C-PS PEEK OPTIMA CERVICAL INTERBODY SPACER, L-PS PEEK OPTIMA LUMBAR INTERBODY SPACER

K092540 · Rsb Spine, LLC · ODP · Jan 27, 2010 · Orthopedic

Device Facts

• Record ID: K092540
• Device Name: C-PS PEEK OPTIMA CERVICAL INTERBODY SPACER, L-PS PEEK OPTIMA LUMBAR INTERBODY SPACER
• Applicant: Rsb Spine, LLC
• Product Code: ODP · Orthopedic
• Decision Date: Jan 27, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The C-PS is indicated for intervertebral body fusion of the cervical 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 C-PS 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. The C-PS is intended to be used with a supplemental internal fixation system. The The L-PS is indicated for intervertebral body fusion of the lumbar 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 L-PS System is 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 the history and radiographic studies. The lumbar device is to be used in patients who have had six months of non-operative treatment. The L-PS is intended to be used with a supplemental internal fixation system.

Device Story

InterPlate C-PS and L-PS are interbody spacers; designed for intervertebral body fusion. C-PS is a closed annular ring for cervical spine; L-PS is a closed annular ring with integral anteroposterior cross-piece for lumbar spine. Both feature hollow centers for autograft placement and sawtooth surface teeth to resist migration/expulsion. Used by surgeons in clinical settings; implanted during spinal fusion procedures. Devices provide structural support to intervertebral space while bone graft facilitates fusion. Requires supplemental internal fixation system. Benefits include stabilization of spinal segment and promotion of fusion in patients with discogenic pain.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: Polyetheretherketone (PEEK-OPTIMA LT1, ASTM F2026) and titanium alloy (Ti-6Al-4V, ASTM F136) radiopaque markers. Design: Closed annular ring (C-PS) or ring with cross-piece (L-PS) with sawtooth surface teeth. Energy source: None (mechanical). Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for intervertebral body fusion in skeletally mature patients. C-PS: cervical spine (C3-T1) for discogenic neck pain after 6 weeks of failed non-operative treatment. L-PS: lumbar spine (L2-S1) for degenerative disc disease with up to Grade I spondylolisthesis after 6 months of failed non-operative treatment. Both require autograft and supplemental internal fixation.

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.

Predicate Devices

• InterPlate™ PEEK Cervical IFD (K081194)
• Pioneer Cervical IBF (K073177)
• Pioneer vertebral spacer (K043206)
• InterPlate™ IFD (K071922)
• MC+ (K043479)

Submission Summary (Full Text)

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K092540 Page/K

| 510(k) Summary |
|----------------|
|----------------|

| Sponsor: | RSB Spine, LLC<br>3030 Superior Ave., Suite 703<br>Cleveland, OH 44114<br>Phone: [phone]<br>Fax: [phone]<br>JAN 2 7 2010 | |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Contact Person: | James M. Moran, D. Eng.<br>Vice President of Engineering and Chief Technical Officer | |
| Trade Name: | InterPlate™ C-PS and L-PS Interbody Spacers | |
| Device Classification | Class II | |
| Classification Name: | Intervertebral body fusion device | |
| Regulation: | 888.3080 | |
| Device Product Code: | ODP, MAX | |
| Device Description: | The C-PS comprises a closed annular ring, a hollow center for placement of<br>bone graft and sawtooth "teeth" on the inferior and superior surfaces for<br>resisting migration and expulsion.<br><br>The L-PS comprises a closed annular ring with integral anteroposterior<br>cross-piece, a hollow center for placement of bone graft and sawtooth<br>"teeth" on the inferior and superior surfaces for resisting migration and<br>expulsion. | |
| Materials: | The C-PS and L-PS are manufactured from polyetheretherketone (PEEK-<br>OPTIMA® LT1, Invibio™) as described by ASTM F2026. Radiopaque<br>markers are manufactured from titanium alloy (Ti-6Al-4V) according to<br>ASTM F136. | |
| Intended Use: | The C-PS is indicated for intervertebral body fusion of the cervical 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.<br>The C-PS is intended for use at one level in the cervical spine, from C3 to<br>T1, for the treatment of cervical disc disease (defined as neck pain of<br>discogenic origin with degeneration of the disc confirmed by history and<br>radiographic studies). The cervical device is to be used in patients who<br>have had six weeks of non-operative treatment. The C-PS is intended to be<br>used with a supplemental internal fixation system.<br>The The L-PS is indicated for intervertebral body fusion of the lumbar<br>spine in skeletally mature patients. The device system is designed for use<br>with autograft to facilitate fusion. One device is used per intervertebral<br>space. The L-PS System is intended for use at either one level or two<br>contiguous levels in the lumbar spine, from L2 to S1, for the treatment of<br>degenerative disc disease (DDD) with up to Grade I spondylolisthesis.<br>DDD is defined as back pain of discogenic origin with degeneration of the<br>disc confirmed by history and radiographic studies. The lumbar device is to<br>be used in patients who have had six months of non-operative treatment.<br>The L-PS is intended to be used with a supplemental internal fixation<br>system. | |

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## Substantial Equivalence:

Documentation was provided which demonstrated the C-PS and L-PS to be substantially equivalent to the previously cleared devices including the InterPlate™ PEEK Cervical IFD (K081194), Pioneer Cervical IBF (K073177), Pioneer vertebral spacer (K043206), InterPlate™ IFD (K071922) and the MC+ (K043479). The substantial equivalence is based upon equivalence in basic design, intended use, indications, performance and anatomic sites.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized image of a bird, possibly an eagle, with its wings spread. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird. The seal is in black and white.

#### Public Health Service

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

# JAN 27 2010

RSB Spine, LLC % Mr. James M. Moran, D. Eng. Vice President of Engineering and Chief Technical Office 3030 Superior Avenue, Suite 703 Cleveland, Ohio 44114

Re: K092540

Trade/Device Name: InterPlate™ C-PS and L-PS Interbody Spacers Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, ODP Dated: December 28, 2009 Received: December 28, 2009

Dear Mr. Moran:

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

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Page 2 - Mr. James M. Moran, D. Eng.

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 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 Statement

510(k) Number: K092540

### Device Name: InterPlate™ C-PS and L-PS Interbody Spacers

Indications for Use:

The C-PS is indicated for intervertebral body fusion of the cervical 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 C-PS 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. The C-PS is intended to be used with a supplemental internal fixation system.

The L-PS is indicated for intervertebral body fusion of the lumbar 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 L-PS System is 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. The L-PS is intended to be used with a supplemental internal fixation system.

Prescription Use X (21 CFR 801 Subpart D) AND/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)

signature

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(Division Sign-O! Division of Surgi. . . . . . . . . pepedic, and Restorative Devices

§10(k) Number K092540