BRIGHT SPINE GALILEO SPINAL SPACER SYSTEM

K102449 · Bright Spine, Inc. · ODP · Feb 11, 2011 · Orthopedic

Device Facts

• Record ID: K102449
• Device Name: BRIGHT SPINE GALILEO SPINAL SPACER SYSTEM
• Applicant: Bright Spine, Inc.
• Product Code: ODP · Orthopedic
• Decision Date: Feb 11, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

To provide the surgeon with a cervical intervertebral body fusion device, intended for spinal fusion procedures at one level (C2 to T1) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be packed with autogenous bone graft. These patients should have had six months of non-operative treatment. The Galileo™ Spinal Spacer System is to be used with a supplemental fixation system.

Device Story

The Galileo™ Spinal Spacer System is an implantable titanium alloy device designed for cervical intervertebral body fusion. Used by surgeons in clinical settings, the spacer is packed with autogenous bone graft and implanted at a single level (C2-T1) to facilitate spinal fusion. The device requires use with a supplemental fixation system to stabilize the construct. By maintaining disc space height and promoting fusion, the device aims to alleviate symptoms of degenerative disc disease. It is intended for patients who have failed six months of non-operative treatment.

Clinical Evidence

No clinical data was required or provided to determine substantial equivalence. Evidence is based on bench testing per ASTM F2077-03 (static/dynamic compression, compressive shear, torsion, expulsion) and ASTM F2267-04 (subsidence).

Technological Characteristics

Manufactured from titanium alloy. Designed for cervical intervertebral fusion. Dimensions are similar to the predicate device. Performance testing conducted per ASTM F2077-03 and ASTM F2267-04. No software or electronic components.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease of the cervical spine (C2-T1) requiring spinal fusion at one level. Patients must have history of discogenic back pain confirmed by radiography and six months of failed 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

• Novel® Spinal Spacer System (K081730)

Submission Summary (Full Text)

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K102449

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## 510(k) SUMMARY

Submitter's Name:

Submitter's Address:

Contact Person:

Telephone / Facsimile:

Date Prepared:

Device Trade Name:

Device Common Name:

Classification Name:

Classification Number(s)/Product Code(s)

Predicate Device:

Device Description:

Intended Use:

Bright Spine

799 N.E. 71st Street Boca Raton, Florida 33489

Robert E. Simonson

Tel: [phone] Fax: [phone]

July 22, 2010

Galileo™ Spinal Spacer System

Intervertebral Body Fusion Device

Orthosis, Spinal Intervertebral Fusion with Bone Graft, Cervical

21 CFR 888.3080 (ODP)

Alphatec Spine, Inc. Novel® Spinal Spacer System K081730

The Bright Spine Galileo™ Spinal Spacer System is an implantable device manufactured from titanium alloy

To provide the surgeon with a cervical intervertebral body fusion device, intended for spinal fusion procedures at one level (C2 to TI) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be packed with autogenous bone graft. These patients should have had six months of non-operative treatment. The Galileo™ Spinal Spacer System is to be used with a supplemental fixation system.

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K10249

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Technological Characteristics and Comparison to Predicate:

Performance Data:

The Bright Spine Galileo™ Spinal Spacer System is manufactured from equivalent materials, with similar dimensions, to achieve the same surgical objectives as the predicate Novel® Spinal Spacer System.

When used as designed, the Galileo™ Spinal Spacer System functions in as safe and effective a manner as the predicate device. Complies with ASTM F2077-03 and ASTM F2267-04 Performance Testing.

ASTM F2077-03 Includes:

Static and dynamic compression, compressive shear, torsion and expulsion

ASTM F2267-04 Includes: Subsidence

The Galileo™ Spinal Spacer System was shown to be substantially equivalent to the predicate system.

Clinical Data:

It was determined that Clinical Data was not required to determine substantial equivalence.

The Bright Spine Galileo™ Spinal Spacer System is safe and effective and is Conclusion: substantially equivalent to the predicate device.

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

Bright Spine, Inc. % Mr. Robert E. Simonson 799 N.E. 71st Street Boca Raton, Florida 33489

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Re: K102449

Trade/Device Name: Bright Spine Galileo" Spinal Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Invertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: January 10, 2011 Received: January 11, 2011

Dear Mr. Simonson:

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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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.

AZ B. R. for

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

510(k) Number (if known): _ K102449 '

Device Name: Bright Spine Galileo™ Spinal Spacer System

Indications for Use:

## When used as a Cervical Intervertebral Body Fusion Device

When used as a cervical intervertebral body fusion device, the Galileo™ Spinal Spacer System is intended for spinal fusion procedures at one level (C2 to T1) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be packed with autogenous bone graft. These patients should have had six months of non-operative treatment. The Galileo™ Spinal Spacer System is to be used with a supplemental fixation system.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
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| (Division Sign-Off) | Page __ of __ |
| Division of Surgical, Orthopedic, and Restorative Devices | |
| 510(k) Number | K102449 |

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