KLS Martin IPS Distraction includes devices intended as bone stabilizers and lengthening (and or transport) devices for correction of congenital deficiencies or post traumatic defects of the mandible (including ramus, body, alveolar ridge, palate, and symphysis) and mid-face bones that require gradual distraction in adults, adolescents, children and infants weighing more than 2.5 kg.

Device Description

KLS Martin IPS Distraction System is comprised of patient-specific models, guides and distraction footplates used in conjunction with previously cleared distractor bodies and metallic bone screws for internal fixation and reconstruction of maxillofacial / midface and mandibular bones. 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 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 personnel during the planning session. For each design iteration, verification is performed by virtually fitting the generated device model over a 3D model of the patient's anatomy to ensure its dimensional properties allow an adequate fit.

Implants are provided sterile or non-sterile, range in thickness from 0.6 - 10 mm, and are manufactured using additive or traditional (subtractive) methods from either CP Titanium (ASTM F67) or Ti-6A1-4V (ASTM F136) materials. These patient-specific devices are fixated with previously cleared KLS Martin screws.

AI/ML Overview

This document describes the 510(k) summary for the KLS Martin IPS Distraction device. It provides information regarding the device's indications for use, technological characteristics, and a comparison to predicate and reference devices to support a claim of substantial equivalence.

Based on the provided text, the device in question is a medical implant (bone plates) designed for cranial and facial bone distraction. Therefore, the acceptance criteria and study proving its performance will relate to its mechanical properties, biocompatibility, sterilization, software validation, and clinical safety and effectiveness for its intended patient population.

Here's an analysis of the provided text to extract the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of acceptance criteria with corresponding performance metrics in a pass/fail format. Instead, it describes various tests performed and their outcomes in narrative form to demonstrate substantial equivalence. I will infer the "acceptance criteria" from the types of tests conducted and the "reported device performance" from the stated results.

Acceptance Criteria (Inferred)	Reported Device Performance
Mechanical Strength (Weld Strength): Withstand forces reflecting clinical use for different material combinations.	A direct comparison weld strength test was performed. The titanium alloy/titanium alloy material combination (subject device) was able to withstand a greater tensile load than the CP titanium alloy material combination (predicate/reference devices).
Biocompatibility: Meet ISO 10993 standards for biological safety (cytotoxicity, sensitization, chemical analysis, material characterization).	Biocompatibility testing (cytotoxicity, chemical analysis, sensitization, and chemical/material characterization) was leveraged from K191028 (reference device) for titanium devices. The subject devices are similar in final finished form, material formulations, manufacturing methods, and sterilization methods. The report states this adequately addresses biocompatibility.
Sterilization: Achieve a specified sterility assurance level (SAL).	Steam sterilization validations were performed according to ISO 17665-1:2006 to a sterility assurance level (SAL) of 10^-6 (standard is 10^-6, not 10^-9 as written, likely a typo in the document or a more stringent internal target) using the biological indicator (BI) overkill method. All test method acceptance criteria were met. Validations for titanium devices were leveraged from the reference device K191028, as subject devices are similar.
Pyrogenicity: Ensure endotoxin levels are below specified limits.	LAL endotoxin testing was conducted according to AAMI ANSI ST72:2019. The results demonstrate that the subject devices contain endotoxin levels below the USP allowed limit for medical devices and meet pyrogen limit specifications. This testing was leveraged from the reference device K191028 due to similar materials and processes.
Software Verification and Validation: Ensure software used for planning and design functions correctly and meets requirements.	Software verification and validation was performed on each individual software application. 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. Risk analysis and impact assessments showed conformity with pre-defined specifications and acceptance criteria. Software documentation demonstrates mitigation of potential risks and performance as intended.
Clinical Performance (Pediatric Subpopulations): Demonstrate safety and effectiveness in pediatric patients.	Risk mitigation assessments based on FDA guidance "Premarket Assessment of Pediatric Medical Devices" were completed. 5 clinical studies were analyzed as supporting evidence. The conclusion is that the device can be used for infants (>2.5 kg), children, and adolescents (29 days through 21 years) if additional precautions are taken into account (e.g., avoiding permanent implants in skeletally immature patients, low-dose CT protocols).

2. Sample Size Used for the Test Set and the Data Provenance

Mechanical Testing (Weld Strength): The document does not specify the exact sample size for the weld strength test. It states "A direct comparison weld strength test was performed," implying sufficient samples for a comparative analysis, but no number is given.
Biocompatibility, Sterilization, Pyrogenicity: These tests leveraged data from a previously cleared device (K191028). No new sample sizes are explicitly mentioned for these, as the substantial equivalence hinges on the similarity to the already-tested reference device. If new samples were tested for verification, their numbers are not stated.
Software V&V: No specific sample size (e.g., number of cases or simulations) is mentioned for software testing. It refers to "all software requirements and specifications" and "on-site user acceptance testing."
Clinical Performance (Pediatric): 5 clinical studies were analyzed to support the pediatric indications. The document lists the studies, but does not state how many patients were in the "test set" for the KLS Martin device specifically. These appear to be literature reviews, not new clinical trials conducted for this device clearance.
- Data Provenance: The provenance of the data for the 5 analyzed clinical studies is implied to be from published literature ("Based on published literature findings"). Specific country of origin is not mentioned, nor is whether the studies were retrospective or prospective, though typical clinical trials are prospective, and reviews can be of either.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Mechanical, Biocompatibility, Sterilization, Pyrogenicity, Software V&V: The document does not mention the use of external "experts" to establish ground truth for these non-clinical performance tests. These are typically assessed against pre-defined engineering and biological standards by internal or contract testing labs.
Clinical Performance (Pediatric): The "ground truth" for the pediatric clinical performance is based on "published literature findings" and risk assessments performed based on FDA guidance. There is no mention of a specific number of experts used to establish a new ground truth for this 510(k) submission's test set. The experts are implicitly the authors of the peer-reviewed clinical literature analyzed and the regulatory/clinical affairs personnel conducting the risk assessment. Qualifications of these implied experts are not detailed in this document.

4. Adjudication Method for the Test Set

No adjudication method (e.g., 2+1, 3+1) is described for any of the tests, as these are technical performance tests or literature reviews, not studies involving human interpretation of medical images or data requiring reader consensus.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC comparative effectiveness study was mentioned or performed. This device is a passive implantable device, not an AI-assisted diagnostic tool.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable. The device is a surgical implant, not a software algorithm. The software mentioned (for planning and design) is a tool for manufacturing patient-specific implants, not a diagnostic algorithm in itself that would have standalone performance.

7. The Type of Ground Truth Used

Mechanical Testing: Ground truth is implicitly defined by engineering standards for tensile strength and material properties.
Biocompatibility: Ground truth is established by the accepted international standard ISO 10993 series.
Sterilization: Ground truth is defined by the accepted international standard ISO 17665-1:2006 and a target SAL of 10^-6.
Pyrogenicity: Ground truth is defined by AAMI ANSI ST72:2019 and USP allowed limits for endotoxins.
Software V&V: Ground truth is established by pre-defined software requirements, specifications, and risk assessment outcomes.
Clinical Performance (Pediatric): Ground truth for the safety and effectiveness in pediatric applications is based on peer-reviewed clinical literature and FDA guidance on pediatric medical devices, interpreted through a risk assessment. This is a form of outcomes data and expert consensus derived from previous studies, rather than a new "ground truth" adjudicated for this submission.

8. The Sample Size for the Training Set

This question is not applicable to an implantable device like KLS Martin IPS Distraction. "Training set" usually refers to data used to train a machine learning algorithm.
For the patient-specific design, the "training" data is the individual patient's CT scan. Each device's design is unique to the patient's anatomy. The "training" for the process comes from accumulated experience, validated software, and adherence to design specifications described in the section about patient-specific manufacturing.

9. How the Ground Truth for the Training Set was Established

This question is not applicable for the reasons stated above. For the individual patient design process, the "ground truth" (the patient's anatomy for which the device is being designed) is established directly from the patient's CT scan data. The "virtual planning" involves interactions between the physician and trained KLS Martin personnel to refine the design, with "verification" performed by virtually fitting the generated device model over a 3D model of the patient's anatomy to ensure adequate fit.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.

KLS Martin L.P. Susan Leander Regulatory Affairs Project Manager 11201 Saint Johns Industrial Parkway S Jacksonville, Florida 32246

8/11/22

Re: K220050

Trade/Device Name: KLS Martin IPS Distraction Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: Class II Product Code: MQN Dated: June 30, 2022 Received: July 12, 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.

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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.

for Andrew 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 Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K220050

Device Name KLS Martin IPS Distraction

Indications for Use (Describe)

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/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. The logo is simple and modern.

11201 Saint Johns Industrial Pkwy S · Jacksonville, FL 32246 Phone: 904-641-7746 · 800-625-1557 · Fax: 904-641-7378 www.klsmartinnorthamerica.com

K220050

510(k) Summary 21 CFR 807.92

Submitter:	KLS-Martin L.P.11201 Saint Johns Industrial Pkwy SJacksonville, FL 32246
Contact Person:	Susan LeanderRegulatory Affairs Project ManagerPhone: 800-625-1557Email: susan.leander@klsmartin.com
Date Prepared:	August 11, 2022
Trade Name:	KLS Martin IPS Distraction
Common Name:	Plate, Bone
Classification Name:	Bone Plate
Regulatory Class:	II
Product Code:	MQN
Primary Predicate:	KLS Martin Internal Distraction – Sterile (K161470)
Reference Devices:	KLS Martin Individual Patient Solutions (K191028)KLS Martin Zurich Distraction System (K010139)

Device Description

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Indications for Use

Technological Characteristics & Substantial Equivalence Discussion

The intended use and technological characteristics of the subject device, KLS Martin IPS Distraction are the same as those of the predicate device. KLS Martin Internal Sterile Distraction, cleared under K161470. Both are distraction devices made of titanium. Both use standard distractors with attached footplates. The potential impact on substantial equivalence of each technological difference was addressed through risk analysis and verification and validation testing.

Similarities to Predicate and Reference Devices

The primary predicate device, KLS Martin Internal Sterile Distraction, K161470, and the subject device, KLS Martin IPS Distraction are intended for gradual distraction in the facial skeleton and share the same fundamental principle of operation - metallic bone plates used in conjunction with metallic bone screws for bone stabilization and lengthening of bones. The indications for use for the subject device are the same as the predicate device. The skeletal regions for the subject and predicate devices are similar.

Both the primary predicate device and the KLS Martin Zurich Distraction System reference device, cleared under K010139, present evidence of substantially equivalent use of similar devices. The method to attach the patient-specific footplates to the distraction bodies is the same for the subject, predicate and reference devices.

The KLS Martin IPS Distraction devices are provided sterile (same as K161470) or non-sterile (same as K010139 and K191028). The non-sterile devices require the end-user to process them using validated cleaning and sterilization methods prior to use as recommended in the labeling.

The KLS Martin Individual Patient Solutions is included as a reference device to support the use of patient-specific metallic implants. Both the subject and the KLS Martin Individual Patient Solutions (K191028) reference devices use image data obtained from medical scanners, such as a CT scan. They both use validated commercial-off-the-shelf (COTS) software applications to transfer patient imaging from a DICOM format to an .STL format and manipulate the images to produce a final design file.

The manufacturing materials used for the implants in the subject device are similar to those cleared in their own prior clearance. K191028. The design and dimensions of the plates will be based on patientspecific data. using similar methods described in K191028. made from either CP Titanium (ASTM F67) or Ti-6Al-4V (ASTM F136) using traditional (subtractive) or additive manufacturing methods. The bone plates are similar in final finished form to those presented in the K191028 reference device, and therefore performance and biocompatibility are adequately addressed.

IPS Distractor bone plates will be attached to maxillofacial, midface or mandibular bones and to distractor bodies for distraction osteogenesis. Bone plates in the subject device may be implanted permanently in skeletally mature patients or they may be removed on completion of the procedure, as is common for K161470 and K010139 predicate and reference devices. Permanent implants are not recommended for use in skeletally immature patients (16 years of age or younger).

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Differences from Predicate and Reference Devices

The indications for use statements for the subject device and predicate devices are the same, except the subject device statement specifically lists the following targeted patient populations:

· Infants that weigh more than 2.5 kg (29 days to < 2 years of age) *
· Children (2 years of age to < 12 years of age)
· Adolescents (12 years of age 21 years of age)
Adults

*Premature neonates are not included in the proposed target population. The lowest patient weight for the subject device is 2.5 kg (5 pounds, 8 ounces), which is considered normal weight at delivery.

A risk assessment has been performed based on FDA guidance, "Premarket Assessment of Pediatric Medical Devices, March 24, 2014" for these pediatric subpopulations with supporting peer-reviewed clinical literature to demonstrate the safety and effectiveness of the subject device implants for use in the target pediatric subpopulations.

The reference device. K191028, was previously cleared only for the adult population, but the primary predicate, K161470, supports the use of implants in pediations infant, children, and adolescents.

The KLS Martin IPS Distraction alloy footplates are attached to titanium alloy distraction bodies, whereas the predicate and reference device CP titanium footplates are attached to the same style titanium alloy distraction bodies. The different material combinations were addressed through performance testing.

Previously cleared specifications for the K191028 reference device plate thicknesses range from 0.3 mm - 10 mm and are fixated with previously cleared KLS Martin titanium screws ranging in diameter from 1.0 mm - 3.2 mm in lengths from 3.5 mm - 22 mm. The subject device plates range in thickness from 0.6 mm - 10 mm and are fixated with previously cleared KLS Martin titanium screws ranging in diameter from 1.0 mm - 2.3 mm in lengths from 3 mm - 22 mm. The screw dimensions for the subject device are similar to those previously evaluated in K161470. The predicate and reference device dimensions encompass the entire range of dimensions for the subject device.

A device comparison table of the subject, predicate, and reference devices is presented, below.

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Device Comparison Table
	KLS Martin IPS Distraction	KLS Martin Internal Distraction - SterileK161470	KLS Martin Individual Patient SolutionsK191028	KLS Martin Zurich Distraction SystemK010139
	(Subject Device)	(Primary Predicate)	(Reference Device)	(Reference Device)
Indications for Use	KLS Martin IPS Distraction includes devicesintended as bone stabilizers and lengthening(and or transport) devices for correction ofcongenital deficiencies or post traumatic defectsof the mandible (including ramus, body,alveolar ridge, palate, and symphysis) and mid-face bones that require gradual distraction inadults, adolescents, children and infantsweighing more than 2.5 kg.	Internal Distraction - Sterile includes devicesintended as bone stabilizers and lengthening(and or transport) devices for correction ofcongenital deficiencies or post traumatic defectsof the mandible (including ramus, body,alveolar ridge, palate, and symphysis) and mid-face bones that require gradual distraction.	KLS Martin Individual Patient Solutions implantdevices are intended for use in the stabilization,fixation, and reconstruction of the maxillofacial /midface and mandibular skeletal regions.	The Zurich Distraction System includes devicesintended as a bone stabilizer and lengthening(and or transport) device when correction ofcongenital deficiencies or post traumaticdefects of the mandible (including ramus, body,alveolar ridge, palate, symphysis), mid-face,and cranial bones require gradual distraction.
Contraindications	1. Active infection2. Patient conditions including: blood supplylimitations, insufficient quantity or qualityof bone or latent infections3. Patients with mental or neuralgic conditionswho are unwilling or incapable of followingpostoperative care instructions4. Foreign body sensitivity- where materialsensitivity is suspected, tests are to be madeprior to implantation	1. Active infection2. Patient conditions including: blood supplylimitations, insufficient quantity or qualityof bone or latent infections3. Patients with mental or neuralgicconditions who are unwilling or incapableof following postoperative care instructions4. Foreign body sensitivity- where materialsensitivity is suspected, tests are to bemade prior to implantation	1. Obvious infections.2. Hypersensitivity to foreign bodies.3. Suspected sensitivity to the implant material.4. Circulatory problems, systemic diseases, andmetabolic disorders.5. Insufficient or inadequate bone tissue.6. Secondary diseases such as degenerativeprocesses that may negatively influence thehealing process.7. Interventions carried out in a non-sterileenvironment (e.g. paranasal sinuses).8. Regions exposed to inappropriate forces orexcessive weight loads.9. Patients unwilling or unable to followinstructions during the postoperative phasedue to their mental, neurological, or physicalcondition.10. Osteoporosis or osteomalacia or otherstructural bone damage preventing the stablefixation of implant components.11. Bone tumors located in the implant baseregion.12. Obvious drug or alcohol abuse.	1. Active infection2. Patient conditions including: blood supplylimitations, insufficient quantity or qualityof bone or latent infections3. Patients with mental or neuralgicconditions who are unwilling or incapableof following postoperative careinstructions4. Foreign body sensitivity- where materialsensitivity is suspected, tests are to bemade prior to implantation5. For Symphysis: In those patients wherethere is inadequate volume or quality ofbone to place the distractor securely.6. For Ramus: In these cases where is an in-adequate volume or quality of bone toplace the distractor securely.
Device Comparison Table
	KLS Martin IPS Distraction	KLS Martin Internal Distraction - SterileK161470	KLS Martin Individual Patient SolutionsK191028	KLS Martin Zurich Distraction SystemK010139
	(Subject Device)	(Primary Predicate)	(Reference Device)	(Reference Device)
Patient-specific?	Yes. Devices are manufactured patient-specific,based on a CT scan of the patient.	No. Standard distraction plates are available in avariety of sizes in thicknesses of 0.6 mm – 2.0mm.	Yes. Devices are manufactured patient-specific,based on a CT scan of the patient.	No. Standard distraction plates are available ina variety of sizes in thicknesses of 0.6 mm –1.0 mm.
Classification	21 CFR 872.4760, Class II	21 CFR 872.4760, Class II	21 CFR 872.4760, Class II	21 CFR 872.4760, Class II
Product Code	MQN	MQN	JEY	MQN
Material	Anatomical Models: Epoxy/Acrylic ResinsImplants: CP Titanium or Ti-6Al-4V	Implants: CP Titanium or Ti-6Al-4V	Anatomical Models: Epoxy/Acrylic ResinsImplants: CP Titanium or Ti-6Al-4V	Traditional (Subtractive) and Ti-6Al-4V:Traditional (Subtractive)
Manufacturing Method	Epoxy/Acrylic Resins: Stereolithography (SLA)CP Titanium or Ti-6Al-4V: Traditional(Subtractive)Ti-6Al-4V: 3D (Additive; Selective LaserMelting)	Traditional (Subtractive) and Ti-6Al-4V:Traditional (Subtractive)	Epoxy/Acrylic Resins: Stereolithography (SLA)CP Titanium: Traditional (Subtractive)Ti-6Al-4V: 3D (Additive; Selective Laser Melting)	Traditional (Subtractive) and Ti-6Al-4V:Traditional (Subtractive)
Sterilization	Sterile (Gamma)Non-sterile (Steam)	Sterile (Gamma Radiation)	Non-sterile (Steam)	Non-sterile (Steam)
Anatomical Sites	Maxillofacial / Midface & Mandible	Maxillofacial / Mandible	Maxillofacial / Midface & Mandible	Maxillofacial / Mandible
Patient Population	• Infants that weigh at least 2.5kg (29 days to<2 years of age)• Children (2 years of age to < 12 years of age)• Adolescents (12 years of age - 21 years ofage)• Adults	• Infants (29 days to < 2 years of age)• Children (2 years of age to < 12 years of age)• Adolescents (12 years of age - 21 years ofage)• Adults	Adult	Pediatric & Adult
DistractionLength	Max 60 mm	Max 60 mm	Not specified	15mm - 50 mm
Device Comparison Table
	KLS Martin IPS Distraction	KLS Martin Internal Distraction - SterileK161470	KLS Martin Individual Patient SolutionsK191028	KLS Martin Zurich Distraction SystemK010139
	(Subject Device)	(Primary Predicate)	(Reference Device)	(Reference Device)
Plate Specifications
Thickness	• 0.6mm-10mm	• 0.6mm-2.0mm	• Orbital floor only: 0.3mm–1.0mm• Maxillofacial / midface reconstruction: 0.6mm–10 mm• Mandibular reconstruction: 1.0mm–3.0mm	• 0.6mm-1.0mm
Plate Style	Locking & non-locking	Locking & non-locking	Locking & non-locking	Locking & non-locking
Plate Width	Maxillofacial / midface /mandibular:Min: ≥ 3 mmMax: Dependent on screw-hole	Not specified	Maxillofacial / midface:Min: ≥ 3 mmMax: Dependent on screw-holeMandibular:Min: ≥ 7 mmMax: 8.5 mm	Not specified
Plate Length	Maxillofacial / midface /mandibular:Min: 5 mmMax: 350 mm	Not specified	Maxillofacial / midface:Min: 18 mmMax: 350 mmMandibular:Min: 31 mmMax: 320 mm	Not specified
Degree of Curvature	In-planeMin: 30°Max: 180°Out-of-planeMin: 15°Max: 180°	Not specified	In-planeMin: 30°Max: 180°Out-of-planeMin: 15°Max: 180°	Not specified
Device Comparison Table
	KLS Martin IPS Distraction	KLS Martin Internal Distraction - SterileK161470	KLS Martin Individual Patient SolutionsK191028	KLS Martin Zurich Distraction SystemK010139
	(Subject Device)	(Primary Predicate)	(Reference Device)	(Reference Device)
Number of Holes	Min: ≥ 2 per side of defectMax: Dependent on length & hole spacing	Not specified	Maxillofacial / midface:Min: ≥ 2 per side of defectMax: Dependent on length & hole spacingMandibular:Min: ≥ 4Max: Dependent on length & hole spacing	Not specified
Hole Spacing	Min: ≥ 2.3 mm	Min: ≥ 2.3 mm	Maxillofacial /midface: ≥ 4.5 mmMandibular: ≥ 8 mm	Min: ≥ 2.3 mm
Screw Specifications
Screw Diameter	1.0 mm - 2.3 mm	1.0 mm - 3.2 mm	Maxillofacial / midface1.0 mm - 2.3 mmMandibular:2.0 mm - 3.2 mm	1.5 mm – 2.7 mm
Screw Length	3 mm – 22 mm	2 mm – 22 mm	Maxillofacial / midface3.5 mm - 22 mmMandibular: 5 mm - 22 mm	4 mm – 22 mm

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Performance Testing - Non-clinical

Performance Testing

Performance testing was completed to demonstrate substantial equivalence of the subject device to the predicate and reference devices.

A direct comparison weld strength test was performed to address the difference in material combinations (titanium alloy/titanium alloy connection vs. CP titanium/titanium alloy connection) used for the subject versus predicate/reference devices, respectively. The titanium alloy/titanium alloy material combination was able to withstand a greater tensile load than the CP titanium alloy material combination.

Additional performance testing presented in K191028 and equally relevant to the subject device, was conducted in accordance with the device testing considerations outlined in Technical Considerations for Additive Manufactured Medical Devices, issued December 5, 2017.

Biocompatibility Testing

Biocompatibility endpoints were evaluated in accordance with ISO 10993. The battery of cytotoxicity. chemical analysis, sensitization, and chemical/material characterization testing was leveraged from K191028 for titanium devices. The subject devices are similar to the reference devices in final finished form, including 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

KLS Martin IPS Distraction implants are provided sterile. Models are provided non-sterile. Models and non-sterile implants are to be cleaned and sterilized by the end user before use. Validated cleaning and sterilization methods are provided in the instructions for use to the end user.

Steam sterilization validations were performed using the dynamic-air-removal cvcle in accordance with ISO 17665-1:2006 to a sterility assurance level (SAL) of 10-9 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 similar in formulation, manufacturing processes, and post-processing procedures (cleaning & sterilization) as the reference device.

Pvrogenicitv Testing

As part of the sterilization. LAL endotoxin testing was conducted according to AAMI ANSI ST72:2019 to address the presence of bacterial endotoxins and ensure the devices 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 reference device, KLS Martin Individual Patient Solutions (K191028). Subject titanium devices are similar 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 each individual software application that is used in the planning and design of 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 required resulting from risk analysis and impact assessments showed conformity with pre-defined specifications and acceptance criteria.

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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.

Performance Testing - Clinical

Risk mitigation assessments have been completed based on FDA guidance, "Premarket Assessment of Pediatric Medical Devices, " issued March 24, 2014, to demonstrate the safety and effectiveness for use of the IPS output devices in the pediatric population. These risk assessments evaluated the following risk factors for pediatric patients: age, size, growth and development, body habitus, developmental milestones, pathophysiology, behavioral factors, psychosocial factors, surgical factors, and cumulative effects from repeat or unplanned radiation exposure (i.e., CT scan).

The short-term and long-term mitigations for both children and adolescents are similar with regard to implantation. The size of the implant will be dictated by the patient's anatomy and the approving medical practitioner. Assuming no physes are violated when placing the implant, there are no short-term concerns when placing the patient-specific implant. The most challenging long-term impact for both subpopulations is use of permanent implants in a growing patient. There is a possibility that an implant may restrict growth and development when implanted into a maturing individual. Permanent implants should not be used in patients that are skeletally immature, specifically in patients less than 16 years of age. Caution should be taken when considering permanent implant placement in any patient with potential for continued facial growth.

Unplanned or repeat radiation exposure prior to or following the pediatric patient's initial surgery is a risk that is mitigated by device labeling to include special considerations for pediatric populations to minimize ionizing radiation by using low-dose and child-size CT scan protocols when deemed appropriate based on patient size, weight, height, and clinical needs.

To demonstrate clinical performance of KLS Martin IPS implants in the pediatric subpopulations of infants (weighing more than 2.5 kg), children, and adolescents (29 days through 21 years of age), 5 clinical studies including patients 26 days of age through 21 years of age, were analyzed:

	Doscher, et al(2014)	Gray, et al(2017)	Steinbacher(2015)	Resnick(2017)	Meena, et al(2017)
Patientage	26 days	3 – 17 years	<1 month - 21+years	Infants
PatientPopulation	Neonate	Children &Adolescents	Neonates, Infants,Children & Adults	Infants
Treatment	CT-based patient-specific surgicalplanning formandibulardistractionosteogenesis (DO)	Virtual SurgicalPlanning (VSP)using CT scans andCAD/CAMtechnology incraniofacialreconstructivesurgeries	3D analysis andsurgical planning incraniomaxillofacialsurgeries using CTscan data	Mandibulardistractionosteogenesis ininfants withRobin sequence	Development ofa customzygomaticimplant usingmetalsintering

Based on published literature findings of the subject device and similar bone plate devices and the results from the risk analysis, it can be concluded that the subject device can be used for the treatment of infants (weighing more than 2.5 kg), children, and adolescents (29 days through 21 years of age) if additional precautions are taken into account.

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Image /page/12/Picture/0 description: The image shows the logo for KLS Martin LP. The letters "KLS" are in red, while the word "martin" is in gray. The letters "LP" are in black and are larger than the other letters in the logo.

Substantial Equivalence Conclusion

KLS Martin IPS Distraction footplates have the same intended use and technological characteristics as the predicate device. The indications for use for the subject device are the same as the predicate device with the exception of specifically calling out targeted patient populations. Testing to evaluate performance of the subiect device demonstrates that any differences in technological characteristics do not alter the intended therapeutic outcomes and provides adequate comparison to the predicate and reference devices. Testing has demonstrated that any differences in technological characteristics do not raise new or different issues of safety or effectiveness and the information submitted supports substantial equivalence.

Regulation Number and Section

§ 872.4760 Bone plate.

(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.