LEVA (TM) SPACER SYSTEM

K141980 · Spine Wave, Inc. · MAX · Jan 26, 2015 · Orthopedic

Device Facts

• Record ID: K141980
• Device Name: LEVA (TM) SPACER SYSTEM
• Applicant: Spine Wave, Inc.
• Product Code: MAX · Orthopedic
• Decision Date: Jan 26, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Leva™ Spacer System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The Leva™ Spacer System is to be used with autogenous bone graft and with supplemental fixation. Patients should have at least six (6) months of nonoperative treatment prior to treatment with an intervertebral body fusion device.

Device Story

Leva™ Spacer System is an intervertebral body fusion device for lumbar spine surgery. Available in fixed and expandable configurations; expandable version deployed in-situ to predefined height via Leva™ Inserter Instrument. Implants feature curved, ridged endplates to conform to anatomy and resist expulsion; designed to house autogenous bone graft. Used by surgeons in clinical settings to facilitate fusion in patients with DDD. Provides structural support to the disc space; promotes spinal stability when used with supplemental fixation. Benefits patients by addressing discogenic back pain through surgical fusion.

Clinical Evidence

Bench testing included static and dynamic axial compression (ASTM F2077), static and dynamic compression shear (ASTM F2077), and subsidence testing (ASTM F2267). Additionally, cadaveric validation was performed. No clinical trial data was required or presented.

Technological Characteristics

Fabricated from unalloyed commercially pure (Class II) titanium per ASTM F67. Available in fixed and expandable configurations. Expandable version utilizes an inserter instrument for in-situ height adjustment. Features curved, ridged endplates. Mechanical performance validated per ASTM F2077 and ASTM F2267.

Indications for Use

Indicated for skeletally mature patients with lumbar degenerative disc disease (DDD) at one or two contiguous levels (L2-S1), including up to Grade I spondylolisthesis or retrolisthesis. Requires use with autogenous bone graft and supplemental fixation 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

• Distractable Wave Cage (K083626)
• Patriot™ Spacer (K072970)
• Ray Threaded Fusion Cage (P950019)

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

January 26, 2015

Spine Wave, Incorporated Ms. Roaida Johnson Senior Regulatory Affairs Manager 3 Enterprise Drive, Suite 210 Shelton, Connecticut 06484

Re: K141980

Trade/Device Name: Leva™ Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: January 2, 2015 Received: January 5, 2015

Dear Ms. Johnson:

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 - Ms. Roaida Johnson

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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known)

K141980

Device Name Leva(TM) Spacer System

#### Indications for Use (Describe)

The Leva™ Spacer System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radios. These DDD patients may have up to Grade I spondylolisthesis at the involved level(s). The Leva™ Spacer System is to be used with autogenous bone graft and with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral body fusion device.

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

#### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

SE OFFOR FDA USE ONLY AND A

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

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Image /page/3/Picture/0 description: The image shows the words "Spine Wave" in a bold, sans-serif font. The words are arranged horizontally, with "Spine" on the left and "Wave" on the right. A blue wave design is located under the word "Wave". The wave design adds a visual element to the logo.

# 510(k) Summary Leva™ Spacer System

## 1. Submitter Information

| Submitter: | Spine Wave, Inc. |
|----------------|----------------------------------------------------------|
| Address: | Three Enterprise Drive<br>Suite 210<br>Shelton, CT 06484 |
| Telephone: | 203-712-1839 |
| Telefax: | 203-944-9493 |
| Contact: | Roaida R. Johnson |
| Date Prepared: | January 21, 2015 |

#### 2. Device Information

| Trade Name: | LevaTM Spacer System |
|----------------------|------------------------------------------------------|
| Common Name: | Intervertebral Body Fusion Device |
| Classification: | Class II (special controls) per 21 CFR 888.3080 |
| Classification Name: | Intervertebral Fusion Device with Bone Graft, Lumbar |
| Product Code: | MAX |

#### 3. Purpose of Submission

The purpose of this submission is to gain clearance for a new intervertebral body fusion device.

### 4. Predicate Device Information

The Leva™ Spacer System described in this submission is substantially equivalent to the following predicates:

| Primary Predicate Device | Manufacturer | 510(k) No. |
|------------------------------|----------------|------------|
| Distractable Wave Cage | AMT | K083626 |
| Additional Predicate Devices | Manufacturer | 510(k) No. |
| Patriot™ Spacer | Globus Medical | K072970 |
| Ray Threaded Fusion Cage | Stryker Spine | P950019 |

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## 5. Device Description

The Leva™ Spacer System is a lumbar intervertebral body fusion device fabricated from unalloyed commercially pure (Class II) titanium per ASTM F67. The device is available in both expandable and fixed configurations. The expandable device is provided in a collapsed form and is expanded to a predefined height in-situ using the Leva™ Inserter Instrument. Both the fixed and expandable implants are provided in different heights to accommodate the anatomical needs for a range of patients. The implants are designed to accommodate autogenous bone graft material. The implants have curved endplates to conform to the bony endplates of the patient and ridges on the endplates to resist expulsion.

## 6. Intended Use

The Leva™ Spacer System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The Leva™ Spacer System is to be used with autogenous bone graft and with supplemental fixation. Patients should have at least six (6) months of nonoperative treatment prior to treatment with an intervertebral body fusion device.

## 7. Comparison of Technological Characteristics

The substantial equivalence of the Leva™ Spacer System to the predicates is shown by similarity in intended use, indications for use, materials and performance.

#### 8. Performance Data

The following testing was performed to demonstrate the substantial equivalence of the Leva™ Spacer System to its predicate:

- Static and dynamic axial compression (per ASTM F2077) ●
- Static and dynamic compression shear (per ASTM F2077) ●
- Subsidence (per ASTM F2267) .
- Cadaveric Validation .

#### 9. Conclusion

Based on the indications for use, technological characteristics, performance testing and comparison to the predicates, the Leva™ Spacer System has been shown to be substantially equivalent to the predicate devices identified in this submission, and does not present any new issues of safety or effectiveness.