RibFix Blu Thoracic Fixation System

K212608 · Biomet Microfixation · HRS · Apr 22, 2022 · Orthopedic

Device Facts

• Record ID: K212608
• Device Name: RibFix Blu Thoracic Fixation System
• Applicant: Biomet Microfixation
• Product Code: HRS · Orthopedic
• Decision Date: Apr 22, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

System consists of metallic locking bone plates and locking screws; provides rigid fixation for chest wall fractures and osteotomies. Used in surgical settings by clinicians. Implants stabilize bone segments to promote union. Differences from predicate include updated indications for flail chest and addition of MR conditional labeling/parameters. No software or algorithmic components.

Clinical Evidence

No clinical data; substantial equivalence determined via non-clinical performance testing including Magnetic Resonance Testing (ASTM F2182-11), physiologic loading, fatigue, and failure testing.

Technological Characteristics

Metallic locking bone plates and screws; materials: Commercially Pure Titanium and Titanium Alloy (Ti-6Al-4V). Steam sterilization. MR conditional.

Indications for Use

Indicated for stabilization and fixation of chest wall fractures, including sternal reconstruction, trauma, rib fractures associated with flail chest, or planned osteotomies. Suitable for use in normal and poor bone to promote union.

Regulatory Classification

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.

Predicate Devices

• Biomet Microfixation RibFix Blu Thoracic Fixation System (K162974)

Submission Summary (Full Text)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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### 510(k) Summary

## Biomet Microfixation RibFix Blu Thoracic Fixation System April 22, 2022

| Company: | Biomet Microfixation<br>1520 Tradeport Drive<br>Jacksonville, FL 32218 |
|-------------------------------------------------|----------------------------------------------------------------------------------|
| Primary Contact: | Christine Scifert<br>[e-mail]<br>Phone: [phone] |
| Company Contact: | Lauren Jasper<br>[e-mail]<br>Phone: [phone] |
| 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.