← Product Code [MAX](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MAX) · K211388

# Lateral Spine Truss System (LSTS) Interbody Fusion Device (K211388)

_4Web Medical, Inc. · MAX · Aug 5, 2021 · Orthopedic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MAX/K211388

## Device Facts

- **Applicant:** 4Web Medical, Inc.
- **Product Code:** [MAX](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MAX.md)
- **Decision Date:** Aug 5, 2021
- **Decision:** SESE
- **Submission Type:** Special
- **Regulation:** 21 CFR 888.3080
- **Device Class:** Class 2
- **Review Panel:** Orthopedic
- **Attributes:** Therapeutic

## Intended Use

The Lateral Spine Truss System (LSTS) 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 discogence 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. All LSTS Interbody Fusion Devices 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. Interbodies with 18° lordosis or greater must be used with the 4WEB Lumbar Spine Truss System Plating Solution (LSTS-PS) with integrated fixation. If using the 1-hole 4WEB LSTS-PS with integrated fixation, additional supplemental fixation is required (e.g. posterior fixation). These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s).

## Device Story

Lateral Spine Truss System (LSTS) is an interbody fusion device featuring an open-architecture truss design manufactured via additive manufacturing. It provides structural support while facilitating bone growth through its open structure and hierarchical surface roughness. The device is implanted by surgeons in a clinical setting to treat degenerative disc disease. It is constructed from Ti6Al4V alloy and is available in various sizes and lordotic angles (including 18°, 24°, and 30°). For lordotic angles ≥18°, the device must be used with the 4WEB Lumbar Spine Truss System Plating Solution (LSTS-PS) for integrated fixation. The device requires supplemental fixation (e.g., posterior fixation) and bone graft (autograft/allogenic) to achieve fusion. The surgeon uses the device to stabilize the spinal segment, aiming to reduce pain and promote fusion in patients with DDD.

## Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including finite element analysis, axial screw pushout (ASTM F543), static/dynamic axial compression, static/dynamic compression shear (ASTM F2077), expulsion testing, and MR conditional testing.

## Technological Characteristics

Material: Ti6Al4V alloy. Manufacturing: Additive manufacturing with hierarchical surface roughness. Design: Open architecture truss. Connectivity: None. Sterilization: Not specified. Standards: ASTM F543 (screw pushout), ASTM F2077 (compression/shear/fatigue).

## Regulatory 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 Lateral Spine Truss System (LSTS) Interbody Fusion Device ([K172392](/device/K172392.md))

## Reference Devices

- 4WEB Lumbar Spine Truss System Plating Solution (LSTS-PS) ([K203065](/device/K203065.md))
- Zimmer-Biomet (Lanx) Timberline MPF ([K131547](/device/K131547.md))

## Submission Summary (Full Text)

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August 5, 2021

4WEB Medical, Inc. % Richard Jansen, Pharm. D. President Silver Pine Consulting, LLC 3851 Mossy Oak Drive Fort Myers, Florida 33905

Re: K211388

Trade/Device Name: Lateral Spine Truss System (LSTS) Interbody Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, OVD Dated: July 7, 2021 Received: July 9, 2021

Dear Dr. 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Brent L. Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K211388

#### Device Name

Lateral Spine Truss System (LSTS) Interbody Fusion Device

#### Indications for Use (Describe)

The Lateral Spine Truss System (LSTS) 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 discogence 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. All LSTS Interbody Fusion Devices 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. Interbodies with 18° lordosis or greater must be used with the 4WEB Lumbar Spine Truss System Plating Solution (LSTS-PS) with integrated fixation. If using the 1-hole 4WEB LSTS-PS with integrated fixation, additional supplemental fixation is required (e.g. posterior fixation). These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s).

Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)

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

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# 510(k) Summary

| Date Prepared:      | July 6, 2021                                                                                                                            |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Contact:            | Jessee Hunt, President<br>4WEB, Inc.<br>2801 Network Blvd., Suite 620<br>Frisco, TX 75034<br>Phone: (800) 285-7090<br>Fax: 972-488-1816 |
| Regulatory Contact: | Rich Jansen, Pharm. D.<br>Silver Pine Consulting, LLC<br>richj@s-pineconsulting.com                                                     |
| Trade Name:         | Lateral Spine Truss System (LSTS) Interbody Fusion Device                                                                               |
| Product Class:      | Class II                                                                                                                                |
| Classification:     | 21 CFR §888.3080                                                                                                                        |
| Common Name:        | Intervertebral Body Fusion Device                                                                                                       |
| Product Codes:      | MAX, OVD                                                                                                                                |
| Panel Code:         | 87                                                                                                                                      |

#### Purpose:

The purpose of this submission is to expand the Lateral Spine Truss System (LSTS) Interbody Fusion Device lordotic offering to include 18°, 24°, and 30° of lordosis. Additionally, the Indications for Use are being updated to include use of the 4WEB Lumbar Spine Truss System Plating Solution (LSTSbs).

### Indications for Use:

The Lateral Spine Truss System (LSTS) 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. All LSTS Interbody Fusion Devices 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. Interbodies with 18° lordosis or greater must be used with the 4WEB Lumbar Spine Truss System Plating Solution (LSTS-PS) with integrated fixation. If using the 1hole 4WEB LSTS-PS with integrated fixation, additional supplemental fixation is required (e.g. posterior fixation). These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s).

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## 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 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 Lateral Spine Truss System (LSTS) Interbody Fusion Device (K172392). Reference predicates include the 4WEB Lumbar Spine Truss System Plating Solution (LSTS-PS) (K203065) and the Zimmer-Biomet (Lanx) Timberline MPF (K131547).

## Performance Standards:

Validated finite element analysis demonstrated that the product line extension for the Lateral Spine Truss System (LSTS) Interbody Fusion Device does not introduce a new worst-case compared to the previously cleared 4WEB Lumbar Interbody Fusion Devices for mechanical properties of the device.

Performance testing has been completed per the following standards for the combined Lateral Spine Truss System (LSTS) Interbody Fusion Device and the Lumbar Spine Truss System Plating Solution (LSTS-PS):

- Axial screw pushout per ASTM F543
- Static axial compression per ASTM F2077
- Static compression shear per ASTM F2077
- Dynamic axial compression fatigue per ASTM F2077
- o Dynamic compression shear fatigue per ASTM F2077
- Expulsion testing
- 0 MR Conditional testing

The results of this non-clinical testing show that the strength of the LSTS Interbody Fusion Device and LSTS Plating Solution is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.

### Technological Characteristics:

4WEB, Inc. has compared these devices to the previously cleared predicate devices in regard to indications for use, materials, function, sizes and simulated testing. These comparisons demonstrate substantial equivalence to the predicate devices.

## Conclusion:

4WEB, Inc. concludes that the LSTS Interbody Fusion Device is substantially equivalent to the predicate devices and raise no new questions of safety or effectiveness.

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**Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MAX/K211388](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MAX/K211388)

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