedures, and selective | ||||||||||||
| orthognathic surgery of the maxilla, mandible | ||||||||||||
| and chin. | Synthes 1.5 mm / 2.0 mm Orthognathic | |||||||||||
| Maxillary Plates and Screws are generally | ||||||||||||
| intended for a variety of pan facial indications. | ||||||||||||
| Specifically, they are intended for selective | ||||||||||||
| trauma of the midface and craniofacial skeleton; | ||||||||||||
| craniofacial surgery; reconstructive procedures; | ||||||||||||
| and selective orthognathic surgery of the maxilla | ||||||||||||
| and chin. | Intended for use in the treatment of cranial or | |||||||||||
| midface conditions for which reconstructive | ||||||||||||
| osteotomy and segment advancement are | ||||||||||||
| indicated. This includes conditions such as, | ||||||||||||
| syndromic craniosynostosis, midfacial | ||||||||||||
| retrusion, hemifacial microsomia, and | ||||||||||||
| micrognathia. The OsteoMed Maxillary / | ||||||||||||
| LeFort III Distraction device is intended to | ||||||||||||
| provide temporary stabilization and gradual | Not available on FDA 510(k) database webpage | 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; | ||||||||||||
| lengthening of the cranial or midfacial bones. | ||||||||||||
| The OsteoMed Maxillary / LeFort Ill | ||||||||||||
| Distraction System is intended for single patient | ||||||||||||
| use only. | coverings for burr holes in the skull; trauma of | |||||||||||
| nasal bones; surgical correction of dentofacial | ||||||||||||
| deformations; and reconstruction after tumor | ||||||||||||
| surgery. | ||||||||||||
| Plate Designs for Comparison | Orthognathic L Plates | |||||||||||
| Orthognathic Y Plates | ||||||||||||
| Orthognathic Canine Pillar Plates | ||||||||||||
| Orthognathic Zygomatic Pillar Plates | ||||||||||||
| Orthognathic Le Fort Plates | ||||||||||||
| Orthognathic Chin Plates | ||||||||||||
| Orthognathic Paulus Plates | ||||||||||||
| Orthognathic Straight Sagittal Plates | ||||||||||||
| Orthognathic Straight Adjustable Sagittal Plates | ||||||||||||
| Orthognathic Y Adjustable Sagittal Plates | ||||||||||||
| Orthognathic Locking Straight Sagittal Plates | ||||||||||||
| Orthognathic Locking Straight Adjustable | ||||||||||||
| Sagittal Plates | ||||||||||||
| Orthognathic Locking Y Adjustable Sagittal | ||||||||||||
| Plates | Orthognathic L Plates | |||||||||||
| Orthognathic Y Plates | ||||||||||||
| Orthognathic Le Fort Plates | ||||||||||||
| Orthognathic Chin Plates | ||||||||||||
| Orthognathic Paulus Plates | ||||||||||||
| Orthognathic Straight Sagittal Plates | ||||||||||||
| Orthognathic Locking Straight Sagittal | ||||||||||||
| Plates | Orthognathic L Plates | |||||||||||
| Orthognathic Y Plates | ||||||||||||
| Orthognathic Zygomatic Pillar Plates | ||||||||||||
| Orthognathic Y Adjustable Sagittal Plates | ||||||||||||
| Orthognathic Locking Y Adjustable Sagittal | ||||||||||||
| Plates | Orthognathic Y Plates | |||||||||||
| Orthognathic Le Fort Plates | Orthognathic Le Fort Plates | Orthognathic L Plates | ||||||||||
| Orthognathic Y Plates | ||||||||||||
| Orthognathic Canine Pillar Plates | ||||||||||||
| Orthognathic Zygomatic Pillar Plates | ||||||||||||
| Orthognathic Le Fort Plates | ||||||||||||
| Orthognathic Chin Plates | ||||||||||||
| Orthognathic Paulus Plates | ||||||||||||
| Orthognathic Straight Sagittal Plates | ||||||||||||
| Orthognathic Straight Adjustable Sagittal | ||||||||||||
| Plates | ||||||||||||
| Orthognathic Y Adjustable Sagittal Plates | ||||||||||||
| Orthognathic Locking Straight Sagittal | ||||||||||||
| Plates | ||||||||||||
| Orthognathic Locking Straight Adjustable | ||||||||||||
| Sagittal Plates | ||||||||||||
| Orthognathic Locking Y Adjustable Sagittal | ||||||||||||
| Plates | ||||||||||||
| Comparison of Designs | Thickness (mm)/ | |||||||||||
| Features | Lengths or | |||||||||||
| Overall Sizes (mm) | Thickness (mm)/ | |||||||||||
| Features | Lengths or | |||||||||||
| Overall Sizes (mm) | Thickness (mm)/ | |||||||||||
| Features | Lengths or | |||||||||||
| Overall Sizes (mm) | Thickness (mm)/ | |||||||||||
| Features | Lengths or | |||||||||||
| Overall Sizes (mm) | Thickness (mm)/ | |||||||||||
| Features | Lengths or | |||||||||||
| Overall Sizes (mm) | Thickness (mm)/ | |||||||||||
| Features | Lengths or | |||||||||||
| Overall 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 | K180204 | |||||||||||
| Mini and Micro Fragments Reconstruction | ||||||||||||
| System - CMF Visionare | ||||||||||||
| Visionare LLC | K102641 | |||||||||||
| Mini and Micro Fragments Reconstruction | ||||||||||||
| System – NEOFACE | K980199 | |||||||||||
| Synthes® (USA) 1.5mm/2.0mm | ||||||||||||
| Orthognathic Maxillary Plates and Screws | K031708 | |||||||||||
| Osteomed Maxillary/LeFort III Distraction | ||||||||||||
| System | K944565 | |||||||||||
| KLS-Martin Micro Osteosynthesis System | ||||||||||||
| (1.5 mm) | K050934 | |||||||||||
| MODUS® 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 mm | ||||||||
| 3x3 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 Adjustable | ||||||||||||
| Sagittal 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 Sagittal | ||||||||||||
| Plates | 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 Straight | ||||||||||||
| Sagittal Plates | 1.0 mm | 22.3 - 37.3 | 1.0 | 25.2 - 34.2 | 1.0 mm | 27.0 - 49.0 | ||||||
| Orthognathic Locking Straight | ||||||||||||
| Adjustable Sagittal Plates | 1.0 mm | 26.6 - 41.6 | 0.7 / 0.8 mm | 27.0 - 47.0 | ||||||||
| Orthognathic Locking Y Adjustable | ||||||||||||
| Sagittal 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 | K180204 | ||
| Mini and Micro Fragments Reconstruction System – CMF Visionare | |||
| Visionare LLC | K102641 | ||
| Mini and Micro Fragments Reconstruction System – NEOFACE | |||
| NEOORTHO Produtos Ortopédicos S/A | K052061 | ||
| MODUS | |||
| Medartis | |||
| 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. | Mini and Micro Fragments Reconstruction System - NEOFACE is intended for use in selective | ||
| trauma of the midface, maxillofacial surgery, reconstructive procedures, and selective orthognathic | |||
| surgery of the maxilla, mandible and chin. | MODUS | ||
| method in | |||
| condylar | |||
| procedure | |||
| Screw Designs | 2.0 Blocking screw series | ||
| 2.0 SW3 Blocking screw series | |||
| Self-drilling thread design | 2.0 Blocking screw series | ||
| 2.0 SH Blocking screw series | |||
| Self-drilling thread design | 2.0 IMF | ||
| Self-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 Visionare | |||||||||
| Visionare LLC | Mini and Micro Fragments Reconstruction System – | ||||||||
| NEOFACE | |||||||||
| NEOORTHO Produtos Ortopédicos S/A | Synthes (USA) 1.5mm/2.0mm Orthognathic Maxillary plates and Screws | ||||||||
| Synthes (USA) | Lorenz 1.5mm Neuro Pack/Lorenz | ||||||||
| (sterile version) | |||||||||
| Walter Lorenz Surgical, 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. | Mini and Micro Fragments Reconstruction System - | ||||||||
| NEOFACE is intended for use in selective trauma of the | |||||||||
| midface, maxillofacial surgery, reconstructive procedures, and | |||||||||
| selective orthognathic surgery of the maxilla, mandible and | |||||||||
| chin. | Synthes 1.5 mm / 2.0 mm Orthognathic Maxillary plates and | ||||||||
| Screws are generally intended for a variety of pan facial | |||||||||
| indications. Specifically, they are intended for selective | |||||||||
| trauma of the midface and craniofacial skeleton; craniofacial | |||||||||
| surgery; reconstructive procedures; and selective orthognathic | |||||||||
| surgery of the maxilla and chin. | Rigid fixation of cranio, facial and neck | ||||||||
| Comparison of | |||||||||
| Screw 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 Ø | |||||||||
| Threads 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 Ø | |||||||||
| Threads 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 | K091144 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Synthes MatrixMANDIBLE Preformed Reconstruction plates | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Synthes 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 |
15
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
16
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.