STAXX IBL SYSTEM

K132719 · Spine Wave, Inc. · MAX · Oct 4, 2013 · Orthopedic

Device Facts

• Record ID: K132719
• Device Name: STAXX IBL SYSTEM
• Applicant: Spine Wave, Inc.
• Product Code: MAX · Orthopedic
• Decision Date: Oct 4, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The StaXx® IBL 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 1 spondylolisthesis or retrolisthesis at the involved level(s). The StaXx® IBL 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

Intervertebral body fusion device; consists of stackable PEEK-OPTIMA wafers with 6% Barium Sulfate and tantalum markers; used to adjust implant height during surgery. Includes delivery device for implantation and expansion. Used in lumbar spine fusion procedures; requires autogenous bone graft and supplemental fixation. Operates via mechanical expansion of stacked wafers to restore disc height. Benefits patient by stabilizing spinal segment and facilitating fusion in DDD cases.

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 (ASTM F2267).

Technological Characteristics

Materials: PEEK-OPTIMA with 6% Barium Sulfate and tantalum markers. Design: Stackable wafer system for height adjustment. Mechanical testing standards: ASTM F2077 (axial compression, compression shear), ASTM F2267 (subsidence).

Indications for Use

Indicated for skeletally mature patients with lumbar degenerative disc disease (DDD) at one or two contiguous levels (L2-L5). Includes patients with up to Grade 1 spondylolisthesis or retrolisthesis. Requires 6 months of prior 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)

Submission Summary (Full Text)

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## 510(k) Summary StaXx® IBL System

#### 1. Submitter Information

Submitter: Spine Wave. Inc. Address: Three Enterprise Drive Suite 210 Shelton, CT 06484 Telephone: [phone] Telefax:

Contact: Roaida Rizkallah Date Prepared: August 29, 2013

OCT 0 4 2013

#### 2. Device Information

| Trade Name: | StaXx ® IBL 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 additional sizes of implants utilizing the StaXx® technology for intervertebral body fusion.

#### 4. Predicate Device Information

The StaXx® IBL 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 |

#### 5. Device Description

The StaXx® IBL System is an intervertebral body fusion device composed of wafers that are stacked into an expandable implant to adjust the height of the implant. The implants are to be used with autogenous bone graft material. The implant components are manufactured from PEEK-OPTIMA with 6% Barium

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Sulfate and tantalum markers. The system also includes a delivery device to both implant and expand the implant.

#### 6. Intended Use

The StaXx® IBL 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 1 spondylolisthesis or retrolisthesis at the involved level(s). The StaXx® IBL 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 StaXx® IBL System to the predicate is shown by similarity in intended use. indications for use, materials and performance.

#### 8. Performance Data

The modified implants were compared to constructs previously tested in static and dynamic axial compression (ASTM F2077), static and dynamic compression shear (ASTM F2077), and subsidence (ASTM F2267). An engineering rationale determined that the proposed implants do not represent a new worst case and were therefore determined to the substantially equivalent to the predicate devices.

#### 9. Conclusion

Based on the indications for use, technological characteristics, and comparison to the predicate, the StaXx® IBL. System has been shown to be substantially equivalent to the predicate device identified in this submission, and does not present any new issues of safety or effectiveness

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three tail feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public I lealth Service

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

October 4, 2013

Spine Wave, Incorporated Roaida Rizkallah Regulatory Affairs Manager Three Enterprise Drive, Suite 210 Shelton, Connecticut 06484

Re: K132719

Trade/Device Name: StaXx 18 IBI. System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: September 5, 2013 Received: September 6, 2013

Dear Roaida Rizkallah:

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 cither 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 – Roaida Rizkallah

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic 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" (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 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,

# Erin詞《eith

for

Mark N. Melkerson Director Division of Orthonedic 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

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

510(k) Number (if known) K132719

Device Name StaXx(R) IBL System

Indications for Use (Describe)

The StaXx® IBL System is indicated for intervertebral body fusion procedures in skeletally mature patients with disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-L5. Degenerative disc discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolistesis at the involved level(s). The StaXx® IBL System is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an interverebral 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)

### Anton E. Dmitriev, PhD Division of Orthopedic Devices

Post Ituldmining versues | Bell | 481-f.740