Who is the manufacturer of KLS Martin L1 MMF System?

KLS Martin L.P. filed the 510(k) submission for KLS Martin L1 MMF System (K173320).

What is the FDA product code for KLS Martin L1 MMF System?

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 L1 MMF System?

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

What are the predicate devices for KLS Martin L1 MMF System?

Synthes MatrixWAVE MMF System (K141165); Stryker Universal SMARTLock Hybrid MMF System (K122313); Biomet Microfixation OmniMax MMF System (K143336).

Who can help prepare an FDA 510(k) submission like KLS Martin L1 MMF System?

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 L1 MMF System

K173320 · KLS Martin L.P. · JEY · Feb 23, 2018 · Dental

Device Facts

Record ID	K173320
Device Name	KLS Martin L1 MMF System
Applicant	KLS Martin L.P.
Product Code	JEY · Dental
Decision Date	Feb 23, 2018
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.4760
Device Class	Class 2
Attributes	Therapeutic

Indications for Use

The KLS Martin L1 MMF System is intended for temporary stabilization of mandibular and maxillary fractures. It is designed to maintain proper occlusion during intraoperative bone fixation and postoperative bone healing (app. 6-8 weeks). It is indicated for the temporary treatment of maxillomandibular fixation (MMF) in adults or adolescents who have permanent teeth present (ages 12 and older).

Device Story

System consists of metallic archbars with sliding locking plates and self-drilling locking screws; used for temporary stabilization of mandibular and maxillary fractures; maintains occlusion during intraoperative fixation and postoperative healing (6-8 weeks). Physician fixates plates to dental arches using screws; patient brought into occlusion by wiring around archbar hooks. Used in hospitals/clinics by trained physicians. Provides temporary bone stabilization; benefits patient by ensuring proper fracture healing and alignment. System includes necessary placement instruments.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including tensile strength comparison against Synthes MatrixWAVE, torsional/pullout screw testing, and LAL endotoxin pyrogenicity testing per AAMI ANSI ST72.

Technological Characteristics

Plates: CP Titanium (ASTM F67:2013); Screws: Ti-6Al-4V (ASTM F136:2013). 0.5 mm plate thickness. Self-drilling, locking screw interface. Available sterile (gamma irradiation) or non-sterile (steam).

Indications for Use

Indicated for temporary maxillomandibular fixation (MMF) in adults and adolescents (ages 12+) with permanent teeth for stabilization of mandibular and maxillary fractures.

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

Synthes MatrixWAVE MMF System (K141165)
Stryker Universal SMARTLock Hybrid MMF System (K122313)
Biomet Microfixation OmniMax MMF System (K143336)

Reference Devices

Internal Distraction - Sterile (K161470)

Submission Summary (Full Text)

{0}------------------------------------------------ February 23, 2018 Image /page/0/Picture/1 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized emblem. To the right is the FDA logo, with the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text. KLS Martin LP Gary Moore Quality Management and Regulatory Affairs Manager 11201 Saint Johns Industrial Parkway S Jacksonville, Florida 32246 Re: K173320 Trade/Device Name: KLS Martin L1 MMF System Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: Class II Product Code: JEY Dated: October 17, 2017 Received: October 20, 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); {1}------------------------------------------------ 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). 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) K173320 Device Name KLS Martin L1 MMF System #### Indications for Use (Describe) The KLS Martin L1 MMF System is intended for temporary stabilization of mandibular and maxillary fractures. It is designed to maintain proper occlusion during intraoperative bone fixation and postoperative bone healing (app. 6-8 weeks). It is indicated for the temporary treatment of maxillomandibular fixation (MMF) in adults or adolescents who have permanent teeth present (ages 12 and older). | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------| | <div> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for KLS Martin L.P. The letters "KLS" are in red, while "martin" is in gray, and "L.P." is in black. Above the logo is the text "K173320". 11201 Saint Johns Industrial Pkwy S • Jacksonville, FL 32246 Phone: 904-641-7746 • 800-625-1557 • Fax: 904-641-7378 www.klsmartinnorthamerica.com # Section 5 510(k) Summary 21 CFR 807.92 | Submitter: | KLS Martin 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: | January 25, 2018 | | Trade Name: | KLS Martin L1 MMF System | | Common Name: | Plate, Bone | | Classification Name: | Bone plate (21 CFR 872.4760) | | Regulatory Class: | II | | Product Code: | JEY | | Predicate Devices: | Synthes MatrixWAVE MMF System (K141165) - Primary Stryker Universal SMARTLock Hybrid MMF System (K122313) Biomet Microfixation OmniMax MMF System (K143336) | | Reference Device: | Internal Distraction - Sterile (K161470) | | Device Description: | The KLS Martin L1 MMF System is a bone-borne maxillomandibular fixation (MMF) system consisting of metallic archbars with sliding locking plates that attach to the dental arches with self-drilling locking screws. The system is intended to provide temporary stabilization of mandibular and maxillary fractures as well as maintain proper occlusion during intraoperative bone fixation and postoperative bone healing (app. 6-8 weeks). The patient is brought into occlusion by wiring around the archbar wire hooks. The L1 MMF system plates are manufactured from CP Titanium (ASTM F67:2013), are available in either a 7-hole or 9-hole sliding plate configuration with two different lengths, and are 0.5 mm in plate thickness. The L1 MMF system sliding locking plates are fixated with either 2.0 x 6 mm or 2.0 x 8 mm self-drilling locking screws manufactured from Ti-6Al- 4V (ASTM F136:2013). Implants are available both sterile and non-sterile. The system also includes the necessary instruments to facilitate placement of the implants. | {4}------------------------------------------------ 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 and are smaller than the other letters/word in the logo. 11201 Saint Johns Industrial Pkwy S • Jacksonville, FL 32246 Phone: 904-641-7746 • 800-625-1557 • Fax: 904-641-7378 www.klsmartinnorthamerica.com The KLS Martin L1 MMF System is intended for temporary Indications for Use: stabilization of mandibular and maxillary fractures. It is designed to maintain proper occlusion during intraoperative bone fixation and postoperative bone healing (app. 6-8 weeks). It is indicated for the temporary treatment of maxillomandibular fixation (MMF) in adults or adolescents who have permanent teeth present (ages 12 and older). {5}------------------------------------------------ # KLS martın L.P. 11201 Saint Johns Industrial Pkwy S • Jacksonville, FL 32246 Phone: 904-641-7746 • 800-625-1557 • Fax: 904-641-7378 www.klsmartinnorthamerica.com # Technological Characteristics/Substantial Equivalence Discussion: | | KLS Martin L1 MMF System (Subject Device) | Synthes MatrixWAVE System (Primary Predicate) | Stryker Universal SMARTLock Hybrid MMF System (Predicate) | Biomet Microfixation OmniMax MMF System (Predicate) | KLS Martin Internal Distraction – Sterile (Reference Device) | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | The KLS Martin L1 MMF System is intended for temporary stabilization of mandibular and maxillary fractures. It is designed to maintain proper occlusion during intraoperative bone fixation and postoperative bone healing (app. 6-8 weeks). It is indicated for the temporary treatment of maxillomandibular fixation (MMF) in adults or adolescents who have permanent teeth present (ages 12 and older). | Intended Use: The system is intended for temporary stabilization of mandibular and maxillary fractures and osteotomies to maintain proper occlusion during intraoperative bone fixation and postoperative bone healing (approximately 6-8 weeks). The system affords the ability to compress bone segments across a fracture. The system is not intended to be used as a tension band. Indications for Use: The MatrixWAVE MMF System is indicated for the temporary treatment of mandibular and maxillary fractures and osteotomies in adults and adolescents (age 12 and higher) in whom permanent teeth have erupted. | Intended Use: The Stryker Universal SMARTLock Hybrid MMF System is intended to be used for temporary stabilization of mandibular and maxillary fractures in order to maintain proper occlusion during fracture healing. Indication for Use: The Stryker Universal SMARTLock Hybrid MMF System is indicated for the treatment of mandibular and maxillary fractures in adults and adolescents (age 12 and higher) in whom permanent teeth have erupted. | The Biomet Microfixation OmniMax MMF System is indicated for temporary stabilization of mandibular and maxillary fractures to maintain proper occlusion during surgery and for post-operative fracture healing in adults and adolescents (age 12 and older) in whom permanent teeth have erupted. | Internal Distraction - Sterile 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, symphysis) and mid- face bones that require gradual distraction. | | Contraindications | 1. Active or latent infection. 2. Patients with limited blood supply, insufficient quantity or | 1. Unstable fractures that cannot be stabilized in occlusion using the system. 2. Patients in whom | Unknown | 1. Patients with mental or neurological conditions who are unwilling or incapable of following postoperative | 1. Active infection. 2. Patient conditions including: blood supply limitations. | | KLS Martin L1 MMF System | Synthes MatrixWAVE System | Stryker Universal SMARTLock Hybrid MMF System | Biomet Microfixation OmniMax MMF System | KLS Martin Internal Distraction - Sterile | | | (Subject Device) | (Primary Predicate) | (Predicate) | (Predicate) | (Reference Device) | | | quality of bone. Patients with poor bone density in whom failure of screw fixation may be anticipated. 3. Patients who are unwilling or unable to adhere to restriction in eating and mouth opening associated with maxillomandibular fixation. 4. Patients with mental or neurological conditions who are unwilling or incapable of following postoperative care instructions. 5. Severely comminuted fractures or unstable fractures. 6. Foreign body sensitivity. Where material sensitivity is suspected, testing is to be completed prior to implantation. 7. Patients in whom damage to un-erupted permanent teeth is anticipated. 8. Adolescents whose permanent teeth have NOT erupted | damage to un-erupted permanent teeth by screw insertion may be anticipated. 3. Patients for whom maxillomandibular fixation represents a higher than usual psychological or physical risk. 4. Patients who are unwilling to adhere to restrictions in eating and mouth opening associated with maxillomandibular fixation 5. Patients with poor bone density in whom failure of screw fixation may be anticipated. | | care instructions. 2. Patients with limited blood supply, insufficient quantity or quality of bone. 3. Foreign body sensitivity; where material sensitivity is suspected, testing is to be completed prior to implantation. 4. Severely comminuted fractures or unstable fractures. 5. Active or latent infection. 6. Patients in whom damage to un-erupted permanent teeth is anticipated. | insufficient quantity or quality of bone or latent infections. 3. Patients with mental or neurologic conditions who are unwilling or incapable of following postoperative care instructions. 4. Foreign body sensitivity - Where material sensitivity is suspected, tests are to be made prior to implantation. | | | | KLS Martin L1 MMF System (Subject Device) | Synthes MatrixWAVE System (Primary Predicate) | Stryker Universal SMARTLock Hybrid MMF System (Predicate) | Biomet Microfixation OmniMax MMF System (Predicate) | KLS Martin Internal Distraction – Sterile (Reference Device) | | Product Code | JEY | JEY | JEY | JEY | HRS | | Material | Plates: CP Titanium Screws: Titanium Alloy | Plates: CP Titanium Screws: Titanium Alloy | Plates: CP Titanium Screws: Titanium Alloy | Plates: CP Titanium Screws: Titanium Alloy | CP Titanium & Titanium Alloy | | Sterilization | Sterile (gamma irradiation) and Non- sterile (steam) | Non-sterile | Non-sterile | Non-sterile | Sterile (gamma irradiation) | | Target Population | Adolescents and Adults | Adolescents and Adults | Adolescents and Adults | Adolescents and Adults | Not applicable | | Anatomical Sites | Mandibular and Maxillofacial Areas | Mandibular and Maxillofacial Areas | Mandibular and Maxillofacial Areas | Mandibular and Maxillofacial Areas | Mandibular and Maxillofacial Areas | | Plate/Archbar Thickness | 0.5 mm | 1.0 mm | 0.5 mm | unknown | Not applicable | | Plate/Archbar Length | 109.5 mm and 130 mm | Variable, depending on stretching of plate | 110 mm and 130 mm | Unknown | Not applicable | | Screw Diameter | 2.0 mm | 1.85 mm | 2.0 mm | 2.0 mm | Not applicable | | Screw Length | 6 and 8 mm | 6 and 8 mm | 6 and 8 mm | 7, 9, and 11 mm | Not applicable | | Screw Style | self-drilling, locking | self-drilling, locking | self-drilling, locking | self-drilling, locking | Not applicable | {6}------------------------------------------------ # kıs martın L.P. 11201 Saint Johns Industrial Pkwy S • Jacksonville, FL 32246 Phone: 904-641-7746 • 800-625-1557 • Fax: 904-641-7378 www.klsmartinnorthamerica.com {7}------------------------------------------------ # KLS MG # 11201 Saint Johns Industrial Pkwy S · Jacksonville, FL 32246 Phone: 904-641-7746 • 800-625-1557 • Fax: 904-641-7378 www.klsmartinnorthamerica.com # Similarities to Predicates The subject and predicate device systems are identical with respect to intended use and materials. All devices are intended for temporary stabilization of mandibular and maxillary fractures in order to maintain proper occusion during intractor and postoperative healing, Both subject and predicate device plates are manufactured from CP Titanium, while screws are manufactured from Titanium Alloy. All devices have very similar principles of operation, design, and device mechanisms: metallic plates and screws each fixated to the maxilla, then wired together to achieve maxillomandibular fixation (MMF). Anatomical sites and fixation methods used for the subject and predical. All device systems use self-drilling screws, have a locking plate/screw interface, have plates that can be cut and hooks to support wires or elastics. The subject and predicate devices are for prescription use only by qualified and trained physicians in healthcare facilities/hoopitals. {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for KLS Martin L.P. The letters "KLS" are in red, while "martin" is in gray. The letters "L.P." are in black and are larger than the other letters in the logo. ## Differences to Predicates The subject and predicate devices are slightly different in regard to screw design, screw diameter, and screw lengths. The Synthes MatrixWave screw has a raised head with a groove to accommodate wire(s) for additional stability. The subject device screw is not designed to be used as additional support for wires. In addition, the subject device has a bigger screw head d…

KLS Martin L1 MMF System

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Reference Devices

Submission Summary (Full Text)

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KLS Martin L1 MMF System

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Reference Devices

Submission Summary (Full Text)

Panel 1

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