STAXX(R) IB SYSTEM

K123461 · Spine Wave, Inc. · MAX · Apr 11, 2013 · Orthopedic

Device Facts

• Record ID: K123461
• Device Name: STAXX(R) IB SYSTEM
• Applicant: Spine Wave, Inc.
• Product Code: MAX · Orthopedic
• Decision Date: Apr 11, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The StaXx® IB 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 StaXx® IB 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

StaXx® IB System is an intervertebral body fusion device; consists of stackable wafers forming an expandable implant. Used in lumbar spine fusion procedures; requires autogenous bone graft and supplemental fixation. Implanted via specialized delivery device; allows for in-situ expansion to adjust implant height. Used by surgeons in clinical settings. Provides structural support for fusion; benefits patients with discogenic back pain by restoring disc space height and facilitating stabilization.

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 and PEEK-OPTIMA with 6% Barium Sulfate. Design: Stackable wafer system for in-situ expansion. 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-S1), including those with up to Grade I spondylolisthesis or retrolisthesis, who 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

• Distractable Wave Cage (K083626)
• Caliber™ Spacer (K102293)
• Opticage™ Interbody Fusion Device (K113527)

Submission Summary (Full Text)

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K123461

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APR 1 1 2013

# 510(k) Summary StaXx® IB System

# 1. Submitter Information

SPINE WAVE

| 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 Rizkallah | |

| Contact: | Roalda Rizkania |
|----------------|-----------------|
| Date Prepared: | April 11, 2013 |

# 2. Device Information

| Trade Name: | StaXx® IB 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 StaXx® IB System described in this submission is substantially equivalent to the following predicates:

| Predicate Device | Manufacturer | 510(k) No. |
|--------------------------------------|----------------------------------|------------|
| Distractable Wave Cage | Advanced Medical<br>Technologies | K083626 |
| Caliber™ Spacer | Globus Medical, Inc. | K102293 |
| Opticage™ Interbody<br>Fusion Device | Interventional Spine, Inc. | K113527 |

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#### 5. Device Description

The StaXx® IB System is an intervertebral body fusion device composed of wafers that are stacked into an expandable implant to adjust the implant. The implant. The implants are to be used with autogenous bone graft material. The implant components are manufactured from both PEEK-OPTIMA and PEEK-OPTIMA with 6% Barium Sulfate. The system also includes a delivery device to both implant and expand the system.

#### 6. Intended Use

The StaXx® IB 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 StaXx® IB 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® IB 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 StaXx® IB System to its predicate:

- . Static and dynamic axial compression (per ASTM F2077)
- Static and dynamic compression shear (per ASTM F2077) t
- Subsidence (per ASTM F2267) .

#### 9. Conclusion .

Based on the indications for use, technological characteristics, performance testing and comparison to the predicates, the StaXx® IB 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

Public Health Service

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

# Letter dated: April*11, 2013

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

Re: K123461

Trade/Device Name: StaXx® IB System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: March 13, 2013 Received: March 14, 2013

Dear Ms. 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 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 Rizkallah

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" (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,

Mark NMelkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### A. Indications for Use

:

ﻨﯽ

K123461 510(k) Number (if known): StaXx® IB System Device Name: _______________

Indications for Use:

The StaXx® IB 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 StaXx® IB 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.

Prescription Use X (Part 21 CFR 801 Subpart D)

And / Or

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

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elizabet摘@grank -S

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Division of Orthopedic Devices