ORIA NATURA SPACER

K073669 · Choicespine, LP · MAX · Feb 13, 2008 · Orthopedic

Device Facts

• Record ID: K073669
• Device Name: ORIA NATURA SPACER
• Applicant: Choicespine, LP
• Product Code: MAX · Orthopedic
• Decision Date: Feb 13, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

When used as an intervertebral body fusion device, the ORIA Natura Spacer is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels 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 device system is designed for use with supplemental fixation (e.g., ORIA Claris, ORIA Spinal Clip System, etc.) and with autograft to facilitate fusion. When used as a vertebral body replacement device, the ORIA Natura Spacer is intended for use in the thoracic and lumbar spine, from T1 to L5, for the replacement of a collapsed or unstable vertebral body resulting from a tumor or traumatic injury. The device system is designed for use with supplemental fixation (e.g., ORIA Claris, ORIA Spinal Clip System, etc.) and with autograft to facilitate fusion.

Device Story

ORIA Natura Spacer is a rectangular, hollow spinal implant with a smooth, bullet-shaped anterior surface; designed to hold bone graft. Available in various heights, lengths, and angulations to accommodate patient anatomy. Used by surgeons in spinal procedures; requires supplemental fixation (e.g., ORIA Claris, ORIA Spinal Clip System) and autograft. Functions as an intervertebral body fusion device or a vertebral body replacement device to stabilize the spine and facilitate fusion. Benefits patients by providing structural support for collapsed/unstable vertebrae or treating discogenic back pain.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Manufactured from PEEK-OPTIMA LT1 (ASTM F2026) with tantalum radiopaque markers (ASTM F560). Rectangular, hollow form factor with variable dimensions and angulation.

Indications for Use

Indicated for skeletally mature patients requiring lumbar intervertebral body fusion (L2-S1) for degenerative disc disease with up to Grade I spondylolisthesis after 6 months of failed non-operative treatment, or for thoracic/lumbar (T1-L5) vertebral body replacement due to tumor or trauma.

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.

Reference Devices

• ORIA Claris
• ORIA Spinal Clip System

Submission Summary (Full Text)

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K073669 Page 10f / 1

## 6. 510(k) Summary

:

| Sponsor: | Choice Spine, LP<br>314 Erin Drive, Suite 102<br>Knoxville, TN 37919<br>Phone: [phone]<br>Fax: [phone] | |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Contact<br>Person: | G. Todd Hawkins.<br>Director of Regulatory Affairs / Quality Assurance | FEB 13 200 |
| Proposed<br>Proprietary<br>Trade Name: | ORIA Natura Spacer | |
| Classification<br>Name | 888.3060 - Spinal Intervertebral Body Fixation Orthosis,<br>888.3080 - Spinal Intervertebral Body Fusion Device | |
| Device Product<br>Code: | MQP, MAX | |
| Device<br>Description: | The ORIA Natura has a basic rectangular shape, a hollow center for placement<br>of bone graft and a smooth bullet-shaped anterior surface. It is available in an<br>assortment of height, length and anteroposterior angulation combinations to<br>accommodate many different anatomic requirements. | |
| Intended Use: | When used as an intervertebral body fusion device, the ORIA Natura Spacer is<br>indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in<br>skeletally mature patients who have had six months of non-operative treatment.<br>The device is intended for use at either one level or two contiguous levels for<br>the 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>device system is designed for use with supplemental fixation (e.g., ORIA<br>Claris, ORIA Spinal Clip System, etc.) and with autograft to facilitate fusion. | |
| | When used as a vertebral body replacement device, the ORIA Natura Spacer is<br>intended for use in the thoracic and lumbar spine, from T1 to L5, for the<br>replacement of a collapsed or unstable vertebral body resulting from a tumor or<br>traumatic injury. The device system is designed for use with supplemental<br>fixation (e.g., ORIA Claris, ORIA Spinal Clip System, etc.) and with autograft<br>to facilitate fusion. | |
| Materials: | The ORIA Natura Spacer components are manufactured from<br>polyetheretherketone (PEEK-OPTIMA® LT1, Invibio™) as described by<br>ASTM F2026. Integral radiopaque markers are manufactured from tantalum as<br>described by ASTM F560. | |
| Substantial<br>Equivalence: | Documentation was provided which demonstrated the ORIA Natura Spacer to<br>be 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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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three bars representing the agency's mission of promoting health, well-being, and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle symbol.

Public Health Service

FEB 13 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Choice Spine, LP % Ms. Karen Warden Regulatory Affairs Specialist 8202 Sherman Road Chesterland, OH 44026-2141

Re: K073669

> Trade/Device Name: ORIA Natura Spacer Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, MQP Dated: December 21, 2007 Received: December 26, 2007

Dear Ms. 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 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. Karen Warden

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 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 M Millman

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

Enclosure

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K073669
Page 1 of 1

## 5. Indications for Use Statement

07 3669 510(k) Number:

Device Name: ORIA Natura Spacer

Indications for Use:

When used as an intervertebral body fusion device, the ORIA Natura Spacer is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels 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 device system is designed for use with supplemental fixation (e.g., ORIA Claris, ORIA Spinal Clip System, etc.) and with autograft to facilitate fusion.

When used as a vertebral body replacement device, the ORIA Natura Spacer is intended for use in the thoracic and lumbar spine, from T1 to L5, for the replacement of a collapsed or unstable vertebral body resulting from a tumor or traumatic injury. The device system is designed for use with supplemental fixation (e.g., ORIA Claris, ORIA Spinal Clip System, etc.) and with autograft to facilitate fusion.

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)

Dalvare Bneehn

on Sign-t Division of General, Restorative, and Neurological Devices

**510(k) Number** k073669

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