(248 days)
Not Found
No
The summary describes a system of metallic plates and screws for bone fixation and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as being used for "stabilization and fixation of fractures" and to "promote union," indicating its role in treating and healing a medical condition.
No
Explanation: The device is a surgical fixation system for stabilizing and fixing fractures in the chest wall. It is a treatment device, not a diagnostic one.
No
The device description explicitly states it is composed of metallic locking bone plates and screws, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The description clearly states the device is composed of "metallic locking bone plates and locking screws" used for "stabilization and fixation of fractures in the chest wall." This is a surgical implant, not a device that analyzes biological samples.
- Intended Use: The intended use is for "stabilization and fixation of fractures in the chest wall," which is a surgical procedure, not a diagnostic test performed on a sample.
The information provided describes a surgical implant used for treating physical injuries, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Biomet Microfixation RibFix Blu Thoracic Fixation System is in the stabilization and fixation of fractures in the chest wall including sternal reconstructive surgical procedures, trauma, rib fractures associated with flail chest, or planned osteotomies. The system may be used in normal and poor bone to promote union.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The Biomet Microfixation RibFix Blu Thoracic Fixation System is composed of metallic locking bone plates and locking screws that provide rigid fixation to fractures and osteotomies of the chest wall. 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
chest wall, sternal, rib
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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
- Physiologic Loading Thoracic Testing
- Thoracic Fatigue Testing
- Thoracic Failure Testing
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
§ 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.
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April 22, 2022
Image /page/0/Picture/1 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is 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: K212608
Trade/Device Name: Biomet Microfixation RibFix Blu Thoracic Fixation 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. HWC Dated: August 16, 2021 Received: August 17, 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.
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
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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: 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
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Indications for Use
510(k) Number (if known) K212608
Device Name
Biomet Microfixation RibFix Blu Thoracic Fixation System
Indications for Use (Describe)
The Biomet Microfixation RibFix Blu Thoracic Fixation System is in the stabilization and fixation of fractures in the chest wall including sternal reconstructive surgical procedures, trauma, rib fractures associated with flail chest, or planned osteotomies. The system may be used in normal and poor bone to promote union.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
Biomet Microfixation RibFix Blu Thoracic Fixation System April 22, 2022
| Company: | Biomet Microfixation
1520 Tradeport Drive
Jacksonville, FL 32218 |
|-------------------------------------------------|----------------------------------------------------------------------------------|
| Primary Contact: | Christine Scifert
Christine.scifert@askmrcglobal.com
Phone: (901) 831-8053 |
| Company Contact: | Lauren Jasper
lauren.jasper@zimmerbiomet.com
Phone: (904) 741-9259 |
| Trade Name: | Biomet Microfixation RibFix Blu Thoracic Fixation System |
| Common Name: | Bone Plate and Bone Screw |
| Classification: | Class II |
| Regulation Number: 21 CFR 888.3030 and 888.3040 | |
| Panel: | 87- Orthopedic |
| Product Code: | HRS and HWC |
Device Description:
The Biomet Microfixation RibFix Blu Thoracic Fixation System is composed of metallic locking bone plates and locking screws that provide rigid fixation to fractures and osteotomies of the chest wall. 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 RibFix Blu Thoracic Fixation System is indicated for use in the stabilization and fixation of fractures in the chest wall including sternal reconstructive surgical procedures, trauma, rib fractures associated with flail chest, or planned osteotomies. The system may be used in normal and poor bone to promote union.
Predicate Device:
K162974, Biomet Microfixation RibFix Blu Thoracic Fixation System The similarities of the subject devices to the predicate devices are as follows:
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- The contraindications are identical to that of the predicate device.
- . The design of the subject devices is equivalent to the predicate devices.
- 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 indications for use to include fixation of "rib fractures associated with flail chest."
- Update package insert to include MR conditional parameters and symbol. ●
- . Update outer package label to include MR conditional symbol.
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
- Physiologic Loading Thoracic Testing
- Thoracic Fatigue Testing ●
- . Thoracic Failure Testing
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.