INTERPLATE INTERBODY FUSION DEVICE, MODELS C, CGC, L AND LGC

K071922 · Rsb Spine, LLC · OVD · Sep 18, 2007 · Orthopedic

Device Facts

• Record ID: K071922
• Device Name: INTERPLATE INTERBODY FUSION DEVICE, MODELS C, CGC, L AND LGC
• Applicant: Rsb Spine, LLC
• Product Code: OVD · Orthopedic
• Decision Date: Sep 18, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The InterPlate™ IFD 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. The InterPlate™ C and CGC Systems are 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. The InterPlate™ L and LGC Systems are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to SI, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used in patients who have had six months of non-operative treatment.

Device Story

InterPlate™ system comprises titanium alloy plates, bone screws, and screw covers; designed for anterior spinal fixation and intervertebral body fusion. Used in cervical (C3-T1) or lumbar (L2-S1) spine to treat discogenic pain or degenerative disc disease. System implanted by surgeons during spinal fusion procedures; requires autograft to facilitate bone fusion. Provides mechanical stabilization of intervertebral space; promotes fusion; reduces pain associated with disc degeneration. Device sizes vary to accommodate patient anatomy.

Clinical Evidence

No clinical data provided; substantial equivalence established via bench testing.

Technological Characteristics

Components manufactured from Ti-6Al-4V titanium alloy (ASTM F136). System includes plates, bone screws, and screw covers. Mechanical fixation device; no energy source or software.

Indications for Use

Indicated for intervertebral body fusion in skeletally mature patients. Cervical (C3-T1) for discogenic neck pain after 6 weeks of failed non-operative treatment. Lumbar (L2-S1) for degenerative disc disease with up to Grade I spondylolisthesis after 6 months of failed non-operative treatment. Used with autograft.

Regulatory Classification

Identification

An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.

Special Controls

*Classification.* (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval. (c) *Date premarket approval application (PMA) or notice of product development protocol (PDP) is required.* Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

Submission Summary (Full Text)

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## K071922

## 510(k) Summary

SEP 1 8 2007

| Sponsor: | RSB Spine, LLC<br>3030 Superior Ave., Suite 703<br>Cleveland, OH 44114 |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact<br>Person: | James M. Moran, D. Eng.<br>Vice President of Engineering and Chief Technical Officer |
| Proposed<br>Proprietary<br>Trade Name: | InterPlate™ |
| Classification<br>Name | 888.3080 - Spinal Intervertebral Body Fusion Device |
| Device Product<br>Code: | MAX, ODP |
| Device<br>Description: | The InterPlate™ System consists of plates, bone screws and screw covers.<br>Various plate sizes are available to accommodate individual patient anatomy<br>and graft material size. Screw covers are individually matched to the plate size. |
| Intended Use: | The InterPlate™ IFD is indicated for intervertebral body fusion of the spine in<br>skeletally mature patients. The device system is designed for use with autograft<br>to facilitate fusion. One device is used per intervertebral space. |
| | The InterPlate™ C and CGC Systems are intended for use at one level in the<br>cervical spine, from C3 to T1, for the treatment of cervical disc disease (defined<br>as neck pain of discogenic origin with degeneration of the disc confirmed by<br>history and radiographic studies). The cervical device is to be used in patients<br>who have had six weeks of non-operative treatment. |
| | The InterPlate™ L and LGC Systems are intended for use at either one level or<br>two contiguous levels in the lumbar spine, from L2 to SI, for the treatment of<br>degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is<br>defined as back pain of discogenic origin with degeneration of the disc<br>confirmed by history and radiographic studies. The lumbar device is to be used<br>in patients who have had six months of non-operative treatment. |
| Materials: | The InterPlate™ components are manufactured from Ti-6Al-4V titanium alloy<br>(ASTM F136). |
| Substantial<br>Equivalence: | Documentation was provided which demonstrated the InterPlate™ to be<br>substantially equivalent to previously cleared devices. The substantial<br>equivalence is based upon equivalence in intended use, indications, anatomic<br>sites. performance and material of manufacture. |

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

## NOV 1 5 2011

RSB Spine, LLC % BackRoads Consulting, Inc. Karen E. Warden, Ph.D. 8202 Sherman Rd. Chesterland, OH 44026

Re: K071922

> Trade/Device Name: InterPlate™ Interbody Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD, OVE, KWQ Dated: July 12, 2007 Received: July 12, 2007

Dear Dr. Warden:

This letter corrects our substantially equivalent letter of September 12, 2011.

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 (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

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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/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 A. Milliman

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

K071922 510(k) Number:_

Device Name: InterPlate®

Indications for Use:

The InterPlate is indicated for anterior screw fixation or 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.

The InterPlate C and CGC Systems are 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.

The InterPlate L and LGC Systems are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used in patients who have had six months of non-operative treatment.

Prescription Use X (21 CFR 801 Subpart D) OR Over-the-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

K071922 510(k) Number_