KLS Martin IPS Preprosthetic

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION". KLS-Martin L.P. Susan Leander Regulatory Affairs Project Supervisor 11201 Saint Johns Industrial Parkway S Jacksonville, Florida 32246 Re: K210228 Trade/Device Name: KLS Martin IPS Preprosthetic Regulation Number: 21 CFR 872.3645 Regulation Name: Subperiosteal Implant Material Regulatory Class: Class II Product Code: ELE Dated: June 1, 2022 Received: June 7, 2022 Dear Susan Leander: 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/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 medical devices and radiation-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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K210228 Device Name KLS Martin IPS Preprosthetic #### Indications for Use (Describe) The KLS Martin IPS Preprosthetic Implant is a subperiosteal implant composed of titanium intended to construct patient specific prosthetic devices which are surgically implanted into the lower or upper jaw between the periosteum (connective tissue covering the bone) and supporting bony structures. The device is intended to provide support for multi-unit prostheses, such as dentures. Type of Use (Select one or both, as applicable) | <span>☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> | |-------------------------------------------------------------| | <span>☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> | #### 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}------------------------------------------------ Image /page/3/Picture/1 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 and are slightly larger than the other letters in the logo. 11201 Saint Johns Industrial Pkwy S . Jacksonville, FL 32246 Phone: 904-641-7746 · 800-625-1557 · Fax: 904-641-7378 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: | Susan Leander<br>Regulatory Affairs Project Supervisor<br>Phone: 800-625-1557<br>Email: susan.leander@klsmartin.com | | Alternate Contact: | Melissa Bachorski<br>Assistant Director RA/QMS<br>Phone: 800-625-1557<br>Email: melissa.bachorski@klsmartin.com | | Date Prepared: | July 7, 2022 | | Trade Name: | KLS Martin IPS Preprosthetic | | Common Name: | Dental implant | | Classification Name: | Implant, subperiosteal (21 CFR 872.3645) | | Regulatory Class: | II | | Product Code: | ELE | | Predicate Device: | Hollow Basket Titanium Dental Implant (K801208) | | Reference Devices: | Pacific Implants Intraosseous Dental Implant (K813227)<br>KLS Martin Individual Patient Solutions (K191028) | #### Device Description The KLS Martin Individual Patient Solutions (IPS) Preprosthetic system is comprised of patient-specific models and metallic bone plates with integrated pillars used in conjunction with metallic bone screws for internal fixation of the implant to maxillofacial / midface and mandibular bones. The integrated pillars will serve as the base for temporary dentures as well as a permanent prosthesis. The devices are manufactured based on medical imaging (CT scan) of the patient's anatomy with input from the physician during virtual planning and prior to finalization and production of the device. The physician only provides input for model manipulation and interactive feedback by viewing digital models of planned outputs that are modified by trained KLS Martin engineers during the planning session. For each design iteration, verification is performed by virtually fitting the generated implant over a 3D model of the patient's anatomy to ensure its dimensional properties allow an adequate fit. The KLS Martin IPS Planning System is utilized to plan and design the IPS Preprosthetic implant. The 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 {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for KLS Martin L.P. The letters "KLS" are in red, "martin" is in gray, and "L.P." is in black. The logo is simple and modern, with a clean font. 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, implants, and case reports. Implants are provided non-sterile, range in thickness from 1.2 - 10.0 mm, and are manufactured using additive methods from Ti-6Al-4V (ASTM F136). These patient-specific devices are fixated with previously cleared KLS Martin screws. Implants have a minimum of two (2) transgingival pillars for the attachment of dental prostheses. The straight pillars (0° to the occlusal plane) have a diameter of 4 mm and are provided at lengths up to 20 mm. #### Indications for Use The KLS Martin IPS Preprosthetic Implant is a subperiosteal implant composed of titanium intended to construct patient specific prosthetic devices which are surgically implanted into the lower or upper jaw between the periosteum (connective tissue covering the bone) and supporting bony structures. The device is intended to provide support for of multi-unit prostheses, such as dentures. #### Technological Characteristics & Substantial Equivalence Discussion The intended use of the subject device, KLS Martin IPS Preprosthetic is similar to the predicate device, K801208 and the reference device, K813227. The potential impact on substantial equivalence of each technological difference was addressed through risk analysis and verification and validation testing. #### Similarities to Predicate The subject and predicate devices are intended to be used to provide support for prosthetic devices. Both are subperiosteal implants made of titanium that are surgically placed in the upper or lower jaw to support prostheses. Both devices have transgingival pillars for the attachment of prostheses. The subject and predicate devices are safe and effective at restoring a patient's chewing function when the maxilla and/or mandible have been compromised. The subject device is provided non-sterile and requires the end-user to process the implants using validated cleaning and sterilization methods prior to use as recommended in the labeling. Sterilization information is not available for the predicate device. #### Differences from Predicate The subject and predicate devices are attached to the bony substructures of the jaw. The predicate device is an intraosseous implant whereas the subject device is implanted using bone screws to attach the device to the bone. Although attachment to the bone is achieved differently, both are effective methods. Studies of the predicate device present evidence of osseointegration that results in stable attachment of the implant. The attachment method used by the subject device has been safely and effectively demonstrated in more than one hundred clinical cases in the EU, where the device is currently marketed. Real-world evidence of the subject device's safe and effective use is cited in peer-reviewed literature. {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. #### Reference Devices KLS Martin Individual Patient Solutions (K191028), included as a reference device, is comprised of patient-specific models and metallic bone plates used in conjunction with metallic bone screws for internal fixation of maxillofacial / midface and mandibular bones. Both the subject and reference devices are manufactured based on medical imaging (CT scan) of the patient's anatomy with input from the physician during virtual planning and prior to finalization and production of the device. The physician only provides input for model manipulation and interactive feedback by viewing digital models of planned outputs that are modified by trained KLS Martin engineers during the planning session. For each design iteration, verification is performed by virtually fitting the generated implant over a 3D model of the patient's anatomy to ensure its dimensional properties allow an adequate fit. Subject and reference device implants are provided non-sterile and are manufactured using additive methods from Ti-6Al-4V. These patient-specific devices are fixated with previously cleared KLS Martin screws. The Pacific Implant, Inc. Endosseous Dental Implant (K813227) has been included as a reference device for comparison of typical loading values for dental implants. The subject and reference devices are intended to be used to provide support for prosthetic devices. Both are made of titanium; both are surgically placed in the upper or lower jaw and both are devices to support prostheses. Both devices have transgingival pillars for the attachment of prostheses. Both devices are designed for use in patients that have sub-optimal quantity or quality of bone in the upper or lower jaw. Both the subject and reference devices are safe and effective at restoring a patient's chewing function when the jawbone has been compromised. The subject and reference devices are provided non-sterile and require the end-user to process the implants using validated cleaning and sterilization methods prior to use as recommended in the labeling. {6}------------------------------------------------ ## kıs martı L.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 Preprosthetic<br>K210228 | Hollow Basket Titanium Dental<br>Implants<br>K801208 | Pacific Implant, Inc. Intraosseous Dental<br>Implant<br>K813227 | KLS Martin Individual Patient Solutions<br>K191028 | | | (Subject Device) | (Primary Predicate) | (Reference Device) | (Reference Device) | | Indications for Use | The KLS Martin IPS Preprosthetic Implant is a subperiosteal implant<br>composed of titanium intended to construct patient specific<br>prosthetic devices which are surgically implanted into the lower or<br>upper jaw between the periosteum (connective tissue covering the<br>bone) and supporting bony structures. The device is intended to<br>provide support for multi-unit prostheses, such as dentures. | The Hollow Basket Titanium Dental<br>Implant is a subperiosteal implant<br>composed of titanium intended to<br>construct patient specific prosthetic<br>devices which are surgically implanted<br>into the lower or upper jaw between the<br>periosteum (connective tissue covering the<br>bone) and supporting bony structures. | An endosseous dental implant is a<br>prescription device made of a material such as<br>titanium or titanium alloy that is intended to<br>be surgically placed in the bone of the upper<br>or lower jaw arches to provide support for<br>prosthetic devices, such as artificial teeth, in<br>order to restore a patient's chewing function.¹ | The KLS Martin Individual Patient Solutions<br>implant devices are intended for use in the<br>stabilization, fixation, and reconstruction of the<br>maxillofacial / midface and mandibular skeletal<br>regions. | | Contraindications | 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<br>disorders<br>5. Insufficient or inadequate bone tissue<br>6. Secondary diseases such as degenerative processes that may<br>negatively influence the healing process<br>7. Interventions carried out in a non-sterile environment (e.g.<br>paranasal sinuses)<br>8. Regions exposed to inappropriate forces or excessive weight<br>loads<br>9. Patients unwilling or unable to follow instructions during the<br>postoperative phase due to their mental, neurological or<br>physical condition<br>10. Osteoporosis or osteomalacia or other severe structural bone<br>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<br>13. Failure to locate a primary nerve in the lower jaw<br>14. Uncontrolled Type II diabetes<br>15. Oral or intravenous bisphosphonates<br>16. Bruxism (tooth grinding or clenching)<br>17. Smoking | Unknown – similar to K813227 | 1. Local tissue or existing dentition<br>degeneration due to²:<br>a. Excessive mobility<br>b. Loss of integration<br>c. Incompatibility of the device<br>components<br>d. Structural failure of the device<br>2. Pain<br>3. Infection<br>4. Adverse tissue reaction<br>5. Bone or nerve damage<br>a. Sinus perforation<br>b. Alveolar plate perforation<br>c. Transient or chronic pain/facial<br>paresis<br>6. Migration or thermal injury<br>a. Incompatibility with MRI<br>7. Patient Selection Criteria<br>a. Previous radiation therapy (affects<br>bone quality) | 1. Obvious infections.<br>2. Hypersensitivity to foreign bodies.<br>3. Suspected sensitivity to the implant<br>material.<br>4. Circulatory problems, systemic diseases,<br>and metabolic disorders.<br>5. Insufficient or inadequate bone tissue.<br>6. Secondary diseases such as degenerative<br>processes that may negatively influence the<br>healing process.<br>7. Interventions carried out in a non-sterile<br>environment (e.g. paranasal sinuses).<br>8. Regions exposed to inappropriate forces or<br>excessive weight loads.<br>9. Patients unwilling or unable to follow<br>instructions during the postoperative phase<br>due to their mental, neurological, or<br>physical condition.<br>10. Osteoporosis or osteomalacia or other<br>structural bone damage preventing the<br>stable fixation of implant components.<br>11. Bone tumors located in the implant base<br>region.<br>12. Obvious drug or alcohol abuse. | | Patient-specific? | Yes. Devices are manufactured patient-specific, based on a CT scan<br>of the patient. | | No. | Yes. Devices are manufactured patient-specific,<br>based on a CT scan of the patient. | | Classification | 21 CFR 872.3645<br>Class II | | 21 CFR 872.3640<br>Class II | 21 CFR 872.4760<br>Class II | | Product Code | ELE | | DZE | JEY | | Material | Anatomical Models: Epoxy/Acrylic Resins Implants: Ti-6Al-4V | | Implants: CP Titanium | Anatomical Models: Epoxy/Acrylic Resins Cutting/Marking Guides: Polyamide,<br>Ti-6Al-4V, CP Titanium Splints: acrylic/methacrylic resins | | Manufacturing<br>Method | Epoxy/Acrylic Resins: Stereolithography (SLA) Ti-6Al-4V: 3D (Additive; Selective Laser Melting) | | Traditional milling/stamping | Epoxy/Acrylic Resins: Stereolithography<br>(SLA) CP Titanium: Traditional (Subtractive) Ti-6Al-4V: 3D (Additive; Selective Laser<br>Melting) Polyamide: 3D (Additive; Selective Laser<br>Sintering) | | Sterilization | Unknown | | Non-sterile | Non-sterile | | Anatomical Sites | Maxillofacial/Midface & Mandible | | Mandible | Maxillofacial / Midface & Mandible | | Plate Specifications | | | | | | Thickness | 1.2 mm - 10.0 mm | | Unknown | Orbital floor only: 0.3 mm – 1.0 mm Maxillofacial / midface reconstruction:<br>0.6 mm - 10.0 mm Mandibular reconstruction: 1.0 mm - 3.0 mm | | Style | Non-locking<br>Compression<br>Threaded | | One-piece hollow, grooved, bore-holed<br>cylinders with upper portions designed to<br>support an artificial denture | Non-locking<br>Compression<br>Threaded | | Width<br>(between screws) | Min: 4.5 mm | | No screws are used with this device | Maxillofacial / midface:<br>Min: ≥ 4.5 mm (around screw holes)<br>Min: ≥ 3 mm (not around screw hole)<br>Max: Dependent on screw-hole<br>Mandibular:<br>Min: 7 mm<br>Max: 8.5 mm | | Length | Maxillofacial / midface:<br>Min: 29 mm<br>Max: 320 mm<br>Mandibular:<br>Min: 29 mm<br>Max: 320 mm | | Unknown | Maxillofacial / midface:<br>Min: 18 mm<br>Max: 350 mm<br>Mandibular:<br>Min: 31 mm<br>Max: 320 mm | | Width around<br>Screws | 1.5 System: ≥ 4.5 mm<br>2.0/2.3 System: ≥ 6.5 mm<br>2.7 System: ≥ 8 mm | No screws are used with this device | No screws are used with this device | 1.5 System: ≥ 4.5 mm<br>2.0/2.3 System: ≥ 6.5 mm<br>2.7 System: ≥ 8 mm | | Number of Screw<br>Holes | Maxillofacial / midface:<br>Min: 4 per side of defect<br>Max: Dependent on length & hole spacing<br>Mandibular:<br>Min: 4<br>Max: Dependent on length & hole spacing | Holes are present but are not screw holes.<br>These are to allow for bone ingrowth. | 14 holes are present but are not screw holes.<br>These are to allow for bone ingrowth. | Maxillofacial / midface:<br>Min: ≥ 2 per side of defect<br>Max: Dependent on length & hole spacing<br>Mandibular:<br>Min: 4<br>Max: Dependent on length & hole spacing | | Pillar Diameter | ≥ 4 mm | Unknown | N/A | N/A | | Angulation of<br>Pillar to the<br>Occlusal Plane | 0° | Unknown | N/A | N/A…