(190 days)
Not Found
No
The summary does not mention AI, ML, or related terms, and the device description focuses on patient-specific 3D printed implants and accessories for surgical planning transfer, not AI/ML-driven analysis or decision support.
Yes
The device is described as an implant system for bone repositioning, fixation, and reconstruction of the maxillofacial skeleton, midface, mandible, and chin, which directly addresses medical conditions and aims to restore normal function.
No
The device is an implant system intended for bone repositioning, fixation, and reconstruction of the maxillofacial skeleton, midface, mandible, and chin. It is a treatment device, not designed to diagnose a condition.
No
The device description explicitly states it is a "System" that provides "patient-specific plates and patient-specific osteotomy and drill accessories," which are physical components. The performance studies also detail mechanical and biocompatibility testing of these physical implants and accessories.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The TruMatch CMF Titanium 3D Printed Implant System is a surgical implant system used for bone repositioning, fixation, and reconstruction within the patient's body. It is a physical device implanted during surgery.
- Intended Use: The intended use clearly describes surgical procedures on the maxillofacial skeleton.
- Device Description: The description focuses on patient-specific plates and surgical accessories, not analysis of biological samples.
- Input: The input is a CT scan of the patient, which is used for planning the surgical procedure and creating the patient-specific implants, not for analyzing biological markers.
The device is a surgical implant system, not a diagnostic tool that analyzes samples outside the body.
N/A
Intended Use / Indications for Use
The TruMatch CMF Titanium 3D Printed Implant System is intended for bone repositioning, fixation and reconstruction of the maxillofacial skelon, midface, mandible and chin in adolescents (greater than 12 to 21 years of age) and adults.
Specific indications for use:
- 0 Orthognathic surgery.
- 0 Reconstructive mandible and maxillofacial surgery.
- O Mandible and maxillofacial trauma surgery.
Product codes
JEY
Device Description
The TruMatch CMF Titanium 3D Printed Implant System is intended for bone repositioning, fixation and reconstruction of the maxillofacial skeleton, midface, mandible and chin.
The TruMatch CMF Titanium 3D Printed Implant System provides a solution with patient-specific plates and patient-specific osteotomy and drill accessories, for the accurate transfer of the surgical plan to the operating room.
The TruMatch CMF Titanium 3D Printed Implant System contains the following applications:
Orthognathic applications: TruMatch CMF Ti 3D-Printed Plates and TruMatch CMF Ti 3D-Printed Surgical Guides. Material: Commercially pure titanium. Type of design: Patient Specific. Range of length: 20 mm maximum advancement. Type of application: Maxillary fixation (Interconnected Straight, L-plate, Y-plate, double Y-plate, combinations of the above), Mandibular fixation BSSO (Single strut, double strut), Mandibular fixation genioplasty (Interconnected Straight, curved, combinations of the above). Plate thickness: 0.8-1.5 mm (maxillary/genioplasty), 1-1.5 mm (mandibular BSSO). Range of curvature/angulation: 0-119° (maxillary/genioplasty), 0-90° (mandibular BSSO). Patient Specific associated instrument: Maxillary guide, BSSO guide, Genioplasty guide.
Reconstruction applications: orbit. Brand name: TruMatch CMF Ti 3D-Printed Implants. Material: Commercially pure titanium. Type of design: Patient Specific. Plate width: 5.5-45 mm. Type of application: Orbital fracture treatment. Plate thickness: 0.8-1.2 mm. Range of curvature: 12°/mm length. Patient Specific associated instrument: Orbital guide.
Reconstruction applications: Mandible, midface. Brand name: TruMatch CMF Ti 3D-Printed Plates and TruMatch CMF Ti 3D-Printed Surgical Guides. Material: Commercially pure titanium. Type of design: Patient Specific. Range of length: 20 mm maximum bridging of osteotomy gap Small: 20-120mm, Large: 20-294mm. Type of application: Mandibular reconstruction (small): Mandibular bone fixation, Mandibular reconstruction (large): Mandibular bone fixation and mandibular reconstruction with bone grafts, Midface reconstruction. Range of shapes: Straight, curved, crescent, lambda, trapezoidal, strut, subcondylar, combinations of the above (mandibular small); Single angle, double angle, curved, double barrel, combinations of the above (mandibular large); Straight, Y, X, H, L, Double Y, Box, Strut, Oblique L, T (midface). Plate thickness: 1.5-2 mm (mandibular small), 2-3 mm (mandibular large), 0.8-1.5 mm (midface). Range of curvature/angulation: 12°/mm length. Patient Specific associated instrument: Mandibular guide, Midface guide.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scan of the patient.
Anatomical Site
maxillofacial skeleton, midface, mandible and chin
Indicated Patient Age Range
adolescents (greater than 12 to 21 years of age) and adults.
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 testing was conducted including:
- Performance testing of the TruMatch CMF Titanium 3D Printed implants and accessories:
- Mechanical performance of the subject device compared to the predicate devices: ASTM F382 (static and fatigue four point plate bending). Results: The subject device has a higher static bending strength and has fatigue bending properties compared to the predicate devices.
- Compatibility testing: Combination of user need validation lab and engineering rationale. Results: The subject device is compatible with the Synthes fixation system.
- Biocompatibility testing:
- Cytotoxicity: ISO 10993-5 (L929 Neutral red uptake Cytotoxicity). Conclusion: no cytotoxic effect.
- Sensitization: ISO 10993-10 (Kligman Maximization test). Conclusion: in compliance with requirements of the ISO 10993-10 guidelines.
- Intra-cutaneous reactivity: ISO 10993-10 (Intra-cutaneous Injection Test). Conclusion: in compliance with requirements of the ISO 10993-10 guidelines.
- Systemic toxicity: ISO 10993-11 (Systemic injection test). Conclusion: test passed and is considered negative based on standards set by ISO 10993-11.
- Chemical characterization: ISO10993-18 (Chemical Characterization of Materials (2005)). Conclusion: chemical characterization as per report.
- Assessment of allowable limits for leachable substances: ISO 10993-17 (Establishment of allowable limits for leachable substances). Conclusion: no toxicological concern remains, further biological testing are considered not justified.
- Sterilization testing:
- Steam sterilization validation according to ISO 17665-1:2006, ISO 11737-2:2009 and ISO 14161:2009. Conclusion: The implants, accessories and models can be sterilized to a SAL of 10^-6 using the recommended steam sterilization instructions.
Clinical performance was assessed by analyzing 5 clinical studies from published literature including patients from 8-21 years and adults. Key results include:
- Schendel et al. 1978: The surgical-orthodontic correction of mandibular deficiency in growing children (8 to 16 years of age) can be employed to achieve excellent results. Mandibular advancement by a modified sagittal osteotomy proves to be an acceptable procedure with good skeletal stability. Dentofacial growth following surgery will be harmonious and not adversely affected. Direction of growth varies, with the mandibular plane angle becoming more vertical with an increasing mandibular plane angle.
- Precious et al. 1985 (1) & (2): Surgery for the correction of dentofacial deformities can be performed on children and adolescent patients with little morbidity and few complications. The correction of dentofacial deformities in children using orthodontic and surgical means can be carried out reliably if careful attention is paid to the systematic evaluation of each deformity.
- Li et al. 2017: The maximum positional and orientational differences between the planned and post-operative positions were within 1.1 mm and 3°. The system is capable of accurately and effectively transferring the surgical plan without the use of a surgical splint. No complications were reported in the article.
- Heufelder et al. 2017 (Subject device): In this study all the operations were performed successfully, without any unexpected incidence. The results demonstrate the high predictability of maxillary positioning by CAD/CAM fabricated customized surgical guides and patient specific osteosynthesis plates.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 8, 2017
Materialise N.V. Lina Ramirez Regulatory Officer Technologielaan 15 Leuven, 3001 Belgium
Re: K170272
Trade/Device Name: TruMatch CMF Titanium 3D Printed Implant System Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: Class II Product Code: JEY Dated: July 14, 2017 Received: July 17, 2017
Dear Lina Ramirez:
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. 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 801); medical device reporting of medical device-
Image /page/0/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
1
related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Mary S. Runner -S
for Michael Ryan 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name
TruMatch CMF Titanium 3D Printed Implant System
Indications for Use (Describe)
The TruMatch CMF Titanium 3D Printed Implant System is intended for bone repositioning, fixation and reconstruction of the maxillofacial skelon, midface, mandible and chin in adolescents (greater than 12 to 21 years of age) and adults.
Specific indications for use:
- 0 Orthognathic surgery.
- 0 Reconstructive mandible and maxillofacial surgery.
- O Mandible and maxillofacial trauma surgery.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(K) SUMMARY
K170272
The following section is included as required by the Safe Medical Devices Act (SMDA) of 1990 and 21CFR 807.92
Submitter information
| Company name | Materialise N.V. |
|---|---|
| Establishment registration number | 3003998208 |
| Street Address | Technologielaan 15 |
| City | Leuven |
| Zip code | 3001 |
| Country | Belgium |
| Phone number | +32 16 74 49 56 |
| Fax number | +32 16 39 66 00 |
| Principal contact person | Lina Ramirez |
| Contact title | Regulatory Officer |
| Contact e-mail address | regulatory.affairs@materialise.be |
| Additional contact person | Mieke Janssen |
| Contact title | Senior Regulatory Officer |
| Contact e-mail address | mieke.janssen@materialise.be |
Date of preparation
This summary was last updated on August 4, 2017.
4
Submission information
| TruMatch CMF Titanium 3D Printed Implant System | |
|---|---|
| Trade name(s) | TruMatch CMF Ti 3D-Printed Plates and TruMatch CMF Ti 3D- |
| Printed Surgical Guides. | |
| Trade name(s) | TruMatch CMF Ti 3D-Printed Implants. |
| Common or Usual name | Bone plate |
| Classification name | Bone plate |
| Product code (classification regulation) | JEY |
| Classification Panel | Dental |
| Device class | Class II (21 CFR 872.4760) |
Predicate devices
The primary predicate device to which substantial equivalence is claimed to:
| Primary predicate: Synthes MatrixORTHOGNATHIC Plating System | |
|---|---|
| Bone plate and screw | |
| Trade or proprietary or model name | Synthes MatrixORTHOGNATHIC Plating System |
| 510(k) number | K083388 |
| Decision date | 03/12/2009 |
| Product code | JEY (21 CFR 872.4760) |
| Manufacturer | Synthes (USA) |
Additional predicate devices to which substantial equivalence is claimed to:
5
| Synthes MatrixMANDIBLE Plate and Screw System | |
|---|---|
| Bone plate and screw | |
| Trade or proprietary or model name | Synthes MatrixMANDIBLE Plate and Screw System |
| 510(k) number | K063790 |
| Decision date | 04/16/2007 |
| Product code | JEY (21 CFR 872.4760) |
| Manufacturer | Synthes (USA) |
| Synthes Craniofacial Plate and Screw System | |
|---|---|
| Bone plate and screw | |
| Trade or proprietary or model name | Synthes Craniofacial Plate and Screw System |
| 510(k) number | K080331 |
| Decision date | 04/30/2008 |
| Product code | JEY (21 CFR 872.4760) |
| Manufacturer | Synthes (USA) |
Device Information
Indications for use
The TruMatch CMF Titanium 3D Printed Implant System is intended for bone repositioning, fixation and reconstruction of the maxillofacial skeleton, midface, mandible and chin in adolescents (greater than 12 to 21 years of age) and adults.
Specific indications for use:
- o Orthognathic surgery.
- Reconstructive mandible and maxillofacial surgery. o
- Mandible and maxillofacial trauma surgery. o
6
Device Description
The TruMatch CMF Titanium 3D Printed Implant System is intended for bone repositioning, fixation and reconstruction of the maxillofacial skeleton, midface, mandible and chin.
The TruMatch CMF Titanium 3D Printed Implant System provides a solution with patient-specific plates and patient-specific osteotomy and drill accessories, for the accurate transfer of the surgical plan to the operating room.
The TruMatch CMF Titanium 3D Printed Implant System contains the following applications:
| Orthognathic applications | ||||||
|---|---|---|---|---|---|---|
| Brand name | TruMatch CMF Ti 3D-Printed Plates and TruMatch CMF Ti 3D-Printed Surgical Guides. | |||||
| Material | Commercially pure titanium | |||||
| Type of design | Patient Specific | |||||
| Range of length | 20 mm maximum advancement | |||||
| Type of application | Range of shapes | Plate thickness | Range ofcurvature/angulation | Patient Specific associated instrument | ||
| Maxillary fixation | Interconnected | |||||
| Straight, L-plate, Y-plate, | ||||||
| double Y-plate, | ||||||
| combinations | ||||||
| of the above | 0.8-1.5 mm | 0-119° | Maxillary guide | |||
| Mandibular fixation BSSO | Single strut, | |||||
| double strut | 1-1.5 mm | 0-90° | BSSO guide | |||
| Mandibular fixation genioplasty | Interconnected | |||||
| Straight, | ||||||
| curved, | ||||||
| combinations | ||||||
| of the above | 0.8-1.5 mm | 0-119° | Genioplasty guide | |||
| Reconstruction applications: orbit | ||||||
| Brand name | TruMatch CMF Ti 3D-Printed Implants. | |||||
| Material | Commercially pure titanium | |||||
| Type of design | Patient Specific | |||||
| Plate width | 5.5-45 mm | |||||
| Type of application | Plate thickness | Range of curvature | Patient Specific associated instrument | |||
| Orbital fracture treatment | 0.8-1.2 mm | 12°/mm length | Orbital guide |
7
| Reconstruction applications: Mandible, midface | ||||
|---|---|---|---|---|
| Brand name | TruMatch CMF Ti 3D-Printed Plates and TruMatch CMF Ti 3D-Printed Surgical | |||
| Guides. | ||||
| Material | Commercially pure titanium | |||
| Type of design | Patient Specific | |||
| Range of length | 20 mm maximum bridging of osteotomy gap | |||
| Small: 20-120mm, Large: 20-294mm | ||||
| Type of | ||||
| application | Range of | |||
| shapes | Plate | |||
| thickness | Range of | |||
| curvature/angulation | Patient Specific associated | |||
| instrument | ||||
| Mandibular | ||||
| reconstruction | ||||
| (small): | ||||
| Mandibular | ||||
| bone fixation | Straight, | |||
| curved, | ||||
| crescent, | ||||
| lambda, | ||||
| trapezoidal, | ||||
| strut, | ||||
| subcondylar, | ||||
| combinations | ||||
| of the above | 1.5-2 mm | 12°/mm length | Mandibular guide | |
| Mandibular | ||||
| reconstruction | ||||
| (large): | ||||
| Mandibular | ||||
| bone fixation | ||||
| and | ||||
| mandibular | ||||
| reconstruction | ||||
| with | ||||
| bone | ||||
| grafts | Single angle, | |||
| double angle, | ||||
| curved, | ||||
| double | ||||
| barrel, | ||||
| combinations | ||||
| of the above | 2-3 mm | 12°/mm length | Mandibular guide | |
| Midface | ||||
| reconstruction | Straight, Y, X, | |||
| H, L, Double | ||||
| Y, Box, Strut, | ||||
| Oblique L, T | 0.8-1.5 mm | 12°/mm length | Midface guide |
8
Comparison to Predicate Devices
| Subject device:
TruMatch CMF 3D Printed
Implant System | Primary predicate device:
Synthes MatrixORTHOGNATHIC
Plating System
(K083388) | Predicate device:
Synthes MatrixMANDIBLE
Plate and Screw System
(K063790) | Predicate device:
Synthes Craniofacial Plate and
Screw System
(K080331) | |
|--------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product
code | JEY | JEY | JEY | JEY |
| Classification | Class II | Class II | Class II | Class II |
| Intended
Use | The TruMatch CMF 3D Printed
Implant System is intended for
bone repositioning, fixation
and reconstruction of the
maxillofacial skeleton, midface,
mandible and chin in
adolescents (greater than 12 to
21 years of age) and adults.
Specific indications for use:
Orthognathic surgery. Reconstructive
mandible and
maxillofacial surgery. Mandible and
maxillofacial trauma
surgery. | Synthes MatrixORTHOGNATHIC
Plating System is intended for use
in selective trauma of the midface
and craniofacial skeleton;
craniofacial surgery; reconstructive
procedures; and selective
orthognathic surgery of the
maxilla, mandible, and chin in
adolescents (greater than 12 to 21
years of age) and adults.
Specific Indications for Use:
Fractures of the midface
and craniofacial skeleton. LeFort I osteotomies,
sagittal split osteotomies,
and genioplasties. Orthognathic surgery
including reconstructive
procedures. | The MatrixMANDIBLE plate
and screw system is intended
for oral, maxillofacial surgery:
Trauma. Reconstructive
surgery. Orthognathic
surgery (surgical
correction of
dentofacial
deformities) | The Synthes Craniofacial Plate and
Screw System is 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 |
9
Both subject device and primary predicate have indications for use: orthognathic surgery, including Le Fort I osteotomies, saggital split osteotomies and genioplasty, reconstructive surgery and trauma of the mandible and maxillofacial skeleton.
The subject device is additionally indicated for midface reconstruction and for midface reconstruction including orbital reconstruction. These additional indications for use are covered by the secondary predicates.
| Characteristics | TruMatch CMF Titanium
3D Printed Implant
System | Synthes MatrixORTHOGNATHIC
Plating System
(K083388) | Synthes MatrixMANDIBLE
Plate and Screw System
(K063790) | Synthes Craniofacial Plate and
Screw System
(K080331) |
|------------------------------------|----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|
| Product code | JEY | JEY | JEY | JEY |
| Classification | Class II | Class II | Class II | Class II |
| Technical
specification | Bone plate | Bone plate | Bone plate | Bone plate |
| Fixation method | Synthes screw system | Synthes screw system | Synthes screw system | Synthes screw system |
| Material(s) | Commercially pure
titanium | Commercially pure titanium | Commercially pure titanium | Commercially pure titanium |
| Manufacturing
method | Additive manufacturing | Machined | Machined | Machined |
| Provided sterile? | No | No | No | No |
| Sterilization method | Moist heat | Moist heat | Moist heat | Moist heat |
| Plate thickness | 0.8 mm – 3.0 mm | 0.5 mm – 1.0 mm | 1.0 mm – 2.8 mm | 0.2 mm – 0.5 mm |
| Patient-specific
configuration? | Yes. Devices are
manufactured patient-
specific, based on a CT
scan of the patient. | No. Devices are provided in a
standard shape and matched to
the patient's anatomy intra-
operatively. | No. Devices are provided in a
standard shape and matched
to the patient's anatomy
intra-operatively. | No. Devices are provided in a
standard shape and matched to
the patient's anatomy intra-
operatively. |
10
Both the subject device and all predicates are manufactured in commercially pure titanium and have the same fixation method.
Both the subject device and the predicate devices are not provided sterile and have the same sterilization method, moist heat.
The manufacturing technique differs between the subject device and the reference devices. While the subject device is manufactured by additive manufacturing, the predicate devices are machined.
The subject device is made patient specific, manufactured from patient CT scan data, while the predicate devices are provided in a standard shape and adapted to the patient intra-operatively.
Performance data
The following non-clinical testing was conducted as a basis for the determination of substantial equivalence:
- . Performance testing of the TruMatch CMF Titanium 3D Printed implants and accessories, including
- o Mechanical performance of the subject device compared to the predicate devices
- o Compatibility testing
- Biocompatibility testing
- Sterilization testing
An overview of the testing performed can be found below.
| Performance testing overview | ||
|---|---|---|
| Test | Test method summary | Results |
| Mechanical testing | ASTM F382: static and fatigue | |
| four point plate bending | The results of this test indicate that | |
| the subject device has a higher | ||
| static bending strength and has | ||
| fatigue bending | ||
| properties compared to the | ||
| predicate devices. | ||
| Compatibility testing | Combination of user need | |
| validation lab and engineering | ||
| rationale | The subject device is compatible | |
| with the Synthes fixation system. |
| Sterilization test overview | |
|---|---|
| Test / assessment description | Test report conclusion |
| Steam sterilization validation according to | |
| ISO 17665-1:2006, ISO 11737-2:2009 and ISO | |
| 14161:2009 | - The results of the steam sterilization validation |
| show that the implants, accessories and models | |
| can be sterilized to a SAL of 10-6 using the | |
| recommended steam sterilization instructions |
11
| Biocompatibility test overview | |
|---|---|
| Test / assessment description | Test report conclusion |
| • Cytotoxicity: | |
| ISO 10993-5: Tests for in-vitro cytotoxicity - | |
| L929 Neutral red uptake Cytotoxicity | - no cytotoxic effect |
| • Sensitization: | |
| ISO 10993-10: Tests for irritation and delayed- | |
| type hypersensitivity - Kligman Maximization test | - in compliance with requirements of the ISO |
| 10993-10 guidelines | |
| • Intra-cutaneous reactivity: | |
| ISO 10993-10: Tests for irritation and delayed- | |
| type hypersensitivity – Intra-cutaneous | |
| Injection Test | - in compliance with requirements of the ISO |
| 10993-10 guidelines | |
| • Systemic toxicity: | |
| ISO 10993-11: Tests for systemic toxicity - | |
| Systemic injection test | - test passed and is considered negative based |
| on standards set by ISO 10993-11 | |
| • Chemical characterization: | |
| ISO10993-18: Biological Evaluation of Medical | |
| Devices - Part 18: Chemical Characterization of | |
| Materials (2005). | - chemical characterization as per report |
| • Assessment of allowable limits for leachable | |
| substances: | |
| ISO 10993-17 (2009) "Biological evaluation of | |
| medical devices — Part 17: Establishment of | |
| allowable limits for leachable substances" | - no toxicological concern remains |
| further biological testing are considered not | |
| justified |
Clinical performance of the device in the patient population of adolescents (greater than 21 to 21 years of age) and adults
To demonstrate clinical performance of the TruMatch CMF Titanium 3D Printed Implant System in the patient population of adolescents (greater than 21 to 21 years of age) and adults, 5 clinical studies including patients from 8-21 years and adults, were analyzed:
12
| | Schendel et al.
19781 | Precious et al. 1985
(1)2 | Precious et al.
1985(2)3 | Li et al. 20174 | Heufelder et al.
20175
Subject device |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Patient range of age | 8-16 years | 6-15 years | 11-14 years | 18-27 years | 17-59 years |
| Treatment | Standard bone plate
fixation | Standard bone plate
fixation | Standard bone plate
fixation | Patient-specific
bone plate fixation | Patient-specific
bone plate fixation |
| Results and analysis | The surgical-orthodontic
correction of mandibular
deficiency in growing children (8
to 16 years of age) can be employed to
achieve excellent results. Mandibular
advancement by a modified sagittal
osteotomy proves to be an acceptable
procedure with good skeletal
stability.
Dentofacial growth following surgery
will be harmonious and not adversely
affected. Direction of growth varies,
with the mandibular plane angle
becoming more vertical with an
increasing mandibular plane angle. | Surgery for the correction of
dentofacial deformities can be
performed on children and
adolescent patients with little morbidity
and few complications. | The correction of dentofacial
deformities in children using
orthodontic and surgical
means can be carried out reliably
if careful attention is paid to the
systematic evaluation of each
deformity. Selected cases from more
than 100 children whom we have
treated are presented to
illustrate salient clinical features of
specific deformities. | The maximum positional and
orientational differences between
the planned and post-operative
positions were within 1.1 mm and
3°. The system is capable of
accurately and effectively
transferring the surgical plan
without the use of a surgical splint. No
complications were reported in the
article. | In this study all the operations were
performed successfully, without any
unexpected incidence.
The results demonstrate the
high predictability of maxillary positioning
by CAD/CAM fabricated
customized surgical guides and patient
specific osteosynthesis plates. |
Based on published literature findings of the subject device and similar bone plate devices and a risk analysis, it can be concluded that the subject device can be used for treatment of the adolescent patient population (greater than 12 to 21 years of age), if additional precautions are taken into account:
4 Schendel S., Wolford M., Epker N. "Surgical advancement of the deficient mandible in growing children: Treatments", Journal of Oral Surgery, Volume 45, No 3., pp 364-377.
4 Precious D.S., McFadden L.R., Fitch S.J. "Orthognathic surgery for children, analysis of 88 consecutive cases" Int J. of Oral Surgery, 1985, Volume 14, pp 466-471
3 Precious D.S., McFadden L.R., Fitch S.J. "Orthognathic surgery for children, analysis of 88 consecutive cases" Int J. of Oral Surgery, 1985, Volume 14, pp 466-471
4 B. Li, S. Shen, W. liang, J. Li, T. Jiang, J.J. Wang. " A new approach to splint-less orthognathic surgery using a personalized orthognathic surgical guide system: A preliminary study, Int J. of Oral Surgery 2017
్ Heufelder M., Wilde F., Pietzka S., Mascha F., Winter K., Schramm A., Rana M. "Clinical accuracy of waferless maxillary positioning using customized surgical guides and patient specific osteosynthesis in bimaxillary orthognathic surgery, 2017 510(k) Summary K170272 - Materialise N.V.
13
Important considerations in achieving quality outcomes for the treatment of facial deformities in growing patients include accurate diagnosis and patient selection and proper treatment planning.
Conclusion
Non clinical tests and a review of clinical performance data demonstrate that the TruMatch CMF Titanium 3D Printed Implant System is substantially equivalent to the predicate devices.