(258 days)
Not Found
No
The device description and performance studies focus on mechanical fixation and material properties, with no mention of AI/ML algorithms or data processing.
No
The device is described as an implantable system for stabilizing fractures, promoting fusion, and providing fixation of the anterior chest wall. While it aids in the healing process, it does not actively treat a disease or condition in a therapeutic sense; instead, it provides structural support.
No
Explanation: The device is a surgical fixation system used for stabilizing fractures, not for diagnosing medical conditions. Its purpose is to promote fusion after reconstructive procedures.
No
The device description explicitly states it is composed of metallic locking bone plates 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 clearly states the device is for the "stabilization of fractures of the anterior chest wall including sternal fixation following sternal reconstructive surgical procedures, to promote fusion." This describes a surgical implant used in vivo (within the body) for structural support and healing.
- Device Description: The description details "metallic locking bone plates and locking screws" made of titanium. These are physical implants, not reagents, instruments, or systems used to examine specimens in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens taken from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Biomet Microfixation SternaLock® System is intended for use in the stabilization of fractures of the anterior chest wall including sternal fixation following sternal reconstructive surgical procedures, to promote fusion. The Biomet Microfixation SternaLock® System is intended for use in patients with normal and poor bone quality.
Product codes
HRS
Device Description
The Biomet Microfixation SternaLock® System is composed of metallic locking bone plates and locking screws that provide stabilization and fixation of fractures of the anterior chest wall including sternal fixation following sternotomy and sternal reconstructive surgical procedures, to promote fusion. These implants are available in multiple sizes and manufactured from Commercially Pure Titanium and Titanium Alloy (Ti-6Al-4V).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior chest wall, sternal
Indicated Patient Age Range
Not Found
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: The following non-clinical testing has been performed and met all established acceptance criteria:
- Magnetic Resonance Testing per ASTM F2182-11
Clinical Performance Data: Clinical testing was not necessary for the determination of substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
May 17, 2022
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Biomet Microfixation % Christine Scifert Principal Consultant MRC Global, LLC 9085 E Mineral Circle, Suite 110 Centennial, Colorado 80112
Re: K212782
Trade/Device Name: Biomet Microfixation SternaLock® System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS Dated: August 31, 2021 Received: September 1, 2021
Dear Christine Scifert:
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.
Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K212782
Device Name Biomet Microfixation SternaLock® System
Indications for Use (Describe)
The Biomet Microfixation SternaLock® System is intended for use in the stabilization of fractures of the anterior chest wall including sternal fixation following sternal reconstructive surgical procedures, to promote fusion. The Biomet Microfixation SternaLock® System is intended for use in patients with normal and poor bone quality.
| 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) |
|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
Biomet Microfixation SternaLock® System
May 16, 2022
| Company: | Biomet Microfixation
1520 Tradeport Drive
Jacksonville, FL 32218 |
|--------------------|--------------------------------------------------------------------------------|
| Primary Contact: | Christine Scifert
Christine.Scifert@askmrcglobal.com
Phone: 901-831-8053 |
| Company Contact: | Mark Wladkowski
mark.wladkowski@zimmerbiomet.com
Phone: (904) 362-3940 |
| Trade Name: | Biomet Microfixation SternaLock® System |
| Common Name: | Bone Plate |
| Classification: | Class II |
| Regulation Number: | 21 CFR 888.3030 |
| Panel: | 87- Orthopedic |
| Product Code: | HRS |
Device Description:
The Biomet Microfixation SternaLock® System is composed of metallic locking bone plates and locking screws that provide stabilization and fixation of fractures of the anterior chest wall including sternal fixation following sternotomy and sternal reconstructive surgical procedures, to promote fusion. These implants are available in multiple sizes and manufactured from Commercially Pure Titanium and Titanium Alloy (Ti-6Al-4V).
Indications for Use:
The Biomet Microfixation SternaLock® System is intended for use in the stabilization and fixation of fractures of the anterior chest wall including sternal fixation following sternotomy and sternal reconstructive surgical procedures, to promote fusion. The Biomet Microfixation SternaLock® System is intended for use in patients with normal and poor bone quality.
4
Predicate Device:
K161896, Biomet Microfixation Sternal Closure System
The similarities of the subject devices to the predicate devices are as follows:
- The design of the subject devices is equivalent to the predicate device. ●
- The indications and contraindications of the subject device are identical to the predicate ● device.
- . The sterilization method (steam sterilization) of the subject devices is identical to the predicate devices.
- The materials of the subject devices are identical to the predicate devices. ●
The differences of the subject devices as compared to the predicate devices are as follows:
- Update package insert to include MR conditional parameters and symbol. .
- . Update outer package label to include MR conditional symbol.
- Minor updates to the package insert content not related to product indications. ●
Non-Clinical Performance Data: The following non-clinical testing has been performed and met all established acceptance criteria:
- Magnetic Resonance Testing per ASTM F2182-11
Clinical Performance Data: Clinical testing was not necessary for the determination of substantial equivalence.
Sterilization Information: There have been no changes to the sterilization. The implants and instruments are provided non-sterile to be sterilized by steam at the end user facility.
Substantial Equivalence: The proposed device has similar indications for use as the predicate devices. The submission demonstrates that (1) any differences in technological characteristics of the predicates do not raise any new questions of safety and (2) the proposed device is at least as safe and effective as the predicates. It is concluded that the information included in this summary supports substantial equivalence.