KLS Martin Individual Patient Solutions (IPS) Planning System

K182889 · KLS-Martin L.P. · PPT · Jul 26, 2019 · Neurology

Device Facts

• Record ID: K182889
• Device Name: KLS Martin Individual Patient Solutions (IPS) Planning System
• Applicant: KLS-Martin L.P.
• Product Code: PPT · Neurology
• Decision Date: Jul 26, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4310
• Device Class: Class 2

Intended Use

The KLS Martin Individual Patient Solutions (IPS) Planning System is intended for use as a software system and image segmentation system for the transfer of imaging information from a computerized tomography (CT) medical scan. The input data file is processed by the IPS Planning 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 anatomical models, guides and case reports for use in the marking of cranial surgery. The IPS Planning System is also intended as a pre-operative software tool for simulating surgical treatment options.

Device Story

The KLS Martin IPS Planning System is a software and additive manufacturing platform for cranial reconstructive surgery. It takes patient CT scan data as input. Trained engineers use COTS software (Materialise Mimics, Geomagic Freeform Plus) to segment and manipulate images in collaboration with the physician to create virtual surgical plans. The system outputs digital models, case reports, and physical patient-specific anatomical models and marking guides. Physical outputs are produced via stereolithography (SLA) for resins/acrylics, selective laser melting for titanium, or selective laser sintering for polyamide. The device is used in a clinical setting to assist surgeons in pre-operative simulation and intra-operative bone marking. The system helps improve surgical precision and planning accuracy. All physical outputs are provided non-sterile and require user-performed steam sterilization.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including tensile and bending tests, biocompatibility testing per ISO 10993-1, steam sterilization validation per ISO 17665-1, and LAL endotoxin testing per AAMI ANSI ST72. Software verification and validation confirmed that all software requirements were implemented correctly.

Technological Characteristics

Materials: Epoxy/resin, acrylic, polyamide, CP Titanium, Ti-6Al-4V. Manufacturing: SLA (models), selective laser melting (titanium), selective laser sintering (polyamide), traditional subtractive (titanium). Software: Materialise Mimics, Geomagic Freeform Plus. Sterilization: Steam (non-sterile delivery). Connectivity: DICOM to .STL conversion. Dimensions: Marking guides 1.0-5.0mm thickness, 7-200mm width, 15-350mm length.

Indications for Use

Indicated for adult patients undergoing cranial surgery. Used as a software and image segmentation system to process CT scan data for the creation of patient-specific anatomical models, marking guides, and case reports to assist in surgical planning and bone marking.

Regulatory Classification

Identification

Powered simple cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments are used with a power source but do not have a clutch mechanism to disengage the tip after penetrating the skull.

Predicate Devices

• KLS Martin Individual Patient Solutions (IPS) Planning System (K181241)

Reference Devices

• KLS Martin Individual Patient Solutions (K163579)
• KLS Martin Individual Patient Solutions (K180962)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, 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.

KLS-Martin L.P. Katie Rutland Senior Regulatory Affairs Specialist 11201 Saint Johns Industrial Parkway S Jacksonville, Florida 32246

Re: K182889

Trade/Device Name: KLS Martin Individual Patient Solutions (IPS) Planning System Regulation Number: 21 CFR 882.4310 Regulation Name: Powered Simple Cranial Drills, Burrs, Trephines, And Their Accessories Regulatory Class: Class II Product Code: PPT Dated: July 17, 2019 Received: July 18, 2019

Dear Katie Rutland:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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

{1}------------------------------------------------

requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about 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,

For Matthew Krueger Assistant Director DHT5A: Division of Neurosurgical. Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known) K182889

Device Name

KLS Martin Individual Patient Solutions (IPS) Planning System

#### Indications for Use (Describe)

The KLS Martin Individual Patient Solutions (IPS) Planning System is intended for use as a software system and image segmentation system for the transfer of imaging information from a computerized tomography (CT) medical scan. The input data file is processed by the IPS Planning 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 anatomical models, guides and case reports for use in the marking of cranial surgery. The IPS Planning System is also intended as a pre-operative software tool for simulating surgical treatment options.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size:16px">✖</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for KLS Martin L.P. The letters "KLS" are in red, while the words "martin L.P." are in gray. The font is sans-serif and bolded.

11201 Saint Johns Industrial Pkwy S • Jacksonville, FL 32246 Phone: [phone] • 800-625-1557 • Fax: [phone] www.klsmartinnorthamerica.com

## Section 5 510(k) Summary 21 CFR 807.92

| Submitter: | KLS-Martin L.P.<br>11201 Saint Johns Industrial Pkwy S<br>Jacksonville, FL 32246 | |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Contact Person: | Katie Rutland<br>Senior Regulatory Affairs Specialist<br>Phone: [phone]<br>Email: [e-mail] | |
| Date Prepared: | July 25, 2019 | |
| Trade Name: | KLS Martin Individual Patient Solutions (IPS) Planning<br>System | |
| Common Name: | System for the creation of patient specific anatomical<br>models, marking guides, and case reports | |
| Classification Name: | Powered Simple Cranial Drills, Burrs, Trephines, and Their<br>Accessories | |
| Regulatory Class: | II, 21 CFR 882.4310 | |
| Product Code: | PPT | |
| Predicate Devices: | KLS Martin Individual Patient Solutions (IPS) Planning<br>System (K181241) - Primary | |
| Reference Devices: | KLS Martin Individual Patient Solutions (K163579)<br>KLS Martin Individual Patient Solutions (K180962) | |
| Device Description: | The KLS Martin Individual Patient Solutions (IPS) Planning<br>System is a collection of software and associated additive<br>manufacturing (rapid prototyping) equipment intended to<br>provide a variety of outputs to support reconstructive cranial<br>surgeries. The system uses electronic medical images of the<br>patients' anatomy (CT data) with input from the physician,<br>to manipulate original patient images for planning and<br>executing surgery. The system processes the medical images<br>and produces a variety of patient specific physical and/or<br>digital output devices which include anatomical models,<br>guides, and case reports for use in the marking of cranial<br>bone in cranial surgery. | |
| Indications for Use: | The KLS Martin Individual Patient Solutions (IPS) Planning<br>System is intended for use as a software system and image<br>segmentation system for the transfer of imaging information<br>from a computerized tomography (CT) medical scan. The<br>input data file is processed by the IPS Planning System and<br>the result is an output data file that may then be provided as<br>digital models or used as input to a rapid prototyping portion<br>of the system that produces physical outputs including | |

anatomical models, guides, and case reports for use in the

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for KLS Martin L.P. The letters "KLS" are in red, while "martin" is in gray. The letters "L.P." are in black and are smaller than the other letters. The logo is simple and modern.

marking of cranial bone in cranial surgery. The IPS Planning System is also intended as a pre-operative software tool for simulating / evaluating surgical treatment options.

## Technological Characteristics/Substantial Equivalence Discussion:

The intended use of the subject device, KLS Martin Individual Patient Solutions (IPS) Planning System, is similar to the predicate device, KLS Martin Individual Patient Solutions (IPS) Planning System (K181241):

The subject and predicate device are intended for use as a software system and image segmentation system for the transfer of imaging from a computerized tomography (CT) medical scan. The input data file is processed through the virtual planning software systems 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. These physical outputs can be anatomical models, guides, and case reports. All digital data and physical devices are used to aid the surgeon during surgery. They are both also intended as a pre-operative software tool for simulating surgical treatment options.

The indications for use statement for the subject device is nearly identical to the predicate device, differing only in anatomical region and output devices. The anatomical region for which the predicate device is intended is listed as maxillofacial, indicating that the device may be used only for maxillofacial applications. The subject device system is specific to only the cranial region and excludes maxillofacial applications. The change in anatomical region presented in the indications for use statement of the subject device system as compared to the predicate device does not change the therapeutic effects of the device. In addition, the subject device offers output devices that include anatomical models, marking guides, and case reports only. The predicate device offers output devices that include anatomical models, cutting guides, marking guides, splints, and case reports. Splints are not applicable to cranial reconstructive surgeries as they are only intended for orthognathic surgeries.

## Similarities to Predicate

Both the subject and primary predicate devices use image data obtained from a CT scan. They both use identical validated commercially off-the-shelf (COTS) software applications to transfer patient imaging from a DICOM format to a .STL format and manipulate the images to produce a final design file. In addition, both devices require trained employees/engineers who utilize the software applications to manipulate data and work with the physician to create the virtual planning session. The physician provides input for model manipulation and interactive feedback through viewing of digital models of system outputs that are modified by the trained employee/engineer during the planning session.

Design validation activities performed to verify the finished output device matches the initial input data (.STL) are identical to the predicate and reference devices, K181241 and K163579.

The subject and predicate device specifications are identical in device thickness, width, length, degree of curvature (in-plane and out-of-plane), screw hole spacing and number of screw holes. A comparison of the subject and predicate device specifications is provided in the table below. The marking guides are non-load bearing, non-implantable, and are only temporarily fixated for the duration of the surgery. A thickness range up to 5.0 mm for the

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the logo for KLS Martin L.P. The text "KLS" is in red, while "martin" is in gray. The letters "L.P." are in black and are larger than the other letters in the logo.

cranial marking guides is to ensure the marking wall is thick enough and clearly visible for accurate marking of bone for resection.

Both systems use traditional (subtractive) and additive manufacturing methods to produce physical output devices that include patient specific anatomical models and guides. In addition, the systems produce digital models and case reports for the physician to use for planning the surgeries or to use during surgery.

Materials used in the manufacture of the output devices are identical in that both the subject and predicate devices use biocompatible polymers/acrylic resins, polyamide, and titanium (CP Titanium & Titanium Alloy). All output devices from both systems are provided non-sterile and must be sterilized by the end user prior to use. Validated sterilization studies performed to ensure a sterility assurance level (SAL) of 10- are identical for both the subject and predicate devices.

Both the subject and predicate devices are temporarily fixated with previously cleared screws of varying sizes and lengths to aid the surgeon in marking of bone more precisely and accurately.

## Differences to Predicate

The intended use of the subject device system is very similar to the predicate device, differing only in the anatomical region in which the device is intended for. The subject device is intended for cranial regions in cranial surgeries, while the predicate device is intended for maxillomandibular regions for maxillofacial surgeries.

The subject device utilizes the same commercially off-the-shelf (COTS) software applications for image segmentation and manipulation as the predicate device, except for the use of the software application IPS CaseDesigner and MathWorks® MATLAB, which are used to manipulate data for production of splints. The subject device system will not be outputting splints as these are intended for orthognathic surgeries.

The subject devices are temporarily fixated with previously cleared screws that range in diameter sizes of 1.0 mm - 2.7 mm with lengths ranging 2 mm - 22 mm. The predicate devices are temporarily fixated with the same previously cleared screws except for the 1.0 mm and 1.2 mm diameter screws.

The potential impact on substantial equivalence of each technological difference was addressed through risk analysis and verification and validation testing.

## Reference Devices

The KLS Martin Individual Patient Solutions (K163579 and K180962) have been included as reference devices to leverage performance testing regarding the material composition (material recycling process, degradation, tensile & bending), biocompatibility, manufacturing processes, as well as cleaning and sterilization for titanium output devices. The KLS Martin IPS Planning System titanium output devices are manufactured from identical materials, undergo the same manufacturing processes (traditional & additive), have the same biocompatibility, demonstrate similar performance characteristics, and are designed, verified, cleaned and sterilized using the same validated methods as the reference devices cleared in K163579 and K180962.

{6}------------------------------------------------

| Device Comparison Table | | | | |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | KLS Martin IPS Planning<br>System<br>(Subject Device) | KLS Martin IPS Planning<br>System<br>K181241<br>(Primary Predicate) | KLS Martin Individual Patient<br>Solutions<br>K163579<br>(Reference Device) | KLS Martin Individual Patient<br>Solutions<br>K180962<br>(Reference Device) |
| Indications for Use | The KLS Martin Individual<br>Patient Solutions (IPS) Planning<br>System is intended for use as a<br>software system and image<br>segmentation system for the<br>transfer of imaging information<br>from a computerized<br>tomography (CT) medical scan.<br>The input data file is processed<br>by the IPS Planning System and<br>the result is an output data file<br>that may then be provided as<br>digital models or used as input<br>to a rapid prototyping portion of<br>the system that produces<br>physical outputs including<br>anatomical models, guides, and<br>case reports for use in the<br>marking of cranial bone in<br>cranial surgery. The IPS<br>Planning System is also intended<br>as a pre-operative software tool<br>for simulating / evaluating<br>surgical treatment options. | The KLS Martin Individual<br>Patient Solutions (IPS) Planning<br>System is intended for use as a<br>software system and image<br>segmentation system for the<br>transfer of imaging information<br>from a medical scanner such as a<br>CT based system. The input data<br>file is processed by the IPS<br>Planning System and the result is<br>an output data file that may then<br>be provided as digital models or<br>used as input to a rapid<br>prototyping portion of the<br>system that produces physical<br>outputs including anatomical<br>models, guides, splints, and case<br>reports for use in maxillofacial<br>surgery. The IPS Planning<br>System is also intended as a<br>pre-operative software tool for<br>simulating/ evaluating surgical<br>treatment options. | KLS Martin Individual Patient<br>Solutions implant devices are<br>intended for use in the stabilization<br>and fixation of mandibular<br>fractures and mandibular<br>reconstruction. | KLS Martin Individual Patient<br>Solutions implant devices are<br>intended for use in the<br>stabilization and fixation of<br>mandibular fractures and<br>mandibular reconstruction. |
| Device Comparison Table | | | | |
| | KLS Martin IPS Planning System<br>(Subject Device) | KLS Martin IPS Planning System<br>K181241<br>(Primary Predicate) | KLS Martin Individual Patient Solutions<br>K163579<br>(Reference Device) | KLS Martin Individual Patient Solutions<br>K180962<br>(Reference Device) |
| Contraindications | 1. Obvious infections.<br>2. Hypersensitivity to foreign bodies.<br>3. Circulatory problems, systemic diseases, and metabolic disorders.<br>4. Insufficient or inadequate bone tissue.<br>5. Secondary diseases such as degenerative processes that may negatively influence the healing process.<br>6. Interventions carried out in a non-sterile environment (e.g. paranasal sinuses).<br>7. Regions exposed to inappropriate forces or excessive weight loads.<br>8. Patients unwilling or unable to follow instructions during the postoperative phase due to their mental, neurological, or physical condition.<br>9. Bone tumors located in the implant base region.<br>10. Obvious drug or alcohol abuse.<br>11. Significant changes to the patient's anatomy has occurred since the medical scan used for planning purposes was obtained. | 1. Obvious infections.<br>2. Hypersensitivity to foreign bodies.<br>3. Circulatory problems, systemic diseases, and metabolic disorders.<br>4. Insufficient or inadequate bone tissue.<br>5. Secondary diseases such as degenerative processes that may negatively influence the healing process.<br>6. Interventions carried out in a non-sterile environment (e.g. paranasal sinuses).<br>7. Regions exposed to inappropriate forces or excessive weight loads.<br>8. Patients unwilling or unable to follow instructions during the postoperative phase due to their mental, neurological, or physical condition.<br>9. Bone tumors located in the implant base region.<br>10. Obvious drug or alcohol abuse.<br>11. Significant changes to the patient's anatomy has occurred since the medical scan used for planning purposes was obtained. | 1. Obvious infections.<br>2. Hypersensitivity to foreign bodies.<br>3. Suspected sensitivity to the implant material.<br>4. Circulatory problems, systemic diseases and metabolic disorders.<br>5. Insufficient or inadequate bone tissue.<br>6. Secondary diseases such as degenerative processes that may negatively influence the healing process.<br>7. Interventions carried out in a non-sterile environment (e.g. paranasal sinuses).<br>8. Regions exposed to inappropriate forces or excessive weight loads.<br>9. Patients unwilling or unable to follow instructions during the postoperative phase due to their mental, neurological or physical condition.<br>10. Osteoporosis or osteomalacia or other structural bone damage preventing the stable fixation of implant components.<br>11. Bone tumors located in the implant base region.<br>12. Obvious drug or alcohol abuse. | 1. Obvious infections.<br>2. Hypersensitivity to foreign bodies.<br>3. Suspected sensitivity to the implant material.<br>4. Circulatory problems, systemic diseases and metabolic disorders.<br>5. Insufficient or inadequate bone tissue.<br>6. Secondary diseases such as degenerative processes that may negatively influence the healing process.<br>7. Interventions carried out in a non-sterile environment (e.g. paranasal sinuses).<br>8. Regions exposed to inappropriate forces or excessive weight loads.<br>9. Patients unwilling or unable to follow instructions during the postoperative phase due to their mental, neurological or physical condition.<br>10. Osteoporosis or osteomalacia or other structural bone damage preventing the stable fixation of implant components.<br>11. Bone tumors located in the implant base region.<br>12. Obvious drug or alcohol abuse. |
| Device Comparison Table | | | | |
| | KLS Martin IPS Planning<br>System<br>(Subject Device) | KLS Martin IPS Planning<br>System<br>K181241<br>(Primary Predicate) | KLS Martin Individual Patient<br>Solutions<br>K163579<br>(Reference Device) | KLS Martin Individual Patient<br>Solutions<br>K180962<br>(Reference Device) |
| Classification | 21 CFR 882.4310, Class II | 21 CFR 872.4120, Class II<br>21 CFR 892.2050, Class II | 21 CFR 872.4760, Class II | 21 CFR 872.4760, Class II |
| Product Code | PPT | DZJ, LLZ | JEY | JEY |
| Material | Anatomical Models:<br>Epoxy/Resin, Acrylic<br>Marking Guides: Polyamide,<br>Titanium Alloy (Ti-6Al-4V), CP<br>Titanium | Anatomical Models:<br>Epoxy/Resin, Acrylic<br>Cutting/Marking Guides:<br>Polyamide, Titanium Alloy (Ti-<br>6Al-4V), CP Titanium<br>Splints: methacrylate | Anatomical Models: Epoxy/Resin,<br>Acrylic<br>Implants: CP Titanium & Titanium<br>Alloy (Ti-6Al-4V) | Anatomical Models:<br>Epoxy/Resin, Acrylic<br>Cutting Guides: CP Titanium &<br>Titanium Alloy (Ti-6Al-4V)<br>Implants: CP Titanium &<br>Titanium Alloy (Ti-6Al-4V) |
| Manufacturing<br>Method | Epoxy/Resin, Acrylic:<br>Stereolithography (SLA)<br>CP Titanium: Traditional<br>(Subtractive)<br>Ti-6Al-4V: 3D (Additive:<br>Selective Laser Melting)<br>Polyamide: 3D (Additive;<br>Selective Laser Sintering) | Epoxy/Resin, Acrylic:<br>Stereolithography (SLA)<br>CP Titanium: Traditional<br>(Subtractive)<br>Ti-6Al-4V: 3D (Additive:<br>Selective Laser Melting)<br>Polyamide: 3D (Additive;<br>Selective Laser Sintering) | Epoxy/Resin, Acrylic:<br>Stereolithography (SLA)<br>CP Titanium: Traditional<br>(Subtractive)<br>Ti-6Al-4V: 3D (Additive:<br>Selective Laser Melting) | Epoxy/Resin, Acrylic:<br>Stereolithography (SLA)<br>CP Titanium: Traditional<br>(Subtractive)<br>Ti-6Al-4V: 3D (Additive:<br>Selective Laser Melting) |
| Software | Materialise Mimics (K073468)<br>Geomagic® Freeform Plus™ | Materialise Mimics (K073468)<br>Geomagic® Freeform Plus™<br>IPS CaseDesigner (K161634)<br>MathWorks® MATLAB | Materialise Mimics (K073468)<br>Geomagic® Freeform Plus™ | Materialise Mimics (K073468)<br>Geomagic® Freeform Plus™ |
| Sterilization | Non-sterile (Steam) | Non-sterile (Steam) | Non-sterile (Steam) | Non-sterile (Steam) |
| Device Comparison Table | | | | |
| | KLS Martin IPS Planning<br>System<br>(Subject Device)…