ROMEO 2 PAD POSTERIOR AXIAL DEVICE

K141508 · Spineart · PEK · Aug 21, 2014 · Orthopedic

Device Facts

• Record ID: K141508
• Device Name: ROMEO 2 PAD POSTERIOR AXIAL DEVICE
• Applicant: Spineart
• Product Code: PEK · Orthopedic
• Decision Date: Aug 21, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

ROMEO®2 PAD is a spinous process fixation device; consists of two titanium plates linked by a titanium cylinder. Implanted in lumbar spine (L1-S1) by surgeons to immobilize adjacent spinous processes; provides supplemental stabilization to facilitate fusion. Plates feature spikes for bone attachment; mobile plate translates along cylinder to accommodate anatomy. Integrated locking anti-back-out system secures plates against spinous processes. Device is non-standalone; used as adjunct to fusion. Benefits patient by providing stabilization in degenerative disc disease, spondylolisthesis, trauma, or tumor cases.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Titanium construction. Spinous process fixation via two plates and a connecting cylinder. Plates include spikes for bone attachment. Features a mobile plate with a locking anti-back-out system. Available in multiple sizes. Provided sterile via gamma sterilization; surgical instruments are reusable and provided non-sterile.

Indications for Use

Indicated for patients requiring supplemental fixation as an adjunct to single-level lumbar (L1-S1) fusion. Patient population includes those with degenerative disc disease (discogenic back pain confirmed by history/radiography), spondylolisthesis, trauma (fracture/dislocation), or tumor. Not for standalone use.

Regulatory Classification

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.

Predicate 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)
• Spire® Spinous Process Plate by Medtronic (K032037)

Submission Summary (Full Text)

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

Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them. The profiles are stacked slightly on top of each other, creating a sense of depth.

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

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

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 [phone] or [phone] 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 [phone] or [phone] 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

{2}------------------------------------------------

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)

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.

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)

#### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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."

FORM FDA 3881 (1/14)

PSC Publishing Services [phone] EF

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

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

Traditional 510k ROMEO®2 PAD Posterior Axial Device

Image /page/3/Picture/1 description: The image shows the logo for Spineart. The logo consists of the word "spineart" in a stylized font, with a butterfly above the text. The first part of the word, "spin", is in black, while the "ea" is in purple.

## 510(k) SUMMARY

| Submitted by | SPINEART<br>International Center Cointrin<br>20 route de pré-bois<br>CP1813<br>1215 GENEVA 15<br>SWITZERLAND |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contacts | Franck PENNESI Director of Industry & Quality<br>Phone : [phone] Fax : [phone]<br>Mail : [e-mail]<br>Regulatory contact : Dr Isabelle DRUBAIX (Idée Consulting)<br>[e-mail] |
| 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 marketed<br>predicate devices | SP-Fix® by Globus Medical (K102195); Axle® System by X-Spine<br>(K112592, K130438); Spinous Process Fusion Plate by Lanx<br>(K071877, K092536); Affix® spinous Process Plate by NuVasive<br>(K073278, K131238) and Spire® Spinous Process Plate by Medtronic<br>(K032037). |
| Indications for use | The ROMEO®2 PAD Posterior Axial Device is a posterior, non-pedicle<br>supplemental fixation device, intended for use as an adjunct to fusion<br>at a single level in the lumbar spine (L1-S1). It is intended for<br>attachment to the spinous processes for the purpose of achieving<br>stabilization as an adjunction to fusion in patients with degenerative<br>disc disease - defined as back pain of discogenic origin with<br>degeneration of the disc confirmed by history and radiographic<br>studies, spondylolisthesis, trauma (i.e.,fracture or dislocation) and<br>/or tumor. The ROMEO®2 PAD Posterior Axial Device is not intended<br>for standalone use. |

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

| Description of the device | The ROMEO®2 PAD is a Spinous Process Fixation device consisting of<br>two titanium plates linked by a titanium cylinder that is used to |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | perform immobilization of spinous processes of adjacent vertebras<br>and thus provide supplemental stabilization of spinal segments to<br>facilitate fusion. The device is locked and secure automatically at the<br>same time. |
| Technological<br>Characteristics | The plates include spikes on their opposing faces to provide<br>attachment to bone. The mobile plate can translate along the<br>titanium cylinder and includes some features that insure continuous<br>locking at any position. The locking anti-back-out system<br>maintains the plates in the desired position and pressed firmly<br>against the spinous processes. The ROMEO®2 PAD is available in a<br>range of sizes to fit the anatomical needs of a variety of patients.<br>Components are provided pre-assembled and delivered sterile<br>(gamma sterilization) with dedicated surgical instruments (reusable –<br>provided non sterile).<br>As was established in this submission, the subject ROMEO®2 PAD is<br>substantially equivalent to other predicate devices cleared by the FDA<br>for commercial distribution in the United States. The subject device<br>was shown to be substantially equivalent and have equivalent<br>technological characteristics to its predicate devices through<br>comparison in areas including design, labeling/intended use, material<br>composition, mechanical performance and function. |
| | Discussion of Testing |