SPINEWORKS ANTERIOR LUMBAR DEVICE

K133340 · Spineworks, LLC · MAX · Apr 11, 2014 · Orthopedic

Device Facts

• Record ID: K133340
• Device Name: SPINEWORKS ANTERIOR LUMBAR DEVICE
• Applicant: Spineworks, LLC
• Product Code: MAX · Orthopedic
• Decision Date: Apr 11, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Spineworks Anterior Lumbar Device is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiquous 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). SW ALD Interbody System implants are to be used with autogenous bone graft and implanted via an anterior, lateral or anterolateral approach. SW ALD Interbody System implants are to be used with supplemental fixation. Patients should have at least six (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

SpineWorks Anterior Lumbar Device (ALD) is an intervertebral body fusion cage designed for lumbar spinal stabilization. Device features rounded-trapezoidal geometry with large windows for bone graft packing and surface teeth for stability. Implants are manufactured from medical-grade PEEK (ASTM F2026) with tantalum markers (ASTM F560-08) for radiographic visualization. Available in various heights (10-18mm), widths (26-44mm), and lordotic angles (6°, 11°). Device is implanted by surgeons via anterior, lateral, or anterolateral approaches to maintain disc space distraction and facilitate fusion. Used in conjunction with supplemental fixation. Single-use only.

Clinical Evidence

Bench testing only. Mechanical performance evaluated via static and dynamic compression testing (modified ASTM F2077-03) and subsidence testing (ASTM F2267-04). Results met or exceeded requirements for lumbar intervertebral body fusion devices.

Technological Characteristics

Materials: Medical grade PEEK (ASTM F2026) and tantalum (ASTM F560-08). Form factor: Rounded-trapezoidal cage with lordotic angles (6°, 11°), heights 10-18mm, widths 26-44mm. Sensing/Actuation: None (passive implant). Energy source: None. Sterilization: Not specified. Connectivity: None.

Indications for Use

Indicated for skeletally mature patients with lumbar degenerative disc disease (DDD) at one or two contiguous levels (L2-S1) with discogenic back pain, including those with up to Grade 1 spondylolisthesis or retrolisthesis. Requires use with autogenous bone graft and supplemental fixation. Patients must have failed 6 months of non-operative treatment. Suitable for patients with prior non-fusion spinal surgery at the involved level.

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

• SpineWorks A-Wedge Anterior Interbody System (K111166)
• A-Wedge Anterior Interbody System (K121693)
• XIPHOS™ ALIF (K123969)

Submission Summary (Full Text)

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# 510(k) SUMMARY

## SpineWorks, LLC – Anterior Lumbar Device (ALD)

APR 1 1 2014

In accordance with 21 CFR 807.92 of the Federal Code of Regulations, the following information is a summary of safety and effectiveness SpineWorks' ALD.

### A. SUBMITTERS INFORMATION

| Submitter Name: | BioVera, LLC. |
|---------------------|-------------------------------------|
| Submitter Address: | 815 Iris Lane, Vero Beach, FL 32963 |
| Contact Person: | Robert A Poggie, PhD |
| Phone Number: | [phone]; [phone] |
| Fax Number: | [phone] |
| Date of Submission: | January 20, 2014 |

# B. DEVICE IDENTIFICATION & MANUFACTURER

| Manufacturer Name: | SpineWorks, LLC |
|-----------------------|--------------------------------------------------------|
| Manufacturer Address: | 2802 Florida Street<br>Huntington Beach, CA 92647, USA |
| Registration Number: | 3005471884 |
| Contact Name: | Doug Neary |
| Title: | President |
| Device Trade Name: | SpineWorks Anterior Lumbar Device |
| Device Common Name: | Intervertebral body fusion device |
| Classification Name: | Intervertebral body fusion device - lumbar |
| Classification Code: | MAX - Class II |
| Classification Panel: | Orthopedic |
| Regulation Number: | 21 CFR section 888.3080 |

#### C. PREDICATE DEVICES

| K111166 | SpineWorks A-Wedge Anterior Interbody System; manufactured by<br>SpineWorks, LLC |
|---------|----------------------------------------------------------------------------------|
| K121693 | A-Wedge Anterior Interbody System manufactured by Sapphire<br>Medical Group, LLC |
| K123969 | The XIPHOS™ ALIF manufactured by Diffusion Technologies |

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#### D. DEVICE DESCRIPTION

The SpineWorks Anterior Lumbar Device (SW ALD) was developed for the stabilization of the lumbar spinal column. The body of the device is a rounded-trapezoidal shape with two large windows allowing placement of bone graft and facilitating fusion. The superior and inferior surfaces of the devices have a pattern of teeth to provide increased stability and inhibit movement of the implants. SW ALD implants are available in two lordotic configurations (6° and 11°) of various heights and widths to restore lumbar lordosis and the associated sagittal balance. SW ALD implants have three tantalum x-ray markers. The SW ALD device is single-use only.

Materials: Medical grade PEEK (ASTM F2026) machined from Vestakeep i4R extruded bar stock (Evonik Polymers Technologies GmbH, FDA master file MAF #1922). Medical grade tantalum (ASTM F560-08) was used to fabricate the radio opaque markers.

Function: SW ALD devices are used to maintain disc space distraction in skeletally mature adults requiring intervertebral body fusion.

#### E. INTENDED USE

The Spineworks Anterior Lumbar Device is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiquous levels from L2-\$1. 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). SW ALD Interbody System implants are to be used with autogenous bone graft and implanted via an anterior, lateral or anterolateral approach. SW ALD Interbody System implants are to be used with supplemental fixation. Patients should have at least six (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.

#### F. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

Subject SW ALD devices are machined from medical grade extruded PEEK bar stock and fitted with radio opaque markers made from tantalum for visualization in radiography. The PEEK and tantalum materials are intended for permanent implantation. SW ALD devices are designed to fit the anatomic profile of the lumbar spine. Two lordosis-angle options are offered; 6 and 11 degrees. Height options range from 10 to 18mm, in 2 mm increments. One depth option is offered, 24 mm, and four width options of 26, 30, 38, and 44 mm.

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The technological characteristics of SpineWorks ALD devices are identical to the cited predicated device excepting a change in the extruded PEEK bar stock that is used to machine the subject devices and addition of two width options of 38 and 44mm. The design, instruments, sterilization, labeling, intended use, two of four width options, and machining processes are identical for the subject device and the cited predicate devices. The change in material is as follows: the subject SW ALD devices are machined from Evonik Vestakeep i-Grade stock shapes, and the predicate A-Wedge AIS devices are machined from Orthoplastics Ltd. Vertepeek extruded bar and the predicate SpineWork's A-Wedge A.I.S. devices are machined from Invibio PEEK-OPTIMA extruded bar. The predicate device. K123969, is machined from the identical Evonik i4R PEEK bar stock as the subject SW ALD device, and is similarly indicated for lumbar spinal fusion.

Mechanical testing per the FDA Guidance Document for spinal devices and the information contained in Evonik's master file MAF # 1922 show the change in materials for the subject SW ALD devices and predicates Sapphire Medical Group's A-Wedge AIS and SpineWork's A-Wedge A.I.S. devices do not raise new types of safety and efficacy issues; therefore the subject and predicate devices are substantially equivalent.

# G. PERFORMANCE DATA

Characterization of SW ALD devices was performed per the FDA Guidance Document entitled "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device" issued on June 12, 2007. Mechanical testing of the devices was performed per modified version of ASTM standard F2077-03 for static compression and dynamic compression. Also, ASTM F2267-04 was performed to evaluate subsidence. All static and dynamic test results met or exceeded the requirements for intervertebral body fusion devices intended for use in the lumbar spine.

### H. CONCLUSION

The SW ALD Interbody System is substantially equivalent to the predicate devices in terms of indications for use, design, materials, performance, and function.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three overlapping lines forming a wing-like shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.

#### 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

April 11, 2014

Spine Works, LLC % Robert A. Poggie, Ph.D. BioVera, LLC 815 Iris Lane Vero Beach, Florida 32963

Re: K133340

Trade/Device Name: SpineWorks Anterior Lumbar Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: January 20, 2014 Received: January 23, 2014

Dear Dr. Poggie:

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 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.

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Page 2 - Robert A. Poggie, Ph.D.

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/MedicalDevices/Safcty/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.

# Ronald#. 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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# Indications for Use

510(k) Number (if known) K133340

Device Name Spine Works Anterior Lumbar Device

Indications for Use (Describe)

The SpineWorks Anterior Lumbar Device 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 at the involved level(s). SpineWorks Anterior Lumbar Devices are to be used with autogenous bone graft and implanted via an anterior, lateral or anterolateral approach. SpineWorks Anterior Lumbar Devices are to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage. Patients with previous non-fusion spinal surgery at involved level may be treated with the 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 ONLY ONLY のないと、出張り、日本語として、 1 .. 48 124 12 13 12 13 13 13 13 13 13

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

# Anton E. Dmitriev, PhD

## 12.2.1.1. Introduction

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## 12.2.1.2. RIFF Header

The RIFF header is 12 bytes long and has the following format:

| Offset | Size | Description the RIFF header is 12 bytes long and has the following format:

| Offset | Size | Description |
| - - - | - - - | - - - |
| 0 | 4 | The ASCII string "RIFF". |
| 4 | 4 | The size of the file, in bytes, minus 8. |
| 8 | 4 | The ASCII string "WAVE". |

Division of Orthopedic Devices

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