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 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.

AI/ML Overview

The provided text describes the KLS Martin L1 MMF System, a medical device for temporary stabilization of mandibular and maxillary fractures. It includes information about its indications for use, technological characteristics, and comparison to predicate devices, but it does not contain specific acceptance criteria, a detailed study proving the device meets those criteria, or most of the particular information requested in your prompt (e.g., sample sizes for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, or how ground truth was established).

The document primarily focuses on establishing substantial equivalence for regulatory approval, which often relies on comparison to existing legally marketed devices rather than extensive new clinical trials with detailed statistical endpoints.

Based on the provided text, here's what can be extracted and what is explicitly not available:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Mechanical Properties:
Tensile Strength: Equal or greater than the predicate device (Synthes MatrixWAVE MMF System K141165).	The subject device system demonstrated an equal or greater tensile force than the predicate device.
Torsional Properties of Screws: Successfully withstands testing without device failure.	All screw test articles successfully completed testing without any signs of device failure.
Driving Torque of Screws: Successfully withstands testing without device failure.	All screw test articles successfully completed testing without any signs of device failure.
Axial Pullout Strength of Screws: Successfully withstands testing without device failure.	All screw test articles successfully completed testing without any signs of device failure.
Pyrogenicity (Endotoxin Levels): Below USP allowed limit for medical devices and meets pyrogen limit specifications.	Endotoxin levels in subject device plates and screws are below the USP allowed limit for medical devices and meet pyrogen limit specifications.

2. Sample size used for the test set and the data provenance

Sample Size: Not specified for mechanical or pyrogenicity testing.
Data Provenance: Not specified (e.g., country of origin). The testing was non-clinical.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable as this was non-clinical mechanical and pyrogenicity testing, not an expert-based clinical review or ground truth labeling study.

4. Adjudication method for the test set

Not applicable.

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. This device is a physical bone fixation system, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study is not relevant and was not performed.

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

Not applicable for this type of medical device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

For mechanical properties: Engineering specifications, stress/strain measurements, and comparison to predicate device performance.
For pyrogenicity: LAL endotoxin testing against predefined regulatory limits (USP allowed limit).

8. The sample size for the training set

Not applicable. This is a physical device, not an AI model.

9. How the ground truth for the training set was established

Not applicable.

Summary

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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);

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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

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Indications for Use

510(k) Number (if known)

K173320

Device Name

KLS Martin L1 MMF System

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, 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 LP11201 Saint Johns Industrial Pkwy SJacksonville, FL 32246
Contact Person:	Gary MooreQuality Management and Regulatory Affairs ManagerPhone: 800-625-1557Email: 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) - PrimaryStryker 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-bornemaxillomandibular fixation (MMF) system consisting ofmetallic archbars with sliding locking plates that attach to thedental arches with self-drilling locking screws. The system isintended to provide temporary stabilization of mandibularand maxillary fractures as well as maintain proper occlusionduring intraoperative bone fixation and postoperative bonehealing (app. 6-8 weeks). The patient is brought intoocclusion by wiring around the archbar wire hooks. The L1MMF system plates are manufactured from CP Titanium(ASTM F67:2013), are available in either a 7-hole or 9-holesliding plate configuration with two different lengths, and are0.5 mm in plate thickness. The L1 MMF system slidinglocking plates are fixated with either 2.0 x 6 mm or 2.0 x 8mm self-drilling locking screws manufactured from Ti-6Al-4V (ASTM F136:2013). Implants are available both sterileand non-sterile. The system also includes the necessaryinstruments to facilitate placement of the implants.

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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 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).

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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 UniversalSMARTLock HybridMMF System(Predicate)	Biomet MicrofixationOmniMax MMFSystem(Predicate)	KLS Martin InternalDistraction – Sterile(Reference Device)
Indications forUse	The KLS Martin L1MMF System isintended for temporarystabilization ofmandibular andmaxillary fractures. It isdesigned to maintainproper occlusion duringintraoperative bonefixation andpostoperative bonehealing (app. 6-8weeks). It is indicatedfor the temporarytreatment ofmaxillomandibularfixation (MMF) inadults or adolescentswho have permanentteeth present (ages 12and older).	Intended Use: The systemis intended for temporarystabilization ofmandibular and maxillaryfractures and osteotomiesto maintain properocclusion duringintraoperative bonefixation and postoperativebone healing(approximately 6-8weeks). The systemaffords the ability tocompress bone segmentsacross a fracture. Thesystem is not intended tobe used as a tension band.Indications for Use: TheMatrixWAVE MMFSystem is indicated forthe temporary treatmentof mandibular andmaxillary fractures andosteotomies in adults andadolescents (age 12 andhigher) in whompermanent teeth haveerupted.	Intended Use: TheStryker UniversalSMARTLock HybridMMF System is intendedto be used for temporarystabilization ofmandibular andmaxillary fractures inorder to maintain properocclusion during fracturehealing.Indication for Use: TheStryker UniversalSMARTLock HybridMMF System isindicated for thetreatment of mandibularand maxillary fracturesin adults and adolescents(age 12 and higher) inwhom permanent teethhave erupted.	The BiometMicrofixation OmniMaxMMF System isindicated for temporarystabilization ofmandibular andmaxillary fractures tomaintain properocclusion during surgeryand for post-operativefracture healing in adultsand adolescents (age 12and older) in whompermanent teeth haveerupted.	Internal Distraction -Sterile includesdevices intended asbone stabilizers andlengthening (and ortransport) devices forcorrection ofcongenital deficienciesor post traumaticdefects of themandible (includingramus, body, alveolarridge, palate,symphysis) and mid-face bones that requiregradual distraction.
Contraindications	1. Active or latentinfection.2. Patients with limitedblood supply,insufficient quantity or	1. Unstable fractures thatcannot be stabilized inocclusion using thesystem.2. Patients in whom	Unknown	1. Patients with mentalor neurologicalconditions who areunwilling or incapable offollowing postoperative	1. Active infection.2. Patient conditionsincluding: bloodsupplylimitations.
KLS Martin L1 MMFSystem	Synthes MatrixWAVESystem	Stryker UniversalSMARTLock HybridMMF System	Biomet MicrofixationOmniMax MMFSystem	KLS Martin InternalDistraction - Sterile
(Subject Device)	(Primary Predicate)	(Predicate)	(Predicate)	(Reference Device)
quality of bone. Patientswith poor bone densityin whom failure ofscrew fixation may beanticipated.3. Patients who areunwilling or unable toadhere to restriction ineating and mouthopening associated withmaxillomandibularfixation.4. Patients with mentalor neurologicalconditions who areunwilling or incapableof followingpostoperative careinstructions.5. Severely comminutedfractures or unstablefractures.6. Foreign bodysensitivity. Wherematerial sensitivity issuspected, testing is tobe completed prior toimplantation.7. Patients in whomdamage to un-eruptedpermanent teeth isanticipated.8. Adolescents whosepermanent teeth haveNOT erupted	damage to un-eruptedpermanent teeth by screwinsertion may beanticipated.3. Patients for whommaxillomandibularfixation represents ahigher than usualpsychological orphysical risk.4. Patients who areunwilling to adhere torestrictions in eating andmouth openingassociated withmaxillomandibularfixation5. Patients with poor bonedensity in whom failure ofscrew fixation may beanticipated.		careinstructions.2. Patients with limitedblood supply,insufficient quantity orquality of bone.3. Foreign bodysensitivity; wherematerial sensitivity issuspected, testing is tobe completed prior toimplantation.4. Severely comminutedfractures or unstablefractures.5. Active or latentinfection.6. Patients in whomdamage to un-eruptedpermanent teeth isanticipated.	insufficient quantity orquality of bone orlatent infections.3. Patients with mentalor neurologicconditions who areunwilling or incapableof followingpostoperative careinstructions.4. Foreign bodysensitivity - Wherematerial sensitivity issuspected, tests are tobe made prior toimplantation.
	KLS Martin L1 MMFSystem(Subject Device)	Synthes MatrixWAVESystem(Primary Predicate)	Stryker UniversalSMARTLock HybridMMF System(Predicate)	Biomet MicrofixationOmniMax MMFSystem(Predicate)	KLS Martin InternalDistraction – Sterile(Reference Device)
Product Code	JEY	JEY	JEY	JEY	HRS
Material	Plates: CP TitaniumScrews: Titanium Alloy	Plates: CP TitaniumScrews: Titanium Alloy	Plates: CP TitaniumScrews: Titanium Alloy	Plates: CP TitaniumScrews: Titanium Alloy	CP Titanium &Titanium Alloy
Sterilization	Sterile (gammairradiation) and Non-sterile (steam)	Non-sterile	Non-sterile	Non-sterile	Sterile (gammairradiation)
TargetPopulation	Adolescents and Adults	Adolescents and Adults	Adolescents and Adults	Adolescents and Adults	Not applicable
Anatomical Sites	Mandibular andMaxillofacial Areas	Mandibular andMaxillofacial Areas	Mandibular andMaxillofacial Areas	Mandibular andMaxillofacial Areas	Mandibular andMaxillofacial Areas
Plate/ArchbarThickness	0.5 mm	1.0 mm	0.5 mm	unknown	Not applicable
Plate/ArchbarLength	109.5 mm and 130 mm	Variable, depending onstretching 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

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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

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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.

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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 diameter than the Synthes MatrixWave screws. Screw lengths are the same among the subject and predicate devices, with the exception of Biomet OmniMax which offers screws in greater lengths. The subject device plates are designed to allow variability in screw hole placement, whereas the Biomet OmniMax and Stryker Universal SMARTLock only offer plates with predetermined screw hole locations. Finally, the predicate device systems are provided non-sterile and must be sterilized by the end-user. The subject device components will be provided sterile. Sterile subject devices are provided in sterile packaging via gamma irradiation.

Reference Devices

The KLS Martin L1 MMF System includes devices manufactured from the same materials as the reference device. The subject devices are also identical in manufacturing process, biocompatibility, sterilization, and packaging as the reference devices cleared under K161470 - Internal Distraction - Sterile.

Non-Clinical Performance Data:

Mechanical Properties Testing

Tensile testing to demonstrate the maximum tensile strength of the L1 MMF System devices was performed and compared with the tensile strength of the Synthes MatrixWAVE MMF System (K141165). Results of the testing show the subject device system has an equal or greater tensile force than the predicate device, therefore demonstrating substantial equivalence. Mechanical properties testing was performed on the L1 MMF screws to demonstrate the torsional properties, driving torque, and axial pullout strength. All screw test articles successfully completed testing without any signs of device failure.

Pyrogenicity Testing

LAL endotoxin testing was conducted according to AAMI ANSI ST72 on the subject device plates and screws to address the presence of bacterial endotoxins and ensure they meet pyrogen limit specifications. The results of the testing demonstrate that the KLS Martin L1 MMF System devices contain endotoxin levels below the USP allowed limit for medical devices and meet pyrogen limit specifications.

Clinical Performance Data:

Clinical testing was not necessary for the determination of substantial equivalence.

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Image /page/9/Picture/0 description: The image shows the logo for KLS Martin L.P. The letters "KLS" are in red, while "martin" is in gray. The letters "L.P." are in black and are slightly smaller than the other letters in the logo.

Conclusion:

The KLS Martin L1 MMF System has the same intended use and very similar technological characteristics as the predicate devices. Technological differences have been assessed with performance testing presented in this submission. Testing has demonstrated that any differences in technological characteristics do not raise new issues of safety or effectiveness and concludes the subject device is substantially equivalent to the predicate devices.

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.