CAPTIVA SPINE FUSELOX CERVICAL CAGE

K110585 · Captiva Spine, Inc. · ODP · Mar 25, 2011 · Orthopedic

Device Facts

• Record ID: K110585
• Device Name: CAPTIVA SPINE FUSELOX CERVICAL CAGE
• Applicant: Captiva Spine, Inc.
• Product Code: ODP · Orthopedic
• Decision Date: Mar 25, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Captiva Spine FuseLox Cervical IBF System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level. DDD is defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies. Captiva Spine FuseLox implants are used to facilitate fusion in the cervical spine and are placed via an anterior approach at the C3 to C7 disc levels using autogenous bone graft. Patients should have at least six weeks of non-operative treatment prior to treatment with an intervertebral body fusion device. The device must be used with supplemental fixation.

Device Story

The Captiva Spine FuseLox Cervical IBF System consists of hollow implants designed to facilitate spinal fusion. Implants are placed surgically via an anterior approach into the cervical spine (C3-C7) to replace a degenerated disc. The hollow center is packed with autogenous bone graft to promote fusion. The device is intended for use in skeletally mature patients who have failed at least six weeks of non-operative treatment. It must be used in conjunction with supplemental fixation hardware. The device provides structural support to the intervertebral space, aiding in the stabilization and fusion process, which can alleviate symptoms associated with degenerative disc disease.

Clinical Evidence

No clinical data. Substantial equivalence is based on bench testing and design comparison to predicate devices.

Technological Characteristics

Implant grade PEEK conforming to ASTM F2026-08. Hollow form factor for autogenous bone graft. Non-sterile. No software or energy source.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one level (C3-C7). Requires neck pain of discogenic origin confirmed by history/radiography and at least six weeks of failed non-operative treatment. Must be used with supplemental fixation and autogenous bone graft.

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

• Transcorp ACIF (K092794)
• Alphatec Novel Spinal Spacer System (K081730)

Submission Summary (Full Text)

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KII0582

MAR 2 5 2011

Page 1 | |

510(k) Summary

| Submitter: | Captiva Spine<br>967 Alt A1A Suite 1<br>Jupiter, FL 33477<br>Phone: [phone]<br>Fax: [phone] |
|-------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | John Sanders<br>Consultant<br>QualiReg Resources LLC<br>2361 NW 105th Ln<br>Sunrise, FL 33322<br>Phone: [phone]<br>email: [e-mail] |
| Date Prepared: | February 28, 2011 |
| Trade Name: | Captiva Spine FuseLox Cervical IBF System |
| Classification | Class II |
| Name and Number: | Intervertebral Body Fusion Device<br>21 CFR 888.3080 |
| Product Code: | ODP |
| Predicate Device(s): | The subject device is substantially equivalent to the following devices:<br>K092794 Transcorp ACIF<br>K081730 Alphatec Novel Spinal Spacer System |
| Device Description: | The Captiva Spine FuseLox Cervical IBF System includes various size<br>implants manufactured from implant grade PEEK conforming to ASTM<br>F2026-08. The implant is hollow to allow for autogenous bone graft<br>material. The implant is provided non-sterile. |
| Intended Use: | The Captiva Spine FuseLox Cervical IBF System is indicated for use in<br>skeletally mature patients with degenerative disc disease (DDD) of the<br>cervical spine at one disc level. DDD is defined as neck pain of discogenic<br>origin with the degeneration of the disc confirmed by history and<br>radiographic studies. Captiva Spine FuseLox implants are used to facilitate<br>fusion in the cervical spine and are placed via an anterior approach at the C3<br>to C7 disc levels using autogenous bone graft. Patients should have at least<br>six weeks of non-operative treatment prior to treatment with an<br>intervertebral body fusion device. The device must be used with<br>supplemental fixation. |
| Performance Data: | Indicates subject device is substantially equivalent to predicates. |
| Conclusion: | The documentation provided demonstrates that the Captiva Spine FuseLox<br>Cervical IBF System is substantially equivalent to the predicate devices. |
| Captiva Spine FuseLox Cervical IBF System<br>510(k) Premarket Notification Page 17 of 103 | |

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.

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

Captiva Spine, Inc. % QualiReg Resources LLC Mr. John Sanders 2361 NW 105th Lane Sunrise, Florida 33322

MAR 2 5 2011

Re: K110585

Trade/Device Name: Captiva Spine FuseLox Cervical IBF System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: February 28, 2011 Received: March 01, 2011

Dear Mr. Sanders:

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

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Page 2 - Mr. John Sanders

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); 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/ReportalProblem/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/Resourcesfor You/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: KI10585

Device Name: Captiva Spine FuseLox Cervical IBF System

Indications for Use:

The Captiva Spine FuseLox Cervical IBF System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level. DDD is defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies. Captiva Spine FuseLox implants are used to facilitate fusion in the cervical spine and are placed via an anterior approach at the C3 to C7 disc levels using autogenous bone graft. Patients should have at least six weeks of non-operative treatment prior to treatment with an intervertebral body fusion device. The device must be used with supplemental fixation.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off)

(Div/sion Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K110585

Captiva Spine FuseLox Cervical IBF System 510(k) Premarket Notification

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