The RibFix Advantage System consists of bridges (with locking posts) and locking caps for the thoracoscopic fixation and stabilization of ribs. These implants are manufactured from commercially pure titanium (per ASTM F67) and titanium alloys (Ti-6A1-7Nb per ASTM F1295 and Ti-6Al-4V per ASTM F136 or ASTM F1472). The system is comprised of the following implants:

. Titanium alloy RibFix Advantage Bridge with threaded locking posts
. Commercially pure titanium locking caps
. Commercially pure titanium washers (optional)
When fully assembled, the bridge is placed on the underside of the rib, the threaded locking posts extends through pre-drilled holes in the rib, and the locking caps are fixed to the locking post on the anterior side of the rib. Washers may be placed on the posts prior to assembling with locking caps. The combined threaded locking post/locking cap provides for fixation of the bridge. The devices are sold non-sterile and intended to be sterilized by the user prior to implantation. The system also includes reusable instrumentation to aid in implantation of the devices.

AI/ML Overview

This document (K203474) describes a 510(k) premarket notification for the "Biomet Microfixation RibFix Advantage System." This system is for the fixation and fusion of rib fractures and osteotomies. The FDA determined the device is substantially equivalent to legally marketed predicate devices.

Acceptance Criteria and Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device (K183317, AdvantageRib System) and provides non-clinical performance data related to MR safety. It does not present acceptance criteria in the typical format of accuracy, sensitivity, or specificity commonly used for AI/software devices. Instead, the acceptance criteria are implicitly that the device performs equivalently or better than the predicate device in relevant non-clinical tests.

The document states: "Testing identified in this summary has all passed acceptance criteria established by the predicate device where applicable."

Here's a table based on the provided information, interpreting "acceptance criteria" as meeting the standards set for safe operation in an MRI environment:

Acceptance Criteria Category	Specific Standard/Requirement	Reported Device Performance
MR Safety	ASTM F2052-15: Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment	All testing passed
(implicitly, the device demonstrated acceptable displacement force as per the standard)
	ASTM F2213-17: Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment	All testing passed (implicitly, the device demonstrated acceptable torque as per the standard)
	ASTM F2182-11a: Measurement of Radio Frequency Induced Heating Near Passive Implants During Magnetic Resonance Imaging	All testing passed (implicitly, the device demonstrated acceptable RF induced heating as per the standard)
	ASTM F2119-07 (Reapproved 2013): Evaluation of MR Image Artifacts from Passive Implants	All testing passed (implicitly, the device demonstrated acceptable MR image artifacts as per the standard)
Functional Equivalence	The design, materials, sterilization method, and indications for use are identical between the subject device and the predicate device (K183317, AdvantageRib System).	The subject device maintains identical indications for use, design, materials, and sterilization methods compared to the predicate, with minor updates (package insert, labels, cleaning instructions, sterilization parameters, contraindications statement).
Predicated Performance	Device must be at least as safe and effective as the predicates.	The submission concludes that "the proposed device is at least as safe and effective as the predicates" based on the non-clinical data and similarities.

Study Details:

Sample sizes used for the test set and the data provenance:
- The document primarily refers to non-clinical testing on the device itself for MR safety. It does not describe a clinical study or a test set of patient data.
- For the MR safety evaluations, the "sample" would refer to the physical devices tested. The document does not specify the number of devices or components tested, but implies that a sufficient number were tested to satisfy the ASTM standards.
- Data provenance: Not applicable in the context of clinical data. The non-clinical tests were conducted in a lab setting.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is a non-clinical device clearance. Ground truth is established by the accepted ASTM standards for MR compatibility, which are developed by expert committees in their respective fields (e.g., engineers, physicists, medical professionals specializing in MRI safety).
Adjudication method for the test set:
- Not applicable. The adjudication method relates to resolving disagreements among human reviewers on ground truth, which is not relevant for non-clinical engineering tests.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is a physical medical device (implants for rib fixation), not an AI/software device. Hence, an MRMC study is not relevant, and there's no "human readers improve with AI" component.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This is a physical medical device. Not applicable to standalone algorithm performance.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for demonstrating device safety and equivalence is based on established engineering standards (ASTM) for material properties, mechanical performance, and MR compatibility. For substantial equivalence, it's also based on the established safety and efficacy profile of the predicate device.
The sample size for the training set:
- Not applicable. This is not an AI/machine learning device requiring a training set.
How the ground truth for the training set was established:
- Not applicable.

Summary

{0}------------------------------------------------

January 28, 2021

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Biomet Micofixation Lauren Jasper Regulatory Affairs Manager 1520 Tradeport Drive Jacksonville, Florida 32218

Re: K203474

Trade/Device Name: Biomet Microfixation RibFix Advantage 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. HTN Dated: November 24, 2020 Received: November 25, 2020

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.

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

{1}------------------------------------------------

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, MPH 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) K203474

Device Name Biomet MicrofixationR ibFix Advantage System

Indications for Use (Describe)

TheR ibFix Advantage System is indicated for the fixation, and fusion of rib fractures and osteotomies of normal and osteoporotic bone.

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.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for BIOMET Microfixation. The word "BIOMET" is in large, bold, dark gray letters on the top line. Below that, in smaller, lighter gray letters, is the word "MICROFIXATION". A thin, light green line is below the word "MICROFIXATION". The words "One Surgeon. One Patient" are below the green line in a smaller font.

510(k) Summary

Prepared January 28, 2021

Submitter:	Biomet Microfixation1520 Tradeport DriveJacksonville, FL 32218
Contact:	Lauren Jasper, Regulatory Affairs Managerlauren.jasper@zimmerbiomet.comTelephone: (904) 741-9259

Device Name: Biomet Microfixation RibFix Advantage System

	Device Classification:
--	------------------------

Product Code	Classification Name	DeviceClassification	RegulationNumber	Regulation Description
HRS (Primary)	Plate,Fixation,Bone	2	888.3030	Single/multiple componentmetallic bone fixationappliances and accessories
HWC	Screw,Fixation,Bone	2	888.3040	Smooth or threaded metallicbone fixation fastener
HTN	Washer, BoltNut	2	888.3030	Single/multiple componentmetallic bone fixationappliances and accessories.

Indications for Use: The RibFix Advantage System is indicated for the fixation, stabilization, and fusion of rib fractures and osteotomies of normal and osteoporotic bone.

Contraindications: The RibFix Advantage system is contraindicated for:

Use in patients with latent or active infection, sepsis, and/or device material sensitivity. 1.
1. Use in patients who are unwilling or incapable of following postoperative care instructions.
1. This device is not intended for locking post attachment or fixation to the clavicle or spine.
1. This device is not intended for highly comminuted fractures.

Device Description: The RibFix Advantage System consists of bridges (with locking posts) and locking caps for the thoracoscopic fixation and stabilization of ribs. These implants are manufactured from commercially pure titanium (per ASTM F67) and titanium alloys (Ti-6A1-7Nb

{4}------------------------------------------------

per ASTM F1295 and Ti-6Al-4V per ASTM F136 or ASTM F1472). The system is comprised of the following implants:

. Titanium alloy RibFix Advantage Bridge with threaded locking posts
. Commercially pure titanium locking caps
. Commercially pure titanium washers (optional)

When fully assembled, the bridge is placed on the underside of the rib, the threaded locking posts extends through pre-drilled holes in the rib, and the locking caps are fixed to the locking post on the anterior side of the rib. Washers may be placed on the posts prior to assembling with locking caps. The combined threaded locking post/locking cap provides for fixation of the bridge. The devices are sold non-sterile and intended to be sterilized by the user prior to implantation. The system also includes reusable instrumentation to aid in implantation of the devices.

The design, materials, sterilization method, and indications for use are identical between the subject device and the predicate device.

Substantial Equivalence:

Primary Predicate Device: K183317, AdvantageRib System

The similarities of the subject devices to the predicate devices are as follows:

. The indications for use 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 package insert to include MR conditional parameters and symbol
Update outer package label to include MR conditional symbol
Update cleaning instructions for the processing of reusable instruments and . new/uncompromised implants.
. Add additional sterilization parameters applicable for other geographic locations.
Revise the contraindications statement.

Additional Reference Devices:

K162974. Biomet Microfixation RibFix Blu Thoracic Fixation System K163007, Biomet Microfixation SternaLock 360 Sternal Closure Fixation System

The similarities of the subject devices to these predicate devices are as follows:

. The cleaning and sterilization instructions provided in the package insert are identical.

{5}------------------------------------------------

Non-Clinical Performance Data: The following nonclinical tests were submitted and relied on in this premarket notification submission for a determination of substantial equivalence. Testing identified in this summary has all passed acceptance criteria established by the predicate device where applicable.

MR Safety Evaluation following standards listed below:

ASTM F2052-15, "Standard Test Method for Measurement of Magnetically Induced ● Displacement Force on Medical Devices in the Magnetic Resonance Environment"
ASTM F2213-17, "Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment"
ASTM F2182-11a, "Standard Test Method for Measurement of Radio Frequency Induced Heating Near Passive Implants During Magnetic Resonance Imaging"
ASTM F2119-07 (Reapproved 2013), "Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants"

Clinical Performance Data: Clinical testing was not necessary for the determination of substantial equivalence.

Sterilization Information: There have been no changes to the sterilization method. The implants and instruments are provided non-sterile to be sterilized by steam at the end user facility.

Conclusion: The proposed device has identical 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 efficacy 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.

Regulation Number and Section

§ 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.