Anterior Spine Truss System (STS) Interbody Fusion Device

K170851 · 4Web, Inc. · MAX · Aug 7, 2017 · Orthopedic

Device Facts

• Record ID: K170851
• Device Name: Anterior Spine Truss System (STS) Interbody Fusion Device
• Applicant: 4Web, Inc.
• Product Code: MAX · Orthopedic
• Decision Date: Aug 7, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Anterior Spine Truss System (STS) Interbody Fusion Device is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the device must be used with supplemental fixation and must be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s).

Device Story

Anterior Spine Truss System (STS) is an interbody fusion device featuring an open-architecture truss design created via additive manufacturing. The device provides structural support while allowing space for bone growth and fusion. It is manufactured from Ti6Al4V alloy and features a hierarchical surface roughness. Available in various sizes and lordotic angles to match patient anatomy. Used by surgeons in spinal fusion procedures to treat degenerative disc disease. The device is implanted to facilitate fusion between vertebral bodies, requiring supplemental fixation and bone graft material. Benefits include structural stability and potential for enhanced bone ingrowth due to the truss geometry.

Clinical Evidence

Bench testing only. Performance testing included static and dynamic axial compression, compression shear, and torsion (ASTM F2077), subsidence testing (ASTM F2267-04), MR image artifact (ASTM F2119), MR induced displacement force (ASTM F2052), MR induced torque (ASTM F2213), MR induced heating (ASTM F2182), and expulsion testing.

Technological Characteristics

Material: Ti6Al4V alloy. Design: Open architecture truss via additive manufacturing (EBM) with hierarchical surface roughness. Standards: ASTM F2077, ASTM F2267-04, ASTM F2119, ASTM F2052, ASTM F2213, ASTM F2182. Form factor: Various sizes and lordotic angles. Sterilization: Sterile packaging.

Indications for Use

Indicated for skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1, including those with up to Grade I spondylolisthesis or retrolisthesis. Requires 6 months of failed non-operative treatment. Must be used with supplemental fixation and autograft/allogenic bone graft.

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

• 4WEB ALIF STS (K112316)
• K142112
• K150135
• K160924

Submission Summary (Full Text)

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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

August 7, 2017

Image /page/0/Picture/4 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

4Web. Inc. % Rich Jansen Consultant Silver Pine Consulting, LLC. 3851 Mossy Oak Drive Ft. Myers, Florida 33905

Re: K170851

Trade/Device Name: Anterior Spine Truss System (STS) Interbody Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: July 6, 2017 Received: July 10, 2017

Dear Mr. Jansen:

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

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 contact the Division of Industry and Consumer Education at its toll-free 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/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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

# Mark N. Melkerson -S

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) K170851

Device Name

Anterior Spine Truss System (STS) Interbody Fusion Device

### Indications for Use (Describe)

The Anterior Spine Truss System (STS) Interbody Fusion Device is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the device must be used with supplemental fixation and must be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s).

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

2 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)

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## 510(k) Summary

| Date Prepared: | August 7, 2017 |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Jessee Hunt, President<br>4WEB, Inc.<br>6170 Research Rd. Suite 219<br>Frisco, TX 75033<br>Phone: [phone]<br>Fax: [phone] |
| Regulatory Contact: | Rich Jansen, Pharm. D.<br>Silver Pine Consulting, LLC<br>[e-mail] |
| Trade Name:<br>Product Class: | Anterior Spine Truss System (STS) Interbody Fusion Device<br>Class II |
| Classification: | 21 CFR §888.3080 |
| Common Name: | Intervertebral Body Fusion Device |
| Product Codes: | MAX |
| Panel Code: | 87 |

### Purpose:

The purpose of this submission is to update the system with design changes to implants and instruments, update sterile packaging, add new EBM machining, revise the Indications for Use, and add MR Conditional labeling.

### Indications for Use:

The Anterior Spine Truss System (STS) Interbody Fusion Device is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device must be used with supplemental fixation and must be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s).

## Device Description:

The device is an open architecture truss design mathematically formulated to provide structural support with open space throughout the implant for bone growth and fusion. The 4WEB additive manufacturing process provides a hierarchical surface roughness. The implant is

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made from Ti6Al4V alloy. The device is available in a variety of sizes and lordotic angles to accommodate the patient's anatomy.

## Predicate Device(s):

The primary predicate device is the 4WEB ALIF STS (K112316). Additional predicates include K142112, K150135 and K160924.

## Performance Standards:

Performance testing has been completed per the following standards: ASTMF2077 - Static and dynamic axial compression, static and dynamic compression shear, and static torsion ASTM F2267-04 - Subsidence Testing ASTM F2119 - MR Image Artifact ASTM F2052 - MR Induced Displacement Force ASTM F2213 – MR Induced Torque ASTM F2182 - MR Induces Heating Expulsion testing per accepted industry standard.

## Technological Characteristics:

4Web, Inc. has compared these changes to the previously cleared predicate devices in regards to indications for use, materials, function, sizes and mechanical test results. These comparisons demonstrate substantial equivalence to the predicate devices.

## Conclusion:

4WEB, Inc. concludes that the Anterior Spine Truss System (STS) devices are substantially equivalent to the predicate devices.