ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM

K093170 · Spineart · MNI · Nov 4, 2009 · Orthopedic

Device Facts

• Record ID: K093170
• Device Name: ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
• Applicant: Spineart
• Product Code: MNI · Orthopedic
• Decision Date: Nov 4, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

ROMEO posterior osteosynthesis system is 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; spinal tumor; and failed previous fusion (pseudarthrosis).

Device Story

ROMEO posterior osteosynthesis system is a spinal fixation implant set; includes pedicular screws, spondylolisthesis screws, longitudinal rods, transverse connector rods, connectors, and nuts. Used by surgeons in clinical settings to provide immobilization and stabilization of spinal segments as an adjunct to fusion. Components are implanted during spinal surgery to treat instabilities or deformities. System provides mechanical support to the spine to facilitate fusion and patient recovery.

Clinical Evidence

Bench testing only. The device conforms to special controls for pedicle screw spinal systems and the FDA guidance document 'Spinal System 510(k)s - Guidance for Industry and FDA Staff Document' (May 3, 2004).

Technological Characteristics

Components manufactured from TA6V4ELI titanium alloy conforming to ISO 5832.3 and ASTM F 136. System includes pedicular screws, spondylolisthesis screws, longitudinal rods, transverse connectors, and nuts. Supplied sterile or non-sterile with surgical instrumentation.

Indications for Use

Indicated for skeletally mature patients requiring spinal immobilization and stabilization as an adjunct to fusion for thoracic, lumbar, and sacral spine conditions including severe spondylolisthesis (grades 3-4, L5-S1), degenerative spondylolisthesis with neurologic impairment, fracture, dislocation, scoliosis, spinal tumor, and pseudarthrosis.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• ELLIPSE posterior osteosynthesis system (K081165)

Submission Summary (Full Text)

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## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

As required by section 807.92(c)

| NOV - 4 | 2009 |
|---------|------|
|---------|------|

| Submitter | SPINEART<br>International Center Cointrin 20 route de pré-bois<br>CP1813<br>1215 GENEVA 15<br>SWITZERLAND |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contacts | Franck PENNESI Director of Industry & Quality<br>Phone : [phone]<br>Fax : [phone]<br>Mail : [e-mail]<br>Regulatory contact : Dr Isabelle DRUBAIX (Idée<br>Consulting) [e-mail] |
| Trade Name | ROMEO posterior osteosynthesis system |
| SPECIAL 510k | Modification to ELLIPSE posterior osteosynthesis<br>system |
| Classification Name | Pedicle screw spinal system |
| Class | II |
| Product Code | MNI orthosis, spinal pedicle fixation |
| Subsequent product codes | MNH orthosis, spondylolisthesis spinal fixation<br>KWP Spinal interlaminal fixation orthosis |
| CFR section | 888.3070 |
| Device panel | Orthopedic |
| Legally marketed predicate devices | ELLIPSE posterior osteosynthesis system<br>(K081165) manufactured by SPINEART |
| Description | ROMEO posterior osteosynthesis system includes pedicular screws, spondylolisthesis screws longitudinal rods and transverse connector rods, connector and nut.<br>All components of ROMEO posterior osteosynthesis system are made of TA6V4ELI conforming to ISO 5832.3 and ASTM F 136.<br>ROMEO components are supplied either sterile or not sterile and with a complete set of surgical instruments |
| Intended Use | ROMEO posterior osteosynthesis system is intended<br>to provide immobilization and stabilization of spinal<br>segments in skeletally mature patients as an<br>adjunct to fusion in the treatment of the following<br>acute and chronic instabilities or deformities of the<br>thoracic, lumbar, and sacral spine: severe<br>spondylolisthesis (grades 3 and 4) of the L5-S1<br>vertebra; degenerative spondylolisthesis with<br>objective evidence of neurologic impairment;<br>fracture; dislocation; scoliosis; kyphosis; spinal<br>tumor; and failed previous fusion (pseudarthrosis). |
| Performance data | ROMEO posterior osteosynthesis system conforms<br>to special control established for Pedicle screw<br>spinal system and to « Spinal System 510(k)s -<br>Guidance for Industry and FDA Staff Document »<br>issued on: May 3, 2004. |
| Substantial<br>equivalence | ROMEO posterior osteosynthesis system is<br>substantially equivalent to its predicate device in<br>terms of intended use, material, design, mechanical<br>properties and function. |

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Preparation date, September 30, 2009

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle or other bird-like figure.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Spineart % Mr. Franck Pennesi Director of Industry and Quality International Center Cointrin 20, route de Pre-Bois CP 1813 1215 Geneva 15 Switzerland

NOV - 4 2009

Re: K093170

Trade/Device Name: ROMEO posterior osteosynthesis system Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNI, MNH, KWP Dated: October 5, 2009 Received: October 7, 2009

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.

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

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Page 2 - Mr. Franck Pennesi

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. I

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Neil R.P. Gyle

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

Enclosure

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## INDICATIONS FOR USE

K-093190 510(k) Number (if known): __ Device Name: ROMEO posterior osteosynthesis system Indications for Use:

ROMEO posterior osteosynthesis system is 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; spinal tumor; and failed previous fusion (pseudarthrosis).

Prescription Use >| (Part 21 CFR 801 Subpart AND/OR D)

Over-The-Counter Use

(21 CFR 801 Subpart C)

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Concurrence of CDRH Office of Device Evaluation (ODE)

| (Division Sign-Off) |
|-----------------------------------------------------------|
| Division of Surgical. Orthopedic, and Restorative Devices |

| 510(k) Number | K093170 |
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