(190 days)
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.
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 provided FDA 510(k) summary for the Materialise TruMatch CMF Titanium 3D Printed Implant System (K170272) describes performance data from non-clinical testing and a review of clinical performance data. However, it does not explicitly define acceptance criteria as typically seen for specific sensitivity, specificity, accuracy, or other performance metrics for a diagnostic or AI-driven device.
Instead, the performance data aims to demonstrate substantial equivalence to predicate devices in terms of mechanical properties, biocompatibility, and clinical outcomes based on literature review rather than a direct, head-to-head clinical study powered to show superiority or non-inferiority against a predefined statistical endpoint for this specific device.
Based on the provided information, here's an attempt to structure the requested points, acknowledging the limitations in the original document regarding explicit acceptance criteria and a dedicated study for the device's human-in-the-loop or standalone performance:
Acceptance Criteria and Study for TruMatch CMF Titanium 3D Printed Implant System (K170272)
1. Table of Acceptance Criteria and Reported Device Performance
As explicit quantitative acceptance criteria (e.g., minimum accuracy, sensitivity, specificity) for the device's diagnostic or AI performance are not defined in this 510(k) summary (as it's a patient-specific implant system, not a diagnostic AI device), the "acceptance criteria" can be inferred from the "Results" section of the non-clinical tests. Clinical performance is supported by a literature review, not a specific study with predefined performance metrics for the device itself.
| Category | Assumed (Inferred) Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Testing | Superior or equivalent static bending strength and fatigue bending properties compared to predicate devices. | The subject device has a higher static bending strength and comparable fatigue bending properties compared to the predicate devices (ASTM F382: static and fatigue four-point plate bending). |
| Compatibility | Compatibility with the Synthes fixation system. | The subject device is compatible with the Synthes fixation system (Combination of user need validation lab and engineering rationale). |
| Sterilization | Sterilizable to a Sterility Assurance Level (SAL) of 10^-6. | Can be sterilized to a SAL of 10^-6 using recommended steam sterilization instructions (according to ISO 17665-1:2006, ISO 11737-2:2009 and ISO 14161:2009). |
| Biocompatibility | No cytotoxic effect, in compliance with ISO 10993 guidelines for sensitization, intra-cutaneous reactivity, and systemic toxicity. No toxicological concern from leachable substances. | - No cytotoxic effect. - In compliance with ISO 10993-10 guidelines for sensitization and intra-cutaneous reactivity. - Systemic injection test passed (considered negative based on ISO 10993-11). - No toxicological concern remains from leachable substances. |
| Clinical Performance (Inferred) | Acceptable clinical outcomes in terms of accuracy in transferring surgical plans, predictability of positioning, and minimization of complications (based on literature for patient-specific devices and standard bone plates). | Li et al. 2017 (Patient-specific bone plate fixation): Maximum positional and orientational differences between planned and post-operative positions were within 1.1 mm and 3°. No complications reported. Heufelder et al. 2017 (Subject device): All operations performed successfully, without unexpected incidence. High predictability of maxillary positioning by CAD/CAM fabricated customized surgical guides and patient-specific osteosynthesis plates. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set (for non-clinical testing): Not specified in terms of patient numbers. The "test set" here refers to the device units and materials subjected to mechanical, sterilization, and biocompatibility testing. The number of samples for each test (e.g., number of plates tested for mechanical strength) is not detailed in this summary.
- Data Provenance (for clinical performance):
- Country of Origin: Not explicitly stated for all cited literature. "Li et al. 2017" is likely Asian (given the names), and "Heufelder et al. 2017" involves German researchers (Rana M. often associated with Germany). "Schendel et al. 1978" and "Precious et al. 1985" are likely from Western countries (e.g., USA, Canada) given the names and publication years.
- Retrospective/Prospective: The nature (retrospective/prospective) of each cited clinical study (Schendel et al. 1978, Precious et al. 1985 (1&2), Li et al. 2017, Heufelder et al. 2017) is not specified in this summary. These are generally published clinical studies, not specific studies conducted by Materialise for this 510(k) in a controlled test set format.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- Experts for Non-Clinical Tests: Not applicable in the sense of clinical experts establishing ground truth for device performance. These tests follow standardized protocols (ASTM, ISO).
- Experts for Clinical Literature Review: The clinical performance relies on previously published literature. The experts involved in establishing "ground truth" (i.e., patient outcomes) for those studies would be the clinicians/surgeons who performed the original treatments and assessed the outcomes. Their specific qualifications are not detailed in this 510(k) summary, but implicitly they are medical professionals specializing in maxillofacial surgery.
4. Adjudication Method for the Test Set
- Non-Clinical Testing: Not applicable. Performance is measured objectively according to standard test methods (e.g., force, displacement during mechanical testing; bacterial counts for sterilization).
- Clinical Literature Review: Not applicable. This is a review of existing publications, not a new study requiring adjudication of outcomes for a specific device test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not explicitly reported or conducted for this 510(k) submission. The device is an implant system, not an imaging or AI-assisted diagnostic tool that would typically involve human readers. The clinical evidence relies on a literature review comparing the outcomes of patient-specific plate fixation (which the device provides) to standard bone plate fixation.
- Effect Size of Human Readers Improvement: Not applicable, as no MRMC study was done, and the device's function is not to assist human readers in a diagnostic task.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- The TruMatch CMF Titanium 3D Printed Implant System is a physical implant and associated guides, requiring a human surgeon for implantation. It's not an AI algorithm that functions standalone.
- The system enables patient-specific planning and manufacturing, which could be considered an "algorithm" component in the sense of CAD/CAM processes. The clinical studies (Li et al. 2017, Heufelder et al. 2017) indirectly assess the performance of this patient-specific approach in conjunction with human surgeons, noting high predictability and accurate transfer of surgical plans. However, this is not a "standalone algorithm" in the context of typical AI device evaluation.
7. Type of Ground Truth Used
- Non-Clinical Testing: Ground truth is established by objective measurements based on recognized standards (e.g., mechanical properties conforming to ASTM F382; sterility conforming to ISO standards; biocompatibility conforming to ISO 10993).
- Clinical Performance Review: Ground truth is based on reported patient outcomes from published clinical studies (e.g., "skeletal stability," "little morbidity and few complications," "maximum positional and orientational differences," "high predictability of maxillary positioning," "operations performed successfully without any unexpected incidence"). This could be categorized as outcomes data and expert assessment of clinical success/complications.
8. Sample Size for the Training Set
- Not applicable. This device is not an AI/ML algorithm that requires a "training set" in the traditional sense. It's a medical implant system.
- The patient-specific nature means each implant is "designed" based on an individual patient's CT scan data, but this is a design and manufacturing process, not a machine learning training process.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no AI/ML training set, there is no ground truth established for such a set.
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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-
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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
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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.
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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.
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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:
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| 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
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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 | InterconnectedStraight, L-plate, Y-plate,double Y-plate,combinationsof 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 | InterconnectedStraight,curved,combinationsof 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 |
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| Reconstruction applications: Mandible, midface | ||||
|---|---|---|---|---|
| Brand name | TruMatch CMF Ti 3D-Printed Plates and TruMatch CMF Ti 3D-Printed SurgicalGuides. | |||
| Material | Commercially pure titanium | |||
| Type of design | Patient Specific | |||
| Range of length | 20 mm maximum bridging of osteotomy gapSmall: 20-120mm, Large: 20-294mm | |||
| Type ofapplication | Range ofshapes | Platethickness | Range ofcurvature/angulation | Patient Specific associatedinstrument |
| Mandibularreconstruction(small):Mandibularbone fixation | Straight,curved,crescent,lambda,trapezoidal,strut,subcondylar,combinationsof the above | 1.5-2 mm | 12°/mm length | Mandibular guide |
| Mandibularreconstruction(large):Mandibularbone fixationandmandibularreconstructionwithbonegrafts | Single angle,double angle,curved,doublebarrel,combinationsof the above | 2-3 mm | 12°/mm length | Mandibular guide |
| Midfacereconstruction | Straight, Y, X,H, L, DoubleY, Box, Strut,Oblique L, T | 0.8-1.5 mm | 12°/mm length | Midface guide |
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Comparison to Predicate Devices
| Subject device:TruMatch CMF 3D PrintedImplant System | Primary predicate device:Synthes MatrixORTHOGNATHICPlating System(K083388) | Predicate device:Synthes MatrixMANDIBLEPlate and Screw System(K063790) | Predicate device:Synthes Craniofacial Plate andScrew System(K080331) | |
|---|---|---|---|---|
| Productcode | JEY | JEY | JEY | JEY |
| Classification | Class II | Class II | Class II | Class II |
| IntendedUse | The TruMatch CMF 3D PrintedImplant System is intended forbone repositioning, fixationand reconstruction of themaxillofacial skeleton, midface,mandible and chin inadolescents (greater than 12 to21 years of age) and adults.Specific indications for use:Orthognathic surgery. Reconstructivemandible andmaxillofacial surgery. Mandible andmaxillofacial traumasurgery. | Synthes MatrixORTHOGNATHICPlating System is intended for usein selective trauma of the midfaceand craniofacial skeleton;craniofacial surgery; reconstructiveprocedures; and selectiveorthognathic surgery of themaxilla, mandible, and chin inadolescents (greater than 12 to 21years of age) and adults.Specific Indications for Use:Fractures of the midfaceand craniofacial skeleton. LeFort I osteotomies,sagittal split osteotomies,and genioplasties. Orthognathic surgeryincluding reconstructiveprocedures. | The MatrixMANDIBLE plateand screw system is intendedfor oral, maxillofacial surgery:Trauma. Reconstructivesurgery. Orthognathicsurgery (surgicalcorrection ofdentofacialdeformities) | The Synthes Craniofacial Plate andScrew System is intended for use inselective trauma of the midfaceand craniofacial skeleton,craniofacial surgery, reconstructiveprocedures and selectiveorthognathic surgery of the maxillaand chin |
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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 Titanium3D Printed ImplantSystem | Synthes MatrixORTHOGNATHICPlating System(K083388) | Synthes MatrixMANDIBLEPlate and Screw System(K063790) | Synthes Craniofacial Plate andScrew System(K080331) |
|---|---|---|---|---|
| Product code | JEY | JEY | JEY | JEY |
| Classification | Class II | Class II | Class II | Class II |
| Technicalspecification | 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 puretitanium | Commercially pure titanium | Commercially pure titanium | Commercially pure titanium |
| Manufacturingmethod | 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-specificconfiguration? | Yes. Devices aremanufactured patient-specific, based on a CTscan of the patient. | No. Devices are provided in astandard shape and matched tothe patient's anatomy intra-operatively. | No. Devices are provided in astandard shape and matchedto the patient's anatomyintra-operatively. | No. Devices are provided in astandard shape and matched tothe patient's anatomy intra-operatively. |
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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 fatiguefour point plate bending | The results of this test indicate thatthe subject device has a higherstatic bending strength and hasfatigue bendingproperties compared to thepredicate devices. |
| Compatibility testing | Combination of user needvalidation lab and engineeringrationale | The subject device is compatiblewith the Synthes fixation system. |
| Sterilization test overview | |
|---|---|
| Test / assessment description | Test report conclusion |
| Steam sterilization validation according toISO 17665-1:2006, ISO 11737-2:2009 and ISO14161:2009 | - The results of the steam sterilization validationshow that the implants, accessories and modelscan be sterilized to a SAL of 10-6 using therecommended steam sterilization instructions |
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| 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 ISO10993-10 guidelines |
| • Intra-cutaneous reactivity:ISO 10993-10: Tests for irritation and delayed-type hypersensitivity – Intra-cutaneousInjection Test | - in compliance with requirements of the ISO10993-10 guidelines |
| • Systemic toxicity:ISO 10993-11: Tests for systemic toxicity -Systemic injection test | - test passed and is considered negative basedon standards set by ISO 10993-11 |
| • Chemical characterization:ISO10993-18: Biological Evaluation of MedicalDevices - Part 18: Chemical Characterization ofMaterials (2005). | - chemical characterization as per report |
| • Assessment of allowable limits for leachablesubstances:ISO 10993-17 (2009) "Biological evaluation ofmedical devices — Part 17: Establishment ofallowable limits for leachable substances" | - no toxicological concern remainsfurther biological testing are considered notjustified |
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:
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| Schendel et al.19781 | Precious et al. 1985(1)2 | Precious et al.1985(2)3 | Li et al. 20174 | Heufelder et al.20175Subject device | |
|---|---|---|---|---|---|
| Patient range of age | 8-16 years | 6-15 years | 11-14 years | 18-27 years | 17-59 years |
| Treatment | Standard bone platefixation | Standard bone platefixation | Standard bone platefixation | Patient-specificbone plate fixation | Patient-specificbone plate fixation |
| Results and analysis | The surgical-orthodonticcorrection of mandibulardeficiency in growing children (8to 16 years of age) can be employed toachieve excellent results. Mandibularadvancement by a modified sagittalosteotomy proves to be an acceptableprocedure with good skeletalstability.Dentofacial growth following surgerywill be harmonious and not adverselyaffected. Direction of growth varies,with the mandibular plane anglebecoming more vertical with anincreasing mandibular plane angle. | Surgery for the correction ofdentofacial deformities can beperformed on children andadolescent patients with little morbidityand few complications. | The correction of dentofacialdeformities in children usingorthodontic and surgicalmeans can be carried out reliablyif careful attention is paid to thesystematic evaluation of eachdeformity. Selected cases from morethan 100 children whom we havetreated are presented toillustrate salient clinical features ofspecific deformities. | The maximum positional andorientational differences betweenthe planned and post-operativepositions were within 1.1 mm and3°. The system is capable ofaccurately and effectivelytransferring the surgical planwithout the use of a surgical splint. Nocomplications were reported in thearticle. | In this study all the operations wereperformed successfully, without anyunexpected incidence.The results demonstrate thehigh predictability of maxillary positioningby CAD/CAM fabricatedcustomized surgical guides and patientspecific 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.
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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.
§ 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.