(433 days)
No
The device description focuses on the materials and mechanical properties of bone plates and screws, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is described as an "implant device" intended for "selective trauma," "maxillofacial surgery," "reconstructive procedures," and "orthognathic surgery," indicating it is used to treat or alleviate a condition.
No
This device is a fixation system (plates and screws) used in surgical procedures for trauma and reconstructive purposes, not for diagnosing conditions.
No
The device description explicitly states it consists of bone plates and screws made from titanium, which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description: The MCI - CMF System consists of bone plates and screws made of titanium. These are implants designed to be surgically placed inside the body to fix bones.
- Intended Use: The intended use is for surgical procedures to fix bones in the midface, maxillofacial region, maxilla, mandible, and chin. This is a direct surgical intervention, not a diagnostic test performed on a specimen.
The description clearly indicates a surgical implant system, not a device used for laboratory testing of biological samples.
N/A
Intended Use / Indications for Use
MCI - CMF System 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
JEY, DZL
Device Description
The bone plates are made from commercially pure titanium (ASTM F67) and the bone screws are manufactured from titanium alloy - Ti-6AI-4V (ASTM F136) and are available in different sizes and shapes, according the site of the implantation and the extension of the fracture. The surface of plates and screws are colored-anodized.
MCI - CMF System implant devices are for single use. The devices are provided non-sterile and must be properly cleaned, disinfected and sterilized before use, according the recommendations provided in the Instructions for Use.
The devices must only be used by qualified surgeons mastering the surgical technique, having been trained and qualified in maxillofacial surgery.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Midface, maxillofacial, maxilla, mandible, chin.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Qualified surgeons mastering the surgical technique, having been trained and qualified in maxillofacial surgery.
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)
Biocompatibility testing
The plates are manufactured in commercially pure titanium conforming to ASTM F67 and its surfaces are colored-anodized. The plates types of titanium are the same to that used for fabrication of the primary predicate and reference devices.
The screws are made of titanium alloy conforming to ASTM F136 and its surfaces are coloredanodized. The screws alloy is the same to that used for fabrication of the primary predicate and reference devices.
Biocompatibility of the subject devices were supported by the following tests according to its contact profile: Cytotoxicity (ISO 10993-5), Sensitization (ISO 10993-10), Intracutaneous Reactivity (ISO 10993-10), Acute Systemic Toxicity (ISO 10993-11), Subchronic Systemic Toxicity (ISO 10993-11), Implantation (ISO 10993-6), Genotoxicity and Carcinogenicity (ISO 10993-3).
Mechanical testing
The performance of the subject devices are demonstrated through mechanical testing of plates and screws according to ASTM F382 and ASTM F543.
For the plates the 4 point bending fatigue test was performed. For the screws, pullout, torsion, and driving torque were executed. No clinical data were included in this submission.
Shelf life and Sterilization testing
The subject devices are provided non-sterile and have no expiration date defined. Steam sterilization validation was performed according to ISO 17665-1 and 17665-2.
Conclusion
The documentation submitted in this premarket notification demonstrates that the subject devices have comparable features and performance and, therefore, are substantially equivalent to the identified primary predicate and reference devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K944565, K943347, K083388, K091233, K022185, K182609, K140037, K160363, K050934, K091679, K103778
Predetermined Change Control Plan (PCCP) - All Relevant Information
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, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size, also in blue.
December 5, 2019
MCI Medical Concept Innovation Inc. % Janine Treter Regulatory Affairs Specialist Passarini Regulatory Affairs of America LLC 201 Biscayne Blvd, Suite 1200 Miami, Florida 33131
Re: K182758
Trade/Device Name: MCI - CMF System Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: Class II Product Code: JEY, DZL Dated: November 4, 2019 Received: November 6, 2019
Dear Janine Treter:
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.
1
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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Srinivas Nandkumar, Ph.D. for Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K182758
Device Name
MCI - CMF System
Indications for Use (Describe)
MCI - CMF System 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) | Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
| 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
ADMINISTRATIVE INFORMATION
| Manufacturer Name | MCI Medical Concept Innovation Inc.
4592 North Hiatus Road
Sunrise, Florida, USA 33351 |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact | Carlos Lacerda, Mr.
Manager Director
MCI Medical Concept Innovation Inc.
E-Mail: carlos.lacerda@mci-medical.com
Telephone +01 (954) 306-2521 |
| Date Prepared | 05/Dec/2019 |
| Preparer / Alternate Contact | Janine Treter
Regulatory Affairs Specialist
Passarini Regulatory Affairs
janine@rapassarini.com.br |
| DEVICE NAME AND CLASSIFICATION | |
| Trade/ Proprietary Name | MCI - CMF System |
| Common Names | Bone Plate; Fixation Screws |
| Primary Classification Name | Bone Plate |
| Primary Classification Regulation | 21 CFR 872.4760, Class II |
| Primary Product Code | JEY |
| Subsequent Classification Name | Intraosseous Fixation Screw or Wire |
| Subsequent Classification Regulation | 21 CFR 872.4880, Class II |
| Subsequent Product Code | DZL |
| Classification Panel | Dental Products Panel |
| Reviewing Branch | Dental Devices Branch |
| PREDICATE DEVICE INFORMATION | |
| Primary Predicate Device | K180204 - CranioMaxillofacial Fixation (CMF) System - CMF Visionare
- Visionare LLC |
| Reference Devices | K944565 -KLS-MARTIN MICRO OSTEOSYTHESIS SYSTEM(1.5MM) - KLS-MARTIN L.P.
K943347 - KLS Mini Osteosynthesis System - KLS-MARTIN L.P.
K083388 - Synthes MatrixORTHOGNATHIC Plate System - Synthes (USA)
K091233 - SYNTHES MATRIXMANDIBLE SUBCONDYLAR PLATES - SYNTHES (USA) |
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K022185 - Universal CMF System - Stryker Leibinger K182609 - Delphos Implants Rigid Fixation System - Delphos Implants - Ind. Com. Importação e Exportação K140037 & K160363 - Optimus CMF System - Osteonic Co., Ltd. K050934 - MODUS® Titanium Osteosynthesis System - Medartis Inc. K091679 & K103778 - LeForte Neuro System Bone Plate - Jeil Medical Corporation
INDICATIONS FOR USE
MCI - CMF System 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 bone plates are made from commercially pure titanium (ASTM F67) and the bone screws are manufactured from titanium alloy - Ti-6AI-4V (ASTM F136) and are available in different sizes and shapes, according the site of the implantation and the extension of the fracture. The surface of plates and screws are colored-anodized.
MCI - CMF System implant devices are for single use. The devices are provided non-sterile and must be properly cleaned, disinfected and sterilized before use, according the recommendations provided in the Instructions for Use.
The devices must only be used by qualified surgeons mastering the surgical technique, having been trained and qualified in maxillofacial surgery.
TECHNOLOGICAL CHARACTERISTICS COMPARISON TABLE
The subject and the predicate devices have a range of plates and screws with the same indication for reconstructive surgery, for fixation of maxillofacial and oral fractures, orthognathic reconstructions, mandibular reconstruction and any osteotomy surgery or trauma in maxillofacial.
The subject device is substantially equivalent to the primary predicate device K180204 in intended use, Indications for Use, designs, materials, and function.
The indication for use statement of the subject devices, primary predicate and reference devices is shown in Table 5.1. The indication for use statement of subject and primary predicate device is identical. A comparison between the design and features of the subject devices, primary predicate and reference devices is shown in tabular format for plates (Tables 5.2 and 5.3) and screws (Table 5.4).
The subject device plates are substantially equivalent to the primary predicate device K180204, or reference devices K944565, K943347, K08388, K091233, K022185, K182609, K140037 & K160363, K050934, K091679 & K103778, in designs and range of dimensions. Differences in the plates design features and dimensions between the subject device and the primary predicate device K180204 are addressed by comparison to the reference devices.
5
For System 1.5, the reference device K944565 is for substantial equivalence of part of the Straight Micro Plates, Straight Micro Plates Bridge, L Micro Plates Bridge, and Y Micro Plates Bridge. It is for substantial equivalence of the Orbital Micro Plate L Oblique Bridge, H Nasal Micro Plate, I Nasal Micro Plate, Orbital Floor Micro Mesh and 3D Micro Mesh of 83x83, 122x 122 and 200x200 mm. For System 2.0, the reference device K944565 is for substantial equivalence of part of the Mini Plate Double Pillar for Ment.
The reference device K943347 for System 1.5 is for substantial equivalence of T Micro Plate Bridge 4 holes in design only. For System 2.0, the reference device K943347 is for substantial equivalence of L Mini Plates and L Mini Plates Bridge of 6 holes. Both are reversible plates and are covered by two plates of the reference device in the same design (right/left). It is also for substantial equivalence of T Mini Plate Bridge of 4 holes, Straight Mini Plates Bridge Tab, Chin Mini Plates Bridge Tab and L Mini Plates Bridge Double Tab.
The reference device K083388 for System 1.5 is for substantial equivalence of part of the Micro Plate Bridge. It is for the substantial equivalence of the Micro Plates L Orbital Oblique Bridge. For system 2.0, this reference device is for substantial equivalence of the Straight Mini Plate of 20 holes, L Mini Plate Oblique Bridge, Sagittal Mini Plates Cut Bridge and Sagittal Mini Plates Cut Oblong Bridge.
The reference device K091233 for System 2.0 is for substantial equivalence of Lambda Mini Plates, Support Mini Plates, Trapezoidal Mini Plates and Trapezoidal Parallel Mini Plates.
The reference device K022185 for System 1.5 is for substantial equivalence of part of the T Micro Plate Bridge of 5 holes. It is for substantial equivalence of the Orbital Floor Plate. For System 2.0, K022185 is for substantial equivalence of T Mini Plate of 6 holes, T Orbital Mini Plate Bridge, and for the design features not emcopassed by K944595 for the Mini Plate Double Pillar for Ment.
The reference device K182609 for System 1.5 is for substantial equivalence of the Straight Micro Plate design features not encompassed by K944565, part of the 4 and 6 holes Straight Micro Plates Bridge and for the design features of the T Micro Plates Bridge 5 holes not completely emcopassed by K022185. The K182609 is also for the substantial equivalence of X Micro Plate Bridge and Support Zygomatic Micro Plates. For System 2.0, the reference device K182609 is for substantial equivalence of the Straight Mini Plate of 6 holes, Straight Mini Plate Bridge of 4 holes and for part of the Straight Mini Plate Bridge of 6 holes. It is for the substantial equivalence of the Orbital Mini Plates of 8 and 10 holes, Y Mini Plate, Mini Plates Double Line Bridge and for substantial equivalence of the Chin Mini Plates not encompassed by the primary predicate device.
The reference devices K140037 & K160363 for System 1.5 are for substantial equivalence of the Lefort Micro Plates. For System 2.0 are for substantial equivalence of Straight Mini Plates not emcopassed by K083388 and K182609 and for the Orbital Mini Plate not emcopassed by K182609. The reference devices K140037 & K160363 are also for the substantial equivalence of BSSO Dual Angled Mini Plates Bridge.
For System 1.5 the reference device K050934 is for substantial equivalence of the Straight Micro Plate Bridge features not emcopassed by K944565 and K182609, and of the L Micro Plates Bridge features not encompassed by K944565 and K083388. It is also for substantial equivalence of Y Micro Plate Bridge not emcompassed by K944565 and 3D Micro Mesh of 50x50 mm. For System 2.0 is for substantial equivalence of Straight Mini Plates Bridge not emcopassed by K182609 and L Mini Plates
6
Bridge not encompassed by K943347. It is also for the substantial equivalence of the Mini Plate Sagittal.
The reference devices K091679 & K103778 for System 1.5 are for substantial equivalence of Angled Micro Plates for Piriformis.
The subject device screws are substantially equivalent to the primary predicate device K180204, or reference devices K944565 and K022185, in designs and range of dimensions for all types of screws: Cortical Screw, Emergency Cortical Screw, Cortical Screw AP and Locking Screw AP. Differences in the screw design features and dimensions between the subject device and the primary predicate device K180204 are addressed by comparison to the reference devices.
For screws, the reference device K944565 is for substantial equivalence on the results of comparative performance testing. The reference device K022185 is for substantial equivalence of the length 20 mm for Cortical Screws of 2.0 mm diameter and Emergency Cortical Screw of 2.3 mm. The reference device K022185 is also for substantial equivalence of the Cortical Screws AP of 2.0 mm in diameter for the length of 4 mm.
7
| Table 5.1: Comparison on indication for use statement | |||
|---|---|---|---|
| KNUMBER/ MANUFACTURER | INDICATION FOR USE STATEMENT | SUBSTANTIAL EQUIVALENCE | |
| DISCUSSION | |||
| SUBJECT | |||
| DEVICE | K182758 – MCI - CMF System |
MCI Medical Concept Innovation Inc. | MCI - CMF System is intended for use in selective trauma of the midface,
maxillofacial surgery, reconstructive procedures, and selective orthognathic surgery
of the maxilla, mandible and chin. | Equivalent
The indication for use of subject and
primary predicate device is identical. |
| PRIMARY
PREDICATE
DEVICE | K180204 - CranioMaxillofacial Fixation (CMF) System
- CMF Visionare
Visionare LLC | 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 indication for use is
within the scope of indications of the
reference devices. |
| REFERENCE
DEVICES | K944565 -KLS-MARTIN MICRO OSTEOSYTHESIS
SYSTEM(1.5MM)
KLS Martin LP | No 510(k) summary available | Despite of the reference devices
"K091679 & K103778 - LeForte Neuro
System Bone Plate" citing the word
Neuro in their proprietary name, by the
indication for use itself is possible to
understand they remain in the scope
since are related to midface and
craniomaxillofacial applications.
Therefore, K091679 & K103778 are
suitable as reference predicates. |
| | K943347 - KLS Mini Osteosynthesis System
KLS-MARTIN L.P. | No 510(k) summary available | |
| | K083388- Synthes MatrixORTHOGNATHIC Plating
System | The Synthes MatrixORTHOGNATHIC Plating System is intended for use in selective
trauma of the midface and craniofacial skeleton; craniofacial surgery; | |
| KNUMBER/ MANUFACTURER | INDICATION FOR USE STATEMENT | SUBSTANTIAL EQUIVALENCE
DISCUSSION | |
| Synthes (USA) | reconstructive procedures; and selective orthognathic surgery of the maxilla,
mandible and chin in adolescents (greater than 12 to 21 years of age) and adults. | | |
| | Specific Indications for Use: | | |
| | • Fractures ofthe midface and craniofacial skeleton | | |
| | • LeFort I osteotomies, sagittal split osteotomies and genioplasties | | |
| | • Orthognathic surgery including reconstructive procedures | | |
| K091233 - SYNTHES MATRIXMANDIBLE
SUBCONDYLAR PLATES | The Synthes MatrixMANDIBLE Subcondylar Plates are intended for oral,
maxillofacial surgery; trauma and reconstructive surgery, specifically for fractures of
the subcondylar region of the mandible and fractures of the condylar basis region of
the mandible. | | |
| SYNTHES (USA) | | | |
| K022185 - Universal CMF System | The Stryker® Leibinger Universal CMF System is a Cranio-maxillofacial (CMF) plate
and screw system intended for osteotomy, stabilization and rigid fixation of CMF
fractures and reconstruction. | | |
| Stryker Leibinger | | | |
| REFERENCE
DEVICES | K182609 - Delphos Implants Rigid Fixation System
Delphos Implants - Ind. Com. Importação e
Exportação | The Delpos Implants Rigid Fixation System is intended for fracture fixation in
maxillofacial trauma reconstruction, mandibular reconstruction and orthognatic
reconstruction. | |
| KNUMBER/ MANUFACTURER | INDICATION FOR USE STATEMENT | SUBSTANTIAL EQUIVALENCE
DISCUSSION | |
| | The Delpos Implants Rigid Fixation System implants are intended for single use only. | | |
| K140037 & K160363 - Optimus CMF System
Osteonic Co., Ltd. | Optimus CMF System is implantable bone plates and bone screws for maxillofacial
and mandible surgery procedures including:
- Fractures
- Osteotomies
- Reconstructive procedures
- Revision procedures where other treatments or devices have failed. | | |
| K050934 - MODUS® Titanium Osteosynthesis System
Medartis, Inc. | The MODUS® Titanium Osteosynthesis System is intended for osteotomies and
fractures involving any part ofthe 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 dento facial deformations; and reconstruction
after tumor surgery. | | |
| K091679 & K103778 - LeForte Neuro System Bone
Plate
Jeil Medical Corporation | This device is intended for use in selective trauma of the mid-face and craniofacial
skeleton; craniofacial surgery; reconstructive procedures; and selective orthognatic
surgery of the maxilla and chin. | | |
MCI Medical Concept Innovation Inc.
8
9
10
Table 5.2: Comparison between the subject, primary and reference K944565. K943347. K083388. K091233 devices for plates to be optived
| COMPARISON | SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE DEVICES | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| K182758 | K180204 | K944565 | K943347 | K083388 | K091233 | |||||||||||||
| Product Code | JEY, DZL | JEY, DZL | JEY | JEY | JEY, DZL | JEY | ||||||||||||
| Raw Material | CP Titanium | CP Titanium | CP Titanium | CP Titanium | CP Titanium | CP Titanium | ||||||||||||
| Surface treatment | Anodized | Anodized | Anodized | Anodized | Anodized | Anodized | ||||||||||||
| System 1.5 | ||||||||||||||||||
| Design/Features | Description | Hole nº | Thickness (mm) | Description | Hole nº | Thickness (mm) | Description | Holes | Thickness (mm) | Description | Holes | Thickness (mm) | Description | Holes | Thickness (mm) | Description | Holes | Thickness (mm) |
| Straight Micro Plate | 4, 6, 8, 10, 16, 20 | 0.6 | Straight Mini Plate Regular | 4, 6, 8, 16, 20 | 0.7 | Micro Plate | 4, 6, 8, 16, 20 | 0.6 | Mini Plate | 4, 6, 8, 16 | 0.6, 1.0 | |||||||
| Straight Micro Plate Bridge | 4, 6 | 0.6 | Straight Mini Plate Medium | 4, 6 | 0.7 | Micro Plate | 4, 6 | 0.6 | ||||||||||
| Orbital Micro Plate | 8, 10 | 0.6 | Orbital Mini Plate Regular | 8, 10 | 0.7 | Micro Plate | 8, 10 | 0.6 | Champy Plate | 8, 10 | 0.6 | |||||||
| L Micro Plate Bridge | 4 | 0.6 | L Mini Plate Medium & Extra Long | 4 | 0.7 | Micro Plate | 4 | 0.6 | Mini Plate | 4 | 0.6, 1.0 | 90° L Plate Medium & Long | 4 | 0.5 | ||||
| L Micro Plate Oblique Bridge | 4, 5 | 0.6 | Micro Plate | 4, 5 | 0.6 | |||||||||||||
| L Micro Plate Orbital | 6 | 0.6, 0.7, 0.8 | Anatomical L Plate | 6 | 0.5, 0.7, 0.8 | |||||||||||||
| T Micro Plate Bridge | 4, 5 | 0.6 | T Mini Plate Medium & Extra Long | 5 | 0.7 | Champy Plate | 4 | 1.0 | ||||||||||
| X Micro Plate Bridge | 6 | 0.6 | T Mini Plate Medium & Extra Long | 6 | 0.7 | Micro Plate | 6 | 0.6 | ||||||||||
| Y Micro Plate Bridge | 5 | 0.6 | Micro Plate | 5 | 0.6 | |||||||||||||
| Lefort Micro Plate | 11 | 0.6 | Lindorf Micro Le Fort I Plate | 11 | 1.0 | |||||||||||||
| Angled Micro Plate Piriforms | 10 | 0.8 | Le Fort Mini Plate | 14 | 0.8 | |||||||||||||
| Support Zygomatic Micro Plate | 7 | 0.8 | ||||||||||||||||
| H Nasal Micro Plate | 12 | 0.6 | Micro Plate | 12 | 0.6 | Mini Plate | 12 | 0.6 | ||||||||||
| I Nasal Micro Plate | 11, 12 | 0.6 | Micro Plate | 11, 12 | 0.6 | |||||||||||||
| COMPARISON | SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE DEVICES | |||||||||||||||
| K182758 | K180204 | K944565 | K943347 | K083388 | K091233 | |||||||||||||
| Design/Features | Orbital Floor | |||||||||||||||||
| Micro Mesh | Micro Orbital | |||||||||||||||||
| Mesh | ||||||||||||||||||
| --- | 0.3, 0.5 | --- | 0.3, 0.5 | |||||||||||||||
| Orbital Floor | ||||||||||||||||||
| Plate | --- | 0.3 | ||||||||||||||||
| 3D Micro Mesh | 3D-Mesh | |||||||||||||||||
| 50x50 | ||||||||||||||||||
| 83x83 | ||||||||||||||||||
| 122x122 | ||||||||||||||||||
| 200x200 | 0.6 | 80x80 | ||||||||||||||||
| 120x120 | ||||||||||||||||||
| 200x200 | 0.6 | |||||||||||||||||
| System 2.0 | ||||||||||||||||||
| Design/Features | Description | Hole n° | Thickness | |||||||||||||||
| (mm) | Description | Hole n° | Thickness | |||||||||||||||
| (mm) | Description | Holes | Thickness | |||||||||||||||
| (mm) | Description | Holes | Thickness | |||||||||||||||
| (mm) | Description | Holes | Thickness | |||||||||||||||
| (mm) | Description | Holes | Thickness | |||||||||||||||
| (mm) | ||||||||||||||||||
| Straight Mini | ||||||||||||||||||
| Plate | Straight Mini | |||||||||||||||||
| Plate Regular | Adaptation | |||||||||||||||||
| Plate | ||||||||||||||||||
| 4, 6, 12, 16, | ||||||||||||||||||
| 20 | 0.9 | 4, 6, 12, | ||||||||||||||||
| 16, 20 | 1.0 | 20 | 0.8 | |||||||||||||||
| Straight Mini | ||||||||||||||||||
| Plate Bridge | Straight Mini | |||||||||||||||||
| Plate Bridge | Mini Plate | |||||||||||||||||
| Bridge | ||||||||||||||||||
| 4, 6 | 0.9 | 4, 6 | 1.0 | 4 | 1.0 | |||||||||||||
| Orbital Mini | ||||||||||||||||||
| Plate | Orbital Mini Plate | Champy Plate | ||||||||||||||||
| Bridge | ||||||||||||||||||
| 6, 8, 10 | 0.9 | 6, 8, 10 | 1.0 | 8, 10 | 0.6 | |||||||||||||
| L Mini Plate | L Mini Plate | |||||||||||||||||
| Regular | Mini Plate | |||||||||||||||||
| 4, 6 | 1.0 | 4 | 1.0 | 4, 5 | 1.0 | |||||||||||||
| L Mini Plate | ||||||||||||||||||
| Bridge | L Mini Plate Long | Mini Plate | ||||||||||||||||
| 4, 6 | 1.0 | 4 | 1.0 | 6 | 1.0 | |||||||||||||
| L Mini Plate | ||||||||||||||||||
| Oblique Bridge | Oblique L Plate | |||||||||||||||||
| 6 | 1.0 | 6 | 0.8 | |||||||||||||||
| T Mini Plate | Mini Plate | |||||||||||||||||
| 4 | 1.0 | 4, 6 | 1.0 | |||||||||||||||
| 6 | 0.9 | |||||||||||||||||
| T Orbital Mini | ||||||||||||||||||
| Plate | ||||||||||||||||||
| 8 | 0.9 | |||||||||||||||||
| Y Mini Plate | ||||||||||||||||||
| 5 | 0.9 | |||||||||||||||||
| S/Z Mini Plate | Z Mini Plate | Mini Plate | ||||||||||||||||
| 4 | 1.0 | 4 | 1.0 | 4 | 0.6 | |||||||||||||
| BSSO Dual | ||||||||||||||||||
| Angled Mini | ||||||||||||||||||
| Plate Bridge | BSSO Dual | |||||||||||||||||
| Angled Mini | ||||||||||||||||||
| Plate Bridge | ||||||||||||||||||
| 8 | 0.9, 1.0 | 8 | 0.9, 1.0 | |||||||||||||||
| Straight Mini | ||||||||||||||||||
| Plate Bridge Tab | Mini Plate | |||||||||||||||||
| Mandibular Tab | ||||||||||||||||||
| 4, 6 | 1.0 | 4 | 1.0 | |||||||||||||||
| Chin Mini Plate | Chin Mini Plate | |||||||||||||||||
| 4 | 0.9 | 4 | 0.7 | Mini Plate | ||||||||||||||
| Mandibular Tab | ||||||||||||||||||
| Design/Features | Chin Mini Plate | |||||||||||||||||
| Tab | ||||||||||||||||||
| 4 | 0.8 | 4 | 0.8 |
11
Page 9 of 15
K182758 – MCI -CMF System
MCI Medical Concept Innovation Inc.
12
| COMPARISON | SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE DEVICES | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| K182758 | K180204 | K944565 | K943347 | K083388 | K091233 | |||||||
| L Mini Plate | ||||||||||||
| Bridge Tab | 4 | 0.9 | Arnett | |||||||||
| Orthognathic | ||||||||||||
| System Maxilla | 4 | 0.8 | ||||||||||
| L Mini Plate | ||||||||||||
| Bridge Double | ||||||||||||
| Tab | 4 | 0.9 | Arnett | |||||||||
| Orthognathic | ||||||||||||
| System Maxilla | 4 | 0.8 | ||||||||||
| Sagittal Mini | ||||||||||||
| Plate Cut Bridge | 6 | 1.0 | Sagittal Split | |||||||||
| Plate Bar | 6 | 1.0 | ||||||||||
| Sagittal Mini | ||||||||||||
| Plate Cut | ||||||||||||
| Oblong Bridge | 4 | 1.0 | Sagittal Split | |||||||||
| Plate Oblong | ||||||||||||
| Bar | 4 | 1.0 | ||||||||||
| Mini Plate | ||||||||||||
| Sagittal | 4 | 1.0 | ||||||||||
| Lambda Mini | ||||||||||||
| Plate | 7 | 1.0 | Subcondylar | |||||||||
| Lamda Plate | 7 | 1.0 | ||||||||||
| Support Mini | ||||||||||||
| Plate | 5 | 1.0 | Subcondylar | |||||||||
| Strut Plate | 5 | 1.0 | ||||||||||
| Trapezoidal | ||||||||||||
| Mini Plate | 4 | 1.0 | Subcondylar | |||||||||
| Trapezoidal | ||||||||||||
| Plate | 4 | 1.0 | ||||||||||
| Mini Plate | ||||||||||||
| Double Pillar for | ||||||||||||
| Ment | 6 | 0.6 | Micro Plate | 6 | 0.6 | |||||||
| Sterilization | Non-sterile, Steam sterilized prior | |||||||||||
| to use | Non-sterile, Steam sterilized prior | |||||||||||
| to use | ||||||||||||
| Single Use | Yes | Yes | Yes |
13
Table 5.3: Comparison between the subject and reference devices K022185, K160363, K050934, K091679 & K10378 for plates
| COMPARISON | SUBJECT DEVICE | REFERENCE DEVICES | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| K182758 | K022185 | K182609 | K140037 & K160363 | K050934 | K091679 & K103778 | |||||||||||||
| Product Code | JEY, DZL | JEY, HWC | JEY | JEY, DZL | JEY | JEY | ||||||||||||
| Raw Material | CP Titanium | Not informed | CP Titanium | CP Titanium | CP Titanium | CP Titanium | ||||||||||||
| Surface treatment | Anodized | Anodized | Anodized | Anodized | Anodized | Anodized | ||||||||||||
| System 1.5 | ||||||||||||||||||
| Design/Features | Description | Hole n° | Thickness | |||||||||||||||
| (mm) | Description | Hole n° | Thickness | |||||||||||||||
| (mm) | Description | Holes | Thickness | |||||||||||||||
| (mm) | Description | Holes | Thickness | |||||||||||||||
| (mm) | Description | Holes | Thickness | |||||||||||||||
| (mm) | Description | Holes | Thickness | |||||||||||||||
| (mm) | ||||||||||||||||||
| Straight Micro | ||||||||||||||||||
| Plate | Standard Plate | |||||||||||||||||
| 1.2 Upper Face | Regular Straight | |||||||||||||||||
| Plate | Mini Plate | Cranial Plate | ||||||||||||||||
| Straight | Straight Mid | |||||||||||||||||
| Plate | ||||||||||||||||||
| 4, 6, 8, 10, | ||||||||||||||||||
| 16, 20 | 0.6 | 8, 24 | 0.6 | 10 | 0.6 | 4, 8, 12, 20 | 0.5 | 4, 16 | 0.5 | 4, 6, 10 | 0.6 | |||||||
| 6, 8 | 0.6 | |||||||||||||||||
| Straight Micro | ||||||||||||||||||
| Plate Bridge | Straight Plate | |||||||||||||||||
| Bridge | Cranial Plate | |||||||||||||||||
| Straight Bar | Straight Mid | |||||||||||||||||
| Plate Long | ||||||||||||||||||
| 4,6 | 0.6 | 4, 6 | 0.6 | 4, 6 | 0.6 | 4 | 0.6 | |||||||||||
| Orbital Micro | Curved Plate | Orbital Plate | ||||||||||||||||
| Curved | Orbital Mid | |||||||||||||||||
| Plate | ||||||||||||||||||
| Plate | 8, 10 | 0.6 | 10 | 0.6 | 8 | 0.6 | 8, 10 | 0.6 | ||||||||||
| L Micro Plate | ||||||||||||||||||
| Bridge | L Plate Bridge | Mini Plate | Cranial Plate L | |||||||||||||||
| Bar | L Mid Plate 90° | |||||||||||||||||
| 4 | 0.6 | 4 | 0.6 | 4 | 0.5 | 4 | 0.6 | 4 | 0.6 | |||||||||
| L Micro Plate | ||||||||||||||||||
| Oblique Bridge | Cranial Plate L | |||||||||||||||||
| 100° | L Mid Plate | |||||||||||||||||
| 100° | ||||||||||||||||||
| 4, 5 | 0.6 | 4, 5 | 0.6 | 4 | 0.6 | |||||||||||||
| L Micro Plate | ||||||||||||||||||
| Orbital | Anatomical | |||||||||||||||||
| Plate | ||||||||||||||||||
| 6 | 0.6, 0.7, 0.8 | 6 | 0.8 | |||||||||||||||
| T Micro Plate | ||||||||||||||||||
| Bridge | T-Plate | T-Plate | T Micro Plate | |||||||||||||||
| 4,5 | 0.6 | 5 | 0.6 | 5 | 0.6 | Mini Plate | Cranial Plate X | Double Y Mid | ||||||||||
| Plate | 5 | 0.5 | ||||||||||||||||
| X Micro Plate | ||||||||||||||||||
| Bridge | X-Plate Bridge | Bar | ||||||||||||||||
| 6 | 0.6 | 6 | 0.6 | 6 | 0.5 | 6 | 0.6 | 6 | 0.6 | |||||||||
| Y Micro Plate | ||||||||||||||||||
| Bridge | Y-Plate Bridge | Cranial Plate Y | ||||||||||||||||
| Bar | ||||||||||||||||||
| 5 | 0.6 | Le Fort I Plate | 5 | 0.6 | Le Fort I Plate | 5 | 0.6 | |||||||||||
| Lefort Micro | ||||||||||||||||||
| Plate | ||||||||||||||||||
| 11 | 0.6 | 11 | 0.9 | 11 | 0.6, 1.0 | |||||||||||||
| Angled Micro | ||||||||||||||||||
| Plate Piriforms | Bifurcated | |||||||||||||||||
| Anterior Maxillary | ||||||||||||||||||
| Plate | Segmental Le | |||||||||||||||||
| Fort I Plate | RC Micro Plate | |||||||||||||||||
| 10 | 0.8 | 12 | 0.8 | 12 | 1.0 | 12 | 0.8 | |||||||||||
| Support | ||||||||||||||||||
| Zygomatic | ||||||||||||||||||
| Micro Plate | Pre-shaped | |||||||||||||||||
| Posterior | ||||||||||||||||||
| Maxillary Plate | ||||||||||||||||||
| 7 | 0.8 | 7 | 0.8 | |||||||||||||||
| H Nasal Micro | ||||||||||||||||||
| Plate | Nasal Plate H | |||||||||||||||||
| Bar | H Micro Plate | |||||||||||||||||
| 12 | 0.6 | 12 | 0.6 | 12 | 0.5 | |||||||||||||
| I Nasal Micro | ||||||||||||||||||
| Plate | Cranial Plate H | |||||||||||||||||
| Bar | ||||||||||||||||||
| 11, 12 | 11 | 0.6 | ||||||||||||||||
| Orbital Floor | ||||||||||||||||||
| Micro Mesh | Orbital Floor | |||||||||||||||||
| Plate | Orbital Floor | |||||||||||||||||
| Mid Plate | ||||||||||||||||||
| --- | 0.3, 0.5 | --- | 0.3, 0.4 | --- | 0.3 | |||||||||||||
| Orbital Floor | ||||||||||||||||||
| Plate | Orbital Floor | |||||||||||||||||
| Plate | Orbital Floor | |||||||||||||||||
| Plate | Orbital Floor | |||||||||||||||||
| Mid Plate | ||||||||||||||||||
| --- | 0.3 | --- | 0.3 | --- | 0.3 | --- | 0.3 | |||||||||||
| COMPARISON | SUBJECT DEVICE | REFERENCE DEVICES | ||||||||||||||||
| K182758 | K022185 | K182609 | K140037 & K160363 | K050934 | K091679 & K103778 | |||||||||||||
| Design/Features | 3D Micro Mesh | 3D Standard Plate | Hexagonal Mesh | Vario Mesh | Mesh Mid Plate | |||||||||||||
| Dimension: | ||||||||||||||||||
| 50x50 mm | ||||||||||||||||||
| 83x83 mm | ||||||||||||||||||
| 122x122 mm | ||||||||||||||||||
| 200x200 mm | 0.6 | 10x10 holes | 0.6 mm | Dimension: | ||||||||||||||
| 50x49 | 0.2 | Dimension: | ||||||||||||||||
| 50x49 | 0.3 | Dimension: | ||||||||||||||||
| 48x33.6 | 0.6 | |||||||||||||||||
| System 2.0 | ||||||||||||||||||
| Design/Features | Description | Hole n° | Thickness (mm) | Description | Hole n° | Thickness (mm) | Description | Holes | Thickness (mm) | Description | Holes | Thickness (mm) | Description | Holes | Thickness (mm) | Description | Holes | Thickness (mm) |
| Straight Mini Plate | 4, 6, 12, 16, 20 | 0.9 | Straight Plate Regular | 4, 6 | 1.0 | Straight Plate | 6 | 0.8 | Straight Plate | 4, 6, 16, 20 | 0.8 | Cranial Plate Straight | 4, 6, 20 | 0.7 | Straight Mini Plate | 6, 16 | 0.8 | |
| 16 | 0.8 | 12 | 0.7 | 16 | 1.0 | |||||||||||||
| Straight Mini Plate Bridge | 4, 6 | 0.9 | Straight Plate Bridge | 4, 6 | 0.8 | Straight Plate | 4 | 0.8 | Cranial Plate Straight Bar | 4, 6 | 1.0 | Straight Mini Plate | 4 | 0.8 | ||||
| Orbital Mini Plate | 6, 8, 10 | 0.9 | Curved Plate | 12 | 0.8 | Curved Plate | 8, 10 | 0.8 | Mini Plate | 6, 8, 10 | 0.5 | Orbital Plate Curved | 6, 8 | 1.0 | Orbital Mini Plate | 10 | 0.8 | |
| L Mini Plate | 4, 6 | 1.0 | L-Plate | 4, 5 | 1.0 | L Mini Plate 90° Regular | 4 | 1.0 | ||||||||||
| L Mini Plate Bridge | 4, 6 | 1.0 | Cranial Plate L 90° Bar | 4 | 0.7 | L Mini Plate 90° Long | 4 | 1.0 | ||||||||||
| L Mini Plate Oblique Bridge | 6 | 1.0 | ||||||||||||||||
| T Mini Plate | 4 | 1.0 | T-Plate | 6 | 1.0 | |||||||||||||
| 6 | 0.9 | |||||||||||||||||
| T Orbital Mini Plate | 8 | 0.9 | T-Plate | 8 | 0.8 | |||||||||||||
| Y Mini Plate | 5 | 0.9 | Y-Plate | 5 | 1.0 | V-Plate | 5 | 0.8 | Cranial Plate L 90° Bar | 5 | 1.0 | |||||||
| S/Z Mini Plate | 4 | 1.0 | Z-Plate | 4 | 0.8 | Z-D Plate | 4 | 0.8 | ||||||||||
| BSSO Dual Angled Mini Plate Bridge | 8 | 0.9, 1.0 | BSSO Plate Double | 8 | 0.8 | OSS Plate Double | 8 | 1.0 | ||||||||||
| Straight Mini Plate Bridge Tab | 4, 6 | 1.0 | ||||||||||||||||
| Chin Mini Plate | 4 | 0.9 | Mentoplasty Plate | 4 | 0.7 | Chin X-Plate | 4 | 1.0 | Chin Mini Plate | 4 | 0.6 | |||||||
| Chin Mini Plate Tab | 4 | 0.8 | ||||||||||||||||
| L Mini Plate Bridge Tab | 4 | 0.9 | ||||||||||||||||
| Design/Features | L Mini Plate Bridge Double Tab | 4 | 0.9 |
14
MCI Medical Concept Innovation Inc.
15
| COMPARISON | SUBJECT DEVICE | REFERENCE DEVICES | |||||
|---|---|---|---|---|---|---|---|
| K182758 | K022185 | K182609 | K140037 & K160363 | K050934 | K091679 & K103778 | ||
| Sagittal Mini Plate Cut Bridge | 6 | 1.0 | |||||
| Sagittal Mini Plate Cut Oblong Bridge | 4 | 1.0 | |||||
| Mini Plate Sagittal | 4 | 1.0 | Sagittal Split Plate Closed | ||||
| 6 | 1.0 | ||||||
| Lambda Mini Plate | 7 | 1.0 | |||||
| Support Mini Plate | 5 | 1.0 | |||||
| Trapezoidal Mini Plate | 4 | 1.0 | T.C.P. Trapezoid Condyle Plate | Condyle Plate | |||
| 4 | 1.0 | ||||||
| Mini Plate Double Pillar for Ment | 6 | 0.6 | Chin Plate Bar | 4 | 1.0 | ||
| 6 | 0.6 | ||||||
| Sterilization | Non-sterile, Steam sterilized prior to use | Non-sterile, Steam sterilized prior to use | |||||
| Single Use | Yes | Yes | Yes | Yes | Yes | Yes |
16
| COMPARISON | SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE DEVICES | ||||||
|---|---|---|---|---|---|---|---|---|---|
| K182758 | K180204 | K944565 | K022185 | ||||||
| Product Code | JEY, DZL | JEY, DZL | JEY, HWC | ||||||
| Raw Material | Titanium alloy (Ti-6Al-4V) | Titanium alloy (Ti-6Al-4V) | Not informed | ||||||
| Surface treatment | Anodized | Anodized | Anodized | Anodized | |||||
| Systems 1.5 and 2.0 | |||||||||
| Design/Features | Type | Diameter | Length | Type | Diameter | Length | Type | Diameter | Length |
| System 2.0 | Cortical Screw | ||||||||
| (Self-tapping) | 1.5 | 4, 5, 6, 8, 9, 10, 11, | |||||||
| 12, 14, 15 | Self-tapping Screw | 1.5 | 4, 5, 6, 8, 9, 10, 11, | ||||||
| 12, 14, 15 | Self-retaining | ||||||||
| Screw maxDrive | 1.5 | 4, 5, 6, 8, 9, 11, | |||||||
| 15 | |||||||||
| 2.0 | 4, 5, 6, 8, 10, 12, | ||||||||
| 14, 16, 18, 20 | 2.0 | 4, 5, 6, 8, 10, 12, | |||||||
| 14, 16, 18 | Self-tapping | ||||||||
| Screw | 2.0 | 4, 5, 6, 8, 10, 12, | |||||||
| 14, 16, 18, 20 | |||||||||
| Cortical Screws | |||||||||
| (Emergency Self- | |||||||||
| tapping) | 1.7 | 5, 6, 8, 10, 12 | Emergency Self- | ||||||
| tapping Screw | 2.3 | 5, 6, 8, 10, 12, 14, | |||||||
| 16, 18 | Self-tapping | ||||||||
| Screw | 1.7 | 5, 6, 8, 10, 12 | |||||||
| 2.3 | 5, 6, 8, 10, 12, 14, | ||||||||
| 16, 18, 20 | 2.3 | 5, 6, 8, 10, 12, | |||||||
| 14, 16, 18, 20 | |||||||||
| Cortical Screw AP | |||||||||
| (Self-drilling) | 1.5 | 4, 5, 6, 7 | Self-drilling Screw | 1.5 | 4, 5, 6, 7 | Drill-Free Screw | |||
| maxDrive | 1.5 | 4, 5, 6, 7 | |||||||
| 2.0 | 4, 5, 6 | 2.0 | 5, 6 | MP Self-drilling | 2.0 | 4, 5, 6 | |||
| Locking Screw AP | |||||||||
| (Self-drilling | |||||||||
| Blocking | |||||||||
| Screw) | 2.0 | 6, 8, 10, 12 | Blocking Screw | 2.0 | 6, 8, 10, 12 | ||||
| Sterilization | Non-sterile, Steam sterilized prior to use | Non-sterile, Steam sterilized prior to use | Non-sterile, Steam sterilized prior to use |
Table 5.4: Comparison between the subject, primary and reference predicate devices for screws
17
PERFORMANCE DATA
The following performance data supports the substantial equivalence determination:
Biocompatibility testing
The plates are manufactured in commercially pure titanium conforming to ASTM F67 and its surfaces are colored-anodized. The plates types of titanium are the same to that used for fabrication of the primary predicate and reference devices.
The screws are made of titanium alloy conforming to ASTM F136 and its surfaces are coloredanodized. The screws alloy is the same to that used for fabrication of the primary predicate and reference devices.
Biocompatibility of the subject devices were supported by the following tests according to its contact profile: Cytotoxicity (ISO 10993-5), Sensitization (ISO 10993-10), Intracutaneous Reactivity (ISO 10993-10), Acute Systemic Toxicity (ISO 10993-11), Subchronic Systemic Toxicity (ISO 10993-11), Implantation (ISO 10993-6), Genotoxicity and Carcinogenicity (ISO 10993-3).
Mechanical testing
The performance of the subject devices are demonstrated through mechanical testing of plates and screws according to ASTM F382 and ASTM F543.
For the plates the 4 point bending fatigue test was performed. For the screws, pullout, torsion, and driving torque were executed. No clinical data were included in this submission.
Shelf life and Sterilization testing
The subject devices are provided non-sterile and have no expiration date defined. Steam sterilization validation was performed according to ISO 17665-1 and 17665-2.
CONCLUSION
The documentation submitted in this premarket notification demonstrates that the subject devices have comparable features and performance and, therefore, are substantially equivalent to the identified primary predicate and reference devices.