INTERPLATE C

K092070 · Rsb Spine, LLC · KWQ · Oct 6, 2009 · Orthopedic

Device Facts

• Record ID: K092070
• Device Name: INTERPLATE C
• Applicant: Rsb Spine, LLC
• Product Code: KWQ · Orthopedic
• Decision Date: Oct 6, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The InterPlate™ C is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion. One device is used per intervertebral space. It is intended for use at one level in the cervical spine, from C3 to T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is to be used in patients who have had six weeks of non-operative treatment. In addition, the InterPlate™ C is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system include degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), tumor, pseudarthrosis or failed previous fusion. WARNING: The InterPlate™ C is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

Device Story

InterPlate™ C is a spinal fixation system comprising titanium alloy (Ti-6Al-4V ELI) plates, bone screws, and screw covers. Used by surgeons in clinical settings to provide stabilization as an adjunct to cervical fusion or for intervertebral body fusion. Components are sized to match patient anatomy and graft material. Device is implanted via anterior approach to the cervical spine (C3-T1). Provides mechanical stabilization to facilitate fusion with autograft. Benefits include structural support for patients with degenerative disc disease, trauma, or deformity, potentially reducing pain and restoring spinal stability.

Clinical Evidence

No clinical data provided; substantial equivalence established via bench testing and comparison of technological characteristics.

Technological Characteristics

Constructed from titanium alloy (Ti-6Al-4V ELI) per ASTM F136. System includes plates, bone screws, and screw covers. Mechanical fixation device for cervical spine. No software or electronic components.

Indications for Use

Indicated for skeletally mature patients requiring intervertebral body fusion or anterior screw fixation in the cervical spine (C3-T1). Conditions include degenerative disc disease, spondylolisthesis, trauma (fractures/dislocations), spinal stenosis, deformity (kyphosis, lordosis, scoliosis), tumor, pseudarthrosis, or failed fusion. Contraindicated for posterior element (pedicle) fixation.

Regulatory Classification

Identification

A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.

Submission Summary (Full Text)

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## 8. 510(k) Summary

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| Sponsor: | RSB Spine, LLC<br>3030 Superior Ave., Suite 703<br>Cleveland, OH 44114<br>Phone: [phone]<br>Fax: [phone] | OCT - 6 2009 | |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|--|
| Contact Person: | James M. Moran, D. Eng.<br>Vice President of Engineering and Chief Technical Officer | | |
| Proposed Trade Name: | InterPlate™ C | | |
| Device Classification | Class II | | |
| Classification Name: | Appliance, fixation, spinal intervertebral body | | |
| Regulation: | 888.3060 | | |
| Device Product Code: | KWQ | | |
| Device Description: | The InterPlate™ C consists of plates, bone screws and screw covers in a<br>variety of sizes. Various plate sizes are available to accommodate individual<br>patient anatomy and graft material size. Screw covers are individually<br>matched to the plate size. The InterPlate™ C components are manufactured<br>from titanium alloy (Ti-6Al-4V ELI) as described by ASTM F136. | | |
| Intended Use: | The InterPlate™ C is indicated for intervertebral body fusion of the spine in<br>skeletally mature patients. The device system is designed for use with<br>autograft to facilitate fusion. One device is used per intervertebral space. It<br>is intended for use at one level in the cervical spine, from C3 to T1, for the<br>treatment of cervical disc disease (defined as neck pain of discogenic origin<br>with degeneration of the disc confirmed by history and radiographic<br>studies). The cervical device is to be used in patients who have had six<br>weeks of non-operative treatment.<br><br>In addition, the InterPlate™ C is intended for anterior screw fixation of the<br>cervical spine. These implants have been designed to provide stabilization<br>as an adjunct to cervical fusion. Indications for the use of this implant<br>system include degenerative disc disease (defined as neck pain of<br>discogenic origin with the degeneration of the disc confirmed by history and<br>radiographic studies), spondylolisthesis, trauma (i.e., fractures or<br>dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis or<br>scoliosis), tumor, pseudarthrosis or failed previous fusion.<br>WARNING: The InterPlate™ C is not intended for screw attachment or<br>fixation to the posterior elements (pedicles) of the cervical, thoracic or<br>lumbar spine. | | |
| Substantial<br>Equivalence: | Documentation was provided which demonstrated the InterPlate™ C to be<br>substantially equivalent to previously cleared devices. The substantial<br>equivalence is based upon equivalence in intended use, indications,<br>anatomic sites, material of manufacture and mechanical performance. | | |

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

RSB Spine, LLC % Karen E. Warden, Ph.D. 8202 Sherman Road Chesterland, Ohio 44026

OCT - 6 2009

Re: K092070

Trade/Device Name: Interplate™ C Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWO, ODP Dated: July 7, 2009 Received: July 8, 2009

Dear Dr. Warden:

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 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.

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Page 2 - Karen E. Warden, Ph.D.

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/CDRH/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/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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,
Mark M Millam

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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## 7. Indications for Use Statement

510(k) Number:_| | 09 20 70

Device Name: InterPlate™ C

Indications for Use:

The InterPlate™ C is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion. One device is used per intervertebral space. It is intended for use at one level in the cervical spine, from C3 to T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is to be used in patients who have had six weeks of non-operative treatment.

In addition, the InterPlate™ C is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system include degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), tumor, pseudarthrosis or failed previous fusion.

WARNING: The InterPlate™ C is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

Prescription Use X

AND/OR

Over-the-Counter Use

(21 CFR 807 Subpart C)

(21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices

K092070 510(k) Number .

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