ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM PREBENT CROSS-CONNECTORS; PREBENT RODS

K141835 · Spineart · MNI · Sep 10, 2014 · Orthopedic

Device Facts

• Record ID: K141835
• Device Name: ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM PREBENT CROSS-CONNECTORS; PREBENT RODS
• Applicant: Spineart
• Product Code: MNI · Orthopedic
• Decision Date: Sep 10, 2014
• 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 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-S V vertebra: degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). When used as a posterior, non-cervical, non-pedicle screw fixation system, ROMEO posterior osteosynthesis system is intended for the following indications: degenerative disc disease (DDD) (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, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion

Device Story

ROMEO® posterior osteosynthesis system is a spinal fixation construct used by surgeons in the OR to immobilize spinal segments. The system consists of polyaxial/monoaxial/spondylolisthesis screws, setscrews, cross connectors, and rods (Titanium or CoCr). The device is implanted to provide structural support and stabilization as an adjunct to spinal fusion. The surgeon selects components based on patient anatomy and pathology to construct a rigid posterior frame. The system helps restore spinal alignment and stability, potentially reducing pain and preventing further deformity in patients with spinal instability or disease.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

System components include polyaxial/monoaxial/spondylolisthesis screws, setscrews, cross connectors, and rods. Materials: Titanium alloy Ti6Al4V ELI (ISO 5832.3, ASTM F136) and Cobalt Chromium alloy CrCoMo (ISO 5832-12, ASTM F1537). Screws range 25-90mm length, 4.0-8.0mm diameter. Rods 5.4mm diameter. Sterilization: Gamma radiation.

Indications for Use

Indicated for skeletally mature patients requiring spinal immobilization/stabilization as an adjunct to fusion for thoracic, lumbar, and sacral spine conditions including severe spondylolisthesis (grades 3-4), degenerative spondylolisthesis with neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and pseudarthrosis. Also indicated for non-cervical, non-pedicle screw fixation for DDD, spinal stenosis, and lordosis.

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)
• Romeo® posterior osteosynthesis system (K101678)
• Romeo® posterior osteosynthesis system (K111127)
• Romeo® posterior osteosynthesis system (K130267)
• TSRH spinal system - CD horizon X10 Crosslink Plates (K032578)

Submission Summary (Full Text)

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

September 10, 2014

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

Re: K141835

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 Dated: August 12, 2014 Received: August 14, 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/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.

# Ronald DAean -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

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

#### 510(k) Number (if known)

K141835

#### Device Name

ROMEO® posterior osteosynthesis system

#### Indications for Use (Describe)

ROMEO® posterior osteosynthesis system is intended to provide immobilization 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-S V vertebra: degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

When used as a posterior, non-cervical, non-pedicle screw fixation system, ROMEO posterior osteosynthesis system is intended for the following indications: degenerative disc disease (DDD) (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, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion

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

> Prescription Use (Part 21 CFR 801 Subpart D)

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

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## 510(k) SUMMARY

### As required by section 807.92

| | SPINEART | | |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitted by | International Center Cointrin | | |
| | 20 route de pré-bois | | |
| | CP1813 | | |
| | 1215 GENEVA 15 | | |
| | SWITZERLAND | | |
| Contacts | Franck PENNESI Director of Industry & Quality | | |
| | Phone : [phone] Fax : [phone] | | |
| | Mail : [e-mail] | | |
| | Regulatory contact : Dr Isabelle DRUBAIX (Idée Consulting)<br>[e-mail] | | |
| Date Prepared | September 10th 2014 | | |
| Common Name | Pedicle screw spinal system | | |
| Trade Name | Romeo® posterior osteosynthesis system | | |
| Classification Name | Pedicle screw spinal system | | |
| Class | II | | |
| Product Code | MNH, MNI | | |
| CFR section | 888.3070 | | |
| Device panel | ORTHOPEDIC | | |
| Legally marketed<br>predicate devices | Ellipse posterior osteosynthesis system (K081165), Romeo®<br>posterior osteosynthesis system (K101678, K111127, K130267)<br>and TSRH spinal system - CD horizon X10 Crosslink Plates by<br>Medtronic Sofamor Danek, Inc (K032578) | | |
| | Indications for use | Romeo® posterior osteosynthesis system is intended to provide<br>immobilization and stabilization of spinal segments in skeletally<br>mature patients as an adjunct to fusion in the treatment of the<br>following acute and chronic instabilities or deformities of the<br>thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades<br>3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with<br>objective evidence of neurologic impairment; fracture; dislocation;<br>scoliosis; kyphosis; spinal tumor; and failed previous fusion<br>(pseudarthrosis).<br>When used as a posterior, non-cervical, non-pedicle screw fixation<br>system, Romeo® posterior osteosynthesis system is intended for<br>the following indications: degenerative disc disease (DDD) (defined<br>as back pain of discogenic origin with degeneration of the disc<br>confirmed by history and radiographic studies); spondylolisthesis;<br>trauma (i.e., fracture or dislocation); spinal stenosis; curvatures<br>(i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis;<br>and failed previous fusion | |
| | | Description of the device | The Romeo® posterior fixation system comprises polyaxial screws,<br>monoaxial screws, spondylolisthesis screws, setscrew, straight and<br>pre-bent Titanium or CoCr rods, and cross connectors. The Romeo®<br>Polyaxial Screws come in various lengths (from 25 to 90 mm) and<br>diameters (4.0, 4.5, 5.0, 5.5, 6.0, 7.0 and 8.0 mm) to<br>accommodate different patient anatomies. The modification to<br>Romeo® posterior osteosynthesis system consists of the addition of<br>a prebent cross connectors and prebent CoCr rods. |
| | | Technological<br>Characteristics | Prebent Romeo® Multiaxial Cross Connectors are posterior<br>transverse devices designed to fix the distance between the two<br>longitudinal rods and thus strengthen posterior construct performed<br>on the thoraco-lumbar spine. Prebent Romeo® Multiaxial Cross<br>Connectors are all made of Titanium alloy Ti6Al4V ELI conforming<br>to ISO 5832.3 and ASTM F136 and come in different sizes.<br>The Romeo® range of prebent rods (Ø 5.4 mm) made of cobalt<br>chromium alloy CrCoMo conforming to ISO 5832-12 and ASTM<br>F1537 has been extended with several lengths (from 200 to 550<br>mm).<br>Romeo® components are delivered sterile (gamma sterilization) in<br>a dedicated packaging or not sterile upon request. |
| Discussion of Testing | | Romeo® posterior osteosynthesis system conforms to special<br>control established for Pedicle screw spinal system and to « Spinal<br>System 510(k)s - Guidance for Industry and FDA Staff Document »<br>issued on: May 3, 2004. No additional testing has been performed<br>for the added prebent cross connectors and prebent CoCr rods. | |
| Conclusion | | The extended range of Romeo® posterior osteosynthesis system is<br>substantially equivalent to its predicate devices in terms of<br>intended use, material, design, mechanical properties and function.<br>Verification Activity and Validation Activity demonstrate that the<br>added prebent cross connectors and prebent CoCr rods are<br>substantially equivalent to previously cleared devices. | |

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