ABACUS TM SPACER SYSTEM

K140007 · Spine Wave, Inc. · MAX · Apr 7, 2014 · Orthopedic

Device Facts

• Record ID: K140007
• Device Name: ABACUS TM SPACER SYSTEM
• Applicant: Spine Wave, Inc.
• Product Code: MAX · Orthopedic
• Decision Date: Apr 7, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Abacus "10 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-L5. 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 Abacus™ 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.

Device Story

Abacus™ Spacer System is an intervertebral body fusion device used in lumbar spine surgery. Device is rectangular with textured 'tooth' surfaces to resist migration and an internal cavity for autograft material. Implanted by surgeons during fusion procedures to stabilize spinal segments. Benefits include facilitating fusion in patients with DDD. Device is passive; no software or algorithm involved.

Clinical Evidence

Bench testing only. Mechanical performance evaluated via static and dynamic axial compression (ASTM F2077), static and dynamic compression shear (ASTM F2077), and subsidence testing (ASTM F2267).

Technological Characteristics

Materials: PEEK-OPTIMA (ASTM F2026) and tantalum markers (ASTM 560/ISO 13782). Form factor: Rectangular spacer with textured surface. Principle: Passive intervertebral body fusion device. No software or energy source.

Indications for Use

Indicated for skeletally mature patients with lumbar degenerative disc disease (DDD) at one or two contiguous levels (L2-L5) with up to Grade I spondylolisthesis or retrolisthesis. Requires autogenous bone graft and supplemental fixation. Patients must have failed 6 months of 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

• StaXx® IBL System (K131071, K132719)
• CoRoent® System (K071795)

Submission Summary (Full Text)

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K140007 Page 1 of 2

APR 0 7 2014

Image /page/0/Picture/2 description: The image shows the word "SpineWave" in a bold, sans-serif font. The word is all capitalized except for the "W", which is larger than the other letters. A curved line runs underneath the word, starting below the "E" in "Spine" and ending below the "E" in "Wave".

# 510(k) Summary Abacus™ 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: | Joseph Mercado |
| Date Prepared: | March 25, 2014 |

### 2. Device Information

| Trade Name: | Abacus™ 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 Abacus™ Spacer System described in this submission is substantially equivalent to the following predicates:

| Predicate Device | Manufacturer | 510(k) No. |
|-------------------|------------------|------------------|
| StaXx® IBL System | Spine Wave, Inc. | K131071, K132719 |
| CoRoent® System | NuVasive, Inc. | K071795 |

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## 5. Device Description

The Abacus™ Spacer System is an intervertebral body fusion device manufactured from PEEK-OPTIMA (ASTM F2026) and includes tantalum markers (ASTM 560/ISO 13782). The Abacus™ Spacer System is available in a variety of shapes and sizes to accommodate variations in anatomy. The Abacus™M Spacer System is a rectangular-shaped device with a textured "tooth" pattern on both the superior and inferior surfaces designed to resist migration of the device once it is surgically positioned. The device also incorporates an internal cavity that allows for the placement of autograft material.

### 6. Intended Use

The Abacus "10 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-L5. 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 Abacus™ 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.

### 7. Comparison of Technological Characteristics

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

### 8. Performance Data

The following mechanical tests were performed to demonstrate the substantial equivalence of the Abacus The 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)

### 9. Conclusion

Based on the indications for use, technological characteristics, performance testing and comparison to the predicates, the Abacus™ 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.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three tails, representing the three levels of government: federal, state, and local. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

### Public Health Service

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

April 7, 2014

Spine Wave, Incorporated Mr. Joseph Mercado Regulatory Affairs Specialist Three Enterprise Drive, Suite 210 Shelton, Connecticut 06484

Re: K140007

Trade/Device Name: Abacus™ Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: January 16, 2014 Received: January 17, 2014

### Dear Mr. Mercado:

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 - Mr. Joseph Mercado

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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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/McdicalDevices/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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

# Ronald: P.Jean -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) K140007

Device Name AbacusTM Spacer System

### Indications for Use (Describe)

The AbacusTM Spacer System is indicated for interverebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-L5. 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 or retrolisthesis at the involved level(s). The AbacusTM Spacer System is to be used with autogenous bone grafi and with supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral body fusion device.

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

> 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.

FOR FDA USE ONLY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page,