Lucent Intervertebral Body Fusion Device

K152011 · Spinal Elements, Inc. · MAX · Jun 9, 2016 · Orthopedic

Device Facts

• Record ID: K152011
• Device Name: Lucent Intervertebral Body Fusion Device
• Applicant: Spinal Elements, Inc.
• Product Code: MAX · Orthopedic
• Decision Date: Jun 9, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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, 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

Lucent XP is an intervertebral body fusion device (interbody cage) for lumbar spinal surgery. Device features two PEEK endplates with teeth for vertebral engagement and an internal titanium expansion mechanism. Box-shaped design includes apertures for autograft placement. Surgically implanted by a surgeon to facilitate spinal fusion. Device provides structural support to the disc space while bone graft promotes fusion. Used in conjunction with supplemental spinal fixation systems (pedicle screws/rods or anterior plates). Benefits include stabilization of the spinal segment in patients with degenerative disc disease.

Clinical Evidence

Bench testing only. Performance data included static and dynamic compression testing (ASTM F2077-14) and subsidence testing (ASTM F2267-11). No clinical data provided.

Technological Characteristics

Intervertebral body fusion device. Materials: PEEK-Optima grade LT1 (ASTM F2026), optional commercially pure titanium coating (ASTM F1580), and titanium alloy internal mechanism (ASTM F136). Features PEEK endplates with teeth and internal expansion mechanism. Mechanical device; no software or energy source.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1). Includes patients with up to Grade 1 spondylolisthesis or retrolisthesis and those with prior non-fusion spinal surgery. Requires use with supplemental fixation and autogenous bone graft after at least 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 Ti-Bond (K071724)
• Lucent Lateral (K110632)
• K122967
• K150061
• K123231

Reference Devices

• K093242

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of three human profiles facing right, stacked on top of each other.

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

June 9, 2016

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

Re: K152011

Trade/Device Name: Lucent® Intervertebral Body Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: May 6, 2016 Received: May 9, 2016

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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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/ResourcesforYou/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 yours,

# Mark N. Melkerson -S

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) K152011

Device Name

Lucent® Intervertebral Body Fusion Device

#### Indications for Use (Describe)

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, 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.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------|----------------------------------------------------------------------|
| <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |

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

## 510(k) Number K152011

| Manufacturer Identification<br>Submitted by: | Spinal Elements, Inc.<br>3115 Melrose Dr., Suite 200<br>Carlsbad, CA 92010<br>P. 760-607-0121<br>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: | July 17th, 2015 |
| Proprietary Name<br>Device Classification<br>Proposed Regulatory Class<br>Device Product Code | Lucent® Intervertebral Body Fusion Device<br>21 CFR 888.3080 (Appliance, Fixation Spinal<br>Intervertebral Body)<br>Class II<br>MAX |

#### Purpose of this 510(k)

This 510(k) seeks clearance for line additions to the Lucent Ti-Bond and Lucent Lateral previously cleared for use under K071724 and K150061. K110632. K122967. respectively.

#### Device Description

The Lucent® XP 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 Lucent® XP device is comprised of two PEEK endplates with teeth for engaging the vertebral body endplates on the outside of the device and an internal titanium mechanism for expanding the PEEK endplates of the device. The device is generally box-shaped with various holes throughout its design to allow for the placement of autograft. The exterior

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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. The device is made from PEEK-Optima® grade LT1 conforming to ASTM F2026 with or without a coating of commercially pure titanium conforming to ASTM F1580. The internal mechanism is made from titanium alloy conforming to ASTM F136.

## Indications 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.

## Substantial Equivalence

Lucent® XP and Lucent XP Ti-Bond® is identical in indications for use, manufacturing method, raw material and operating principles to the predicate devices cleared in: K071724 - Primary Predicate

- K093242 Reference Device
- K110632 Additional Predicate
- K122967 Additional Predicate
- K150061 Additional Predicate
- K123231 Additional Predicate

## Performance Data

Performance testing included:

- . Static Compression Testing per ASTM F 2077-14
- Dynamic Compression Testing per ASTM F 2077-14 ●
- Subsidence Testing per ASTM F 2267-11 ●
- . Static & Dynamic Compression Shear Testing per ASTM F2077-14

All data indicates that the device will perform as intended.

Based on the indications for use, technological characteristics, performance testing, comparison to predicate devices, the subject device has been shown to be and substantially equivalent to the aforementioned predicate devices cleared by FDA for commercial distribution in the United States.