Lucent® XP

K182584 · Spinal Elements, Inc. · MAX · Dec 10, 2018 · Orthopedic

Device Facts

• Record ID: K182584
• Device Name: Lucent® XP
• Applicant: Spinal Elements, Inc.
• Product Code: MAX · Orthopedic
• Decision Date: Dec 10, 2018
• 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). 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). This device is intended to be used with autograft or allogenic bone graft comprised of cancellous 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. Box-shaped implant with internal voids for autograft or allogenic bone graft (cancellous/corticocancellous); superior/inferior surfaces feature sharp teeth to prevent migration. Used by surgeons in clinical settings to facilitate spinal fusion; requires supplemental fixation (pedicle screw/rod or anterior plate/screw systems). Device provides structural support to disc space during fusion process; benefits patient by stabilizing vertebral segments and reducing pain associated with DDD.

Clinical Evidence

No clinical studies were performed. Substantial equivalence supported by non-clinical bench testing, including static and dynamic compression and compression-shear testing per ASTM F2077-14.

Technological Characteristics

Intervertebral body fusion device; box-shaped with graft-holding voids and surface teeth. Materials and manufacturing identical to K152011. Available with or without plasma-sprayed porous titanium coating. Mechanical testing per ASTM F2077-14. No electrical/EMC components.

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 confirmation; may include up to Grade 1 spondylolisthesis or retrolisthesis. Includes patients with prior non-fusion surgery at involved levels. Requires 6 months non-operative treatment. Contraindications: none stated.

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® devices (K152011)
• Lucent® devices (K110632)
• Lucent® devices (K170235)

Submission Summary (Full Text)

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December 10, 2018

Image /page/0/Picture/11 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Spinal Elements, Inc. Ms. Cheryl Allen Regulatory Affairs Manager 3115 Melrose Dr., Suite 200 Carlsbad, California 92010

Re: K182584

Trade/Device Name: Lucent® XP Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: September 20, 2018 Received: September 21, 2018

Dear Ms. Allen:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Melissa Hall -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) K182584

Device Name Lucent® XP

#### 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).

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).

This device is intended to be used with autograft or allogenic bone graft comprised of cancellous 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) | |
|------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| <span style="text-decoration: overline;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="text-decoration: overline;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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#### 510(k) Summary Lucent® XP

#### 510(k) Number K182584

#### I. SUBMITTER

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

| Contact Information: | Cheryl Allen |
|----------------------|-----------------------------|
| | Regulatory Affairs Manager |
| | Spinal Elements, Inc. |
| | 3115 Melrose Dr., Suite 200 |
| | Carlsbad, CA 92010 |
| | 760-607-1840 |
| | [e-mail] |

| Date Prepared: | October 29, 2018 |
|----------------|------------------|
|----------------|------------------|

| II. DEVICE | |
|---------------------------|---------------------------------------------------------------------|
| Proprietary Name | Lucent® XP |
| Common Name | Intervertebral Body Fusion Device |
| Device Classification | 21 CFR 888.3080 (Appliance, Fixation Spinal<br>Intervertebral Body) |
| Proposed Regulatory Class | Class II |
| Device Product Code | MAX |

#### III. Purpose of this 510k

This Traditional 510(k) seeks clearance for minor modifications to Lucent® XP intervertebral body fusion devices previously cleared under K152011 (10mm footprint), additional sizes (12mm footprint) and an expanded indication for all devices cleared under K152011 to include the use of allogenic bone graft comprised of cancellous and/ or corticancellous bone graft. The new devices have an identical intended use and fundamental scientific technology as the predicate.

## 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 or allogenic bone graft composed of cancellous and/or corticocancellous bone graft. The exterior of the device has "teeth" or other generally sharp

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engagement members on the superior and inferior surfaces to help prevent the device from migrating once it is surgically positioned.

#### V. 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 autograph or allogenic bone graft comprised of cancellous and/or corticancellous 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. SUBSTANTIAL EQUIVALENCE

The subject devices are substantially equivalent in indications for use, surgical technique, design features, manufacturing methods and raw materials to the following predicate devices:

Lucent® devices (K152011): Primary Predicate Lucent® devices (K110632): Additional Predicate Lucent® devices (K170235): Additional Predicate

## VII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The subject device is identical in manufacturing method, raw material, basic operating principles and fundamental scientific technology to the predicate devices cleared in K152011. The subject devices include modifications to the existing 10mm footprint devices and additional sizes to the Lucent® XP devices. The subject device is seeking clearance for expanded indications for use to include autograph or allogenic bone graft comprised of cancellous and/or corticancellous bone graft. The subject device indications for use are identical to the indications for use as the additional predicate cleared in K170235. The devices will be marketed sterile and non-sterile. The specifications and manufacturing of the titanium coating is identical to that of the predicate devices cleared in K152011. The devices will be marketed with and without a plasma-sprayed porous titanium surface. The modifications do not raise any new issues of safety or effectiveness when compared to the predicate devices.

#### VIII. PERFORMANCE DATA Biocompatibility Testing

The materials used to manufacture the subject devices as well as the manufacturing processes for the devices seeking clearance are identical as the materials and processes identified in previously cleared K152011 Lucent XP® submission.

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#### 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

The subject device has the same performance characteristics as the previously cleared predicate device K152011. Non-clinical testing was used to support the decision of substantial equivalence. Non-clinical testing consisted of the following testing performed in accordance with the FDA guidance Class II Special Controls Guidance Document: Intervertebral Body Fusion Device:

- Static and Dynamic Compression Testing per ASTM F 2077-14
- Static and Dynamic Compression Shear Testing per ASTM F 2077-14 o

All data indicates that the device will perform as intended.

#### Animal Study

No animal studies were performed.

#### Clinical Studies

No clinical studies were performed.

## VIIII. CONCLUSIONS

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