(132 days)
No
The device description and performance studies focus on mechanical properties and surgical application of metallic plates and screws, with no mention of AI or ML.
Yes.
The device is used for temporary stabilization and fracture healing, which falls under the definition of therapy.
No
Explanation: The device is used for temporary stabilization of fractures and maintaining occlusion, which are therapeutic functions, not diagnostic ones.
No
The device description explicitly states it is composed of metallic plates and locking screws, which are hardware components. The performance studies also focus on the mechanical properties of these hardware components.
Based on the provided information, the Biomet Microfixation OmniMax MMF System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Biomet Microfixation OmniMax MMF System is a surgical device used for the temporary stabilization of bone fractures in the jaw. It is applied directly to the patient's bone.
- Lack of Biological Sample Analysis: The description does not mention any analysis of biological samples. The device's function is mechanical fixation.
Therefore, the device falls under the category of a surgical implant or fixation device, not an in vitro diagnostic.
N/A
Intended Use / 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.
Product codes
JEY, DZL
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 arch bar plate is manufactured from Commercially Pure Titanium; and the locking screws are manufactured from Titanium Alloy (Ti-6Al-4V).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mandibular and maxillary fractures
maxilla and mandible
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
Non-Clinical Performance Data: All non-clinical performance testing passed according to the acceptance criteria. Testing was conducted as follows:
- . Screw - Insertion/Fracture Torque, Bending/Shear, Push-Through
- Plate and Screw Construct Static and Fatigue Testing .
- Simulated Use Cadaver Lab .
Clinical Performance Data: Clinical testing was not necessary for the determination of substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are rendered in a dark color, creating a sense of depth and unity. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 1, 2015
Biomet Microfixation Ms. Lauren Jasper Senior Regulatory Affairs Specialist 1520 Tradeport Drive Jacksonville, Florida 32218
Re: K143336
Trade/Device Name: Biomet Microfixation OmniMax MMF System Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY. DZL Dated: February 27, 2015 Received: March 2, 2015
Dear Ms. 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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tina
Kiang -S
for Erin I. Keith, M.S. Division 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): K143336
Device Name: Biomet Microfixation OmniMax MMF System
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.
Prescription Use xx (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
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Image /page/3/Picture/0 description: The image shows the text 'K143336' in a bold, sans-serif font. The text is black and appears to be on a white background. The characters are evenly spaced and easily readable.
Image /page/3/Picture/1 description: The image shows the logo for Biomet Microfixation. The word "BIOMET" is in large, bold, dark gray letters. Below that, the word "MICROFIXATION" is in smaller, lighter gray letters. There is a thin green line below the word "MICROFIXATION."
One Surgeon. One Patient.
510(k) Summary
Prepared April 1, 2015
| Submitter: | Biomet Microfixation
1520 Tradeport Drive
Jacksonville, FL 32218 |
|------------|---------------------------------------------------------------------------------|
| Contact: | Lauren Jasper, Senior Regulatory Affairs Specialist
lauren.jasper@biomet.com |
| | Telephone: (904) 741-9259
Fax: (904) 741-9425 |
Device Name: Biomet Microfixation OmniMax MMF System
Device Classification:
| Product Code | Device Name | Device
Classification | Regulation
Number | Regulation
Description |
|--------------|----------------------------------|--------------------------|----------------------|----------------------------------------|
| JEY | Plate, Bone | 2 | 872.4760 | Bone Plate |
| 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: 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.
The Biomet Microfixation OmniMax MMF System is composed of Device Description: 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 arch bar
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plate is manufactured from Commercially Pure Titanium; and the locking screws are manufactured from Titanium Alloy (Ti-6Al-4V).
Predicate Devices:
Primary: K061271, KLS Erich Arch Bar Secondary: K122313, Stryker Universal SMARTLock Hybrid MMF System K040983, Lorenz Self-Drilling IMF Screw
Similarities to Predicate Devices: The predicate and subject devices are metallic implants intended to be used for the temporary stabilization of mandibular and maxillary bone during fracture healing and/or temporarily maintain a stable occlusion during surgery. The subject device combines the technology of the primary predicate (arch bar) with that of reference predicates (bone screws). Primary predicate and subject device consist of an arch bar plate used to achieve MMF when secured by wires or elastics. Subject device is also similar to reference predicate Lorenz Self-Drilling IMF screws by incorporating a screw design with the same thread geometry, material, and similar lengths.
The indications for use and intended use of the subject device and all predicates are similar.
Subject and predicate devices are similar in dimensions; arch bars and plates may be cut to length as needed by patient anatomy. Screw diameters and lengths are similar and the proposed screws do not fall outside of the dimensions set by predicate devices.
Differences to Predicate Devices: The subject device has design differences from the predicate devices which are intended to eliminate the need for interdental wiring of the arch bar for fixation, help approximate the bar in an anatomic position and provide greater screw placement options. The subject device includes an arch bar manufactured from Commercially Pure Titanium and screws manufactured from Titanium Alloy (Ti-6Al-4V). The KLS Erich Arch Bar is manufactured from Stainless Steel.
Non-Clinical Performance Data: All non-clinical performance testing passed according to the acceptance criteria. Testing was conducted as follows:
- . Screw - Insertion/Fracture Torque, Bending/Shear, Push-Through
- Plate and Screw Construct Static and Fatigue Testing .
- Simulated Use Cadaver Lab .
Clinical Performance Data: Clinical testing was not necessary for the determination of substantial equivalence.
Sterilization Information: The implants are provided non-sterile to be sterilized by the end user.
Substantial Equivalence: The predicate and subject devices are metallic implants for the temporary stabilization of mandibular and maxillary bone during fracture healing and/or
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temporarily maintain a stable occlusion during surgery. The primary predicate device achieves fixation through the use of an arch bar that is wired to the teeth (interdental wiring). The subject device achieves fixation through the use of an arch bar that is fixated with bone-borne screws.
The indications are considered substantially equivalent because both devices are intended to be used in MMF procedures. The principles of operation are also considered substantially equivalent because both systems include an arch bar as the main component used to achieve MMF closure. This arch bar, in both designs, has hooks spaced across the length of the bar; wires or elastics are wrapped around the hooks of the mandible and maxilla bars to bring the jaws into proper occlusion and maintain this placement until healing has occurred.
The subject device includes an arch bar manufactured from Commercially Pure Titanium and screws manufactured from Titanium Alloy (Ti-6Al-4V). The KLS Erich Arch Bar is manufactured from Stainless Steel. This is substantially equivalent as all materials are standard metals and alloys appropriate for use in dental applications. The materials used in the subject device are identical to those used in reference predicates, where information is known.
The Biomet Microfixation OmniMax MMF System utilizes similar principles of operation of the predicate devices. It has nearly identical intended use, indications for use, material, and technological characteristics similar to the legally marketed predicate devices. It is concluded that the information included in this summary supports substantial equivalence.
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| | Subject Device:
Biomet Microfixation
OmniMax MMF System | Primary Predicate:
KLS Erich Arch Bar
(K061271) | Reference Predicate:
Stryker Universal
SMARTLock Hybrid MMF | Reference Predicate:
Lorenz Self-Drilling IMF
Screw (K040983) |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | System (K122313) | |
| Principle of
Operation | Metallic implants for the
temporary stabilization of
mandibular and maxillary
bone during fracture healing
and/or temporarily maintain a
stable occlusion during
surgery | Metallic implants for the
temporary stabilization of
mandibular and maxillary
bone during fracture healing
and/or temporarily maintain a
stable occlusion during
surgery | Metallic implants for the
temporary stabilization of
mandibular and maxillary
bone during fracture healing
and/or temporarily maintain a
stable occlusion during
surgery | 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 | Mandibular and Maxillary
Fixation (MMF) is achieved
through application of arch
bars wired to the teeth with
ligature wire; wire or elastics
are then secured around hooks | 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 | Intermaxillary Fixation
(IMF) is achieved through
application of screws to
bone; wire or elastics are
secured through relief
grooves or holes in the
screws |
| 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. | The Erich Arch Bar is
indicated for use in
intermaxillary and maxilla-
mandibular fixation. | 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 Lorenz IMF screw is
intended for use as a bone
screw in temporary fixation
of the maxilla and
mandible, providing
indirect stabilization of
fractures of the maxilla
and/or the mandible. |
| Components | Fixation Plate (Arch Bar),
Locking Screws | Arch Bar | Fixation Plate (Arch Bar),
Locking Screws | IMF Screws |
| | Subject Device:
Biomet Microfixation
OmniMax MMF System | Primary Predicate:
KLS Erich Arch Bar
(K061271) | Reference Predicate:
Stryker Universal
SMARTLock Hybrid MMF
System (K122313) | Reference Predicate:
Lorenz Self-Drilling IMF
Screw (K040983) |
| Plate
Geometry | Design: Plate with an in-plane
bend and 12 slots to accept
screws and 12 hooks | Design: Arch Bar sold a bulk
length of material that is cut to
the length necessary for the
patient anatomy; hooks are
spaced over the entire length | Design: Straight plate with 9
holes to accept screws and 17
hooks | Not Applicable |
| Screw
Geometry | Design: Self-drilling screws
Diameter: 2.0mm
Length: minimum 7mm,
maximum 11mm | Not Applicable | Design: Self-drilling screws
Diameter: 2.0mm
Length: minimum 6mm,
maximum 8mm | Design: Self-drilling screws
Diameter: 2.0mm
Length: minimum 5mm,
maximum 11mm |
| Material | Plates: Commercially Pure
Titanium
Screws: Titanium Alloy, Ti-
6Al-4V | Stainless Steel | Plates: Commercially Pure
Titanium
Screws: Titanium Alloy | Titanium Alloy,
Ti-6Al-4V |
| Sterility | Non-sterile to be sterilized by
the end user | Non-sterile to be sterilized by
the end user | Non-sterile to be sterilized by
the end user | Non-sterile to be sterilized
by the end user |
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