LUCENT MAGNUM

K083475 · Spinal Elements, Inc. · OVD · Feb 13, 2009 · Orthopedic

Device Facts

• Record ID: K083475
• Device Name: LUCENT MAGNUM
• Applicant: Spinal Elements, Inc.
• Product Code: OVD · Orthopedic
• Decision Date: Feb 13, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Magnum+ is a stand alone device intended to be used with bone screws. If the physician chooses to use fewer than the maximum number of screws accommodated by the device, then additional supplemental fixation, which has been cleared by the FDA for use in the lumbar spine, must be used to augment stability. When used as a vertebral body replacement: When used as a vertebral body replacement, the 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). The interior of the spacer can be packed with allograft or autograft. When used as an intervertebral body fusion device: Lucent Magnum+ is an intervertebral body fusion device 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 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 device.

Device Story

Lucent Magnum+ is an intervertebral body fusion and vertebral body replacement device. System consists of an oval-shaped spacer with fixation screws. Spacer features superior/inferior engagement members to prevent migration. Used in spinal surgery to replace collapsed/unstable vertebral bodies or facilitate fusion in DDD patients. Surgeon implants device into thoracic/lumbar spine; spacer interior packed with autograft/allograft. Device provides structural support and stability; bone screws provide fixation. Benefits include restoration of spinal height and stabilization of vertebral segments. Intended for single-use only.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, material, and functional characteristics compared to legally marketed predicate devices.

Technological Characteristics

Materials: Titanium alloy (Ti-6Al-4V) per ASTM F 136/ISO 5832-3; PEEK-OPTIMA LTI per ASTM F 2026; Tantalum markers per ASTM F 560. Form factor: Oval-shaped spacer with integrated screw holes and surface engagement members. Energy source: None (mechanical). Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1) with up to Grade 1 spondylolisthesis or retrolisthesis, or for vertebral body replacement in thoracic/thoracolumbar spine (T1-L5) due to tumor or trauma. Contraindicated for patients without 6 months of 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® by Spinal Elements (K071724)
• STALIF TT™ by Surgicraft (K073109)
• Solitaire™ by Biomet Spine (K081395)

Submission Summary (Full Text)

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Spinal Elements, Inc. Premarket Notification - Lucent® Magnum

K083475

## 510(k) Summary Lucent® Magnum+

FEB 1 3 2009

## 510(k) Number.

Manufacturer Identification Submitted by:

Spinal Elements, Inc. 2744 Loker Ave. W., Suite 100 Carlsbad, CA 92010 760-607-0121

## Contact Information:

Kerri DiMartino Regulatory Affairs Specialist Spinal Elements, Inc. 2744 Loker Ave. W., Suite 100 Carlsbad, CA 92010 760-607-1816 [e-mail]

Date Prepared:

February 9, 2009

Device Identification Proprietary Name Common Name Device Classification

Proposed Regulatory Class

Lucent® Magnum+ Intervertebral Body Fusion Device 21CFR 888.3080 (orthosis, spinal intervertebral fusion) Class II MAX

#### Device Description

Device Product Code

Spinal Elements' Lucent Magnum+ device is composed of a main device body (spacer) and fixation screws. The spacer is generally oval-shaped with various holes throughout its geometry. The superior and inferior surfaces of the spacer have engagement members to help prevent migration once surgically positioned. The spacer has holes through it that allow for the passage of bone screws that affix to bone to help prevent migration.

Devices are available in a multitude of sizes. The spacer may be made from titanium alloy (Ti-6Al-4V) conforming to ASTM F 136 or ISO 5832-3 or polyetheretherketone (PEEK-OPTIMA LTI, provided by Invibio) conforming to ASTM F 2026. Because PEEK is radiolucent, tantalum (per ASTM F 560) pins are embedded into PEEK spacers to serve as markers for radiographic visualization of spacer orientation. Screws are manufactured from titanium alloy (Ti-6A1-4V) conforming to ASTM F 136 or ISO 5832-3. All implants are intended for single use only and should not be reused under any circumstances. Components from this system should not be used in conjunction with components from other systems.

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## Premarket Notification - Lucent® Magnum

## Intended Use of the Device

Magnum+ is a stand alone device intended to be used with bone screws. If the physician chooses to use fewer than the maximum number of screws accommodated by the device, then additional supplemental fixation, which has been cleared by the FDA for use in the lumbar spine, must be used to augment stability,

### When used as a vertebral body replacement:

When used as a vertebral body replacement, the 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).

The interior of the spacer can be packed with allograft or autograft.

## When used as an intervertebral body fusion device:

Lucent Magnum+ is an intervertebral body fusion device 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 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 device.

#### Substantial Equivalence

The Lucent Magnum+ device was shown to be substantially equivalent in indications for use, general design features, function, and materials to the following predicates: Lucent® by Spinal Elements (K071724), STALIF TT™ by Surgicraft (K073109), and Solitaire™ by Biomet Spine (K081395).

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines forming its body and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle image.

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

SEP 11:2 2011

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

Re: K083475

> Trade/Device Name: Lucent® Magnum+ Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD, MOP Dated: November 21, 2008 Received: November 24, 2008

Dear Ms. DiMartino:

This letter corrects our substantially equivalent letter of February 13, 2009.

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 (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 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

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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/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 yours.

Sincerely yours,

Mulh A. Mulkerson

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):

Lucent® Magnum+ Device Name:

## Indications for Use:

Magnum+ is a stand alone device intended to be used with bone screws. If the physician chooses to use fewer than the maximum number of screws accommodated by the device, then additional supplemental fixation, which has been cleared by the FDA for use in the lumbar spine, must be used to augment stability.

## When used as a vertebral body replacement:

When used as a vertebral body replacement, the 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).

The interior of the spacer can be packed with allograft or autograft.

## When used as an intervertebral body fusion device:

Lucent Magnum+ is an intervertebral body fusion device 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 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 device.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over The Counter Use (2) 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)

Munk A. Millener Page 1 of 1

(Division Sign-Off Division of General. Restorative, and Neurelogical Devices

**510(k) Number**