MODIFICATION TO LUCENT

K081968 · Spinal Elements, Inc. · MAX · Aug 5, 2008 · Orthopedic

Device Facts

• Record ID: K081968
• Device Name: MODIFICATION TO LUCENT
• Applicant: Spinal Elements, Inc.
• Product Code: MAX · Orthopedic
• Decision Date: Aug 5, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

When used as a vertebral body replacement: When used as a vertebral body replacement, the Lucent device is intended for use in the thoracic and/or thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture). This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The interior of the spacer can be packed with allograft or autograft. When used as an intervertebral body fusion device: When used as an intervertebral body fusion device, the Lucent device is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). This device is intended to be used with autogenous bone graft. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the Lucent device.

Device Story

Lucent is a box-shaped spinal implant featuring surface teeth for fixation and internal voids for bone graft packing. Available in titanium alloy (Ti-6Al-4V) or PEEK. Used by surgeons in spinal procedures to replace collapsed/damaged vertebral bodies or facilitate intervertebral fusion. Implanted in conjunction with cleared supplemental spinal fixation systems (pedicle screws, rods, or plates). Provides structural support to the spinal column; promotes fusion via bone graft containment. Benefits patients by restoring spinal stability and addressing pain associated with DDD, tumor, or trauma.

Clinical Evidence

No clinical data. Substantial equivalence based on design and material identity to predicate devices.

Technological Characteristics

Box-shaped intervertebral body fusion/vertebral body replacement device. Materials: Titanium alloy (Ti-6Al-4V) or PEEK. Features superior/inferior surface teeth and internal geometry for bone graft. Dimensions vary to suit patient anatomy.

Indications for Use

Indicated for skeletally mature patients with DDD (back pain of discogenic origin, confirmed by history/radiography, +/- Grade 1 spondylolisthesis/retrolisthesis, prior non-fusion surgery) at 1-2 contiguous levels (L2-S1) requiring fusion, or patients requiring vertebral body replacement (T1-L5) due to tumor or trauma (fracture) following vertebrectomy. Requires 6 months prior 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

• Lucent® (K071724)
• Lucent® Magnum (K073348)

Submission Summary (Full Text)

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K081968
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Spinal Elements, Inc. Special 510(k) - Lucent®

## 510(k) Summary Lucent®

AUG - 5 2008 510(k) Number_

| Manufacturer Identification<br>Submitted by: | Spinal Elements, Inc.<br>2744 Loker Ave. W., Suite 100<br>Carlsbad, CA 92010<br>760-607-0121 |
|-----------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Information: | Kerri DiMartino<br>Regulatory Affairs Specialist<br>Spinal Elements, Inc.<br>2744 Loker Ave. W., Suite 100<br>Carlsbad, CA 92010<br>760-607-1816<br>760-607-0125(fax)<br>[e-mail] |
| Date Prepared: | July 30, 2008 |
| Device Identification<br>Proprietary Name<br>Common Name<br>Device Classification | Lucent®<br>Vertebral Body Replacement;<br>Intervertebral Body Fusion Device<br>21 CFR 888.3060 (spinal intervertebral body<br>fixation orthosis); 21CFR 888.3080 (orthosis, spinal<br>intervertebral fusion) |

#### Device Description

Spinal Elements' Lucent device is a generally box-shaped device with various holes located throughout its geometry and teeth on the superior and inferior surfaces.

The device body may be made from titanium alloy (Ti-6A1-4V) or polyetheretherketone (PEEK).

Devices are available in a multitude of sizes to suit the individual pathology and anatomic condition of the patient.

## Intended Use of the Device

When used as a vertebral body replacement:

When used as a vertebral body replacement, the Lucent device is intended for use in the thoracic and/or thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable

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vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture).

This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The interior of the spacer can be packed with allograft or autograft.

## When used as an intervertebral body fusion device:

When used as an intervertebral body fusion device, the Lucent device is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s).

This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). This device is intended to be used with autogenous bone graft.

Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the Lucent device.

## Substantial Equivalence

The Lucent device was shown to be substantially equivalent through comparison to predicate Spinal Elements devices: Lucent® (K071724) and Lucent® Magnum (K073348).

## Summary of Technological Characteristics

The Lucent devices of this submission are identical to predicates in indications for use, general design, function, and materials. Dimensional measurements are the only difference between predicates and the devices of this submission.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Spinal Elements, Inc. % Ms. Kerri DiMartino Regulatory Affairs Specialist 2744 Loker Avenue West, Suite 100 Carlsbad, California 92010

AUG - 5 2008

Re: K081968 Trade/Device Name: Lucent® Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device. Regulatory Class: II Product Code: MAX, MQP Dated: July 9, 2008 Received: July 10, 2008

Dear Ms. DiMartino:

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. Kerri DiMartino

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 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 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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# Indications for Use

510(k) Number (if known): KO81968

Device Name: Lucent®

#### Indications for Use:

When used as a vertebral body replacement:

When used as a vertebral body replacement, the Lucent device is intended for use in the thoracic and/or thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture).

This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The interior of the spacer can be packed with allograft or autograft.

When used as an intervertebral body fusion device:

When used as an intervertebral body fusion device, the Lucent device is intended for spinal fusion procedures at one or two contiguous levels (12-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s).

This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). This device is intended to be used with autogenous bone graft.

Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the Lucent device.

Prescription Use X (Part 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)

urrence of CDRH, Office of Device Evaluation (ODE) Division of General, Restorative, Page 1 of 1 and Neurological Devices

510(k) Number K081968

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