Who is the manufacturer of KLS Martin Individual Patient Solutions (IPS) Planning System?

KLS-Martin L.P. filed the 510(k) submission for KLS Martin Individual Patient Solutions (IPS) Planning System (K181241).

What is the FDA product code for KLS Martin Individual Patient Solutions (IPS) Planning System?

DZJ. It is classified under 21 CFR 872.4120 as a Class 2 device in the Dental panel.

What is the regulatory pathway for KLS Martin Individual Patient Solutions (IPS) Planning System?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like KLS Martin Individual Patient Solutions (IPS) Planning System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

KLS Martin Individual Patient Solutions (IPS) Planning System

K181241 · KLS-Martin L.P. · DZJ · Sep 13, 2018 · Dental

Device Facts

Record ID	K181241
Device Name	KLS Martin Individual Patient Solutions (IPS) Planning System
Applicant	KLS-Martin L.P.
Product Code	DZJ · Dental
Decision Date	Sep 13, 2018
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.4120
Device Class	Class 2
Attributes	Software as a Medical Device

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 medical scamer such as a CT based system. 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, splints, and case reports for use in maxillofacial surgery. The IPS Planning System is also intended as a pre-operative software tool for simulating / evaluating surgical treatment options.

Device Story

System processes CT imaging data to support maxillofacial surgery planning; utilizes four COTS software applications for image segmentation and manipulation. Physician and trained engineer collaborate to create virtual surgical plans; system generates digital models and physical outputs via additive manufacturing (SLA, SLS, Selective Laser Melting) or traditional subtractive methods. Physical outputs include anatomical models, cutting/marking guides, and splints; guides may be temporarily fixated with screws (1.5-2.7mm). Output devices are provided non-sterile for steam sterilization by end-user. System aids surgeons in precise bone cutting/marking and surgical simulation; benefits include improved surgical accuracy and patient-specific treatment planning.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including tensile/bending strength, biocompatibility (ISO 10993-1), steam sterilization validation (ISO 17665-1), and pyrogenicity (AAMI ANSI ST72).

Technological Characteristics

Software-based image segmentation and planning system. Materials: Polyamide, Titanium Alloy (Ti-6Al-4V), CP Titanium, epoxy/resin, acrylic. Manufacturing: Stereolithography (SLA), Selective Laser Sintering (SLS), Selective Laser Melting, and traditional subtractive methods. Connectivity: DICOM to .STL conversion. Sterilization: Steam (SAL 10^-6).

Indications for Use

Indicated for use in maxillofacial surgery as a pre-operative software tool for image segmentation, simulation, and evaluation of surgical treatment options, and for the creation of patient-specific anatomical models, surgical guides, splints, and case reports.

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

VSP System (K120956)

Reference Devices

KLS Martin Individual Patient Solutions (K163579)
KLS Mini Osteosynthesis System (K943347)
KLS Martin Centre-Drive Drill-Free Screws (K971297)

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 consists of a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that. KLS-Martin L.P. Gary Moore Quality Management and Regulatory Affairs Manager 11201 Saint Johns Industrial Pkwy S Jacksonville, Florida 32246 September 13, 2018 Re: K181241 Trade/Device Name: KLS Martin Individual Patient Solutions (IPS) Planning System Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument And Accessories Regulatory Class: Class II Product Code: DZJ, LLZ Dated: September 7, 2018 Received: September 10, 2018 Dear Gary Moore: 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. {1}------------------------------------------------ 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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Mary S. Runner -S forTina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) ### K181241 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 medical scamer such as a CT based system. 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, splints, and case reports for use in maxillofacial surgery. The IPS Planning System is also intended as a pre-operative software tool for simulating / evaluating surgical treatment options. Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D) | <input checked="" type="checkbox"/> | |----------------------------------------------|-------------------------------------| | Over-The-Counter Use (21 CFR 801 Subpart C) | <input type="checkbox"/> | ### 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 PRAStaff@fda.hhs.gov "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}------------------------------------------------ ## KUS ITT CIT CIT CIIN LIP T H201 Saint John Industrial Play S • Iocksoriile, FL322 Previous Clin Clin Carpe Phone: 904-04-1378 • Fax: 904-641-737 11201 Saint Johns Industrial Pkwy S • Jacksonville, FL 32246 www.klsmartinnorthamerica.com ### K181241 510(k) Summary 21 CFR 807.92 | Submitter: | KLS-Martin L.P. 11201 Saint Johns Industrial Pkwy S Jacksonville, FL 32246 | |----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Gary Moore Quality Management and Regulatory Affairs Manager Phone: 800-625-1557 Email: gmoore@klsmartin.com | | Date Prepared: | September 13, 2018 | | Trade Name: | KLS Martin Individual Patient Solutions (IPS) Planning System | | Common Name: | System for the creation of patient specific anatomical models, cutting/marking guides, splints, and case reports | | Classification Name: | Bone Cutting Instruments and Accessories (21 CFR 872.4120); System, Image Processing, Radiological (21 CFR 892.2050 | | Regulatory Class: | II | | Product Code: | DZJ, LLZ | | Predicate Device: | VSP System (K120956) - Primary | | Reference Devices: | KLS Martin Individual Patient Solutions (K163579) KLS Mini Osteosynthesis System (K943347) KLS Martin Centre-Drive Drill-Free Screws (K971297) | | 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 and orthognathic 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, splints and case reports. | | 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 medical scanner such as a CT based system. 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 | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for KLS Martin L.P. The letters "KLS" are in red, while the word "martin" is in gray. The letters "L.P." are in black. The logo is simple and modern. of the system that produces physical outputs including anatomical models, guides, splints, and case reports for use in maxillofacial 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, VSP System (K120956): The subject and primary predicate devices are 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 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, splints, templates, and case reports. All digital data and physical devices are used to aid the surgeon during maxillofacial surgeries. They are both also intended as a pre-operative software tool for simulating / evaluating surgical treatment options. ### Similarities to Predicate Both the subject and primary predicate devices use image data obtained from medical scanners, such as a CT scan. They both use 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. Both systems use additive manufacturing methods to produce physical output devices that include patient specific anatomical models, guides, and splints. In addition, the systems produce digital models and case reports for the physician to use for planning of maxillofacial surgeries or to use during surgery. Materials used in the manufacture of the output devices are similar in that both the subject and predicate devices use biocompatible polymers/acrylic resins. 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. Output devices in both systems are temporarily fixated with screws of varying sizes and lengths to aid the surgeon in cutting and marking bone more precisely and accurately. 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. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for KLS Martin L.P. The letters "KLS" are in red, while the word "martin" is in gray. The letters "L.P." are in black. The logo is simple and modern. ### Differences to Predicate The indications for use statements differ slightly in that the predicate device stipulates physical outputs to include "anatomical models, templates, and surgical guides" whereas the subject device includes "anatomical models, guides, splints, and case reports." The predicate device includes splints and case reports in the narrative description, but splints and case reports were included in the indications for use of the subject device to describe all physical outputs. The subject device utilizes four (4) commercially off-the-shelf (COTS) software applications for image segmentation and manipulation, whereas the predicate device utilizes thirteen (13) pieces of software that is a combination of COTS and custom. Materials used in the manufacture of the subject output devices are synthetic polymers, acrylic resins, and titanium (CP titanium & Titanium Alloy). The predicate device manufactures output devices from acrylic and polymers only and uses surgical grade stainless steel cutting and drilling inserts for use in the cutting guides. In addition, the subject device uses previously cleared fixation screws that are utilized for temporary guide fixation during cutting and marking of the bone. The screws range from 1.5 mm – 2.7 mm with lengths of 4 mm – 22 mm. The predicate device does not indicate screw diameter or length for temporary fixation of cutting guides. ### Reference Devices The KLS Martin Individual Patient Solutions (K163579) has been included as a reference device to address differences in technological characteristics between the KLS Martin IPS Planning System and the predicate device with regard to material composition, biocompatibility, manufacturing process, performance testing, as well as cleaning and sterilization for titanium guides. The KLS Martin IPS Planning System titanium guides are manufactured from identical materials (CP Titanium Alloy), undergo the same manufacturing processes, have the same biocompatibility, demonstrate similar performance characteristics, and are cleaned and sterilized using the same validated methods as the titanium implants in the KLS Martin Individual Patients Solutions clearance (K163579). The KLS Mini Osteosynthesis System (K943347) has been included as a reference device to address the differences in screw dimensions from the reference device KLS Martin Individual Patient Solutions (K163579). In reference device K163579, screw dimensions range from 2.0 mm - 3.2 mm with lengths of 5 mm - 22 mm. The KLS Mini Osteosynthesis System has been included to cover the 1.5 mm screw dimensions and a minimum length down to 4 mm that is identical to the subject device temporary fixation screws. The KLS Martin Centre-Drive Drill-Free Screw (K971297) has been included as a reference device to address the difference in screw dimension and style from the reference device KLS Martin Individual Patient Solutions (K163579). In reference device K163579, screw dimensions ranged from 2.0 mm - 3.2 mm with lengths of 5 mm - 22 mm and a drill-free screw style. The KLS Martin Centre-Drive Drill-Free Screw has been included to cover the 1.5 mm screw dimensions with a drill-free screw style that is identical to the subject device temporary fixation screws. {6}------------------------------------------------ ## kıs martın ı.p. 11201 Saint Johns Industrial Pkwy S • Jacksonville, FL 32246 Phone: 904-641-7746 • 800-625-1557 • Fax: 904-641-7378 www.klsmartinnorthamerica.com | Device Comparison Table | | | | | | |---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | KLS Martin IPS Planning System (Subject Device) | Medical Modeling VSP® System K120956 (Primary Predicate) | KLS Martin Individual Patient Solutions K163579 (Reference Device) | KLS Mini Osteosynthesis System K943347 (Reference Device) | KLS Martin Centre-Drive Drill-Free Screw K971297 (Reference Device) | | 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 medical scanner such as a CT based system. 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, splints, and case reports for use in maxillofacial surgery. The IPS Planning System is also intended as a pre-operative software tool for simulating/ evaluating surgical treatment options. | The VSP® 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 VSP® 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, templates, and surgical guides for use in maxillofacial surgery. The VSP® System is also intended as a pre-operative software tool for simulating/evaluating surgical treatment options. | KLS Martin Individual Patient Solutions implant devices are intended for use in the stabilization and fixation of mandibular fractures and mandibular reconstruction. | 1) Fractures 2) Osteotomies 3) Reconstruction procedures | KLS Martin Centre-Drive Drill-Free Screws are intended for use in rigid internal fixation of the oral- maxillo-cranio-facial bones. The bone screws are used to anchor plates which are contoured to fit the bony surface and stabilize the bone fragments. The addition of the self drilling feature is the only difference between the submitted device and the predicate device referenced. | | Device Comparison Table | | | | | | | | KLS Martin IPS Planning System (Subject Device) | Medical Modeling VSP® System K120956 (Primary Predicate) | KLS Martin Individual Patient Solutions K163579 (Reference Device) | KLS Mini Osteosynthesis System K943347 (Reference Device) | KLS Martin Centre-Drive Drill-Free Screw K971297 (Reference Device) | | Contraindications | 1. Obvious infections. 2. Hypersensitivity to foreign bodies. 3. Circulatory problems, systemic diseases, and metabolic disorders. 4. Insufficient or inadequate bone tissue. 5. Secondary diseases such as degenerative processes that may negatively influence the healing process. 6. Interventions carried out in a non-sterile environment (e.g. paranasal sinuses). 7. Regions exposed to inappropriate forces or excessive weight loads. 8. Patients unwilling or unable to follow instructions during the postoperative phase due to their mental, neurological, or physical condition. 9. Bone tumors located | The models, templates and guides from the VSP System and the associated case report should not be used if any of the following occur: 1. Patient has an active infection. 2. Significant changes to patient's anatomy have occurred since the medical scan used for product definition was obtained. | 1. Obvious infections. 2. Hypersensitivity to foreign bodies. 3. Suspected sensitivity to the implant material. 4. Circulatory problems, systemic diseases and metabolic disorders. 5. Insufficient or inadequate bone tissue. 6. Secondary diseases such as degenerative processes that may negatively influence the healing process. 7. Interventions carried out in a non-sterile environment (e.g. paranasal sinuses). 8. Regions exposed to inappropriate forces or excessive weight loads. 9. Patients unwilling or unable to follow instructions during the postoperative phase due to their mental, neurological or physical condition. 10. Osteoporosis or | 1. Active infection. 2. Patient conditions including: blood supply limitations, insufficient quantity or quality of bone or latent infections. 3. Patients with mental or neurologic conditions who are unwilling or incapable of following postoperative care instructions. 4. Foreign body sensitivity. Where material sensitivity is suspected, tests are to be made prior to implantation. | 1. Active infection. 2. Patient conditions including: blood supply limitations, insufficient quantity or quality of bone or latent infections. 3. Patients with mental or neurologic conditions who are unwilling or incapable of following postoperative care instructions. 4. Foreign body sensitivity. Where material sensitivity is suspected, tests are to be made prior to implantation. | | Device Comparison Table | | | | | | | | KLS Martin IPS Planning System (Subject Device) | Medical Modeling VSP® System K120956 (Primary Predicate) | KLS Martin Individual Patient Solutions K163579 (Reference Device) | KLS Mini Osteosynthesis System K943347 (Reference Device) | KLS Martin Centre-Drive Drill-Free Screw K971297 (Reference Device) | | | in the implant base region. 10. Obvious drug or alcohol abuse. 11. Significant changes to the patient's anatomy has occurred since the medical scan used for planning purposes was obtained. | | osteomalacia or other structural bone damage preventing the stable fixation of implant components. 11. Bone tumors located in the implant base region. 12. Obvious drug or alcohol abuse. | | | | Classification | 21 CFR 872.4120, Class II 21 CFR 892.2050, Class II | 21 CFR 872.4120, Class II 21 CFR 892.2050, Class II | 21 CFR 872.4760, Class II | 21 CFR 872.4760, Class II | 21 CFR 888.3040, Class II | | Product Code | DZJ, LLZ | DZJ, LLC | JEY | JEY | HWC | | Material | Anatomical Models: Epoxy/Resin, Acrylic Cutting/Marking Guides: Polyamide, Titanium Alloy (Ti-6Al-4V), CP Titanium Splints: methacrylate | Acrylic and epoxy photopolymers, surgical instrument grade stainless steel | Anatomical Models: Epoxy/Resin, Acrylic Implants: CP Titanium & Titanium Alloy (Ti-6Al-4V) | Implants: CP Titanium & Titanium Alloy (Ti-6Al-4V) | Screws: Titanium Alloy (Ti- 6Al-4V) | | Manufacturing Method | Epoxy/Resin, Acrylic: Stereolithography (SLA) CP Titanium: Traditional (Subtractive) Ti-6Al-4V: 3D (Additive; Selective Laser Melting) Polyamide: 3D (Additive; Selective Laser Sintering) | 3D (Additive) | Epoxy/Resin, Acrylic: Stereolithography (SLA) CP Titanium: Traditional (Subtractive) Ti-6Al-4V: 3D (Additive; Selective Laser Melting) | CP Titanium & Titanium Alloy (Ti-6Al-4V): Traditional (Subtractive) | Titanium Alloy (Ti-6Al-4V): Traditional (Subtractive) | | Device Comparison Table | | | | | | | | KLS Martin IPS Planning System (Subject Device) | Medical Modeling VSP® System K120956 (Primary Predicate) | KLS Martin Individual Patient Solutions K163579 (Reference Device) | KLS Mini Osteosynthesis System K943347 (Reference Device) | KLS Martin Centre-Drive Drill-Free Screw K971297 (Reference Device) | | Sterilization | Non-sterile (Steam) | Non-sterile (Steam) | Non-sterile (Steam) | Non-sterile (Steam) | Non-sterile (Steam) | | Temporary/Permanent Screw Diameter | Temporary: 1.5 mm - 2.7 mm | Temporary: Unknown | Permanent: 2.0 mm - 3.2 mm | Permanent: 1.5 mm - 2.0 mm | Permanent: 1.0 mm - 2.0 mm | | Temporary/Permanent Screw Length | Temporary: 4 mm - 22 mm | Temporary: Unknown | Permanent: 5 mm - 22 mm | Permanent: 4 mm - 19 mm | Permanent: 2 mm - 9 mm…

KLS Martin Individual Patient Solutions (IPS) Planning System

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Reference Devices

Submission Summary (Full Text)

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KLS Martin Individual Patient Solutions (IPS) Planning System

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

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Predicate Devices

Reference Devices

Submission Summary (Full Text)

Panel 1

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