LUCENT OR LUCENT MAGNUM

K110632 · Spinal Elements, Inc. · MAX · May 23, 2012 · Orthopedic

Device Facts

• Record ID: K110632
• Device Name: LUCENT OR LUCENT MAGNUM
• Applicant: Spinal Elements, Inc.
• Product Code: MAX · Orthopedic
• Decision Date: May 23, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Lucent® and Lucent Magnum® are intervertebral body fusion devices intended for spinal fusion procedures at one or two contiguous levels (T1-L5) 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 non-operative treatment prior to being treated with this device.

Device Story

Intervertebral body fusion device; box-shaped cage with internal voids for autograft placement; superior/inferior surface teeth for migration resistance. Manufactured from titanium (Ti-6Al-4V) or PEEK-Optima; modification adds plasma-sprayed titanium coating to PEEK. Used in lumbar spinal surgery; implanted by surgeons. Functions as structural support for vertebral bodies during fusion; requires supplemental fixation (pedicle screws/rods or plates). Benefits patient by facilitating spinal fusion in DDD cases.

Clinical Evidence

Bench testing only. Mechanical testing performed per ASTM F2077 (static compression, torsion, compression-shear; dynamic compression), ASTM F2267 (subsidence), and ASTM F1877/F2025-06 (wear). Coating characterization performed per ASTM F1044 (static/dynamic shear) and ASTM F1147 (static tension). No clinical data provided.

Technological Characteristics

Materials: Titanium (Ti-6Al-4V) or PEEK-Optima. Coating: Plasma-sprayed titanium. Standards: ASTM F2077 (mechanical), ASTM F2267 (subsidence), ASTM F1877/F2025-06 (wear), ASTM F1044 (shear), ASTM F1147 (tension). Form factor: Box-shaped cage with teeth. Energy source: None (mechanical).

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (T1-L5). DDD defined as discogenic back pain with radiographic confirmation. Patients may have up to Grade 1 spondylolisthesis or retrolisthesis and prior non-fusion surgery. Requires use with supplemental fixation and autogenous bone graft. Contraindicated in patients without 6 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

• Lucent (K071724)
• Lucent (K073348)
• X-Spine Calix PC System (K112036)

Submission Summary (Full Text)

{0}------------------------------------------------

Spinal Elements, Inc. Premarket Notification - Lucent" Intervertebral Body Fusion Device

## 510(k) Summary Lucent® and Lucent Magnum®

#### 510(k) Number K110632

MAY 2 3 2012

| Manufacturer Identification | |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitted by: | Spinal Elements, Inc.<br>2744 Loker Ave. W., Suite 100<br>Carlsbad, CA 92010<br>760-607-0121 |
| Contact Information: | Benjamin A. Kimball<br>Regulatory Affairs Manager<br>Spinal Elements, Inc.<br>2744 Loker Ave. W., Suite 100<br>Carlsbad, CA 92010<br>760-607-1816<br>[e-mail] |
| Date Prepared: | March 03, 2011 |
| Proprietary Name | Lucent® and Lucent Magnum® |
| Common Name | Intervertebral Body Fusion Device |
| Device Classification | 21 CFR 888.3080 (Intervertebral Body Fusion Device |
| Proposed Regulatory Class | Class II |
| Device Product Code | MAX |

#### Purpose of this Special 510(k)

This Special 510(k) seeks clearance for a modification to a current system.

#### Device Description

This product is an intervertebral body fusion device, manufactured from titanium (Ti-6Al-4V) or PEEK-Optima®, for use in lumbar spinal surgery. It may also be referred to as an interbody device or interbody cage. The device is generally box-shaped with various holes throughout its design to allow for the placement of autograft. The exterior of the device has "teeth" or other generally sharp engagement members on the superior and inferior surfaces to help prevent the device from migrating once it is surgically positioned. This modification seeks clearance for the addition of PEEK devices coated with a plasma-sprayed titanium coating.

### Intended Use of the Device

Lucent® and Lucent Magnum® are intervertebral body fusion devices intended for spinal fusion procedures at one or two contiguous levels (T1-L5) in skeletally mature patients

Page 1/2

{1}------------------------------------------------

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 non-operative treatment prior to being treated with this device.

#### Predicates

The Lucent intervertebral body fusion device is substantially equivalent to the following cleared devices in indications for use, design, function, and materials used.

- > Lucent 510(k) K071724 and K073348
- > X-Spine Calix PC System (K112036)

#### Performance Data

A comparison of the data to mechanical testing performance results of the previously cleared Lucent system devices indicates that the additional Lucent devices have the capability to perform at least as well the Lucent device.

Testing performed includes:

- Static Compression Testing as per ASTM F2077 .
- . Static Torsion Testing as per ASTM F2077
- . Static Compression-Shear Testing as per ASTM F2077
- Dynamic Compression Testing as per ASTM 2077 .
- Subsidence Testing as per ASTM F2267 ●
- . Wear Characterization as per ASTM F1877, ASTM F2025-06

Coating Characterization testing was performed using coupons.

- Coating Characterization -Static and Dynamic Shear per ASTM F1044 .
- Coating Characterization Static Tension per ASTM F1147 .

All data indicates that the device will perform as intended.

#### Substantial Equivalence

The Lucent intervertebral body fusion device was shown to be substantially equivalent previously cleared devices in indications for use, design, function, and materials used.

- > Lucent 510(k) K071724 and K073348
- > X-Spine Calix PC System (K112036)

{2}------------------------------------------------

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized symbol resembling a human figure with outstretched arms, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper portion of the circle.

#### Public Health Service

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

Spinal Elements Inc. % Benjamin A. Kimball Regulatory Affairs Manager 2744 Loker Ave. W., Suite 100 Carlsbad, California 92010

MAY 2 3 2012

Re: K110632

Trade/Device Name: Lucent® and Lucent Magnum® Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: May 14, 2012 Received: May 15, 2012

Dear Mr. Kimball:

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

{3}------------------------------------------------

#### Page 2 - Mr. Kimball

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/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/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

{4}------------------------------------------------

# Indications for Use

510(k) K: 110632

Device Name: Lucent®

## Indications for Use:

Lucent® and Lucent Magnum® are intervertebral body fusion devices intended for spinal fusion procedures at one or two contiguous levels (T1-L5) 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 non-operative treatment prior to being treated with this device.

Prescription Use × (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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

(Division Sign-Off) Diysson of Surgical, Orthopedic, and Restorative Devices

510(k) Number ..

KII0632