INTERPLATE PEEK CERVICAL INTERBODY FUSION DEVICE (IFD)

K081194 · Rsb Spine, LLC · OVE · May 29, 2008 · Orthopedic

Device Facts

• Record ID: K081194
• Device Name: INTERPLATE PEEK CERVICAL INTERBODY FUSION DEVICE (IFD)
• Applicant: Rsb Spine, LLC
• Product Code: OVE · Orthopedic
• Decision Date: May 29, 2008
• Decision: SESE
• Submission Type: Special
• 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, CGC and PEEK OPTIMA® Cervical 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™ I. and I.GC 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.

Device Story

InterPlate™ IFD is a spinal intervertebral body fusion system consisting of plates, bone screws, and screw covers. Designed for surgical implantation to facilitate fusion in the cervical (C3-T1) or lumbar (L2-S1) spine. Used with autograft; one device per intervertebral space. System accommodates individual patient anatomy via various plate sizes. Implanted by surgeons in clinical settings to treat discogenic pain and degenerative disc disease. Provides structural support to the intervertebral space to promote fusion.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and design characteristics.

Technological Characteristics

Components manufactured from Ti-6Al-4V titanium alloy (ASTM F136) and PEEK-OPTIMA® LTI (ASTM F2026). Includes radiographic markers. System comprises plates, bone screws, and screw covers. Mechanical fixation device.

Indications for Use

Indicated for intervertebral body fusion in skeletally mature patients. Cervical systems (C3-T1) for cervical disc disease after 6 weeks of failed non-operative treatment. Lumbar systems (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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K08/1994

## 7. 510(k) Summary

.

MAY 2 9 2008

| Sponsor: | RSB Spine, LLC<br>3030 Superior Ave., Suite 703<br>Cleveland, OH 44114<br>Phone: [phone]<br>Fax: [phone] |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | James M. Moran, D. Eng.<br>Vice President of Engineering and Chief Technical Officer |
| Proposed Trade Name: | InterPlate™ IFD |
| Classification: | Class II |
| Classification Name: | Spinal Intervertebral Body Fusion Device |
| Regulation: | 888.3080 |
| Device Product Code: | MAX, ODP |
| Device Description: | The InterPlate™ IFD System consists of plates, bone screws and screw<br>covers. Various plate sizes are available to accommodate individual patient<br>anatomy and graft material size. Screw covers are individually matched to<br>the plate size. |
| Intended Use: | The InterPlate™ IFD is indicated for intervertebral body fusion of the spine<br>in skeletally mature patients. The device system is designed for use with<br>autograft to facilitate fusion. One device is used per intervertebral space.<br>The InterPlate™ C, CGC and PEEK OPTIMA® Cervical Systems are<br>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>The InterPlate™ I. and I.GC Systems are intended for use at either one level<br>or two contiguous levels in the lumbar spine, from L2 to S1, for the<br>treatment of degenerative disc disease (DDD) with up to Grade I<br>spondylolisthesis. DDD is defined as back pain of discogenic origin with<br>degeneration of the disc confirmed by history and radiographic studies. The<br>lumbar device is to be used in patients who have had six months of non-<br>operative treatment. |
| Materials: | The InterPlate™ C, CGC, L and LGC components are manufactured from<br>Ti-6Al-4V titanium alloy (ASTM F136). The InterPlate™ PEEK OPTIMA®<br>Cervical IFD components are manufactured from polyetheretherketone<br>(PEEK-OPTIMA® LTI, Invibio™) and Ti-6Al-4V titanium alloy as<br>described by ASTM F2026 and ASTM F136, respectively. Radiographic<br>markers within the InterPlate™ PEEK Cervical IFD are manufactured from<br>Ti-6Al-4V titanium alloy (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,<br>anatomic 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

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

SEP 12 2011

Re: K081194

> 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: OVE, OVD Dated: April 28, 2008 Received: April 28, 2008

Dear Dr. Warden:

This letter corrects our substantially equivalent letter of May 29, 2008.

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 vours.

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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## 6. Indications for Use Statement

## 510(k) Number: KD81194

Device Name: InterPlate™ Interbody Fusion Device

Indications for Use:

The InterPlate™ Interbody Fusion Device (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, CGC and PEEK OPTIMA® Cervical Systems are intended for usc at onc 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 (Per 21 CFR 801.109) OR Over-the-Counter Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nel Rooden forimer
Division S. 1869

Division of General, Restorative, and Neurological Devices

510(k) Number K081194