Lucent; Lucent Ti-Bond Systems

K150061 · Spinal Elements, Inc. · MAX · May 19, 2015 · Orthopedic

Device Facts

• Record ID: K150061
• Device Name: Lucent; Lucent Ti-Bond Systems
• Applicant: Spinal Elements, Inc.
• Product Code: MAX · Orthopedic
• Decision Date: May 19, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Lucent® and Lucent Ti-Bond® are intervertebral body fusion devices 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). These devices are 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, and anterior screw and rod systems). These devices are 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 these devices.

Device Story

Intervertebral body fusion device (interbody cage) used in lumbar spinal surgery; box-shaped with holes for autograft placement; superior/inferior surface teeth prevent migration. Implanted by surgeons to facilitate spinal fusion; used with supplemental fixation (pedicle screw/rod or anterior plate/screw systems). Provides structural support to disc space; promotes fusion via autogenous bone graft. Subject device introduces rounded anterior end and additional size configurations; available with or without plasma-sprayed porous titanium coating.

Clinical Evidence

No clinical studies were performed. Substantial equivalence supported by non-clinical bench testing, including static and dynamic compression testing per FDA Class II Special Controls Guidance for Intervertebral Body Fusion Devices.

Technological Characteristics

Materials: PEEK (Invibio MAF 1209) and commercially pure titanium coating (ASTM F1580). Form factor: Box-shaped interbody cage with superior/inferior teeth. Energy source: None. Connectivity: None. Sterilization: Not specified. Software: None.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1). DDD defined as discogenic back pain with radiographic degeneration; may include up to Grade 1 spondylolisthesis or retrolisthesis. Patients may have prior non-fusion surgery at the level. Requires 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 Ti-Bond® (K110632)
• Lucent® Lateral (K122967)

Submission Summary (Full Text)

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

May 19, 2015

Spinal Elements, Incorporated Julie Lamothe, Ph.D., M.B.A. Regulatory Affairs and Quality Assurance Director 3115 Melrose Drive, Suite 200 Carlsbad, California 92010

Re: K150061

Trade/Device Name: LUCENT®, LUCENT Ti-BOND® Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: March 16, 2015 Received: March 18, 2015

Dear Dr. Lamothe:

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 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

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Page 2 - Dr. Julie Lamothe

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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

# Lori A. Wiggins -S

for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K150061

Device Name LUCENT®, LUCENT TI-BOND®

#### Indications for Use (Describe)

Lucent® and Lucent Ti-Bond® are intervertebral body fusion devices 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).

These devices are 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, and anterior screw and rod systems).

These devices are 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 these devices.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Premarket Notification –Lucent® Intervertebral Body Fusion Device

# 510(k) Summary Lucent® and Lucent Ti-Bond®

#### 510(k) Number: K150061

# I. SUBMITTER

Spinal Elements, Inc. 3115 Melrose Dr., Suite 200 Carlsbad, CA 92010 P. 760-607-0121 F. 760-607-0125

| Contact Information: | Julie Lamothe<br>Director Regulatory Affairs<br>Spinal Elements, Inc.<br>3115 Melrose Dr., Suite 200<br>Carlsbad, CA 92010<br>760-607-1816<br>[e-mail] |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

Date Prepared:

January 12th, 2015

# II. DEVICE

| Proprietary Name | Lucent®; Lucent Ti-Bond® |
|---------------------------|---------------------------------------------|
| Common Name | Intervertebral Body Fusion Device |
| Device Classification | 21 CFR 888.3080 (Appliance, Fixation Spinal |
| | Intervertebral Body) |
| Proposed Regulatory Class | Class II |
| Device Product Code | MAX |

# III. PREDICATE DEVICE

| Primary Predicate Name | Lucent® |
|------------------------|-----------------|
| Regulatory Class | Class II |
| Submission No | K071724 |
| Device Code | MAX |
| Predicate Name | Lucent Ti-Bond® |
| Regulatory Class | Class II |
| Submission No | K110632 |
| Device Code | MAX |

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| Predicate Name | Lucent® Lateral |
|------------------|-----------------|
| Regulatory Class | Class II |
| Submission No | K122967 |
| Device Code | MAX |

### IV. DEVICE DESCRIPTION

The Lucent® device is an intervertebral body fusion device 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.

#### V. INDICATION FOR USE

Lucent intervertebral body fusion devices are 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 non-operative treatment prior to being treated with this device.

# VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The subject device is identical in indications for use, surgical technique, manufacturing method, raw material and instrumentation to the predicate devices cleared in K071724. K110632 and K122967. The difference to the Lucent device is the introduction of a rounded anterior end. The devices will be marketed with and without a plasma-spraved porous titanium surface. The specifications and manufacturing of the titanium coating is identical to that of the predicate devices cleared in K110632 and K122967. In addition, line item configurations have been added to the Lucent line. These sizes do not constitute a smaller or larger footprint than the devices cleared in K110632 and K122967. Neither modification raises any new issues of safety or effectiveness.

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# VII. PERFORMANCE DATA

# Biocompatibility Testing

Biocompatibility testing were performed in accordance with FDA Memorandum #G95-1 and ISO 10993-1 Part 1. The Lucent devices are considered permanent implant devices contacting tissue/bone. The PEEK material biocompatibility relevant to the device contact type is presented in Invibio device master file (MAF 1209). The titanium coating material is commercially pure titanium. The coating is in accordance with ASTMF 1580. which address the biocompatibility of the material. No further testing were required.

# Electrical safety and electromagnetic compatibility (EMC)

No electrical and electromagnetic compatibility testing were performed.

# Software Verification and Validation Testing

The device does not contain software. Therefore no software verification and validation testing were performed.

# Mechanical testing

Non-clinical testing were used to support the decision of substantial equivalence. Nonclinical testing consisted of the following testing performed in accordance with the FDA guidance Class II Special Controls Guidance Document: Intervertebral Body Fusion Device:

- . Static Compression
- . Dynamic Compression

# Animal Study

No animal studies were performed.

# Clinical Studies

No clinical studies were performed.

# VII. CONCLUSIONS

Based on our analysis of the test data, the device performs comparably to the predicate device that is currently marketed for the same intended use.