PARAMOUNT INTERVERTEBRAL BODY FUSION DEVICE

K072120 · Innovative Spinal Technologies, Inc. · MAX · Oct 11, 2007 · Orthopedic

Device Facts

• Record ID: K072120
• Device Name: PARAMOUNT INTERVERTEBRAL BODY FUSION DEVICE
• Applicant: Innovative Spinal Technologies, Inc.
• Product Code: MAX · Orthopedic
• Decision Date: Oct 11, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Paramount™ IBF device, when used with autogenous bone graft, is indicated for use in patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. Paramount™ IBF devices are to be implanted via a direct posterior or transforaminal approach. The Paramount™ IBF device may be used singly or in pairs in the lumbosacral spine with or without supplemental fixation, such as the Paramount™ Pedicle Screw System.

Device Story

Paramount™ Intervertebral Body Fusion Device is a PEEK-OPTIMA® implant designed for spinal fusion. Implanted via direct posterior or transforaminal approach in the lumbosacral spine; used singly or in pairs with autogenous bone graft. May be used with supplemental fixation (e.g., Paramount™ Pedicle Screw System). Intended to stabilize the spinal segment in patients with DDD; facilitates fusion to alleviate discogenic back pain. Surgeon-operated in clinical/surgical settings.

Clinical Evidence

Bench testing only. Mechanical performance evaluated per ASTM F2077, ASTM F2267, and ASTM F-04.25.02.02. Biocompatibility testing performed per ISO 10993.

Technological Characteristics

Material: PEEK-OPTIMA®. Form factor: Various widths, heights, angles, and lengths. Energy source: None (mechanical implant). Sterilization: Provided sterile (implant); instruments provided non-sterile for steam sterilization. Standards: ASTM F2077, ASTM F2267, ASTM F-04.25.02.02, ISO 10993.

Indications for Use

Indicated for skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1, including those with up to Grade 1 spondylolisthesis or retrolisthesis, who have failed six months of non-operative treatment.

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

• Paramount™ VBR System (K062759)
• BAK™ Interbody Fusion System (P950002)

Submission Summary (Full Text)

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K072120
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## 510(k) SUMMARY

DATE:

October 1, 2007

SUBMITTER:

Innovative Spinal Technologies, Inc. 111 Forbes Boulevard Mansfield, MA 02048 Telephone: [phone] Fax:

OCT 】 1 2007

CONTACT PERSON: Gina Yeh

TRADE NAME: Paramount™ Intervertebral Body Fusion Device

FDA CLASSIFICATION / CODE: 888.3080 / MAX

DEVICE DESCRIPTION: The Paramount™ Intervertebral Body Fusion Device is made of PEEK-OPTIMA®. The implant is offered in various widths, heights, angles and lengths to meet individual patient anatomy. The devices are provided sterile and the instruments are provided clean and non-sterile for steam sterilization at the user's facility.

INTENDED USE: The Paramount™ IBF device, when used with autogenous bone graft, is indicated for use in patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.

Paramount™ IBF devices are to be implanted via a direct posterior or transforaminal approach. The Paramount™ IBF device may be used singly or in pairs in the lumbosacral spine with or without supplemental fixation, such as the Paramount™ Pedicle Screw System.

PREDICATE DEVICES: The predicate devices include: Innovative Spinal Technologies. Inc. Paramount™ VBR System (K062759) and Centerpulse/ Zimmer Spine, Inc. BAK™ Interbody Fusion System (P950002).

PERFORMANCE DATA: The mechanical test results based on ASTM F2077, ASTM F2267, and ASTM F-04.25.02.02 demonstrate that the Paramount™ Intervertebral Body Fusion Device can be expected to perform in a manner substantially equivalent to the predicate devices. In addition, biocompatibility of the device was demonstrated via testing per ISO10993.

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Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features the department's name encircling a stylized caduceus symbol. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The caduceus is depicted with a modern, abstract design.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## OCT 1 1 2007

Innovative Spinal Technologies, Incorporated % Ms. Gina Yeh Manager, Regulatory Affairs 111 Forbes Boulevard Mansfield, Massachusetts 02048

Re: K072120

> Trade/Device Name: Paramount Intervertebral Body Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: July 31, 2007 Received: August 1, 2007

Dear Ms. Yeh:

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. Ilsting 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 such 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); 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 - Ms. Gina Yeh

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson

Mark N. Melk Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

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K072120
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## Appendix 1

## Indication for Use Statement

510(k) Number: K072120

Device Name: Paramount TM Intervertebral Body Fusion Device

Indications:

The Paramount™ IBF device, when used with autogenous bone graft, is indicated for use in patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.

Paramount™ IBF devices are to be implanted via a direct posterior or transforaminal approach. The Paramount™ IBF device may be used singly or in pairs in the lumbosacral spine with or without supplemental fixation, such as the Paramount™ Pedicle Screw System.

Prescription Use × or (21 CFR 801 Subpart D)

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)

Seubare BuchMD

. Restorative. and Neurological Devices

**510(k) Number** K072120