A-WEDGE ANTERIOR INTERBODY SYSTEM (A-WEDGE A.I.S.)

K111166 · Spineworks, LLC · MAX · Sep 8, 2011 · Orthopedic

Device Facts

• Record ID: K111166
• Device Name: A-WEDGE ANTERIOR INTERBODY SYSTEM (A-WEDGE A.I.S.)
• Applicant: Spineworks, LLC
• Product Code: MAX · Orthopedic
• Decision Date: Sep 8, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The A-Wedge Anterior Interbody 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 1 spondylolisthesis or retrolisthesis at the involved level(s). A-Wedge Anterior Interbody System implants are to be used with autogenous bone graft and implanted via a transforaminal approach, or an open posterior or lateral approach. The A-Wedge Anterior Interbody System implants are to be used with supplemental fixation. Patients should have at least (6) months of non-operative treatment prior to treatment with an intervertebral cage. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.

Device Story

A-Wedge Anterior Interbody System is a spinal implant for posterior lumbar stabilization; rounded trapezoidal body with windows for bone graft; surface teeth provide stability and inhibit migration. Used by surgeons in clinical settings to maintain disc space distraction during intervertebral body fusion. Implanted via transforaminal, open posterior, or lateral approach; requires supplemental fixation and autogenous bone graft. Benefits patients with discogenic back pain by facilitating fusion and restoring disc height.

Clinical Evidence

No clinical studies were performed. Evidence is based on non-clinical bench testing including static and dynamic compression per ASTM F2077 and subsidence testing per ASTM F2267.

Technological Characteristics

Constructed from PEEK-OPTIMA LT1 polymer (ASTM F2026) and ELI grade Ti-6Al-4V (ASTM F136). Rounded trapezoidal form factor with surface teeth for stability and windows for bone graft. Mechanical performance validated via ASTM F2077 and ASTM F2267. No software or electronic components.

Indications for Use

Indicated for skeletally mature patients with lumbar degenerative disc disease (DDD) at one or two contiguous levels (L2-S1) with up to Grade 1 spondylolisthesis or retrolisthesis. Requires 6 months of failed non-operative treatment. Contraindicated for patients without skeletal maturity or those not requiring supplemental fixation.

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 Straight Intervertebral Body Fusion Device (K071724/ K081968)
• BRANTIGAN I/F CAGE (P960025)
• CoRent System (K071795/K100043)

Reference Devices

• RAY THREADED LUMBAR FUSION CAGE (P950019)
• BRANTIGAN I/F CAGE (P960025)

Submission Summary (Full Text)

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K III 166.

page 1 of 2

### 510(k) Summary for the A-Wedge Anterior Interbody System SEP

In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for the A-Wedge Anterior Interbody System

#### 1. GENERAL INFORMATION

#### DEVICE DESCRIPTION 2.

The A-Wedge Anterior Interbody System (A-Wedge A.I.S.) implants were developed as implants for the posterior stabilization of the lumbar spinal column. The body is rounded trapezoidal in shape with two large windows allowing placement of bone graft and facilitating fusion. The superior and inferior surface of the device has a pattern of teeth to provide increased stability and inhibit movement of the implant.

## Materials:

PEEK-OPTIMA LT1 polymer (ASTM F2026) ELI grade Ti-6AI-4V (ASTM F136)

## Function:

The A-Wedge A.I.S. devices are used to maintain disc space distraction in skeletally mature adults requiring intervertebral body fusion.

#### SUBSTANTIAL EQUIVALENCE CLAIMED TO PREDICATE DEVICES 3.

The A-Wedge A.I.S. is substantially equivalent to the Lucent Straight Intervertebral Body Fusion Device (K071724/ K081968 - Spinal Elements, Inc), BRANTIGAN I/F CAGE (P960025 - DePuy Spine) and CoRent System

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(K071795/K100043 - NuVasive, Inc.) in terms of intended use, design, materials used, mechanical safety and
performances.

The following devices were used as predicates for testing acceptance criteria:

- RAY THREADED LUMBAR FUSION CAGE (P950019)
- . BRANTIGAN I/F CAGE (P960025)

#### 4. INTENDED USE

The A-Wedge Anterior Interbody 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 1 spondylolisthesis or retrolisthesis at the involved level(s). A-Wedge Anterior Interbody System implants are to be used with autogenous bone graft and implanted via an anterior or anterolateral approach. The Anterior Interbody System implants are to be used with supplemental fixation. Patients should have at least (6) months of nonoperative treatment prior to treatment with an intervertebral cage. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.

#### NON-CLINICAL TEST SUMMARY 5.

The following tests were conducted:

- Static and dynamic compression per ASTM F2077 .
- . Subsidence per ASTM F2267

The results of this testing indicate that the ART2 system is equivalent to predicate devices.

#### ર. CLINICAL TEST SUMMARY

No clinical studies were performed

#### 7. CONCLUSIONS NONCLINICAL AND CLINICAL

The A-Wedge A.I.S. is substantially equivalent to the predicate devices in terms of indications for use, design, material, performance and function.

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Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

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

SpineWorks, LLC % OrthoMedix Group, Inc. Mr. J.D. Webb 1001 Oakwood Boulevard Round Rock, Texas 78681

- 8 2011

Re: K111166

Trade/Device Name: A-Wedge Anterior Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: July 22, 2011 Received: July 27, 2011

Dear Mr. Webb:

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

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Page 2 - Mr. J.D. Webb

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson

Director Division of Surgical. Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# INDICATIONS FOR USE

1111166 510(k) Number (if known):

Device Name: _ A-Wedge Anterior Interbody System_

Indications for Use:

The A-Wedge Anterior Interbody 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 1 spondylolisthesis or retrolisthesis at the involved level(s). A-Wedge Anterior Interbody System implants are to be used with autogenous bone graft and implanted via a transforaminal approach, or an open posterior or lateral approach. The A-Wedge Anterior Interbody System implants are to be used with supplemental fixation. Patients should have at least (6) months of non-operative treatment prior to treatment with an intervertebral cage. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

_
(Division Sign-Off)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

KIIII66 510(k) Number_