Tranquil-L Interbody System

K233375 · Nexus Spine, LLC · MAX · Mar 20, 2024 · Orthopedic

Device Facts

• Record ID: K233375
• Device Name: Tranquil-L Interbody System
• Applicant: Nexus Spine, LLC
• Product Code: MAX · Orthopedic
• Decision Date: Mar 20, 2024
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Tranquil-L™ Interbody System is intended 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. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). It is indicated to be used with autograft bone and/or allograft bone comprised of cancellous and/or corticocancellous bone.

Device Story

Lumbar interbody fusion system; used in spinal surgery to treat DDD. Implants manufactured from titanium alloy (Ti-6Al-4V ELI); provided in various angles, widths, heights, and lengths to match patient anatomy. Used by surgeons in clinical settings to facilitate fusion at L2-S1 levels. Implants provided sterile via gamma irradiation; instruments provided clean. Device acts as a spacer to maintain disc height and support fusion when used with supplemental fixation and bone graft. Benefits include stabilization of the spinal segment and promotion of arthrodesis.

Clinical Evidence

No clinical data. Bench testing only. Engineering analysis and confirmatory mechanical testing, including dynamic compression and dynamic compression shear per ASTM F2077, were performed to validate design changes.

Technological Characteristics

Material: Titanium alloy (Ti-6Al-4V ELI) per ASTM F3001. Form factor: Lumbar interbody spacers of varying angles, widths, heights, and lengths. Sterilization: Gamma irradiation. Connectivity: None. Software: None.

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/allograft bone.

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

• Tranquil-L Interbody System (K181702)
• Tranquil Interbody System (K170297)
• Tranquil Interbody System (K181483)
• Biomet Spine Lateral Spacer System (K122989)
• Stable C and Stable L Interbody Systems (K232530)

Submission Summary (Full Text)

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March 20, 2024

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Nexus Spine, LLC % Christine Scifert Partner MRC Global 9085 E. Mineral Cir., Suite 110 Centennial, Colorado 80112

Re: K233375

Trade/Device Name: Tranquil-L Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: February 26, 2024 Received: February 26, 2024

Dear Christine Scifert:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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 ([e-mail]) or phone [phone] or 301-796-7100).

> Sincerely, Katherine D. Kavlock -2 for

Brent 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

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# Indications for Use

510(k) Number (if known) K233375

Device Name Tranquil-L Interbody System

#### Indications for Use (Describe)

The Tranquil-L™ Interbody System is intended 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. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). It is indicated to be used with autograft bone and/or allograft bone comprised of cancellous and/or corticocancellous bone.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------------------|---------------------------------------------|
| <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |

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#### 510(k) Summary

### Tranquil-L Interbody System March 19, 2024

| Company: | Nexus Spine, LLC<br>2825 East Cottonwood Parkway Suite 330<br>Salt Lake City, UT 84121 |
|----------|----------------------------------------------------------------------------------------|
|----------|----------------------------------------------------------------------------------------|

- Primary Contact: Christine Scifert - Partner MRC Global 9085 E. Mineral Cir., Suite 110 Centennial, CO 80112 Phone: [phone] Email: [e-mail]
- Company/Secondary Jared Crocker Vice President of Quality and Regulatory Affairs Contact: Nexus Spine, LLC Phone: [phone] [e-mail]
- Trade Name: Tranquil-L Interbody System

Orthopedic

- Common Name: Intervertebral Fusion Device With Bone Graft, Lumbar
- Classification: Class II
- 21 CFR 888.3080 (Intervertebral Fusion Device) Regulation:
-
- Product Code: MAX

Panel:

- Nexus Spine, LLC Tranquil-L Interbody System K181702 Primary Predicate:
### Device Description:

The Tranquil-L Interbody System is a lumbar interbody fusion system. Implants are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F3001. The implants are offered in various angles, widths, heights, and lengths to meet patient anatomy for the lumbar spine. Implants are provided sterile via gamma irradiation. Instruments are provided clean and non-sterilization at the user's facility.

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The purpose of this special 510(k) is to gain clearance for modifications to existing lumbar implants and add implant footprints for the DLIF surgical approach.

# Indications for Use:

The Tranquil-L™ Interbody System is intended 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 with the devices. The device must be used with supplemental fixation. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be used with autograft bone and/or allograft bone comprised of cancellous and/or corticocancellous bone.

# Substantial Equivalence:

The subject Nexus Spine Tranquil-L Interbody System is substantially equivalent to the following predicate devices:

# Primary Predicate:

- . Nexus Spine, LLC, Tranquil-L Interbody System – K181702
# Additional Predicates:

- . Nexus Spine, LLC, Tranquil Interbody System – K170297
- Nexus Spine, LLC Tranquil Interbody System - K181483
- Biomet Spine Lateral Spacer System – K122989
- Nexus Spine, LLC, Stable C and Stable L Interbody Systems - K232530

There are insignificant differences between the subject Tranquil-L Interbody System and the predicate Tranquil-L devices (K181702; K181483; K170297). Materials of the subject device are identical to those of the primary predicate. There are slight geometry differences between the subject and predicate devices but analysis and testing has shown that the subject Tranquil-L Interbody devices perform equivalent to the predicate devices. Thus, it can be concluded that the subject does not raise new questions about safety and effectiveness.

### Performance Testing:

Engineering analysis and confirmatory testing including dynamic compression and dynamic compression shear per ASTM F2077 has been conducted on the subject devices. Testing has confirmed that the proposed design changes do not raise new issues of safety and effectiveness and therefore, the subject device is substantially equivalent to the previously cleared device.

# Conclusion:

Based on the performance analysis and the comparison to the predicate devices, the subject device is determined to be substantially equivalent to the predicate devices.