tmCMF Solution

K233874 · Techmah Cmf · JEY · Jul 11, 2024 · Dental

Device Facts

• Record ID: K233874
• Device Name: tmCMF Solution
• Applicant: Techmah Cmf
• Product Code: JEY · Dental
• Decision Date: Jul 11, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4760
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The tmCMF Solution is intended for use as a software system and image segmentation system for the transfer of imaging information from a medical scanner such as a CT-based system. The input data file is processed by the tmCMF Solution, and the result is an output data file that may then be provided as digital models or used as input to a manufacturing portion of the system that produces physical outputs, including anatomical models, surgical guides, dental splints, and implants for use in maxillofacial, midface, and mandibular surgery. Implants are intended for bone fixation and reconstruction, restoration of bone defects, and intended to provide continuity in regions where the bone is missing and/or to augment the bone by means of an onlay device in the maxillofacial skeleton, midface, mandible, and chin in adolescents (greater than 12 to 21 years of age) and adults. The tmCMF Solution is also intended as a preoperative software tool for simulating/evaluating virtual surgical treatment options.

Device Story

tmCMF Solution is a software-based system for patient-specific maxillofacial, midface, and mandibular surgical planning; inputs CT/dental scan data; processes images via segmentation; produces digital models and physical outputs including anatomical models, surgical guides, dental splints, and patient-specific implants. Used by surgeons in clinical settings for reconstructive, orthognathic, trauma, and augmentation procedures. Software allows surgeons to review surgical plans and hardware designs via web interface. Physical implants and guides assist in bone repositioning, fixation, and osteotomy marking/cutting. Benefits include improved anatomical fit, structural integrity in bone-deficient regions, and precise transfer of pre-operative plans to the OR. Implants are manufactured from titanium alloy (Ti-6Al-4V).

Clinical Evidence

Bench testing only. Performance validated via cleaning protocols (AAMI TIR 30), sterilization (ISO 17665, ISO 11607), biocompatibility (ISO 10993-1, -5, -10, -11, -17, -18, -23, USP <151>), software V&V (IEC 62304), usability (IEC 62366-1), magnetic compatibility (ASTM F2182, F2052, F2213), and mechanical testing (ASTM F382-17).

Technological Characteristics

Materials: Titanium alloy (Ti-6Al-4V). Sensing/Actuation: Image segmentation of CT/dental scans. Connectivity: Web-based interface. Sterilization: Steam sterilization (SAL 1x10^-6). Software: Web-based planning tool. Hardware: Patient-specific implants, surgical guides, anatomical models, dental splints. Mechanical: Compatible with locking/non-locking screws.

Indications for Use

Indicated for use in maxillofacial, midface, and mandibular surgery for bone fixation, reconstruction, restoration of bone defects, and bone augmentation (onlay device) in adolescents (12-21 years) and adults. Includes preoperative simulation and virtual surgical planning.

Regulatory Classification

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.

Predicate Devices

• tmCMF Solution (K231520)
• TruMatch CMF Titanium 3D Printed Implant (K173039)
• TruMatch CMF Titanium 3D Printed Implant System (K170272)

Reference Devices

• SYNTHES MATRIXMANDIBLE PLATE AND SCREW (K063790)
• KLS Martin Individual Patient Solutions (K210731)
• SurgiCase Viewer (K213684)
• Synthes Craniofacial Plate and Screw System (K080331)
• Synthes (USA) Craniofacial Plate and Screw System (K050608)
• SYNTHES MATRIXORTHOGNATHIS FIXATION SYSTEM (K083388)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

July 11, 2024

TechMah CMF Lyndsay Bowers VP Quality 2099 Thunderhead Road, Suite 302 Knoxville, Tennessee 37922

Re: K233874

Trade/Device Name: tmCMF Solution Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: Class II Product Code: JEY, DZJ, LLZ Dated: June 21, 2024 Received: June 21, 2024

Dear Lyndsay Bowers:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

**Sherrill Lathrop Blitzer**

for Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia,

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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

Submission Number (if known)

K233874

Device Name

tmCMF Solution

#### Indications for Use (Describe)

The tmCMF Solution is intended for use as a software system and image segmentation system for the transfer of imaging information from a medical scanner such as a CT-based system. The input data file is processed by the tmCMF Solution, and the result is an output data file that may then be provided as digital models or used as input to a manufacturing portion of the system that produces physical outputs, including anatomical models, surgical guides, dental splints, and implants for use in maxillofacial, midface, and mandibular surgery. Implants are intended for bone fixation and reconstruction. restoration of bone defects, and intended to provide continuity in regions where the bone is missing and/or to augment the bone by means of an onlay device in the maxillofacial skeleton, midface, mandible, and chin in adolescents (greater than 12 to 21 years of age) and adults. The tmCMF Solution is also intended as a preoperative software tool for simulating/ evaluating virtual surgical treatment options.

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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# K233874 510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92:

### Date Prepared: July 8, 2024

# I. CONTACT DETAILS

| Applicant Name: | TechMah CMF, LLC |
|----------------------------------|---------------------------------------------------------------------|
| Applicant Contact Telephone: | +1.865.200.4376 |
| Applicant Contact: | Dr. Mohamed Mahfouz |
| Applicant Contact Email: | [e-mail] |
| Applicant Address: | 2099 Thunderhead Rd, Suite 302<br>Knoxville, TN 37922 United States |
| Correspondent Name: | TechMah CMF, LLC |
| Correspondent Contact Telephone: | +1.410.258.2770 |
| Correspondent Contact: | Mrs. Lyndsay Bowers |
| Correspondent Contact Email: | [e-mail] |
| Correspondent Address: | 2099 Thunderhead Rd, Suite 302<br>Knoxville, TN 37922 United States |

# II. DEVICE NAME

| Device Trade Name: | tmCMF Solution |
|--------------------------|------------------|
| Regulation Name: | Dental |
| Classification Name: | Plate, Bone |
| Regulation Number: | 21 CFR §872.4120 |
| Product Code: | JEY |
| Subsequent Product Code: | DZJ, LLZ |

# III. LEGALLY MARKETED PREDICATE DEVICES

| Predicate Number: | K231520 |
|----------------------------------------|---------------------------------------------------|
| Predicate Trade Name: | tmCMF Solution |
| Product Code: | DZJ & LLZ |
| Use: | Primary Predicate |
| Predicate Number: | K173039 |
| Predicate Trade Name: | TruMatch CMF Titanium 3D Printed Implant |
| Product Code: | JEY |
| Use: | Secondary Predicate |
| Predicate Number: | K170272 |
| Predicate Trade Name: | TruMatch CMF Titanium 3D Printed Implant System |
| Product Code: | JEY |
| Use: | Secondary Predicate |
| IV. LEGALLY MARKETED REFERENCE DEVICES | |
| Predicate Number: | K063790 |
| Predicate Trade Name:<br>SYSTEM | SYNTHES MATRIXMANDIBLE PLATE AND SCREW |
| Product Code: | JEY |
| Predicate Number: | K210731 |
| Predicate Trade Name: | KLS Martin Individual Patient Solutions |
| Product Code: | JEY |
| Predicate Number: | K213684 |
| Predicate Trade Name: | SurgiCase Viewer |
| Product Code: | LLZ |
| Predicate Number: | K080331 |
| Predicate Trade Name: | Synthes Craniofacial Plate and Screw System |
| Product Code: | JEY |
| Predicate Number: | K050608 |
| Predicate Trade Name: | Synthes (USA) Craniofacial Plate and Screw System |
| Product Code: | JEY |
| Predicate Number: | K083388 |
| Predicate Trade Name: | SYNTHES MATRIXORTHOGNATHIS FIXATION SYSTEM |
| Product Code: | JEY |

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# V. DEVICE DESCRIPTION SUMMARY

TechMah CMF (tmCMF) Solution is a family of personalized product solutions for Reconstructive, Orthognathic, Trauma, and Augmentation procedures in the mandible and midface (including orbital floor, medial and lateral orbital walls). The solution is comprised of Surgeon Review Tool (SRT) software and maxillofacial and mandibular surgical instruments (surgical guides, anatomical models, and dental splints) and implants. The surgical instruments and implants are patient-specific devices and are designed utilizing CT and dental scan patient image data.

Surgical guides are patient-specific devices or templates based on pre-operative software planning designed to fit a specific patient. These guides are used to assist a surgeon in transferring the pre-operative plan to the surgery by guiding the marking/drilling of bone for plate fixation screws and the position of the osteotomy marking/cutting slots. Guides can be used in conjunction with anatomical models to verify anatomical positioning and fit. Surgical guides can be used with either tmCMF Solution patient-specific implants or compatible off-the-shelf DePuy Synthes implants.

Anatomical models are patient-specific models that are based on pre-operative anatomy and surqical planning specific to a patient. These models are used to assist a surgeon in transferring the pre-operative plan to the surgery by representing pre-operative, intra-operative, and post-operative anatomical models as quidance. Anatomical models can be used to check quide fit and facilitate the pre-bending of a non-patient-specific off-the-shelf plate.

Dental splints are patient-specific devices or templates based on pre-operative software planning designed to fit a specific patient. These templates are used to assist a surgeon in transferring the pre-operative plan to the surgery by guiding the dental alignment of bone and teeth.

Implants are patient-specific devices that are based on pre-operative software planning designed to fit a specific patient. These implants are integral components for CMF (craniomaxillofacial) procedures, facilitating bone repositioning, fixation, reconstruction, and the restoration of bone defects. They are designed according to the pre-operative surgical plan to ensure continuity in regions where bone is absent and to provide structural integrity to the maxillofacial skeletal components, midface, mandible, and chin. This could include stabilizing fractured or intraoperatively cut bone, fixating harvested graft segments, or augmenting bone defects. Implants can be used in conjunction with surgical guides and anatomical models to assist with anatomical positioning and fit.

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The Surgeon Review Tool (SRT) software is used by surgeons for the review of surgical plans, surgical instruments, and implant designs. The SRT software is accessed through a web interface.

tmCMF Solution supports the following maxillofacial, midface (including orbital floor, lateral and medial orbital wall), and mandibular surgical procedures:

- . Reconstructive
- Orthognathic
- Trauma
- Augmentation ●

## VI. INTENDED USE/INDICATIONS FOR USE

The tmCMF Solution is intended for use as a software system and image segmentation system for the transfer of imaging information from a medical scanner such as a CT-based system. The input data file is processed by the tmCMF Solution, and the result is an output data file that may then be provided as digital models or used as input to a manufacturing portion of the system that produces physical outputs, including anatomical models, surgical guides, dental splints, and implants for use in maxillofacial, midface, and mandibular surgery. Implants are intended for bone fixation and reconstruction, restoration of bone defects, and intended to provide continuity in regions where the bone is missing and/or to augment the bone by means of an onlay device in the maxillofacial skeleton, midface, mandible, and chin in adolescents (greater than 12 to 21 years of age) and adults. The tmCMF Solution is also intended as a preoperative software tool for simulating/evaluating virtual surgical treatment options.

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## VII. SUBSTANTIAL EQUIVALENCE COMPARISON

### Comparison of the Subject Device to the Primary Predicate Device

| | tmCMF Solution<br>(subject device) | tmCMF Solution<br>(Primary predicate device<br>K231520) | Comment on Substantial<br>Equivalence |
|-----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for Use | The tmCMF Solution is intended for<br>use as a software system and image<br>segmentation system for the transfer<br>of imaging information from a medical<br>scanner such as a CT-based system.<br>The input data file is processed by the<br>tmCMF Solution, and the result is an<br>output data file that may then be<br>provided as digital models or used as<br>input to a manufacturing portion of the<br>system that produces physical<br>outputs, including anatomical models,<br>surgical guides, dental splints, and<br>implants for use in maxillofacial,<br>midface, and mandibular surgery.<br>Implants are intended for bone fixation<br>and reconstruction, restoration of<br>bone defects, and intended to provide<br>continuity in regions where the bone is<br>missing and/or to augment the bone<br>by means of an onlay device in the<br>maxillofacial skeleton, midface,<br>mandible, and chin in adolescents<br>(greater than 12 to 21 years of age)<br>and adults. The tmCMF Solution is<br>also intended as a preoperative<br>software tool for simulating/evaluating<br>surgical treatment options. | The tmCMF Solution is intended for<br>use as a software system and image<br>segmentation system for the transfer<br>of imaging information from a medical<br>scanner such as a CT-based system.<br>The input data file is processed by the<br>tmCMF Solution, and the result is an<br>output data file that may then be<br>provided as digital models or used as<br>input to a rapid prototyping portion of the<br>system that produces physical<br>outputs including anatomical models,<br>surgical guides, and dental splints for<br>use in maxillofacial and mandibular<br>surgery. The surgical guides and<br>dental splints are intended to be used<br>for the maxillofacial and mandibular<br>bone in maxillofacial and mandibular<br>surgery. The tmCMF Solution is also<br>intended as a preoperative software<br>tool for simulating/ evaluating surgical<br>treatment options. | The subject device is a solution that<br>includes software and patient-<br>specific instruments (anatomical<br>models, surgical guides, splints),<br>and patient-specific implants. The<br>subject device is an update to its<br>primary predicate device (K231520)<br>to include patient-specific implants.<br>The subject device and the primary<br>predicate device share identical<br>indications for use for the software<br>and patient-specific instrumentation. |
| | tmCMF Solution<br>(subject device) | tmCMF Solution<br>(Primary predicate device<br>K231520) | Comment on Substantial<br>Equivalence |
| Data Inputs | Images from medical scanners | Images from medical scanners | The subject device is an update to<br>the primary predicate device<br>K231520, with no change in inputs<br>from the predicate device. The data<br>inputs are substantially equivalent. |
| Data Outputs | Output for dental splints, surgical<br>guides, anatomical models, and<br>implants | Output for dental splints, surgical<br>guides, and anatomical models | The subject device outputs for<br>polyamide (PA) surgical guides and<br>anatomical models are identical to<br>the primary predicate device<br>K231520.<br><br>The subject device introduces two<br>additional outputs for Ti surgical<br>guides and implants which are<br>equivalent to the secondary<br>predicate devices K173039 and<br>K170272.<br><br>Subject device and primary<br>predicate device outputs for dental<br>splints are identical with the<br>exception that the subject device<br>introduces an optional titanium (Ti)<br>palatal insert for dental splints, which<br>is equivalent to the reference device<br>K210731. |
| | tmCMF Solution<br>(subject device) | tmCMF Solution<br>(Primary predicate device<br>K231520) | Comment on Substantial<br>Equivalence |
| Physical<br>Outputs | Dental splints, PA surgical guides, Ti<br>surgical guides, anatomical models,<br>implants, and patient-specific case<br>reports | Dental splints, surgical guides,<br>anatomical models, and patient-<br>specific case reports | The subject device's physical<br>outputs for surgical guides (PA), and<br>anatomical models are identical to<br>the primary predicate device<br>K231520. |
| | | | The subject device includes two<br>additional physical outputs for<br>surgical guides (titanium) and<br>implants, which are equivalent to the<br>secondary predicate devices<br>K173039 and K170272. |
| | | | The subject device and primary<br>predicate device K231520 physical<br>outputs for dental splints are<br>identical with the exception that the<br>subject device introduces an<br>optional palatal insert (titanium) for<br>dental splints, which is equivalent to<br>the reference device K210731. |
| Sterilization | Steam sterilization for both terminal<br>and reprocessing.<br>Sterility assurance level of 1x10-6 | Steam sterilization.<br>Sterility assurance level of 1x10-6 | The subject device sterilization<br>method for both end sterilization and<br>terminal sterilization are equivalent<br>to the predicate device. |
| Packaging | Non-Sterile<br>Sterile | Non-Sterile | The subject device offers the same<br>identical non-sterile packaging as<br>the predicate device.<br>The subject device adds sterile<br>packaging which was not present in<br>the primary predicate device. |
| | tmCMF Solution<br>(subject device) | tmCMF Solution<br>(Primary predicate device<br>K231520) | Comment on Substantial<br>Equivalence |
| Patient<br>Contact | Surgical guides: Surface Contacting -<br>Tissue / Bone Limited (< 24 hours)<br>Dental splints: Surface Contacting -<br>Mucosal Membrane Prolonged (< 30<br>days) | Surgical guides: Surface Contacting<br>- Tissue / Bone Limited (< 24 hours)<br>Dental splints: Surface Contacting -<br>Mucosal Membrane Prolonged (< 30<br>days) | The subject device surgical guides'<br>and dental splints' patient contacting<br>surfaces and duration are identical<br>to the primary predicate device<br>K231520. |
| | Implants: Tissue/Bone contacts for<br>Long-term implantation, as directed by<br>HCP | | The subject device differs from the<br>predicate device in that it offers<br>implants with long-term tissue/bone<br>implantation as directed by HCP. |
| Anatomic<br>Areas of Use | Mandible, Midface (including orbit) | Mandible, Midface | The subject device and primary<br>predicate device contact areas are<br>mandible and midface. The subject<br>device adds support for orbit which<br>is part of the midface. |
| Patient<br>Population | Adolescents (12 to 21 years) and<br>adults | Adolescents (12 to 21 years) and<br>adults | The target patient population for<br>both subject and primary predicate<br>device is identical. |
| Web<br>Interface | Yes | Yes | The subject device is an update to<br>the primary predicate device<br>K231520, it utilizes the same<br>identical web interface. |
| 2D Image<br>Display<br>Axial<br>Sagittal<br>Coronal | Yes | Yes | Both the subject device and the<br>primary predicate device K231520<br>display 2D images and are<br>substantially equivalent. |
| 3D<br>Visualization | Yes | Yes | The subject and the primary<br>predicate device K231520 have 3D<br>visualization and are substantially<br>equivalent. |

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510(k) Summary

| TechMah CMF LLC |
|-----------------|
| |

| | tmCMF Solution<br>(subject device) | tmCMF Solution<br>(Primary predicate device<br>K231520) | Comment on Substantial<br>Equivalence |
|-------------------------------------------------------|------------------------------------|---------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Preoperative software | Yes | Yes | The subject device is an update to<br>the primary predicate device<br>K231520. The subject device uses<br>pre-operative software in the same<br>manner as the primary predicate<br>device and is substantially<br>equivalent. |
| Installation Required | No | No | The subject and primary predicate<br>device K231520 do not require<br>installation and are substantially<br>equivalent. |
| Physician Interaction with Planning and Design Review | Yes | Yes | The physician can interact with<br>planning and hardware designs for<br>both the subject device and the<br>primary predicate device K231520;<br>thus, they are substantially<br>equivalent. |
| Single-Use | Yes | Yes | The subject and the primary<br>predicate device K231520 are<br>single-use and are substantially<br>equivalent |
| Implant Visualization | Yes | No | The subject device is an update to<br>the primary predicate device<br>K231520, with an added ability to<br>visualize implants on CT images.<br>This functionality is equivalent to the<br>reference device K213684. |

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| | tmCMF Solution<br>(Subject device) | TruMatch CMF Titanium<br>3D Printed Implant<br>System (K173039) | TruMatch CMF Titanium<br>3D Printed Implant<br>System (K170272) | Comment on Substantial<br>Equivalence |
|--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for<br>Use | The tmCMF Solution is<br>intended for use as a<br>software system and image<br>segmentation system for<br>the transfer of imaging<br>information from a medical<br>scanner such as a CT-<br>based system. The input<br>data file is processed by<br>the tmCMF Solution, and<br>the result is an output data<br>file that may then be<br>provided as digital models<br>or used as input to a<br>manufacturing portion of<br>the system that produces<br>physical outputs, including<br>anatomical models,<br>surgical guides, dental<br>splints, and implants for<br>use in maxillofacial,<br>midface, and mandibular<br>surgery. Implants are<br>intended for bone fixation<br>and reconstruction,<br>restoration of bone<br>defects, and intended to<br>provide continuity in<br>regions where the bone<br>is missing and/or to | The TruMatch CMF<br>Titanium 3D Printed<br>lmplant is a patient specific<br>implant and is intended<br>for bone fixation and<br>reconstruction,<br>restoration of bone<br>defects and intended to<br>provide continuity in<br>regions where the bone<br>is missing and/or to<br>augment the bone by<br>means of an onlay device<br>in the maxillofacial<br>skeleton, midface and<br>chin. | The TruMatch CMF<br>Titanium 3D Printed<br>Implant System is<br>intended for bone<br>repositioning, fixation<br>and reconstruction of the<br>maxillofacial skeleton,<br>midface, mandible and<br>chin in adolescents<br>(greater than 12 to 21<br>years of age) and adults.<br>Specific indications for use:<br>• Orthognathic<br>surgery<br>• Reconstructive<br>mandible and<br>maxillofacial surgery<br>• mandible and<br>maxillofacial trauma<br>surgery | The subject device is a<br>solution that includes<br>software and patient-<br>specific instruments<br>(anatomical models,<br>surgical guides, dental<br>splints) and patient-specific<br>implants. Both secondary<br>predicate devices'<br>indication for use is a<br>subset of the subject<br>device as both are Ti<br>implants and surgical<br>g…