Tranquil Interbody System

K170297 · Nexus Spine, LLC · MAX · Jun 27, 2017 · Orthopedic

Device Facts

• Record ID: K170297
• Device Name: Tranquil Interbody System
• Applicant: Nexus Spine, LLC
• Product Code: MAX · Orthopedic
• Decision Date: Jun 27, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The TranquilTM Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion. The TranquilTM Cervical Interbody System is intended for spinal fusion procedures at one level in the cervical spine (C3 to C7) in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. The cervical device is to be implanted via an open, anterior approach and packed with autogenous bone. The cervical device is to be used in patients who have had six weeks of non-operative treatment. This device system is intended for use with supplemental internal fixation systems. The TranquilTM Lumbar Interbody System is intended for use at either one level or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. The patients may have had a previous non-fusion spinal surgery at the involved level(s). The device is intended to be used with supplemental internal fixation systems.

Device Story

Tranquil Interbody System; spinal fusion implant; Ti-6Al-4V ELI material; additive manufacturing; various angles, widths, heights, lengths; implanted via open, anterior approach (cervical); packed with autogenous bone; used with supplemental internal fixation; provides structural support to intervertebral space; facilitates fusion in skeletally mature patients with degenerative disc disease; used in clinical/surgical settings by physicians.

Clinical Evidence

Bench testing only. Verification activities performed per ASTM F2077, ASTM F2267, and expulsion testing. Results demonstrate performance substantially equivalent to predicate devices.

Technological Characteristics

Material: Ti-6Al-4V ELI. Manufacturing: Additive manufacturing. Form factor: Various angles, widths, heights, lengths for cervical/lumbar anatomy. Sterilization: Provided clean/non-sterile for steam sterilization at user facility. Standards: ASTM F2077, ASTM F2267.

Indications for Use

Indicated for intervertebral body fusion in skeletally mature patients. Cervical: one level (C3-C7) for degenerative disc disease (DDD) with neck pain, failed 6 weeks non-operative treatment. Lumbar: one or two contiguous levels (L2-S1) for DDD with back pain, including Grade 1 spondylolisthesis or retrolisthesis; prior non-fusion surgery allowed. Requires autograft and supplemental internal 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

• Cascadia Interbody System (K160547)
• Fusion Advantage Cervical Cage (K083425)
• Fusion Advantage Lumbar Cage (K083425)
• Aleutian (K130699)
• Lucent (K071724/ K081968)
• Crystal Cervical Cage (K073351)
• Cervical Interbody Fusion System (K091088)
• Talos PLIF (K090707)
• PivoTEC Lumbar Interbody Fusion Device (LFID) (K092017)

Submission Summary (Full Text)

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

Nexus Spine, LLC Mr. Jared Crocker Director of Quality and Regulatory Affairs 2825 East Cottonwood Parkway. Suite 330 Salt Lake City, Utah 84121

June 27, 2017

Re: K170297

Trade/Device Name: Tranquil Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, ODP Dated: May 24, 2017 Received: May 25, 2017

Dear Mr. Crocker:

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

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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 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) K170297

Device Name

Tranquil Interbody System

#### Indications for Use (Describe)

The Tranquil™ Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion.

The Tranquil™ Cervical Interbody System is intended for spinal fusion procedures at one level in the cervical spine (C3 to C7) in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. The cervical device is to be implanted via an open, anterior approach and packed with autogenous bone. The cervical device is to be used in patients who have had six weeks of non-operative treatment. This device system is intended for use with supplemental internal fixation systems.

The Tranquil™ Lumbar Interbody System is intended for use at either one level or two contiguous levels (12-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. The patients may have had a previous nonfusion spinal surgery at the involved level(s). The device is intended to be used with supplemental internal fixation systems.

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| <span style="font-family: sans-serif;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span style="font-family: sans-serif;"> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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#### 510(k) Summary

| Submitter: | Nexus Spine, LLC |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mr. Jared Crocker, Director of Quality and Regulatory Affairs<br>2825 East Cottonwood Parkway, Suite 330<br>Salt Lake City, UT 84121<br>Telephone: [phone]<br>Fax: [phone] |
| Date Prepared: | June 26, 2017 |
| Trade Name: | Tranquil Interbody System |
| Classification, Name<br>and Number: | Class II<br>Intervertebral body fusion device<br>21 CFR 888.3080 |
| Product Code: | MAX, ODP |

# Product Code:

## Predicate Device(s):

| Manufacturer | Device | 510(k)/PMA Number |
|--------------------|----------------------------------------------------------------|-------------------|
| Primary Predicate | | |
| K2M | Cascadia Interbody System | K160547 |
| Other Predicates | | |
| Adaptive Specialty | Fusion Advantage Cervical Cage<br>Fusion Advantage Lumbar Cage | K083425 |
| K2M | Aleutian | K130699 |
| Spinal Elements | Lucent | K071724/ K081968 |
| Spinal Elements | Crystal Cervical Cage | K073351 |
| LDR Spine | Cervical Interbody Fusion System | K091088 |
| Meditech | Talos PLIF | K090707 |
| Captiva Spine | PivoTEC Lumbar Interbody Fusion<br>Device (LFID) | K092017 |

## Device Description:

The Tranquil Interbody System is made of Ti-6Al-4V ELI. The implant is offered in various angles, widths, heights, and lengths to meet patient anatomy for both cervical and lumbar spine. The devices and instruments

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| | are provided clean and non-sterile for steam sterilization at the user's<br>facility. |
|----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | The TranquilTM Interbody System is indicated for intervertebral body<br>fusion of the spine in skeletally mature patients. The device system is<br>designed for use with autograft to facilitate fusion. |
| | The TranquilTM Cervical Interbody System is intended for spinal fusion<br>procedures at one level in the cervical spine (C3 to C7) in skeletally mature<br>patients with degenerative disc disease (defined as neck pain of discogenic<br>origin with degeneration of the disc confirmed by history and radiographic<br>studies) of the cervical spine. The cervical device is to be implanted via an<br>open, anterior approach and packed with autogenous bone. The cervical<br>device is to be used in patients who have had six weeks of non-operative<br>treatment. This device system is intended for use with supplemental interna<br>fixation systems. |
| | The TranquilTM Lumbar Interbody System is intended for use at either one<br>level or two contiguous levels (L2-S1) in skeletally mature patients with<br>degenerative disc disease (DDD). DDD is defined as back pain of<br>discogenic origin with degeneration of the disc confirmed by history and<br>radiographic studies. DDD patients may also have up to Grade 1<br>spondylolisthesis or retrolisthesis at the involved levels. The patients may<br>have had a previous non-fusion spinal surgery at the involved level(s). The<br>device is intended to be used with supplemental internal fixation systems. |
| Statement of<br>Technological<br>Comparison: | The Tranquil Interbody System is manufactured using additive<br>manufacturing, but the predicate devices are machined of the same material.<br>This difference does not impact the substantial equivalence of the devices.<br>The Tranquil Interbody System is substantially equivalent to the above<br>listed predicate devices in terms of materials, design, indications for use and<br>operational principles. |
| Performance Data: | Verification activities based on ASTM F2077, ASTM F2267 and expulsion<br>testing were performed. The mechanical testing demonstrated the device<br>can be expected to perform in a manner substantially equivalent to the<br>predicates listed above. |
| Conclusion: | Documentation provided demonstrates the Tranquil Interbody System is<br>substantially equivalent to predicate devices. |