KLS Martin IPS Distraction

K220050 · KLS Martin L.P. · MQN · Aug 11, 2022 · Dental

Device Facts

• Record ID: K220050
• Device Name: KLS Martin IPS Distraction
• Applicant: KLS Martin L.P.
• Product Code: MQN · Dental
• Decision Date: Aug 11, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4760
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

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 Story

System comprises patient-specific models, guides, and distraction footplates used with previously cleared distractor bodies and metallic bone screws. Input: patient CT scan data. Process: physician provides input for model manipulation/interactive feedback; KLS Martin personnel modify digital models; verification via virtual fitting over 3D patient anatomy. Output: patient-specific titanium implants. Used in maxillofacial/midface/mandibular reconstruction. Operated by surgeons. Output allows for gradual bone distraction/stabilization. Benefits: customized fit for complex anatomical defects; enables bone lengthening/transport in pediatric and adult populations.

Clinical Evidence

No new clinical trials conducted. Safety and effectiveness for pediatric subpopulations (infants >2.5kg, children, adolescents) supported by analysis of 5 peer-reviewed clinical studies (Doscher 2014, Gray 2017, Steinbacher 2015, Resnick 2017, Meena 2017) involving patients aged 26 days to 21+ years. Studies confirm use of CT-based planning, VSP, and custom implants for mandibular distraction and craniofacial reconstruction.

Technological Characteristics

Materials: CP Titanium (ASTM F67) or Ti-6Al-4V (ASTM F136). Manufacturing: Traditional (subtractive) or additive (Selective Laser Melting). Plate thickness: 0.6-10 mm. Fixation: Titanium screws (1.0-2.3 mm diameter). Sterilization: Gamma (sterile) or Steam (non-sterile). Connectivity: Uses COTS software for DICOM to .STL conversion. Design: Patient-specific based on CT imaging.

Indications for Use

Indicated for adults, adolescents, children, and infants (>2.5 kg) requiring gradual distraction for correction of congenital deficiencies or post-traumatic defects of the mandible (ramus, body, alveolar ridge, palate, symphysis) and mid-face bones. Contraindicated in active infection, insufficient bone quality/quantity, blood supply limitations, patients unable to follow post-op instructions, and foreign body sensitivity.

Regulatory Classification

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.

Predicate Devices

• KLS Martin Internal Distraction – Sterile (K161470)

Reference Devices

• KLS Martin Individual Patient Solutions (K191028)
• KLS Martin Zurich Distraction System (K010139)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| <div> <span> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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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: [phone] · 800-625-1557 · Fax: [phone] www.klsmartinnorthamerica.com

# K220050

### 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 Manager<br>Phone: [phone]<br>Email: [e-mail] |
| 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)<br>KLS Martin Zurich Distraction System (K010139) |

### 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.

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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, while the word "martin" is in gray. The letters "L.P." are in black. The logo is simple and modern.

### Indications for Use

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.

### 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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Image /page/5/Picture/0 description: The image shows the logo for KLS Martin L.P. The text "KLS" is in red, while "martin" is in gray. "L.P." is in black and has a unique font style.

### 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 - Sterile<br>K161470 | KLS Martin Individual Patient Solutions<br>K191028 | KLS Martin Zurich Distraction System<br>K010139 |
| | (Subject Device) | (Primary Predicate) | (Reference Device) | (Reference Device) |
| Indications for Use | KLS Martin IPS Distraction includes devices<br>intended as bone stabilizers and lengthening<br>(and or transport) devices for correction of<br>congenital deficiencies or post traumatic defects<br>of the mandible (including ramus, body,<br>alveolar ridge, palate, and symphysis) and mid-<br>face bones that require gradual distraction in<br>adults, adolescents, children and infants<br>weighing more than 2.5 kg. | Internal Distraction - Sterile includes devices<br>intended as bone stabilizers and lengthening<br>(and or transport) devices for correction of<br>congenital deficiencies or post traumatic defects<br>of the mandible (including ramus, body,<br>alveolar ridge, palate, and symphysis) and mid-<br>face bones that require gradual distraction. | KLS Martin Individual Patient Solutions implant<br>devices are intended for use in the stabilization,<br>fixation, and reconstruction of the maxillofacial /<br>midface and mandibular skeletal regions. | The Zurich Distraction System includes devices<br>intended as a bone stabilizer and lengthening<br>(and or transport) device when correction of<br>congenital deficiencies or post traumatic<br>defects of the mandible (including ramus, body,<br>alveolar ridge, palate, symphysis), mid-face,<br>and cranial bones require gradual distraction. |
| Contraindications | 1. Active infection<br>2. Patient conditions including: blood supply<br>limitations, insufficient quantity or quality<br>of bone or latent infections<br>3. Patients with mental or neuralgic conditions<br>who are unwilling or incapable of following<br>postoperative care instructions<br>4. Foreign body sensitivity- where material<br>sensitivity is suspected, tests are to be made<br>prior to implantation | 1. Active infection<br>2. Patient conditions including: blood supply<br>limitations, insufficient quantity or quality<br>of bone or latent infections<br>3. Patients with mental or neuralgic<br>conditions who are unwilling or incapable<br>of following postoperative care instructions<br>4. Foreign body sensitivity- where material<br>sensitivity is suspected, tests are to be<br>made prior to implantation | 1. Obvious infections.<br>2. Hypersensitivity to foreign bodies.<br>3. Suspected sensitivity to the implant material.<br>4. Circulatory problems, systemic diseases, and<br>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 physical<br>condition.<br>10. Osteoporosis or osteomalacia or other<br>structural bone damage preventing the stable<br>fixation of implant components.<br>11. Bone tumors located in the implant base<br>region.<br>12. Obvious drug or alcohol abuse. | 1. Active infection<br>2. Patient conditions including: blood supply<br>limitations, insufficient quantity or quality<br>of bone or latent infections<br>3. Patients with mental or neuralgic<br>conditions who are unwilling or incapable<br>of following postoperative care<br>instructions<br>4. Foreign body sensitivity- where material<br>sensitivity is suspected, tests are to be<br>made prior to implantation<br>5. For Symphysis: In those patients where<br>there is inadequate volume or quality of<br>bone to place the distractor securely.<br>6. For Ramus: In these cases where is an in-<br>adequate volume or quality of bone to<br>place the distractor securely. |
| Device Comparison Table | | | | |
| | KLS Martin IPS Distraction | KLS Martin Internal Distraction - Sterile<br>K161470 | KLS Martin Individual Patient Solutions<br>K191028 | KLS Martin Zurich Distraction System<br>K010139 |
| | (Subject Device) | (Primary Predicate) | (Reference Device) | (Reference Device) |
| Patient-specific? | Yes. Devices are manufactured patient-specific,<br>based on a CT scan of the patient. | No. Standard distraction plates are available in a<br>variety of sizes in thicknesses of 0.6 mm – 2.0<br>mm. | Yes. Devices are manufactured patient-specific,<br>based on a CT scan of the patient. | No. Standard distraction plates are available in<br>a variety of sizes in thicknesses of 0.6 mm –<br>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 Resins<br>Implants: CP Titanium or Ti-6Al-4V | Implants: CP Titanium or Ti-6Al-4V | Anatomical Models: Epoxy/Acrylic Resins<br>Implants: CP Titanium or Ti-6Al-4V | Traditional (Subtractive) and Ti-6Al-4V:<br>Traditional (Subtractive) |
| Manufacturing Method | Epoxy/Acrylic Resins: Stereolithography (SLA)<br>CP Titanium or Ti-6Al-4V: Traditional<br>(Subtractive)<br>Ti-6Al-4V: 3D (Additive; Selective Laser<br>Melting) | Traditional (Subtractive) and Ti-6Al-4V:<br>Traditional (Subtractive) | Epoxy/Acrylic Resins: Stereolithography (SLA)<br>CP Titanium: Traditional (Subtractive)<br>Ti-6Al-4V: 3D (Additive; Selective Laser Melting) | Traditional (Subtractive) and Ti-6Al-4V:<br>Traditional (Subtractive) |
| Sterilization | Sterile (Gamma)<br>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<br><2 years of age)<br>• Children (2 years of age to < 12 years of age)<br>• Adolescents (12 years of age - 21 years of<br>age)<br>• Adults | • Infants (29 days to < 2 years of age)<br>• Children (2 years of age to < 12 years of age)<br>• Adolescents (12 years of age - 21 years of<br>age)<br>• Adults | Adult | Pediatric & Adult |
| Distraction<br>Length | Max 60 mm | Max 60 mm | Not specified | 15mm - 50 mm |
| Device Comparison Table | | | | |
| | KLS Martin IPS Distraction | KLS Martin Internal Distraction - Sterile<br>K161470 | KLS Martin Individual Patient Solutions<br>K191028 | KLS Martin Zurich Distraction System<br>K010139 |
| | (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<br>• Maxillofacial / midface reconstruction: 0.6mm–10 mm<br>• 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:<br>Min: ≥ 3 mm<br>Max: Dependent on screw-hole | Not specified | Maxillofacial / midface:<br>Min: ≥ 3 mm<br>Max: Dependent on screw-hole<br>Mandibular:<br>Min: ≥ 7 mm<br>Max: 8.5 mm | Not specified |
| Plate Length | Maxillofacial / midface /mandibular:<br>Min: 5 mm<br>Max: 350 mm | Not specified | Maxillofacial / midface:<br>Min: 18 mm<br>Max: 350 mm<br>Mandibular:<br>Min: 31 mm<br>Max: 320 mm | Not specified |
| Degree of Curvature | In-plane<br>Min: 30°<br>Max: 180°<br>Out-of-plane<br>Min: 15°<br>Max: 180°…