(526 days)
No
The device description focuses on patient-specific design based on CT data and physician input, with verification through virtual fitting. There is no mention of AI or ML algorithms being used for image processing, design generation, or analysis. The planning system is described as processing images and producing outputs based on physician input, not through autonomous learning or pattern recognition.
Yes
Explanation: The device is intended to provide support for multi-unit prostheses, such as dentures, and is surgically implanted to treat conditions like postablative maxillary defects, severely atrophic maxilla, and cleft lip and palate deformity, which aligns with the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
Explanation: The device is an implant designed to provide structural support for multi-unit prostheses, not to diagnose a condition. While it utilizes medical imaging for design, its primary function is therapeutic/reconstructive.
No
The device description clearly states that the system produces patient-specific physical output devices, specifically implants made of titanium, which are surgically implanted. While software is used in the planning process, the final medical device is a physical implant.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Function: The KLS Martin IPS Preprosthetic Implant is a surgically implanted device. It is a physical structure designed to provide support for dental prostheses within the patient's jawbone.
- Intended Use: The intended use is to construct and support patient-specific prosthetic devices that are surgically implanted. This is a therapeutic and structural function, not a diagnostic one based on analyzing biological specimens.
- Device Description: The description focuses on the physical components (implants, screws, models) and the manufacturing process based on medical imaging. It does not involve the analysis of biological samples.
- Input: The primary input is medical imaging (CT data) of the patient's anatomy, not biological specimens.
The device is a medical device, specifically a surgically implanted device, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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 multi-unit prostheses, such as dentures.
Product codes (comma separated list FDA assigned to the subject device)
ELE
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 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.
Mentions image processing
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.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scan, CT data
Anatomical Site
Maxillofacial/Midface & Mandible, lower or upper jaw
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
A full validation to address a worst-case design of the subject device in terms of the accuracy of the final device as compared to the initial software model design was performed. An evaluation of a worst-case implant device was evaluated using a 3D scanner to determine the dimensions of each manufactured part. An STL of the scanned part was created and compared against the original software model design.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Testing - Non-clinical:
- MR Conditional Labeling: Non-clinical worst-case MRI review was performed to evaluate the metallic IPS Preprosthetic devices in the MRI environment using scientific rationale and published literature. The rationale addressed parameters per the FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment", including magnetically induced displacement force and torque.
- Additive Manufacturing Build Orientation & Location:
- Baseline Study - Build Orientation (#PBN-0478): Fourteen (14) Selective Laser Melting (SLM) test articles were used to examine the influence of various bed positions and any effect of component dimensional accuracy using FEM analysis. Results indicate components placed centrally vs. peripherally have minor impact on the final component.
- Position and Tensile Strength (#PBN-0481): Additional studies performed to determine whether build location in the build space has a significant effect on device characteristics or performance. The baseline study performed on the SLM test articles demonstrates that the components achieved a tensile strength of 860 N/mm² and component position does not significantly impact tensile strength.
- SLM Orientation and Tensile Strength (#PBN-0474): Various component orientations (Z, 45° tilted, 45° horizontal, Y, and X) were evaluated to ensure the SLM test articles met the 860 N/mm² requirement for tensile strength in accordance with ASTM F136. All test setups rendered similar values for the various orientations tested, which exceeded the 860 N/mm² requirement.
- Dimensional Evaluation of Worst-Case Model (#IRN-0004): An evaluation of a worst-case implant device was evaluated using a 3D scanner. The test report results show that deviations of the manufactured part versus the associated original model design file are well within the acceptance criteria. All samples passed the acceptance criteria of deviation relative to nominal part by not exceeding the maximum tolerance of ±1.5 mm.
- Material Characterization:
- Powder Recycling Process and Evaluation of Device Performance (#PBN-0484): An assessment of the material recycling protocol was conducted. The analysis demonstrated the material recycling process, tested with 256 SLM test articles over the course of one year, yielded consistent tensile strength results.
- Biocompatibility Testing: Evaluated in accordance with ISO 10993. Leveraging testing from K191028 for titanium devices.
- Sterilization Testing: Steam sterilization validations performed using the dynamic-air-removal cycle in accordance with AAMI ANSI ISO 17665-1 to a sterility assurance level (SAL) of 10^-6 using the biological indicator (BI) overkill method. All test method acceptance criteria were met. Leveraging validations from K191028 for titanium devices.
- Pyrogenicity Testing: LAL endotoxin testing conducted according to AAMI ANSI ST72. Results demonstrate that subject devices contain endotoxin levels below the USP allowed limit and meet pyrogen limit specifications. Leveraging testing from K191028.
- Software Verification and Validation: Performed on individual software applications used in planning and design. Quality and on-site user acceptance testing provide objective evidence that all software requirements and specifications were implemented correctly and completely and are traceable to system requirements.
Performance Testing - Clinical:
- Clinical testing data of IPS Preprosthetic was collected up to 74 months post-operatively which evaluated 39 total implants from 35 patients.
- Data consisted of 19 patients who received implants due to postablative maxillary defects, 10 patients who received implants to treat a severely atrophic maxilla, and 6 patients who were treated for a cleft lip and palate (CLP) deformity with significant soft and hard tissue impairment.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Clinical Performance:
- No instances of implant loosening (0%)
- No instances of a removed implant (0%)
- One instance of a reduced post (2.9%)
- 3 instances of exposed/removed screws (8.6%)
- 3 instances of infections/abscesses (8.6%)
- 14 instances of a partial exposure of underlying framework (40%)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Hollow Basket Titanium Dental Implant (K801208)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Pacific Implants Intraosseous Dental Implant (K813227), KLS Martin Individual Patient Solutions (K191028)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.3645 Subperiosteal implant material.
(a)
Identification. Subperiosteal implant material is a device composed of titanium or cobalt chrome molybdenum intended to construct custom 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 prostheses, such as dentures.(b)
Classification. Class II.
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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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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.
11201 Saint Johns Industrial Pkwy S
Jacksonville, FL 32246 |
|----------------------|---------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Susan Leander
Regulatory Affairs Project Supervisor
Phone: 800-625-1557
Email: susan.leander@klsmartin.com |
| Alternate Contact: | Melissa Bachorski
Assistant Director RA/QMS
Phone: 800-625-1557
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)
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
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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.
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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 | ||||
| K210228 | Hollow Basket Titanium Dental | |||
| Implants | ||||
| K801208 | Pacific Implant, Inc. Intraosseous Dental | |||
| Implant | ||||
| K813227 | KLS Martin Individual Patient Solutions | |||
| K191028 | ||||
| (Subject Device) | (Primary Predicate) | (Reference Device) | (Reference Device) | |
| 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 multi-unit prostheses, such as dentures. | The Hollow Basket Titanium Dental | |||
| 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. | An endosseous dental implant is a | |||
| prescription device made of a material such as | ||||
| titanium or titanium alloy that is intended to | ||||
| be surgically placed in the bone of the upper | ||||
| or lower jaw arches to provide support for | ||||
| prosthetic devices, such as artificial teeth, in | ||||
| order to restore a patient's chewing function.¹ | The KLS Martin Individual Patient Solutions | |||
| implant devices are intended for use in the | ||||
| stabilization, fixation, and reconstruction of the | ||||
| maxillofacial / midface and mandibular skeletal | ||||
| regions. | ||||
| Contraindications | 1. Obvious infections |
- Hypersensitivity to foreign bodies
- Suspected sensitivity to the implant material
- Circulatory problems, systemic diseases and metabolic
disorders - Insufficient or inadequate bone tissue
- Secondary diseases such as degenerative processes that may
negatively influence the healing process - Interventions carried out in a non-sterile environment (e.g.
paranasal sinuses) - Regions exposed to inappropriate forces or excessive weight
loads - Patients unwilling or unable to follow instructions during the
postoperative phase due to their mental, neurological or
physical condition - Osteoporosis or osteomalacia or other severe structural bone
damage preventing the stable fixation of implant components - Bone tumors located in the implant base region
- Obvious drug or alcohol abuse
- Failure to locate a primary nerve in the lower jaw
- Uncontrolled Type II diabetes
- Oral or intravenous bisphosphonates
- Bruxism (tooth grinding or clenching)
- Smoking | Unknown – similar to K813227 | 1. Local tissue or existing dentition
degeneration due to²:
a. Excessive mobility
b. Loss of integration
c. Incompatibility of the device
components
d. Structural failure of the device - Pain
- Infection
- Adverse tissue reaction
- Bone or nerve damage
a. Sinus perforation
b. Alveolar plate perforation
c. Transient or chronic pain/facial
paresis - Migration or thermal injury
a. Incompatibility with MRI - Patient Selection Criteria
a. Previous radiation therapy (affects
bone quality) | 1. Obvious infections. - Hypersensitivity to foreign bodies.
- Suspected sensitivity to the implant
material. - Circulatory problems, systemic diseases,
and metabolic disorders. - Insufficient or inadequate bone tissue.
- Secondary diseases such as degenerative
processes that may negatively influence the
healing process. - Interventions carried out in a non-sterile
environment (e.g. paranasal sinuses). - Regions exposed to inappropriate forces or
excessive weight loads. - Patients unwilling or unable to follow
instructions during the postoperative phase
due to their mental, neurological, or
physical condition. - Osteoporosis or osteomalacia or other
structural bone damage preventing the
stable fixation of implant components. - Bone tumors located in the implant base
region. - Obvious drug or alcohol abuse. |
| Patient-specific? | Yes. Devices are manufactured patient-specific, based on a CT scan
of the patient. | | No. | Yes. Devices are manufactured patient-specific,
based on a CT scan of the patient. |
| Classification | 21 CFR 872.3645
Class II | | 21 CFR 872.3640
Class II | 21 CFR 872.4760
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,
Ti-6Al-4V, CP Titanium Splints: acrylic/methacrylic resins |
| Manufacturing
Method | Epoxy/Acrylic Resins: Stereolithography (SLA) Ti-6Al-4V: 3D (Additive; Selective Laser Melting) | | Traditional milling/stamping | Epoxy/Acrylic Resins: Stereolithography
(SLA) CP Titanium: Traditional (Subtractive) Ti-6Al-4V: 3D (Additive; Selective Laser
Melting) Polyamide: 3D (Additive; Selective Laser
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:
0.6 mm - 10.0 mm Mandibular reconstruction: 1.0 mm - 3.0 mm |
| Style | Non-locking
Compression
Threaded | | One-piece hollow, grooved, bore-holed
cylinders with upper portions designed to
support an artificial denture | Non-locking
Compression
Threaded |
| Width
(between screws) | Min: 4.5 mm | | No screws are used with this device | Maxillofacial / midface:
Min: ≥ 4.5 mm (around screw holes)
Min: ≥ 3 mm (not around screw hole)
Max: Dependent on screw-hole
Mandibular:
Min: 7 mm
Max: 8.5 mm |
| Length | Maxillofacial / midface:
Min: 29 mm
Max: 320 mm
Mandibular:
Min: 29 mm
Max: 320 mm | | Unknown | Maxillofacial / midface:
Min: 18 mm
Max: 350 mm
Mandibular:
Min: 31 mm
Max: 320 mm |
| Width around
Screws | 1.5 System: ≥ 4.5 mm
2.0/2.3 System: ≥ 6.5 mm
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
2.0/2.3 System: ≥ 6.5 mm
2.7 System: ≥ 8 mm |
| Number of Screw
Holes | Maxillofacial / midface:
Min: 4 per side of defect
Max: Dependent on length & hole spacing
Mandibular:
Min: 4
Max: Dependent on length & hole spacing | Holes are present but are not screw holes.
These are to allow for bone ingrowth. | 14 holes are present but are not screw holes.
These are to allow for bone ingrowth. | Maxillofacial / midface:
Min: ≥ 2 per side of defect
Max: Dependent on length & hole spacing
Mandibular:
Min: 4
Max: Dependent on length & hole spacing |
| Pillar Diameter | ≥ 4 mm | Unknown | N/A | N/A |
| Angulation of
Pillar to the
Occlusal Plane | 0° | Unknown | N/A | N/A |
1 21 CFR 872.3640 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=872.3640
4 https://www.acabine-i.org/7992017041519222 http://www.fitest.com/itesMecine/MedialDevices/drives/drives/drives/drive/com/tree/Doml/Poduct/Poduct/Part/2012/21/201
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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
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Kıs martın LP.
11201 Saint Johns Industrial Pkwy S • Jacksonville, FL 32246 Phone: 904-641-7746 • 800-625-1557 • Fax: 904-641-7378 www.klsmartinnorthamerica.com
| Screw Specifications | ||||
|---|---|---|---|---|
| Screw Diameter | 1.5 mm – 3.2 mm | Not applicable | Not applicable | Maxillofacial / midface |
| 1.5 mm – 2.3 mm | ||||
| Mandibular: | ||||
| 2.0 mm – 3.2 mm | ||||
| Screw Length | 3.5 mm – 21 mm | Not applicable | Not applicable | Maxillofacial / midface |
| 3.5 mm – 22 mm | ||||
| Mandibular: | ||||
| 5 mm – 22 mm | ||||
| Screw Style | maxDrive (Drill-Free, locking, [ThreadLock Taper Screw – TLTS]) | Not applicable | Not applicable | maxDrive & crossDrive (Drill-Free, locking |
| [ThreadLock Taper Screw -TLTS]) |
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Image /page/9/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 and are slightly larger than the word "martin."
Performance Testing - Non-clinical
MR Conditional Labeling
Non-clinical worst-case MRI review was performed to evaluate the metallic IPS Preprosthetic devices in the MRI environment using scientific rationale and published literature (e.g., Woods, Terry O., Jana G. Delfino, and Sunder Rajan. "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices." Journal of Testing and Evaluation 49.2 (2019): 783-795), based on the entire system including all variations (dental implants and fixation screws) and material compositions. The rationale addressed parameters per the FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment", including magnetically induced displacement force and torque.
Additive Manufacturing Build Orientation & Location
Baseline Study - Build Orientation (#PBN-0478)
A baseline study was conducted to demonstrate that placement on the bed has minimal impact on the final component in terms of dimensional accuracy from the build.
Fourteen (14) Selective Laser Melting (SLM) test articles, identical to the final finished device with regard to processing, were used to examine the influence of various bed positions and any effect of component dimensional accuracy using FEM analysis. The results indicate that components placed centrally vs. peripherally have minor impact on the final component.
Position and Tensile Strength (#PBN-0481)
Additional studies were performed to determine whether build location in the build space has a significant effect on device characteristics or performance. The baseline study performed on the SLM test articles demonstrates that the components achieved a tensile strength of 860 N/mm2 and component position does not significantly impact tensile strength.
SLM Orientation and Tensile Strength (#PBN-0474)
Various component orientations (Z, 45° tilted, 45° horizontal, Y, and X) were evaluated to ensure the SLM test articles met the 860 N/mm² requirement for tensile strength in accordance with ASTM F136. All test setups rendered similar values for the various orientations tested, which exceeded the 860 N/mm² requirement for tensile strength per ASTM F136.
Dimensional Evaluation of Worst-Case Model (#IRN-0004)
A full validation to address a worst-case design of the subject device in terms of the accuracy of the final device as compared to the initial software model design was performed. An evaluation of a worst-case implant device was evaluated using a 3D scanner to determine the dimensions of each manufactured part. An STL of the scanned part was created and compared against the original software model design. The test report results show that deviations of the manufactured part versus the associated original model design file are well within the acceptance criteria. All samples passed the acceptance criteria of deviation relative to nominal part by not exceeding the maximum tolerance of ±1.5 mm. These results indicate that Ti-6AL-4V parts manufactured implants within their specification range meet dimensional requirements for fit and function of the devices as defined by the model.
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Image /page/10/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.
Material Characterization
Powder Recycling Process and Evaluation of Device Performance (#PBN-0484)
An assessment of the material recycling protocol was conducted to determine the effect of material recycling on the properties of the final finished device. The analysis demonstrated the material recycling process, tested with 256 SLM test articles over the course of one year, yielded consistent tensile strength results.
Biocompatibility Testing
Biocompatibility endpoints were evaluated in accordance with ISO 10993. The battery of cytotoxicity, chemical analysis, sensitization and irritation, and chemical/material characterization testing was leveraged from the reference device, KLS Individual Patient Solutions (K191028), for titanium devices. The subject device is identical to the reference device in final finished form, which includes material formulations, manufacturing methods and processes, and sterilization methods. No other chemicals have been added (e.g., fillers, additives, cleaning agents). Therefore, this adequately addresses biocompatibility for the subject device system.
Sterilization Testing
Steam sterilization validations were performed using the dynamic-air-removal cycle in accordance with AAMI ANSI ISO 17665-1 to a sterility assurance level (SAL) of 10th using the biological indicator (BI) overkill method. All test method acceptance criteria were met. Validations for devices manufactured from titanium were leveraged from the reference device, KLS Martin Individual Patient Solutions (K191028). Subject titanium devices are identical in formulation, manufacturing processes, and post-processing procedures (cleaning & sterilization) as the reference device.
Pyrogenicity Testing
LAL endotoxin testing was conducted according to AAMI ANSI ST72 to address the presence of bacterial endotoxins and ensure they meet pyrogen limit specifications. The results of the testing demonstrate that the subject devices contain endotoxin levels below the USP allowed limit for medical devices and meet pyrogen limit specifications. LAL endotoxin testing for titanium was leveraged from the predicate device, KLS Martin Individual Patient Solutions (K191028). Subject titanium devices are identical in formulation, manufacturing processes, and post-processing procedures (cleaning & sterilization) as the reference device.
Software Verification and Validation
Software verification and validation was performed on individual software applications that are used in the planning and design of the implant based on the patient's images (CT). Quality and on-site user acceptance testing provide objective evidence that all software requirements and specifications were implemented correctly and completely and are traceable to system requirements. Testing required as a result of risk analysis and impact assessments showed conformity with pre-defined specifications and acceptance criteria. Software documentation demonstrates all appropriate steps have been taken to ensure mitigation of any potential risks and performs as intended based on the user requirements and specifications.
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Image /page/11/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 in the logo.
Performance Testing - Clinical
Clinical testing data of IPS Preprosthetic was collected up to 74 months post-operatively which evaluated 39 total implants from 35 patients. The data consisted of 19 patients who received implants due to postablative maxillary defects, 10 patients who received implants to treat a severely atrophic maxilla, and 6 patients who were treated for a cleft lip and palate (CLP) deformity with significant soft and hard tissue impairment. Of the 39 implants, there were no instances of implant loosening (0%) or a removed implant (0%). There was one instance of a reduced post (2.9%), 3 instances of exposed/removed screws (8.6%), 3 instances of infections/abscesses (8.6%), and 14 instances of a partial exposure of underlying framework (40%).
Substantial Equivalence Conclusion
KLS Martin IPS Preprosthetic has the same intended use, same fundamental principles of operation, and similar technological features compared to the predicate device. Any differences in technological features between the subject and predicate devices do not raise different questions of safety and effectiveness.