Biomet Microfixation OmniMax MMF System

K202969 · Biomet Microfixation · JEY · Aug 5, 2021 · Dental

Device Facts

• Record ID: K202969
• Device Name: Biomet Microfixation OmniMax MMF System
• Applicant: Biomet Microfixation
• Product Code: JEY · Dental
• Decision Date: Aug 5, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4760
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

System consists of metallic fixation plates (arch bars) and 2.0mm locking screws used for temporary stabilization of mandibular and maxillary bone fractures; maintains stable occlusion during surgery. Plates feature in-plane bend for anatomical approximation and slots for screw fixation; hooks allow attachment of wires or elastics. Used in clinical settings by surgeons. Device provides mechanical stabilization to bone segments to facilitate healing and proper dental alignment. Output is physical fixation of bone; healthcare providers use this to manage fracture reduction and post-operative healing. Benefits include stable occlusion and fracture stabilization.

Clinical Evidence

No clinical data. Bench testing only. Cleaning validation performed per FDA guidance 'Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling'. Biocompatibility assessment conducted for manufacturing process updates per ISO 10993-1.

Technological Characteristics

Plates: Commercially Pure Titanium. Screws: Titanium Alloy (Ti-6Al-4V). Wires: Stainless Steel. 2.0mm diameter screws (7mm-11mm length). Low-profile screw head design. Non-sterile, intended for end-user sterilization. MR Conditional.

Indications for Use

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) with erupted permanent teeth. Contraindicated in patients with mental/neurological conditions preventing post-op care, limited blood supply, insufficient bone quantity/quality, foreign body sensitivity, severely comminuted/unstable fractures, active/latent infection, or risk of damage to un-erupted permanent teeth.

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

• Biomet Microfixation OmniMax MMF System (K152326)

Submission Summary (Full Text)

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

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.

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 Microfixation<br>1520 Tradeport Drive<br>Jacksonville, FL 32218 USA |
|------------|----------------------------------------------------------------------------|
| Contact: | Lauren Jasper, Regulatory Affairs Ma |

nager [e-mail] Telephone: [phone]

Device Name: Biomet Microfixation OmniMax MMF System

Common or Usual Name: Bone Plate

Primary Classification Name: Bone Plate

#### Primary Device Classification:

| Product<br>Code | Device Name | Device<br>Classification | Regulation<br>Number | Regulation<br>Description |
|-----------------|-------------|--------------------------|----------------------|---------------------------|
| JEY | Bone Plate | 2 | 872.4760 | Bone Plate |

#### Secondary Device Classification:

| Product Code | Device Name | Device Classification | Regulation Number | Regulation Description |
|--------------|----------------------------------|-----------------------|-------------------|----------------------------------------|
| DZL | Screw, Fixation,<br>Intraosseous | 2 | 872.4880 | Intraosseous fixation<br>screw 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.
- 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.

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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.

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.

| | Subject Device:<br>Biomet Microfixation<br>OmniMax MMF System<br>(K202969) | Primary Predicate:<br>Biomet Microfixation OmniMax MMF System<br>(K152326) |
|---------------------------|----------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Principle of<br>Operation | No change from predicate<br>device | Metallic implants for the temporary stabilization<br>of mandibular and maxillary bone during fracture<br>healing and/or temporarily maintain a stable<br>occlusion during surgery<br><br>Mandibular and Maxillary Fixation (MMF) is<br>achieved through application of fixation plates and<br>locking screws to bone; wire or elastics are then<br>secured around hooks |
| Indications for<br>Use | No change from predicate<br>device | The Biomet Microfixation OmniMax MMF<br>System is indicated for temporary stabilization of<br>mandibular and maxillary fractures to maintain<br>proper occlusion during surgery and for post-<br>operative fracture healing in adults and<br>adolescents (age 12 and older) in whom permanent<br>teeth have erupted. |
| Components | No change from predicate<br>device | Fixation Plate (Arch Bar), Locking Screws |
| Plate Geometry | No change from predicate<br>device | Design: Plate with an in-plane bend and 12 slots to<br>accept screws and 12 hooks |
| Screw Geometry | No change from predicate<br>device | Design: Self-drilling screws<br>Diameter: 2.0mm<br>Length: minimum 7mm, maximum 11mm |
| Material | No change from predicate<br>device | Plates: Commercially Pure Titanium<br>Screws: Titanium Alloy, Ti-6Al-4V<br>Wires: Stainless Steel |

## Substantial Equivalence:

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| | Subject Device:<br>Biomet Microfixation<br>OmniMax MMF System<br>(K202969) | Primary Predicate:<br>Biomet Microfixation OmniMax MMF System<br>(K152326) |
|------------------|---------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|
| User cleaning | Add cleaning instructions for<br>the processing of reusable<br>instruments and<br>new/uncompromised implants. | Not evaluated |
| Sterility | No change from predicate<br>device | Non-sterile to be sterilized by the end user |
| MRI Safety | No change from predicate<br>device | MR Conditional |
| Biocompatibility | Update manufacturing process<br>flow and provide<br>biocompatibility assessment<br>of 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.