Who is the manufacturer of KLS Martin Individual Patient Solutions?

KLS Martin L.P. filed the 510(k) submission for KLS Martin Individual Patient Solutions (K163579).

What is the FDA product code for KLS Martin Individual Patient Solutions?

JEY. It is classified under 21 CFR 872.4760 as a Class 2 device in the Dental panel.

What is the regulatory pathway for KLS Martin Individual Patient Solutions?

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

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

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

KLS Martin Individual Patient Solutions

K163579 · KLS Martin L.P. · JEY · Nov 21, 2017 · Dental

Device Facts

Record ID	K163579
Device Name	KLS Martin Individual Patient Solutions
Applicant	KLS Martin L.P.
Product Code	JEY · Dental
Decision Date	Nov 21, 2017
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.4760
Device Class	Class 2
Attributes	Therapeutic

Intended Use

KLS Martin Individual Patient Solutions implant devices are in the stabilization and fixation of mandibular fractures and mandibular reconstruction.

Device Story

Device consists of patient-specific metallic bone plates and screws for internal fixation of the mandible. Input data derived from patient CT scans; physician provides input during virtual planning to modify digital models. Trained engineers finalize designs; verification performed by virtually fitting device model over 3D patient anatomy model. Plates manufactured via traditional (subtractive) or additive (laser sintering) methods. Used in clinical settings by physicians. Output is a custom-fit implant that stabilizes bone fragments, facilitating reconstruction and fracture healing. Benefits include improved anatomical fit compared to standard pre-contoured plates.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including mechanical testing per ASTM F382 (bending resistance and fatigue life) and biocompatibility testing per ISO 10993 (cytotoxicity, sensitization, irritation, chemical/material characterization). Sterilization validated per ISO 17665-1:2006.

Technological Characteristics

Materials: CP Titanium (ASTM F67) or Ti-6Al-4V (ASTM F136). Manufacturing: Subtractive or additive (laser sintering). Plate thickness: 1.0-3.0 mm. Screw diameter: 2.0-3.2 mm. Sterilization: Non-sterile, steam sterilization by end-user. Patient-specific design based on CT imaging.

Indications for Use

Indicated for the stabilization and fixation of mandibular fractures and mandibular reconstruction in patients requiring surgical intervention.

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 Mandibular Reconstruction System II (K032442)

Reference Devices

Patient Contoured Mesh (K062570)
KLS Mini Osteosynthesis System (K943347)
Centre-Drive Drill-Free Screw (K971297)
KLS Martin Thoracic Plating System (K153482)

Related Devices

K191028 — KLS Martin Individual Patient Solutions · KLS-Martin L.P. · Nov 22, 2019
K180962 — KLS Martin Individual Patient Solutions · KLS-Martin L.P. · Aug 13, 2018
K193280 — MedCAD® AccuPlate® Patient-Specific Plate · Medcad · Feb 12, 2021
K230398 — MedCAD® AccuPlate® 3DTi Patient-Specific Plating System · Medcad · Sep 26, 2023
K122647 — SYNTHES PATIENT SPECIFIC PLATE · Synthes, Inc. · Feb 28, 2013

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are rendered in a dark color, creating a sense of depth. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 November 21, 2017 KLS Martin LP Gary Moore Quality Management And Regulatory Affairs Manager 11201 Saint Johns Industrial Pkwy S Jacksonville, Florida 32246 Re: K163579 Trade/Device Name: KLS Martin Individual Patient Solutions Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: Class II Product Code: JEY Dated: October 20, 2017 Received: October 23, 2017 Dear Gary Moore: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. 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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {1}------------------------------------------------ If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely, # Mary S. Runner -S for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K163579 Device Name KLS Martin Individual Patient Solutions #### Indications for Use (Describe) KLS Martin Individual Patient Solutions implant devices are in the stabilization and fixation of mandibular fractures and mandibular reconstruction. Type of Use (Select one or both, as applicable) 2 Prescription Use (Part 21 CFR 801 Subpart D) _ Over-The-Counter Use (21 CFR 801 Subpart C) ### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. #### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for KLS Martin L.P., a company located in Jacksonville, FL. The logo is in red and gray, with the letters "KLS" in red and "martin" in gray. The company's address is 11201 Saint Johns Industrial Pkwy S, Jacksonville, FL 32246. The phone number is 904-641-7746, the toll-free number is 800-625-1557, and the fax number is 904-641-7378. The website address is www.klsmartinnorthamerica.com. 11201 Saint Johns Industrial Pkwy S • Jacksonville, FL 32246 www.klsmartinnorthamerica.com K163579 Section 5 510(k) Summary 21 CFR 807.92 | Submitter: | KLS Martin LP 11201 Saint Johns Industrial Pkwy S Jacksonville, FL 32246 | |----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Gary Moore Quality Management and Regulatory Affairs Manager Phone: 800-625-1557 Email: gmoore@klsmartin.com | | Date Prepared: | November 20, 2017 | | Trade Name: | KLS Martin Individual Patient Solutions | | Common Name: | Plate, Bone | | Classification Name: | Bone plate (21 CFR 872.4760) | | Regulatory Class: | II | | Product Code: | JEY | | Predicate Device: | KLS Martin Mandibular Reconstruction System II (K032442) | | Reference Devices: | Patient Contoured Mesh (K062570) KLS Mini Osteosynthesis System (K943347) Centre-Drive Drill-Free Screw (K971297) KLS Martin Thoracic Plating System (K153482) | | Device Description: | KLS Martin Individual Patient Solutions is comprised of patient-specific models and metallic bone plates used in conjunction with metallic bone screws for internal fixation of mandibular bone. 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 device model over a 3D model of the patient's anatomy to ensure its dimensional properties allow an adequate fit. | {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for KLS Martin L.P. The text "KLS" is in red, while "martin" is in gray, and "L.P." is in black. The font is sans-serif 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 Implants are provided non-sterile, range in thickness from 1.0 - 3.0 mm, and are manufactured using traditional (subtractive) or rapid prototyping (additive) methods from either CP Titanium (ASTM F67) or Ti-6Al-4V (ASTM F136) materials. These patient-specific devices are fixated with previously cleared KLS Martin screws. - KLS Martin Individual Patient Solutions implant devices are Indications for Use: intended for use in the stabilization and fixation of mandibular fractures and mandibular reconstruction. ### Technological Characteristics & Substantial Equivalence Discussion The intended use and technological characteristics of the subject device, KLS Martin Individual Patient Solutions, are either identical or have been demonstrated to be substantially equivalent to the primary predicate device, KLS Martin Mandibular Reconstruction System II (K032442): The subject and primary predicate devices are intended for reconstructive surgery in the facial skeleton and share the same fundamental principle of operation - metallic plates used in conjunction with metallic screws for mandibular reconstructive surgery. The subject device of this submission is specific for mandibular fractures and reconstruction, which is identical to the predicate device (K032442), and similar to the reference device (K062570) cleared for use in the maxillofacial, mandibular, and craniofacial skeleton. Additional reference devices (K943347, K971297, and K153482) intended for bone fixation have been included to cover the range of screw characteristics described in this submission. The design and materials used for the mandibular reconstruction plates in the subject device is similar to those cleared in KLS Martin Mandibular Reconstruction System II (K032442). The design and dimensions of the plates will be based on the patient-specific data, using similar methods described in Patient Contoured Mesh (K062570), made from either CP Titanium (ASTM F67) using traditional manufacturing methods or Ti-6Al-4V powder (ASTM F136) via additive, laser sintering manufacturing methods, and fall within previously cleared specifications for plate thicknesses ranging from 1.0 - 3.0 mm. Plates will be fixated with previously cleared KLS Martin titanium screws ranging in diameter from 2.0 - 3.2 mm in lengths from 5 - 22 mm (K943347, K971297, K032442, and K153482). The screw characteristics (head style, type, range of size) have been cleared in the reference devices. All devices are provided non-sterile for steam sterilization by the end-user. The angles and dimensions of each KLS Martin Individual Implant Solutions implant devices is determined based on the patient anatomy and surgical plan and should not be further contoured intraoperatively, whereas the plates in the KLS Martin Mandibular Reconstruction System II (K032442) are angled and transversely pre-curved to follow the natural curves of the mandible, but are not designed based on patient specific data as described in the reference device K062570. {5}------------------------------------------------ K163579 Page 3 of 6 # KUS ITOCIO CIT CII LEIT LE PE 1100 Satustial Play S - Jacksoville, FL 3220 12-11-737 11201 Saint Johns Industrial Pkwy S • Jacksonville, FL 32246 www.klsmartinnorthamerica.com | Device Comparison Table | | | | | | | |----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Individual Patient Solutions | KLS Martin Mandibular Reconstruction System II K032442 | Patient Contoured Mesh K062570 | KLS Mini Osteosynthesis System K943347 | Centre-Drive Drill-Free Screw K971297 | KLS Martin Thoracic Plating System K153482 | | | (Subject Device) | (Primary Predicate) | (Reference Device) | (Reference Device) | (Reference Device) | (Reference Device) | | Indications for Use | KLS Martin Individual Patient Solutions implant devices are intended for use in the stabilization and fixation of mandibular fractures and mandibular reconstruction. | The KLS Martin Mandibular Reconstruction System II is intended for use in the stabilization and fixation of mandibular fractures and mandibular reconstruction. | Patient Contoured Mesh (PCM) is intended to replace bony voids in mandibular, maxillofacial, or craniofacial skeleton. | The device system has the same intended use as its predicate (K854886). | KLS Martin Centre-Drive Drill-Free Screws are intended for use in rigid internal fixation of the oral-maxillo- cranid-facial bones. The bone screws are used to anchor plates which are contoured to fit the bony surface and stabilize the bone fragments. The addition of the self drilling feature is the only difference between the submitted device and the predicate device referenced. | The KLS Martin Thoracic Plating System is indicated for use in the stabilization and fixation of fractures in the chest wall including sternal reconstructive surgical procedures, trauma, or planned osteotomies. | | Patient-specific configuration? | Yes. Devices are manufactured | No. Devices are provided in a standard | Yes. Devices are manufactured | No. Devices are provided in a standard | No. Devices are provided in a standard | No. Devices are provided in a standard | | | patient-specific, based on a CT scan of the patient. | shape and matched to the patient's anatomy intraoperatively. | patient-specific, based on a CT scan of the patient. | shape and matched to the patient's anatomy intraoperatively. | shape and matched to the patient's anatomy intraoperatively. | shape and matched to the patient's anatomy intraoperatively. | | Classification | 21 CFR 872.4760. Class II | 21 CFR 872.4760. Class II | 21 CFR 882.5330, Class II | 21 CFR 872.4760. Class II | 21 CFR 888.3030. Class II | 21 CFR 888.3030. Class II | | Device Comparison Table | | | | | | | | | Individual Patient Solutions | KLS Martin Mandibular Reconstruction System II K032442 | Patient Contoured Mesh K062570 | KLS Mini Osteosynthesis System K943347 | Centre-Drive Drill-Free Screw K971297 | KLS Martin Thoracic Plating System K153482 | | | (Subject Device) | (Primary Predicate) | (Reference Device) | (Reference Device) | (Reference Device) | (Reference Device) | | Product Code | JEY | MQN | GXN | JEY | HRS | HRS | | Material | CP Titanium or Ti-6A1-4V | CP Titanium or Ti-6Al-4V | CP Titanium or Ti-6A1-4V | Plates: CP Titanium Screws: Ti-6A1-4V | Ti-6Al-4V | CP Titanium and Ti-6Al-4V | | Manufacturing Method | Traditional (Subtractive) 3D (Additive) | Traditional (Subtractive) | Traditional (Subtractive) 3D (Additive - Skull Models) | Traditional (Subtractive) | Traditional (Subtractive) | Traditional (Subtractive) | | Sterilization | Non-sterile (Steam) | Non-sterile (Steam) | Non-sterile (Steam) | Non-sterile (Steam) | Non-sterile (Steam) | Non-sterile (Steam) or Sterile (gamma irradiation) | | Anatomical Sites | Mandible | Mandible | Craniofacial, Maxillofacial, Mandibular | Craniofacial, Maxillofacial, Mandibular | Craniofacial, Maxillofacial, Mandibular | Thoracic | | Plates | | | | | | | | Thickness | 1.0 mm - 3.0 mm | 1.0 mm - 3.0 mm | 0.6 mm - 1.0 mm | 0.6 - 1.0 mm | Not applicable | 1.0 mm - 3.0 mm | | Style | Non-compression Compression Threaded | Non-compression Compression Threaded | Mesh and solid with or without holes | Standard Low Profile | Not applicable | Sternal: Standard linear shapes (locking) Rib: Bi-linear, pre-contoured X-& Z-shaped (locking) | | Width (screw-hole dependent) | Min: 7 mm Max: 8.5 mm | Min: 6 mm Max: 8 mm | Not applicable | Not applicable | Not applicable | Not applicable | | Device Comparison Table | | | | | | | | | Individual Patient Solutions | KLS Martin Mandibular Reconstruction System II K032442 | Patient Contoured Mesh K062570 | KLS Mini Osteosynthesis System K943347 | Centre-Drive Drill-Free Screw K971297 | KLS Martin Thoracic Plating System K153482 | | | (Subject Device) | (Primary Predicate) | (Reference Device) | (Reference Device) | (Reference Device) | (Reference Device) | | Length | Min: 31 mm Max: 320 mm | Min: 28.5 mm Max: 240.65 mm | Not applicable | Not applicable | Not applicable | Not applicable | | Degree of curvature (in-plane) | Min: 90° Max: 180° | Min: 125° Max: 180° | Not applicable | Not applicable | Not applicable | Not applicable | | Degree of curvature (out-of- plane) | Min: 60° Max: 180° | Min: N/A Max: 180° | Not applicable | Not applicable | Not applicable | Not applicable | | Hole spacing | Greater than or equal to 8 mm | 8 mm | Not applicable | Not applicable | Not applicable | Not applicable | | Number of Holes | Min: 4 Max: Dependent on length & hole spacing | Min: 4 Max: 27 | Not applicable | Not applicable | Not applicable | Not applicable | | Screw Diameter | 2.0 mm - 3.2 mm | 2.0 mm - 3.2 mm | 1.5 mm | 1.5 mm - 2.3 mm | 1.0 mm - 2.0 mm | 2.3 mm - 3.2 mm | | Screw Length | 5 mm - 22 mm | 8 mm - 22 mm | 3.5 mm - 15 mm | 4 mm - 19 mm | 2 mm - 7 mm | 7 mm - 17 mm | | Screw Style | maxDrive & crossDrive (Drill-Free, locking [ThreadLock Taper Screw -TLTS], standard) | Drill-Free, locking (ThreadLock Taper Screw -TLTS) | standard, Drill-Free | crossDrive (slotted, standard, low profile) Centre-Drive (standard) | Centre-Drive, Drill- Free (standard) | maxDrive, Drill-Free screw (locking, standard) | {6}------------------------------------------------ K163579 Page 4 of 6 # KUS ITOCICCIIN LINE 11201 Saint Iohns Industrial Play S - Jacksonille, FL 3220 11-61-737 11201 Saint Johns Industrial Pkwy S ● Jacksonville, FL 32246 www.k1smartinnorthamerica.com {7}------------------------------------------------ K163579 Page 5 of 6 # KUS MOCIC CIM CHIN LINE PHONE: 00461-1714 6 800-62-1537 Fax: 904-61-737 11201 Saint Johns Industrial Pkwy S • Jacksonville, FL 32246 www.klsmartinnorthamerica.com {8}------------------------------------------------ Image /page/8/Picture/1 description: The image shows the logo for KLS Martin L.P. The logo is composed of the text "KLS martin L.P.", with "KLS" in red, "martin" in gray, and "L.P." in black. The font is sans-serif and bolded. 11201 Saint Johns Industrial Pkwy S · Jacksonville, FL 32246 Phone: 904-641-7746 • 800-625-1557 • Fax: 904-641-7378 www.klsmartinnorthamerica.com ### Performance Testing - Non-clinical Bench testing was used to demonstrate that any differences between the subject and predicate devices do not raise any new safety and effectiveness questions. Mechanical testing was conducted in accordance with ASTM F382 to compare the bending properties of the additive manufactured subject plates against the previously cleared subtractive manufactured predicate plates. The bending resistance and fatigue life of the subject devices was determined to be equivalent or better than the predicate devices. Steam sterilization validation was performed for the dynamic-air-removal cycle in accordance with ISO 17665-1:2006 to a sterility assurance level (SAL) of 106 using the biological indicator (BI) overkill method. All test method acceptance criteria were met. Biocompatibility endpoints were evaluated in accordance with ISO 10993. The battery of cytotoxicity, chemical analysis, sensitization and irritation, and chemical/material characterization testing conducted on the subject device were within the pre-defined acceptance criteria, and therefore, adequately addresses biocompatibility for implants with a permanent duration of contact. ### Performance Testing - Clinical Clinical testing was not necessary for the substantial equivalence determination. ### Substantial Equivalence Conclusion: The proposed device has the same intended used as the predicate devices. The performance testing included in the submission demonstrates that the differences in technological characteristics do not raise any new safety and effectiveness questions. The information submitted supports substantial equivalence.