TECHFIT DISRP® System

K242263 · Techfit Digital Surgery, Inc. · DZJ · Dec 11, 2024 · Dental

Device Facts

• Record ID: K242263
• Device Name: TECHFIT DISRP® System
• Applicant: Techfit Digital Surgery, Inc.
• Product Code: DZJ · Dental
• Decision Date: Dec 11, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4120
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

TECHFIT Digitally Integrated Surgical Reconstruction Platform (DISRP) System 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 DISRP System and the result is an outbut data file that may then be provided as digital models or used as input to a rapid prototyping portion of the system that produces physical outputs including surgical guides and splints for use in maxillofacial surgery. The DISRP System is also intended as a preoperative software tool for simulating / evaluating surgical treatment options. The DISRP system is compatible with the TECHFIT Patient- Specific Maxillofacial System and the TECHFIT Diagnostic Models and should be used in conjunction with expert clinical judgment.

Device Story

The TECHFIT DISRP System is a web-based software platform for orthognathic and reconstructive surgery planning. It ingests DICOM data from CT/CBCT scanners; allows surgeons and planning staff to perform 3D visualization, distance/angle measurements, and bone fragment manipulation (translations/rotations) to simulate surgical outcomes. The system outputs encrypted STL files used to manufacture patient-specific surgical guides and splints via rapid prototyping or machining. Guides are used in the OR to assist in osteotomy positioning and bone graft/flap fixation. The system facilitates collaboration between surgeons, sales reps, and planning staff. It is intended for use in maxillofacial surgery to improve surgical accuracy and treatment planning.

Clinical Evidence

Bench testing only. Testing included sterilization validation (AAMI/ISO 17665-1, ANSI/AAMI/ISO 14937), dimensional validation via scanning comparison, compatibility testing with patient-specific systems, and mechanical four-point bending tests. Biocompatibility testing (ISO 10993 series) confirmed no cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, or genotoxicity.

Technological Characteristics

Web-based software platform; compatible with Windows 64-bit and Mac OS. Physical guides manufactured from CP Titanium (grade 4) via subtractive machining or Biomed Clear Resin via SLA 3D printing. Metal sleeves (Ti6Al4V) used in resin guides. Sterilization via steam. Connectivity: Web-based collaboration platform. Software functions include 3D visualization, measurement, and surgical simulation.

Indications for Use

Indicated for adults undergoing maxillofacial and reconstructive surgeries requiring surgical guides and splints for osteotomies and bone graft/flap fixation.

Regulatory Classification

Identification

A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.

Predicate Devices

• KLS Martin Individual Patient Solutions (IPS) Planning system (K182789)

Reference Devices

• VSP® System (K120956)
• TECHFIT DISRP® System (K230276)
• TECHFIT Patient-Specific Maxillofacial System (K203282)
• AFFINITY Proximal Tibia System (K220199)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 11, 2024

TECHFIT Digital Surgery Inc. Susana Munoz Cuartas Regulatory Affairs Specialist 1511 Aviation Center Pkwy, Suite 220H Daytona Beach, Florida 32114

Re: K242263

Trade/Device Name: TECHFIT DISRP® System Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument And Accessories Regulatory Class: Class II Product Code: DZJ, LLZ Dated: September 12, 2024 Received: September 13, 2024

Dear Susana Munoz Cuartas:

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.

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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" (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 QS 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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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-comprehensive-regulatory

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assistance/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,

# MICHAEL E. ADJODHA -S

Michael Adjodha, MChE, RAC, CQIA Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

Submission Number (if known)

K242263

Device Name

TECHFIT DISRP® System

#### Indications for Use (Describe)

TECHFIT Digitally Integrated Surgical Reconstruction Platform (DISRP) System 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 DISRP System and the result is an outbut data file that may then be provided as digital models or used as input to a rapid prototyping portion of the system that produces physical outputs including surgical guides and splints for use in maxillofacial surgery. The DISRP System is also intended as a preoperative software tool for simulating / evaluating surgical treatment options.

The DISRP system is compatible with the TECHFIT Patient- Specific Maxillofacial System and the TECHFIT Diagnostic Models and should be used in conjunction with expert clinical judgment.

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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Image /page/4/Picture/0 description: The image contains the logo for Techfit Digital Surgery. The logo features a blue sphere with a gray teardrop shape overlapping it on the left side. To the right of the sphere, the word "TECHFIT" is written in gray capital letters, and below that, the words "Digital Surgery" are written in a smaller font.

### 1. 510(k) Summary

The 510(k) summary is provided on the following page per 21 CFR 807.92(c).

#### Traditional 510(k): Summary

The following section is included as required by the Safe Medical Devices Act (SMDA) of 1990 and 21CFR 807.92

#### 1.1 Submitter information

Table 1. Submitter Information

| Company name | TECHFIT Digital Surgery Inc. |
|-----------------------------------|-----------------------------------------|
| Establishment registration number | 3004187715 |
| Street Address | 1511 Aviation Center Pkwy<br>Suite 220H |
| City | Daytona Beach |
| Zip code | FL 32114 |
| Country | United States |
| Phone number | [phone] Ext. 165 |
| Fax number | [phone] |
| Principal contact person | Susana Muñoz-Cuartas |
| Contact title | Regulatory Affairs Specialist |
| Contact e-mail address | [e-mail] |
| Additional contact person | Angela María Lema-Pérez |
| Contact title | Regulatory Affairs Specialist |
| Contact e-mail address | [e-mail] |

#### 1.2 Date

December 10, 2024.

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Image /page/5/Picture/0 description: The image shows the logo for Techfit Digital Surgery. The logo features a blue sphere with a gray crescent shape partially covering it on the left side. To the right of the sphere, the word "TECHFIT" is written in gray, block letters. Below "TECHFIT", the words "Digital Surgery" are written in a smaller, gray font.

### 1.3 Submission information

Table 2. Submission Information

| Trade name | TECHFIT DISRP® SYSTEM |
|------------------------------------------|--------------------------------------------------------------|
| Common or Usual name | DISRP |
| Classification name | 21 CFR 872.4120 - Bone Cutting Instrument<br>and Accessories |
| Product code (classification regulation) | DZJ, LLZ |
| Classification Panel | Dental |
| Device class | Class II |

#### 1.4 Predicate Device

Table 3. Predicate device

| Predicate Device: KLS Martin Individual Patient Solutions (IPS) Planning system | | | |
|---------------------------------------------------------------------------------|--------------------------------------------------------|--|--|
| Trade or proprietary or model | KLS Martin Individual Patient Solutions (IPS) Planning | | |
| name | System | | |
| 510(k) number | K182789 | | |
| Decision date | 2019/03/11 | | |
| Product code | DZJ, LLZ | | |
| Manufacturer | KLS-Martin L.P. | | |

#### 1.5 Reference Devices

The general information of the reference devices is the following:

Table 4. General Information of the Reference Devices

| Reference Devices | | |
|-------------------|---------------------------------------|-------------------------------|
| 1. | Trade or proprietary or model<br>name | VSP® System |
| | 510 (k) number | K120956 |
| | Decision date | 2012/12/12 |
| | Product code | DZJ, LLZ |
| | Manufacturer | Medical Modeling Inc. |
| 2. | Trade or proprietary or model<br>name | TECHFIT DISRP® System |
| | 510 (k) number | K230276 |
| | Decision date | 2023/06/23 |
| | Product code | DZJ, LLZ |
| | Manufacturer | TECHFIT Digital Surgery, Inc. |

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Image /page/6/Picture/0 description: The image contains the logo for Techfit Digital Surgery. The logo features a blue sphere with a gray teardrop shape partially covering it on the left side. To the right of the sphere, the word "TECHFIT" is written in a simple, sans-serif font, with the words "Digital Surgery" written in a smaller font below it.

| 3. | Trade or proprietary or model name | TECHFIT Patient-Specific Maxillofacial System |
|----|------------------------------------|-----------------------------------------------|
| | 510 (k) number | K203282 |
| | Decision date | 2021/05/19 |
| | Product code | JEY |
| | Manufacturer | Techfit Digital Surgery INC. |
| 4. | Trade or proprietary or model name | AFFINITY Proximal Tibia System |
| | 510 (k) number | K220199 |
| | Decision date | 2022/03/21 |
| | Product code | HRS, HWC |
| | Manufacturer | Industrias Medicas Sampedro S.A.S |

### 1.6 Device Information

The following table presents the device information of the subject device and the predicate device.

### Table 5. Device Information

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Image /page/7/Picture/0 description: The image shows the logo for Techfit Digital Surgery. The logo consists of a blue sphere with a gray sphere partially overlapping it on the left side. To the right of the spheres is the word "TECHFIT" in gray block letters, with the words "Digital Surgery" in a smaller font below.

| should be used in conjunction with |
|------------------------------------|
| expert clinical judgment. |

#### 1.7 Device Description

The TECHFIT DISRP SYSTEM is composed by Anatomic Specificx Guiding System and the Digitally Integrated Surgical Reconstruction Platform (DISRP).

- . The Digitally Integrated Surgical Reconstruction Platform (DISRP) is a web-based collaboration software for digital surgery case flow management and Orthognathic surgery planning that reflects the production process and allows for the interaction of multiple users: surgeons, sales representatives, and the TECHFIT case planning staff (case planning assistant, case planners, and operations director), using multiple devices. It allows collaboration in the planning process. Detail description of the software can be found in later in this section.
- Anatomic Specificx Guiding System is a Patient-Specific single-use device designed to ● assist surgeons in transferring the pre-surgical plan to the operation room. This system includes surqical quides intended for Orthognathic and Reconstructive surgeries in adults. The surgical guides have drilling holes and slots to make osteotomies and ensure the correct positioning of bones and implants.

The Anatomic Specificx Guiding System is divided into two categories: Anatomic Specificx Orthognathic Guides and Anatomic Specificx Reconstruction Guides.

#### Anatomic Specificx Orthognathic Guides

Anatomic Specificx Orthognathic Guides are classified into Titanium and Resin Surgical Guides.

Anatomic Specificx Orthognathic Titanium Guides are manufactured from Commercially Pure (CP) Titanium grade 4; they include mandibular and maxillofacial surgical guides (e.q. Le Fort, Genioplasty, etc). Palatal Splints are also part of Anatomic Specificx Orthognathic Titanium Guides, which are optional quides used in orthognathic surgery to quide and support the correct teeth positioning and validate the patient's final occlusion.

Anatomic Specificx Orthognathic Resin Guides are manufactured through rapid prototyping using the Form 3B and Form 4B printers and Biomed Clear Resin from Formlabs. These guides include Le Fort and genioplasty surgical guides. During surgery, resin surgical guides must be used with slot, drill, and screw metal sleeves. Slot sleeves are made from commercially pure grade 4 titanium, while drill and screw sleeves are made from alloyed titanium (Ti6Al4V). All sleeves are manufactured by machining. The resin quides also include splints (intermediate, final, and palatal), which are optional quides used in orthognathic surgery to quide and support the correct teeth positioning and validate the patient's final occlusion.

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Image /page/8/Picture/0 description: The image shows the logo for Techfit Digital Surgery. The logo features a blue sphere with a gray oval on top of it. To the right of the sphere is the word "TECHFIT" in gray, with the words "Digital Surgery" in a smaller font below it. The logo is simple and modern, and the colors are calming and professional.

#### Anatomic Specificx Reconstruction Guides

The Anatomic Specificx Reconstruction Guides are intended for mandibular and maxillofacial surqical procedures in adults, using patient grafts/flaps for reconstruction. These guides are made from Commercially Pure (CP) grade 4 titanium, produced through machining and finished with an anodizing process. They are intended for use in the anatomical sites of the maxilla, mandible and fibula. The reconstruction guides provide transfer of the pre-surgical plan to the operating room, facilitating placement and fixation of the patient's bone grafts/flaps at the surgical site.

#### 1.8 Indications for use

TECHFIT Digitally Integrated Surgical Reconstruction Platform (DISRP) System 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 DISRP System, and the result is an output data file that may then be provided as digital models or used as input to a rapid prototyping portion of the system that produces physical outputs including surgical guides and splints for use in maxillofacial surgery. The DISRP System is also intended as a preoperative software tool for simulating / evaluating surgical treatment options.

The DISRP system is compatible with the TECHFIT Patient- Specific Maxillofacial System and the TECHFIT Diagnostic Models and should be used in conjunction with expert clinical judgment.

#### 2. Comparison to Predicate Devices

Section 12 and Table 6 presents the comparison between the subject device, the predicate device, and the reference devices.

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Image /page/9/Picture/0 description: The image shows the logo for Techfit Digital Surgery. The logo features a blue sphere with a gray teardrop shape partially overlapping it on the left side. To the right of the sphere, the word "TECHFIT" is written in gray capital letters, with the words "Digital Surgery" written in a smaller font size below.

## Table 6. Comparison Table

| | Subject device | Predicate Device | Reference Devices | | | |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristic | DISRP® System<br>(Anatomic<br>Specificx<br>Reconstruction<br>Guides and Palatal<br>Splints) | KLS Martin<br>Individual Patient<br>Solutions (IPS)<br>Planning system | VSP® System | TECHFIT DISRP®<br>System | TECHFIT Patient-<br>Specific<br>Maxillofacial<br>system | AFFINITY<br>Proximal Tibia<br>System |
| 510K Number | K242263 | K182789 | K120956 | K230276 | K203282 | K220199 |
| Intended use | TECHFIT<br>Digitally<br>Integrated<br>Surgical<br>Reconstruction<br>(DISRP)<br>Platform<br>System is<br>intended<br>for use as a software<br>system and image<br>segmentation system<br>for the<br>transfer of<br>imaging<br>information<br>medical<br>from<br>a<br>scanner such as a CT<br>based system.<br>The<br>file<br>is<br>data<br>ınput<br>the<br>processed<br>by<br>DISRP System and<br>the result is an output<br>data file that may<br>then be provided as<br>digital<br>models<br>Ol<br>used as input to a<br>rapid<br>prototyping<br>portion of the system<br>that<br>produces<br>physical<br>outputs<br>including<br>surgical<br>guides and splints for<br>use in maxillofacia<br>surgery. The DISRP<br>System<br>also<br>ાડ<br>intended<br>ર્વડ<br>a<br>preoperative<br>for<br>software<br>tool | KLS<br>Martin<br>The<br>Patient<br>Individual<br>(IPS)<br>Solutions<br>Planning System is<br>intended for use as a<br>software system and<br>ımage<br>segmentation<br>system<br>the<br>tor<br>transfer of imaging<br>information<br>trom a<br>medical<br>scanner<br>such as a CT based<br>system. The input<br>data file is processed<br>by the IPS Planning<br>System<br>and<br>the<br>result is an output<br>data file that may<br>then be provided as<br>digital<br>models or used as<br>to<br>ınput<br>a rapıd<br>prototyping portion of<br>system<br>the<br>that<br>produces<br>physical<br>outputs<br>including<br>anatomical<br>models,<br>guides,<br>splints,<br>and<br>case<br>reports for use in<br>maxillofacial surgery.<br>The IPS Planning<br>System<br>also<br>ાડ<br>intended as a | The<br>Medical<br>Modeling<br>VSP®<br>System is intended<br>for use as a software<br>system and image<br>segmentation<br>for<br>the<br>system<br>transfer of imaging<br>information<br>trom a<br>medical<br>scanner<br>such as a CT based<br>system. The input<br>data file is processed<br>by the VSP® System<br>and the result is an<br>output data file that<br>then<br>may<br>be<br>provided as digital<br>models or used as<br>input to<br>a rapıd<br>prototyping portion of<br>that<br>the<br>system<br>produces<br>physical<br>ıncluding<br>outputs<br>anatomical<br>models.<br>templates,<br>and<br>guides for<br>surgical<br>maxillofacial<br>use ın<br>The VSP®<br>surgery.<br>System<br>also<br>ાટ<br>ıntended<br>as a pre-<br>software<br>operative<br>tool<br>for<br>simulating/evaluating<br>surgical<br>treatment<br>options. | TECHFIT<br>Digitally<br>Integrated<br>Surgical<br>Reconstruction<br>(DISRP)<br>Platform<br>System is intended<br>for use as a software<br>system and image<br>segmentation<br>the<br>system<br>for<br>transfer of imaging<br>information from a<br>medical<br>scanner<br>such as a CT based<br>system. The input<br>file<br>data<br>ાટ<br>processed by<br>the<br>DISRP System and<br>the result<br>an<br>ાટ<br>output data file that<br>then<br>may<br>be<br>provided as digital<br>models or used as<br>input to<br>a rapid<br>prototyping portion<br>of the system that<br>produces<br>physical<br>outputs<br>including<br>surgical guides and<br>splints for use in<br>maxillofacial<br>surgery. The DISRP<br>System<br>also<br>ાર<br>intended<br>ટ્રક<br>a | TECHFIT<br>Patient-<br>Specific Maxillofacial<br>System is intended<br>for<br>use<br>ın<br>the<br>stabilization, fixation,<br>and reconstruction of<br>the<br>maxillofacial/midface<br>mandibular<br>and<br>skeletal regions. | AFFINITY<br>Tibia<br>Proximal<br>System<br>ાંટ<br>intended to treat<br>fractures,<br>nonunions,<br>malunions of the<br>tibia<br>proximal<br>including simple,<br>comminuted,<br>lateral<br>wedge,<br>depression,<br>medial<br>wedge,<br>bicondylar<br>of<br>combination<br>wedge<br>lateral<br>and depression,<br>periprosthetic,<br>and<br>fractures<br>with associated<br>shaft fractures.<br>-Simple<br>metaphyseal<br>fractures<br>(Classification<br>AO 41-A2).<br>Multifragmentary<br>metaphyseal<br>fractures<br>(Classification<br>AO 41-A3). |
| | simulating /<br>evaluating surgical<br>treatment options.<br>The DISRP system is<br>compatible with the<br>TECHFIT Patient-<br>Specific Maxillofacial<br>System and the<br>TECHFIT Diagnostic<br>Models and should<br>be used in<br>conjunction with<br>expert clinical<br>judgment. | pre-operative<br>software tool for<br>simulating/evaluating<br>surgical treatment<br>options. | | preoperative<br>software tool for<br>simulating /<br>evaluating surgical<br>treatment options.<br>The DISRP system<br>is compatible with<br>the TECHFIT<br>Patient- Specific<br>Maxillofacial System<br>and the TECHFIT<br>Diagnostic Models<br>and should be used<br>in conjunction with<br>expert clinical<br>judgment. | | -Simple<br>bicondylar<br>fractures<br>(Classification<br>AO41-C1, 41-<br>C2).<br>-<br>Multifragmentary<br>bicondylar<br>fractures<br>(Classification<br>AO 41-C3).<br>-Simple joint,<br>simple<br>metaphyseal<br>fractures<br>(Classification<br>AO 41-C1).<br>-Diaphisary<br>fractures<br>(Classification<br>AO 42A and<br>42B). |
| Indications for<br>use | Maxillofacial and<br>Reconstruction<br>Surgeries | Maxillofacial and<br>Reconstruction<br>Surgeries | | Maxillofacial and<br>Reconstruction<br>Surgeries | Maxillofacial<br>Surgeries | Orthopedic<br>Surgery |
| Clinical Use | Maxillofacial | Maxillofacial | | Maxillofacial | Maxillofacial /<br>Midface & Mandible | Orthopedic<br>Proximal Tibial<br>Condyles |
| Product Code | DZJ, LLZ | DZJ, LLZ | | DZJ, LLZ | JEY | HRS, HWC |

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Image /page/10/Picture/0 description: The image contains the logo for Techfit Digital Surgery. The logo features a blue sphere with a gray teardrop shape overlapping it on the left side. To the right of the sphere and teardrop shape is the word "TECHFIT" in gray capital letters. Below "TECHFIT" are the words "Digital Surgery" in a smaller font, also in gray.

CONFIDENTIAL

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Image /page/11/Picture/0 description: The image is a logo for Techfit Digital Surgery. The logo features a blue sphere with a gray teardrop shape overlapping it on the left side. To the right of the sphere is the word "TECHFIT" in gray, block letters. Below "TECHFIT" is the phrase "Digital Surgery" in a smaller, lighter gray font.

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Image /page/12/Picture/0 description: The image shows the logo for Techfit Digital Surgery. The logo features a blue sphere with a gray shape partially covering it on the left side. To the right of the sphere, the word "TECHFIT" is written in gray capital letters, with the words "Digital Surgery" written in a smaller font size below it.

| Manufacturer | TECHFIT Digital<br>Surgery, Inc. | KLS Martin | Medical Modeling<br>Inc. | TECHFIT Digital<br>Surgery, Inc. | TECHFIT Digital<br>Surgery, Inc. | Industrias<br>Medicas<br>Sampedro S.A.S |
|----------------------------------|-----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|----------------------------------------------------------|
| Target<br>Population | Adults | Pediatric & Adults | Adults | Adults | Adults | Adults |
| Patient-<br>specific<br>devices? | Yes. Devices are<br>manufactured<br>patient-specific,<br>based on a CT scan<br>of the patient | Yes. Devices are<br>manufactured<br>patient-specific,<br>based on a CT scan<br>of the patient | Yes. Devices are<br>manufactured<br>patient-specific,<br>based on a CT scan<br>of the patient | Yes. Devices are<br>manufactured<br>patient-specific,<br>based on a CT scan<br>of the patient | Yes. Devices are<br>manufactured<br>patient-specific,<br>based on a CT scan<br>of the patient | No. The plates<br>are standard<br>manufactured<br>plates |

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Image /page/13/Picture/0 description: The image contains the logo for Techfit Digital Surgery. The logo features a blue sphere with a gray oval partially overlapping it on the left side. To the right of the sphere and oval are the words "TECHFIT" in gray, with the words "Digital Surgery" in a smaller font size below it.

| Material | Palatal Splints: CP<br>Titanium.<br>Anatomic Specificx<br>Reconstruction: CP<br>Titanium. | Anatomical Models:<br>Epoxy/Resin, Acrylic.<br>Cutting/Marking<br>Guides: Polyamide,<br>Titanium Alloy (Ti-<br>6Al-4V), CP<br>Titanium.<br>Splints: methacrylate | Anatomic Models,<br>templates, and<br>surgical guides:<br>Biocompatible<br>polymers and<br>surgical instrument<br>grade stainless<br>steel. | Anatomic Specificx<br>Orthognathic Resin<br>Guides (previously<br>called "Resin<br>Orthognathic<br>Surgical Guides":<br>Biomed Clear<br>Resin.<br>Anatomic Specificx<br>Orthognathic<br>Titanium Guides<br>(previously called<br>"Machined<br>Orthognathic<br>Surgical Guides":<br>CP Titanium.<br>Slot Metal sleeves:<br>CP Titanium.<br>Drill and Screw<br>Metal Sleeves: CP<br>Titanium and<br>Alloyed Titanium<br>(Ti6Al4V). | Plate: CP Titanium. | Plate: CP<br>Titanium.<br>Screw: Alloyed<br>Titanium<br>(Ti6Al4V). |
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Image /page/14/Picture/0 description: The image shows the logo for Techfit Digital Surgery. The logo features a blue sphere with a gray teardrop shape partially overlapping it on the left side. To the right of the sphere, the word "TECHFIT" is written in gray capital letters, with the words "Digital Surgery" written in a smaller font size below it.

| Manufacturing<br>Method | CP Titanium:<br>Traditional<br>(Subtractive). | Epoxy/Resin, Acrylic:<br>Stereolithography<br>(SLA).<br>CP Titanium:<br>Traditional<br>(Subtractive).<br>Ti-6Al-4V: 3D<br>printing (Additive;<br>Selective Laser<br>Melting).<br>Polyamide: 3D<br>printing (Additive;<br>Selective Laser<br>Sintering). | 3D printing | Resin: 3D printing -<br>Stereolithography<br>(SLA).<br>CP Titanium and<br>Alloyed Titanium:<br>Traditional<br>(Subtractive). | CP Titanium:<br>Traditional<br>(Subtractive). | CP Titanium and<br>Alloyed<br>Titanium:<br>Traditional<br>(Subtractive). |
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| Sterilization | Non-sterile (Steam) | Non-sterile (Steam) | Non-sterile (Steam) | Non-sterile (Steam) | Non-sterile (Steam) | Non-sterile<br>(Steam) |
| Contact<br>Duration | Palatal Splints:<br>prolonged (24 h to<br>30 days).<br>Anatomic Specific<br>Reconstruction:<br>limited (≤ 24 h). | Limited (≤ 24 h). | Limited (≤ 24 h). | Limited (≤ 24 h). | Long Term (>30<br>days). | Long Term (>30<br>days). |
| Compatible<br>with DISRP<br>software? | Yes | No | No | Yes | Yes | No |
| Software<br>changes | Palatal Splints:<br>Include the new<br>device visualization.<br>Anatomic Specificx<br>Reconstruction<br>Guides: Include the<br>reconstruction<br>surgical guides<br>visualization, fibula<br>graft/flap, and<br>mandible/maxilla<br>visualization. | N.A. | N.A. | N.A. | N.A. | N.A. |
| Image Import | DICOM data format<br>from CT/CBCT<br>scanner 3D models<br>and surface scan<br>data in generic open<br>file format (STL) | DICOM data format<br>from CT scanner 3D<br>models and surface<br>scan data in generic<br>open file format<br>(STL). | System Inputs:<br>Images from medical<br>scanners (i.e. CT) | DICOM data format<br>from CT/CBCT<br>scanner 3D models<br>and surface scan<br>data in generic open<br>file format (STL) | DICOM data format<br>from CT/CBCT<br>scanner 3D models<br>and surface scan<br>data in generic open<br>file format (STL) | N.A. |
| Software<br>Output | Encrypted STL file<br>with design of the<br>final patient specific<br>device such as<br>surgical guides,<br>splints and case<br>reports | N.A. | System Outputs:<br>Physical and digital<br>outputs such as<br>patient specific<br>anatomical models,<br>cutting and drill<br>guides, templates<br>and splints | Encrypted STL file<br>with design of the<br>final patient specific<br>device such as<br>surgical guides,<br>splints and case<br>reports | N.A. | N.A. |
| Software<br>Functions | 3D Visualization | 2D and 3D<br>Visualization | 3D Visualization | 3D Visualization | N.A. | N.A. |
| | Distance and angle<br>measurements | Distance and angle<br>measurements | Distance and angle<br>measurements | Distance and angle<br>measurements | N.A. | N.A. |
| Software<br>Functions | Bone fragments can<br>be moved in the 3D<br>space (translations<br>and rotations) in<br>order to plan the<br>ideal post-operative<br>position of each<br>fragment. Supported<br>osteotomies: Le Fort<br>I, Chin, Splints, fibula | Bone fragments can<br>be moved in the 3D<br>space (translations<br>and rotations) in<br>order to plan the<br>ideal post-operative<br>position of each<br>fragment. Supported<br>osteotomies: Le Fort<br>I, Sagittal, Splint,<br>Ramus, Chin | The system uses<br>electronic medical<br>images<br>of the patients'<br>anatomy with input<br>from the physician,<br>to manipulate<br>original patient<br>images for planning<br>and executing<br>surgery. The system<br>produces a variety of<br>patient<br>specific outputs<br>including; anatomical<br>models (physical<br>and digital), surgical<br>templates, guides,<br>splints, and patient<br>specific case<br>reports. | Bone fragments can<br>be moved in the 3D<br>space (translations<br>and rotations) in<br>order to plan the<br>ideal post-operative<br>position of each<br>fragment.<br>Supported<br>osteotomies: Le<br>Fort I, Chin, Splint | N.A. | N.A. |
| | 3D Surgical Model<br>creation from<br>CBCT/CT scan data<br>and STL file | 3D Surgical Model<br>creation from CT<br>scan data…