(309 days)
Not Found
No
The device description focuses on mechanical components (plates, screws, wires, elastics) for bone fixation and occlusion maintenance. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
Yes.
The device maintains proper occlusion during surgery and for post-operative fracture healing, which constitutes a therapeutic function.
No
The device is described as a system of metallic plates and screws used for temporary stabilization and fixation of mandibular and maxillary bones during fracture healing or surgery, not for diagnostic purposes.
No
The device description explicitly states it is composed of metallic plates (arch bars) and locking screws, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide temporary stabilization of mandibular and maxillary bone during fracture healing and/or temporarily maintain a stable occlusion during surgery. This is a surgical device used to physically fix bones.
- Device Description: The device is composed of metallic plates and locking screws that are applied to bone. This is consistent with a surgical implant/fixation device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
Therefore, the Biomet Microfixation OmniMax MMF System falls under the category of a surgical device for bone fixation, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
JEY, DZL
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mandibular and maxillary fractures
Indicated Patient Age Range
adults and adolescents (age 12 and older) in whom permanent teeth have erupted.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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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.
1
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
2
Indications for Use
510(k) Number (if known)
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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3
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
1520 Tradeport Drive
Jacksonville, 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:
| Product
Code | Device Name | Device
Classification | Regulation
Number | Regulation
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, | |||
| Intraosseous | 2 | 872.4880 | Intraosseous fixation | |
| 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:
-
- Patients with mental or neurological conditions who are unwilling or incapable of following postoperative care instructions.
-
- Patients with limited blood supply, insufficient quantity or quality of bone.
-
- Foreign body sensitivity. Where material sensitivity is suspected, testing is to be completed prior to implantation.
-
- Severely comminuted fractures or unstable fractures
-
- Active or latent infection
-
- Patients in whom damage to un-erupted permanent teeth is anticipated.
4
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:
Biomet Microfixation
OmniMax MMF System
(K202969) | Primary Predicate:
Biomet Microfixation OmniMax MMF System
(K152326) |
|---------------------------|----------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Principle of
Operation | No change from predicate
device | Metallic implants for the 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 |
| Indications for
Use | No change from predicate
device | 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. |
| Components | No change from predicate
device | Fixation Plate (Arch Bar), Locking Screws |
| Plate Geometry | No change from predicate
device | Design: Plate with an in-plane bend and 12 slots to
accept screws and 12 hooks |
| Screw Geometry | No change from predicate
device | Design: Self-drilling screws
Diameter: 2.0mm
Length: minimum 7mm, maximum 11mm |
| Material | No change from predicate
device | Plates: Commercially Pure Titanium
Screws: Titanium Alloy, Ti-6Al-4V
Wires: Stainless Steel |
Substantial Equivalence:
5
| | Subject Device:
Biomet Microfixation
OmniMax MMF System
(K202969) | Primary Predicate:
Biomet Microfixation OmniMax MMF System
(K152326) |
|------------------|---------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|
| User cleaning | Add cleaning instructions for
the processing of reusable
instruments and
new/uncompromised implants. | Not evaluated |
| Sterility | No change from predicate
device | Non-sterile to be sterilized by the end user |
| MRI Safety | No change from predicate
device | MR Conditional |
| Biocompatibility | Update manufacturing process
flow and provide
biocompatibility assessment
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.