The ROMEO®2 PAD Posterior Axial Device is a posterior, non-pedicle supplemental fixation device, intended for use as an adjunct to fusion at a single level in the lumbar spine (L1-S1). It is intended for attachment to the spinous processes for the purpose of achieving stabilization as an adjunction to fusion in patients with 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) and /or tumor. The ROMEO®2 PAD Posterior Axial Device is not intended for standalone use.

Device Description

The ROMEO®2 PAD is a Spinous Process Fixation device consisting of two titanium plates linked by a titanium cylinder that is used to perform immobilization of spinous processes of adjacent vertebras and thus provide supplemental stabilization of spinal segments to facilitate fusion. The device is locked and secure automatically at the same time. The plates include spikes on their opposing faces to provide attachment to bone. The mobile plate can translate along the titanium cylinder and includes some features that insure continuous locking at any position. The locking anti-back-out system maintains the plates in the desired position and pressed firmly against the spinous processes. The ROMEO®2 PAD is available in a range of sizes to fit the anatomical needs of a variety of patients. Components are provided pre-assembled and delivered sterile (gamma sterilization) with dedicated surgical instruments (reusable – provided non sterile).

AI/ML Overview

I am sorry, but the provided text does not contain any information about acceptance criteria or a study that proves a device meets those criteria. The document is an FDA 510(k) clearance letter for a medical device called "ROMEO® 2 PAD Posterior Axial Device," which confirms its substantial equivalence to previously marketed devices. It outlines the device's indications for use, technological characteristics, and regulatory information, but it does not detail a study with specific acceptance criteria, sample sizes, ground truth establishment, or expert reviews.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 21, 2014

Spineart Mr. Franck Pennesi Director of Industry and Quality International Center Cointrin 20 route de pré-bois, CP 1813 1215 Geneva 15 – SWITZERLAND

Re: K141508

Trade/Device Name: ROMEO® 2 PAD Posterior Axial Device Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: PEK Dated: June 5, 2014 Received: June 6, 2014

Dear Mr. Pennesi:

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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Ronaldf�@Jean -S for

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K141508

Device Name

ROMEO®2 PAD Posterior Axial Device

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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FOR FDA USE ONLY

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Traditional 510k ROMEO®2 PAD Posterior Axial Device

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510(k) SUMMARY

Submitted by	SPINEARTInternational Center Cointrin20 route de pré-boisCP18131215 GENEVA 15SWITZERLAND
Contacts	Franck PENNESI Director of Industry & QualityPhone : +41 22 799 40 25 Fax : +41 22 799 40 26Mail : fpennesi@spineart.comRegulatory contact : Dr Isabelle DRUBAIX (Idée Consulting)idrubaix@nordnet.fr
Date Prepared	August 18th 2014
Common Name	Spinous Process Plate
Trade Name	ROMEO®2 PAD Posterior Axial Device
Classification Name	Spinal interlaminal fixation orthosis
Class	II
Product Code	PEK
CFR section	888.3050
Device panel	Orthopedic
Legally marketedpredicate devices	SP-Fix® by Globus Medical (K102195); Axle® System by X-Spine(K112592, K130438); Spinous Process Fusion Plate by Lanx(K071877, K092536); Affix® spinous Process Plate by NuVasive(K073278, K131238) and Spire® Spinous Process Plate by Medtronic(K032037).
Indications for use	The ROMEO®2 PAD Posterior Axial Device is a posterior, non-pediclesupplemental fixation device, intended for use as an adjunct to fusionat a single level in the lumbar spine (L1-S1). It is intended forattachment to the spinous processes for the purpose of achievingstabilization as an adjunction to fusion in patients with degenerativedisc disease - defined as back pain of discogenic origin withdegeneration of the disc confirmed by history and radiographicstudies, spondylolisthesis, trauma (i.e.,fracture or dislocation) and/or tumor. The ROMEO®2 PAD Posterior Axial Device is not intendedfor standalone use.

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Description of the device	The ROMEO®2 PAD is a Spinous Process Fixation device consisting oftwo titanium plates linked by a titanium cylinder that is used to
	perform immobilization of spinous processes of adjacent vertebrasand thus provide supplemental stabilization of spinal segments tofacilitate fusion. The device is locked and secure automatically at thesame time.
TechnologicalCharacteristics	The plates include spikes on their opposing faces to provideattachment to bone. The mobile plate can translate along thetitanium cylinder and includes some features that insure continuouslocking at any position. The locking anti-back-out systemmaintains the plates in the desired position and pressed firmlyagainst the spinous processes. The ROMEO®2 PAD is available in arange of sizes to fit the anatomical needs of a variety of patients.Components are provided pre-assembled and delivered sterile(gamma sterilization) with dedicated surgical instruments (reusable –provided non sterile).As was established in this submission, the subject ROMEO®2 PAD issubstantially equivalent to other predicate devices cleared by the FDAfor commercial distribution in the United States. The subject devicewas shown to be substantially equivalent and have equivalenttechnological characteristics to its predicate devices throughcomparison in areas including design, labeling/intended use, materialcomposition, mechanical performance and function.
	Discussion of Testing

Regulation Number and Section

§ 888.3050 Spinal interlaminal fixation orthosis.

(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.