The Biomet Microfixation OmniMax MMF System is indication 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.

Device Description

The Biomet Microfixation OmniMax MMF System is composed of metallic plates (arch bars) and locking screws that provide temporary stabilization of mandibular and maxillary bone during fracture healing and/or temporarily maintain a stable occlusion during surgery. Mandibular and Maxillary Fixation (MMF) is achieved through application of fixation plates and locking screws to bone; wire or elastics are then secured around hooks.

The OmniMax MMF system includes a fixation plate (also known as an arch bar) that has an in-plane bend to provide an initial approximation of mandibular and maxillary anatomy. The plate also features slots for locking screw fixation. These slots allow for a maximum of 12 fixation points in the bone as well as screw placement variation within the slot to avoid tooth roots. The OmniMax locking screws are 2.0mm in diameter and vary in length from 7mm to 11mm. The screw head also features a low-profile design to minimize irritation and palpability.

AI/ML Overview

The document provides information about the Biomet Microfixation OmniMax MMF System, specifically for its 510(k) submission, K202969. It describes the device, its indications for use, and a comparison to a predicate device. However, it does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way typically associated with diagnostic AI/ML device submissions (e.g., performance metrics like sensitivity, specificity, AUC).

Instead, the non-clinical performance data section focuses on validation testing for the cleaning process and biocompatibility assessment as the primary acceptance criteria for this specific submission, which seems to be an update or modification rather than a completely new device that requires extensive clinical performance evaluation.

Here's a breakdown of the information available based on your request, highlighting what is present and what is explicitly stated as not necessary or not evaluated:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Cleaning Validation: Meets standards outlined in FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."	"Testing passed all Cleaning validation meets the standards outlined in FDA guidance document acceptance criteria."
Biocompatibility Assessment: Adherence to predicate device standards per ISO 10993-1, following manufacturing process flow updates and review of contact materials.	"Process monitoring results and review of contact materials has passed acceptance criteria established by the predicate device per ISO 10993-1."

Study Details (Based on the provided document)

Since the submission primarily focuses on updates to the cleaning process and biocompatibility, and explicitly states that clinical testing was not necessary for substantial equivalence, many of the typical elements of a clinical performance study (like those involving AI/ML devices) are not applicable or not provided in this document.

Sample size used for the test set and the data provenance: This information is not provided as there wasn't a clinical performance study in the traditional sense for diagnostic accuracy. The "test set" here refers to the materials and controls used for cleaning validation and biocompatibility testing. The document does not specify their origins.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided as it's not relevant for cleaning validation or biocompatibility assessments.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: This information is not provided as it's not relevant for cleaning validation or biocompatibility assessments.
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: This is not applicable. This device is a bone plate and screw system, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This is not applicable. This is not an algorithm-based device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For Cleaning Validation: The ground truth is established by the ability to meet the acceptance criteria derived from FDA guidance documents and industry standards for sterility/cleaning.
- For Biocompatibility: The ground truth is established by meeting acceptance criteria based on ISO 10993-1 standards and predicate device performance, often involving laboratory tests for material safety and biological responses.
The sample size for the training set: This information is not provided as there was no AI/ML training set.
How the ground truth for the training set was established: This information is not applicable as there was no AI/ML training set.

Summary

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August 05, 2021

Biomet Microfixation Lauren Jasper Regulatory Affairs Project Manager 1520 Tradeport Drive Jacksonville, Florida 32218

Re: K202969

Trade/Device Name: Biomet Microfixation OmniMax MMF System Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: Class II Product Code: JEY, DZL Dated: May 6, 2021 Received: May 7, 2021

Dear Lauren Jasper:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

for Andrew Steen Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K202969

Device Name

Biomet Microfixation OmniMax 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 Biomet Microfixation. The word "BIOMET" is in large, bold, dark gray letters. Below that, in smaller letters, is the word "MICROFIXATION". Underneath the words is a thin green line, and below that is the phrase "One Surgeon. One Patient."

510(k) Summary

Prepared August 4, 2021

Submitter:	Biomet Microfixation1520 Tradeport DriveJacksonville, FL 32218 USA
Contact:	Lauren Jasper, Regulatory Affairs Ma

nager lauren.jasper@zimmerbiomet.com Telephone: (904) 741-9259

Device Name: Biomet Microfixation OmniMax MMF System

Common or Usual Name: Bone Plate

Primary Classification Name: Bone Plate

Primary Device Classification:

ProductCode	Device Name	DeviceClassification	RegulationNumber	RegulationDescription
JEY	Bone Plate	2	872.4760	Bone Plate

Secondary Device Classification:

Product Code	Device Name	Device Classification	Regulation Number	Regulation Description
DZL	Screw, Fixation,Intraosseous	2	872.4880	Intraosseous fixationscrew or wire

Indications for Use: 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.

Contraindications:

1. Patients with mental or neurological conditions who are unwilling or incapable of following postoperative care instructions.
1. Patients with limited blood supply, insufficient quantity or quality of bone.
1. Foreign body sensitivity. Where material sensitivity is suspected, testing is to be completed prior to implantation.
1. Severely comminuted fractures or unstable fractures
1. Active or latent infection
1. Patients in whom damage to un-erupted permanent teeth is anticipated.

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Device Description: Biomet Microfixation manufactures and distributes the Biomet Microfixation OmniMax MMF System. The Biomet Microfixation OmniMax MMF System is composed of metallic plates (arch bars) and locking screws that provide temporary stabilization of mandibular and maxillary bone during fracture healing and/or temporarily maintain a stable occlusion during surgery. Mandibular and Maxillary Fixation (MMF) is achieved through application of fixation plates and locking screws to bone; wire or elastics are then secured around hooks.

	Subject Device:Biomet MicrofixationOmniMax MMF System(K202969)	Primary Predicate:Biomet Microfixation OmniMax MMF System(K152326)
Principle ofOperation	No change from predicatedevice	Metallic implants for the temporary stabilizationof mandibular and maxillary bone during fracturehealing and/or temporarily maintain a stableocclusion during surgeryMandibular and Maxillary Fixation (MMF) isachieved through application of fixation plates andlocking screws to bone; wire or elastics are thensecured around hooks
Indications forUse	No change from predicatedevice	The Biomet Microfixation OmniMax MMFSystem is indicated for temporary stabilization ofmandibular and maxillary fractures to maintainproper occlusion during surgery and for post-operative fracture healing in adults andadolescents (age 12 and older) in whom permanentteeth have erupted.
Components	No change from predicatedevice	Fixation Plate (Arch Bar), Locking Screws
Plate Geometry	No change from predicatedevice	Design: Plate with an in-plane bend and 12 slots toaccept screws and 12 hooks
Screw Geometry	No change from predicatedevice	Design: Self-drilling screwsDiameter: 2.0mmLength: minimum 7mm, maximum 11mm
Material	No change from predicatedevice	Plates: Commercially Pure TitaniumScrews: Titanium Alloy, Ti-6Al-4VWires: Stainless Steel

Substantial Equivalence:

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	Subject Device:Biomet MicrofixationOmniMax MMF System(K202969)	Primary Predicate:Biomet Microfixation OmniMax MMF System(K152326)
User cleaning	Add cleaning instructions forthe processing of reusableinstruments andnew/uncompromised implants.	Not evaluated
Sterility	No change from predicatedevice	Non-sterile to be sterilized by the end user
MRI Safety	No change from predicatedevice	MR Conditional
Biocompatibility	Update manufacturing processflow and providebiocompatibility assessmentof those updates.	Not evaluated

Non-Clinical Performance Data: Validation testing to support the cleaning process were submitted in this premarket notification submission for a determination of substantial equivalence. Testing passed all Cleaning validation meets the standards outlined in FDA guidance document acceptance criteria. Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling.

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

Sterilization Information: The implants and instruments are provided non-sterile to be sterilized by the end user.

Biocompatibility Information: Manufacturing process flow updates were provided in this premarket notification submission for a determination of substantial equivalence. Process monitoring results and review of contact materials has passed acceptance criteria established by the predicate device per ISO 10993-1.

Conclusion: The submission demonstrates that: (1) any differences in technological characteristics of the predicates do not raise any new questions of substantial equivalence and (2) the proposed devices are substantially equivalent to the primary predicate.

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.