KLS Martin Individual Patient Solutions (IPS) Planning System

K201052 · KLS-Martin L.P. · PPT · Aug 31, 2020 · Neurology

Device Facts

• Record ID: K201052
• Device Name: KLS Martin Individual Patient Solutions (IPS) Planning System
• Applicant: KLS-Martin L.P.
• Product Code: PPT · Neurology
• Decision Date: Aug 31, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4310
• Device Class: Class 2
• Attributes: Pediatric

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 and cutting of cranial bone in cranial surgery. The IPS Planning System is also intended as a pre-operative software tool for simulating surgical treatment options. Information provided by the software and device output is not intended to eliminate, replace, or substitute, in whole or in part, the healthcare provider's judgment and analysis of the patient's condition.

Device Story

System processes patient CT scan data to create patient-specific anatomical models, cutting/marking guides, and case reports for cranial surgery. Workflow involves trained engineers using COTS software (Materialise Mimics, Geomagic Freeform Plus) to segment and manipulate images based on physician input. Output includes digital models and physical devices produced via additive manufacturing (SLS/SLM) or subtractive methods. Used in clinical settings by surgeons for pre-operative planning and intraoperative guidance. Guides assist in marking and cutting cranial bone, including pediatric applications like craniosynostosis. System provides visual and physical aids to enhance surgical precision; does not replace clinical judgment. Benefits include improved surgical planning and execution accuracy for complex cranial procedures.

Clinical Evidence

No new clinical trials conducted. Evidence consists of bench testing (tensile/bending, biocompatibility per ISO 10993-1, steam sterilization per ISO 17665-1, LAL endotoxin testing), software V&V, and simulated design validation using 18 representative cases across 6 age ranges. Human factors/usability testing via clinical expert review confirmed device utility. Peer-reviewed literature provided to support safety and effectiveness in pediatric and adult populations.

Technological Characteristics

Materials: Polyamide (SLS), Ti-6Al-4V (SLM), CP Titanium (subtractive), Epoxy/Resin/Acrylic (SLA). Energy: Additive/subtractive manufacturing. Connectivity: Standalone software system. Sterilization: Non-sterile, steam-sterilizable by end-user (SAL 10^-6). Software: COTS-based (Materialise Mimics, Geomagic Freeform Plus). Dimensions: Guides 1.0-5.0mm thick, 7-200mm wide, 15-350mm long.

Indications for Use

Indicated for use in pediatric (neonate, infant, children, adolescents) and adult patients requiring cranial surgery. Used for pre-operative simulation, surgical planning, and creation of patient-specific anatomical models and cutting/marking guides. Contraindicated in cases of infection, hypersensitivity to foreign bodies, circulatory/metabolic disorders, insufficient bone tissue, degenerative processes, non-sterile environments, inappropriate force regions, inability to follow post-op instructions, bone tumors in implant region, drug/alcohol abuse, or significant anatomical changes since the medical scan.

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 (K182889)

Reference Devices

• KLS Martin Individual Patient Solutions (IPS) Planning System (K182789)
• Stryker PEEK Customized Cranial Implant (K190229)

Submission Summary (Full Text)

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August 31, 2020

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

Re: K201052

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 30, 2020 Received: July 31, 2020

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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 (QS) 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,

Xiaolin Zheng, Ph.D. 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

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# Indications for Use

510(k) Number (if known) K201052

#### 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 and cutting of cranial surgery.

The IPS Planning System is also intended as a pre-operative software tool for simulating surgical treatment options. Information provided by the software and device output is not intended to eliminate, replace, or substitute, in whole or in part, the healthcare provider's judgment and analysis of the patient's condition.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |

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| | 510(k) Summary<br>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>Regulatory Affairs Project Manager<br>Phone: [phone]<br>Email: [e-mail] |
| Alternate Contact: | Melissa Bachorski<br>RA/QMS Manager<br>Phone: [phone]<br>Email: [e-mail] |
| Date Prepared: | August 31, 2020 |
| 510(k) Number: | K201052 |
| Trade Name: | KLS Martin Individual Patient Solutions (IPS)<br>Planning System |
| Common Name: | System for the creation of patient specific anatomical<br>models, cutting/marking guides, and case reports |
| Classification Name: | Cranial Surgical Planning and Instrument Guides (21 CFR<br>882.4310) |
| Regulatory Class: | II |
| Product Code: | PPT |
| Predicate Device: | KLS Martin Individual Patient Solutions (IPS)<br>Planning System (K182889) |
| Reference Devices: | KLS Martin Individual Patient Solutions (IPS) Planning<br>System (K182789)<br>Stryker PEEK Customized Cranial Implant (K190229) |

### Device Description:

The KLS Martin Individual Patient Solutions (IPS) Planning System is a collection of software and associated additive manufacturing (rapid prototyping) equipment intended to provide a variety of outputs to support reconstructive cranial surgeries. The system uses electronic medical images of the patients' anatomy (CT data) with input from the physician, to manipulate original patient images for planning and executing surgery. The system processes the medical images and produces a variety of patient specific physical and/or digital output devices which include anatomical models, guides, and case reports for use in the marking and cutting of cranial bone in cranial surgery.

#### Indications for 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

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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 and cutting 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.

Information provided by the software and device output is not intended to eliminate, replace, or substitute, in whole or in part, the healthcare provider's judgment and analysis of the patient's condition.

#### Technological Characteristics/Substantial Equivalence Discussion:

The intended use of the subject device, KLS Martin Individual Patient Solutions (IPS) Planning System, is identical to the predicate device, the KLS Martin Individual (IPS) Patient Solutions System (K188789):

The subject and predicate devices are intended for use as a software 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 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 cranial surgeries. They are both also intended as a pre-operative software tool for simulating / evaluating surgical treatment options.

The indications for use statement of the subject device is nearly identical to the predicate, K182889, differing in system outputs. The predicate, K182889, is cleared for use in the marking of bone in cranial surgery. The subject device is indicated for the marking and cutting of cranial bone in cranial surgery. The potential impact on substantial equivalence with regard to each technological difference has been addressed through risk analysis as well as verification and validation testing.

#### Similarities to Predicate

The subject and predicate devices share the same fundamental principle of operation - a system that processes original patient medical images (CT scan) and produces a variety of patient-specific physical and/or digital output devices for planning and executing cranial surgery.

The subject device shares identical technological characteristics as the predicate regarding software, material manufacturing process, performance testing, as well as cleaning and sterilization.

Both the subject and predicate devices use image data obtained from CT scans. The subject device utilizes two (2) commercially off-the-shelf (COTS) software applications for image segmentation and manipulation identical to what was evaluated in the predicate device, K182889. The validated commercially off-theshelf (COTS) software applications are used 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.

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Both systems use 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 surgeries or to use during surgery.

Design validation activities to verify the final finished output device matches the initial input data (.STL) are identical to the predicate and reference devices, K182889

### and K182789.

Materials used in the manufacture of the subject output devices are polyamide, acrylic resins, and titanium (CP titanium & Titanium Alloy) identical to what was evaluated in the predicate device, K182889.

All output devices from both systems are provided non-sterile and must be sterilized by the end user prior to use. Validated sterilization studies were performed to ensure a sterility assurance level (SAL) of 10-6.

## Differences from Predicate

The subject device's indications for use is nearly identical to the predicate device, differing in system outputs. The predicate, K182889, is cleared for use in the marking of bone in cranial surgery. The subject device is indicated for the marking and cutting of cranial bone in cranial surgery.

The IPS Planning System includes cutting and positioning guides, whereas the predicate only includes marking guides. Cutting and positioning guides were included as part of this device system to aid in cranial pediatric surgeries (e.g., craniosynostosis, congenital cranial deformities, etc.).

The predicate patient population includes adults only, whereas the subject device includes pediatric (neonate, infant, children, adolescents) and adult patient populations.

Risk assessments have been performed based on FDA guidance, "Premarket Assessment of Pediatric Medical Devices, March 24, 2014" for these subpopulations with supporting peer-reviewed clinical studies to demonstrate the safety and effectiveness of the subject device for use in the pediatric subpopulations.

### Reference Devices

The KLS Martin Individual Patient Specific Planning System, K182789, and the Stryker PEEK Customized Cranial Implant Kit, K190229 have been included as reference devices to address differences in technological characteristics between the subject and predicate devices.

- o Target Population: The predicate device was cleared for use in the adult patient population only, whereas the subject device includes pediatric (neonate, infant, children, adolescents) and adult patient populations, which is similar to the reference devices. K182789 includes all pediatric subpopulations and adults, while K190229 includes patients 3.5 years of age and older. Risk mitigation studies for pediatric patients were completed in both reference devices along with verbiage provided in the labelling to mitigate any risks (i.e., radiation exposure).

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| Device Comparison Table | | | | |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | KLS Martin IPS Planning System<br>(Subject Device) | KLS Martin IPS Planning System<br>K182889<br>(Primary Predicate) | KLS Martin IPS Planning System<br>K182789<br>(Reference) | Stryker PEEK Customized<br>Cranial Implant Kit<br>K190229<br>(Reference) |
| Indications for Use | The KLS Martin Individual Patient<br>Solutions (IPS) Planning System is<br>intended for use as a software system<br>and image segmentation system for<br>the transfer of imaging information<br>from a computerized tomography<br>(CT) medical scan. The input data<br>file is processed by the IPS Planning<br>System and the result is an output<br>data file that may then be provided<br>as digital models or used as input to<br>a rapid prototyping portion of the<br>system that produces physical<br>outputs including anatomical<br>models, guides, and case reports<br>for use in the marking and cutting<br>of cranial bone in cranial surgery.<br>The IPS Planning System is also<br>intended as a pre-operative<br>software tool for simulating /<br>evaluating surgical treatment<br>options. Information<br>provided by the software<br>and device output is not intended<br>to eliminate, replace, or<br>substitute, in whole or in part, the<br>healthcare provider's judgment and<br>analysis of the patient's condition. | The KLS Martin Individual Patient<br>Solutions (IPS) Planning System is<br>intended for use as a software<br>system and image segmentation<br>system for the transfer of imaging<br>information from a computerized<br>tomography (CT) medical scan. The<br>input data file is processed by the<br>IPS Planning System and the result<br>is an output data file that may then<br>be provided as digital models or<br>used as input to a rapid prototyping<br>portion of the system that produces<br>physical outputs including<br>anatomical models, guides and case<br>reports for use in the marking of<br>cranial bone in cranial surgery. The<br>IPS Planning System is also<br>intended as a pre-operative software<br>tool for simulating / evaluating<br>surgical treatment options. | The KLS Martin Individual Patient<br>Solutions (IPS) Planning System is<br>intended for use as a software<br>system and image segmentation<br>system for the transfer of imaging<br>information from a medical scanner<br>such as a CT based system. The<br>input data file is processed by the<br>IPS Planning System and the result<br>is an output data file that may then<br>be provided as digital models or<br>used as input to a rapid prototyping<br>portion of the system that produces<br>physical outputs including<br>anatomical models, guides, splints,<br>and case reports for use in<br>maxillofacial surgery. The IPS<br>Planning System is also intended as<br>a pre-operative software tool for<br>simulating / evaluating surgical<br>treatment options. | The PEEK Customized Cranial<br>Implant Kit is indicated for the<br>augmentation and/or restoration of<br>bony and/or soft tissue deformities<br>in the cranial and craniofacial<br>skeleton (orbital rim, zygoma, and<br>adjacent bone); including but not<br>limited to, the correction and<br>prevention of persistent temporal<br>hollowing (PTH) in patients 3.5<br>years of age and older. |
| Device Comparison Table | | | | |
| | KLS Martin IPS Planning System<br>(Subject Device) | KLS Martin IPS Planning System<br>K182889<br>(Primary Predicate) | KLS Martin IPS Planning System<br>K182789<br>(Reference) | Stryker PEEK Customized<br>Cranial Implant Kit<br>K190229<br>(Reference) |
| Contraindications | 1. Obvious infections.<br>2. Hypersensitivity to foreign<br>bodies.<br>3. Circulatory problems, systemic<br>diseases, and metabolic<br>disorders.<br>4. Insufficient or inadequate bone<br>tissue.<br>5. Secondary diseases such as<br>degenerative processes that may<br>negatively influence the healing<br>process.<br>6. Interventions carried out in a<br>non-sterile environment (e.g.<br>paranasal sinuses).<br>7. Regions exposed to inappropriate<br>forces or excessive weight loads.<br>8. Patients unwilling or unable to<br>follow instructions during the<br>postoperative phase due to their<br>mental, neurological, or physical<br>condition.<br>9. Bone tumors located in the<br>implant base region.<br>10. Obvious drug or alcohol abuse.<br>11. Significant changes to the<br>patient's anatomy has occurred<br>since the medical scan used for<br>planning purposes was obtained. | 1. Obvious infections.<br>2. Hypersensitivity to foreign<br>bodies.<br>3. Circulatory problems, systemic<br>diseases, and metabolic<br>disorders.<br>4. Insufficient or inadequate bone<br>tissue.<br>5. Secondary diseases such as<br>degenerative processes that may<br>negatively influence the healing<br>process.<br>6. Interventions carried out in a<br>non-sterile environment (e.g.<br>paranasal sinuses).<br>7. Regions exposed to inappropriate<br>forces or excessive weight loads.<br>8. Patients unwilling or unable to<br>follow instructions during the<br>postoperative phase due to their<br>mental, neurological, or physical<br>condition.<br>9. Bone tumors located in the<br>implant base region.<br>10. Obvious drug or alcohol abuse.<br>11. Significant changes to the<br>patient's anatomy has occurred<br>since the medical scan used for<br>planning purposes was obtained. | 1. Obvious infections.<br>2. Hypersensitivity to foreign<br>bodies.<br>3. Circulatory problems, systemic<br>diseases, and metabolic<br>disorders.<br>4. Insufficient or inadequate bone<br>tissue.<br>5. Secondary diseases such as<br>degenerative processes that may<br>negatively influence the healing<br>process.<br>6. Interventions carried out in a<br>non-sterile environment (e.g.<br>paranasal sinuses).<br>7. Regions exposed to inappropriate<br>forces or excessive weight loads.<br>8. Patients unwilling or unable to<br>follow instructions during the<br>postoperative phase due to their<br>mental, neurological, or physical<br>condition.<br>9. Bone tumors located in the<br>implant base region.<br>10. Obvious drug or alcohol abuse.<br>11. Significant changes to the<br>patient's anatomy has occurred<br>since the medical scan used for<br>planning purposes was obtained. | Unknown |
| Device Comparison Table | | | | |
| | KLS Martin IPS Planning System<br>(Subject Device) | KLS Martin IPS Planning System<br>K182889<br>(Primary Predicate) | KLS Martin IPS Planning System<br>K182789<br>(Reference) | Stryker PEEK Customized<br>Cranial Implant Kit<br>K190229<br>(Reference) |
| Classification | 21 CFR 882.4310, Class II | 21 CFR 882.4310, Class II | 21 CFR 872.4120, Class II<br>21 CFR 892.2050, Class II | 21 CFR 882.5320, Class II |
| Product Code | PPT | PPT | DZJ, LLZ | GWO |
| Material | Anatomical Models: Epoxy/Resin,<br>Acrylic<br>Cutting/Marking Guides:<br>Polyamide, Ti-6Al-4V, CP<br>Titanium | Anatomical Models: Epoxy/Resin,<br>Acrylic<br>Cutting/Marking Guides:<br>Polyamide, Ti-6Al-4V, CP<br>Titanium | Anatomical Models: Epoxy/Resin,<br>Acrylic<br>Cutting/Marking Guides: PA, Ti<br>6Al-4V, CP Titanium<br>Splints: methacrylate | Polyether ether ketone (PEEK) |
| Manufacturing<br>Method | Epoxy/Resin, Acrylic: 3D (SLA)<br>CP Titanium: Traditional<br>(Subtractive)<br>Ti-6Al-4V: 3D (Additive: SLM)<br>Polyamide: 3D (Additive; SLS) | Epoxy/Resin, Acrylic: 3D (SLA)<br>CP Titanium: Traditional<br>(Subtractive)<br>Ti-6Al-4V: 3D (Additive; SLM)<br>Polyamide: 3D (Additive; SLS) | Epoxy/Resin, Acrylic: 3D (SLA)<br>CP Titanium: Traditional<br>(Subtractive)<br>Ti-6Al-4V: 3D (Additive: SLM)<br>Polyamide: 3D (Additive; SLS) | Unknown |
| Software | Materialise Mimics (K073468)<br>Geomagic® Freeform PlusTM | Materialise Mimics (K073468)<br>Geomagic® Freeform PlusTM | Materialise Mimics (K073468)<br>Geomagic® Freeform PlusTM<br>IPS CaseDesigner (K161634)<br>MathWorks® MATLAB | Unknown |
| Target Population | Pediatric & Adult | Pediatric & Adult | Pediatric & Adult | Pediatric & Adult |
| Sterilization | Non-sterile (steam) | Non-sterile (steam) | Non-sterile (steam) | Non-sterile (steam) |
| Anatomical Sites | Cranial | Cranial | Mandibular and Maxillofacial | Cranial |
| Thickness | Cutting/Marking Guide<br>Min: 1.0 mm<br>Max: 5 mm | Cutting/Marking Guide<br>Min: 1.0 mm<br>Max: 5 mm | Cutting/Marking Guide<br>Min: 1.0 mm<br>Max: 5.0 mm | Not applicable |
| Device Comparison Table | | | | |
| | KLS Martin IPS Planning System<br>(Subject Device) | KLS Martin IPS Planning System<br>K182889<br>(Primary Predicate)…