The EUROPA™ Pedicle Screw System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.

The EUROPA™ Pedicle Screw System is intended for posterior, noncervical pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

Device Description

The EUROPA™ Pedicle Screw System is comprised of both Open and Minimally Invasive Surgery (MIS) polyaxial pedicle screw and rod components that are available in different sizes to accommodate various patient anatomical and physiological requirements.

The pedicle screws are manufactured from Ti-6Al-4V ELI alloy (ASTM F136). The rods are manufactured from Molybdenum-47.5Rhenium alloy (ASTM F3273) or cobalt chromium alloy (ASTM F1537).

The system also includes adjustable-length transverse rod cross connectors manufactured from Ti-6Al-4V ELI alloy (ASTM F136-13) that may be used in EUROPA™ systems with cobalt chromium rods where increased structural rigidity of the construct is needed.

The purpose of this 510(k) submission is to obtain market clearance for additional EUROPA™ Pedicle Screw System rod to rod connectors manufactured from Ti-6AI-4V ELI alloy (ASTM F136-13) which may be used to connect or extend constructs in an in-line or parallel fashion.

AI/ML Overview

This document, a 510(k) summary for the Europa Pedicle Screw System, describes a medical device, specifically a pedicle screw system for spinal fixation, and its substantial equivalence to previously marketed devices. It does not contain any information about an AI/ML powered device, acceptance criteria, or a study that proves the device meets acceptance criteria.

Therefore, I cannot fulfill your request as the provided text does not contain the necessary information regarding:

Acceptance criteria for an AI/ML device.
Reported device performance against such criteria.
Sample sizes for test or training sets.
Data provenance.
Expert involvement in ground truth establishment or adjudication.
MRMC studies or effect sizes.
Standalone algorithm performance.
Ground truth methodology.

The supplied text is a standard FDA 510(k) clearance letter and summary for a physical medical implant (pedicle screw system), focusing on its mechanical performance and substantial equivalence to predicates, not on AI/ML diagnostic or assistive technology.

Summary

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October 22, 2019

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MiRus, LLC Jordan Bauman Vice President, Regulatory Affairs 1755 West Oak Parkway, Suite 100 Marietta. Georgia 30062

Re: K192268

Trade/Device Name: Europa Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB Dated: September 3, 2019 Received: September 4, 2019

Dear Jordan Bauman:

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/cfpmp/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 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

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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

Ronald P. Jean, Ph.D. Director (Acting) DHT6B: Division of Spinal 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) K192268

Device Name EUROPA™ Pedicle Screw System

Indications for Use (Describe)

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

This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92(c).

I. SUBMITTER	MiRus™, LLC1755 West Oak ParkwaySuite 100Marietta, Georgia 30062Tel: (678)-324-6272Fax: (678) 401-5607
II. OFFICIAL CORRESPONDENT	Jordan BaumanVice President, Regulatory AffairsMiRus™, LLC1755 West Oak ParkwaySuite 100Marietta, Georgia 30062Tel: (678)-324-6272Fax: (678) 401-5607
III. DATE PREPARED	October 21, 2019
IV. DEVICEName of DeviceCommon NameClassification NameRegulatory ClassProduct CodesSubmission Type	EUROPA™ Pedicle Screw SystemThoracolumbosacral pedicle screw system21 CFR §888.3070Class IINKBTraditional 510(k)
V. PREDICATE DEVICE	EUROPA™ Pedicle Screw System (K180337,K182970, K191757) [Primary Predicate]

VI. DEVICE DESCRIPTION

The pedicle screws are manufactured from Ti-6Al-4V ELI alloy (ASTM F136). The rods are manufactured from Molybdenum-47.5Rhenium alloy (ASTM F3273) or cobalt chromium alloy (ASTM F1537).

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VII. INDICATIONS FOR USE

The EUROPA™ Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.

VIII. PREDICATE DEVICE COMPARISON

The purpose of this 510(k) submission is to obtain market clearance for additional EUROPA™ Pedicle Screw System rod to rod connectors. All other aspects of the subject device are identical to the predicate device.

IX. PERFORMANCE DATA

The following performance testing was completed in accordance with ASTM F1798:

Axial (z) Gripping Capacity (Axial Grip) ●
Axial Torque (Mz) Gripping Capacity (Torsional Grip) ●
. Flexion-Extension Moment (My)

The results demonstrate the performance of the EUROPA™ Pedicle Screw System with rod connectors are substantially equivalent to legally marketed devices.

X. CONCLUSION

The EUROPA™ Pedicle Screw System with rod to rod connectors is substantially equivalent to the predicate devices in intended use, indications for use, technological characteristics and labeling.

Regulation Number and Section

§ 888.3070 Thoracolumbosacral pedicle screw system.

(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.