TirboLOX-C Cervical IBFD

K181229 · Captiva Spine, Inc. · ODP · Sep 19, 2018 · Orthopedic

Device Facts

• Record ID: K181229
• Device Name: TirboLOX-C Cervical IBFD
• Applicant: Captiva Spine, Inc.
• Product Code: ODP · Orthopedic
• Decision Date: Sep 19, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Captiva Spine TirboLOX-C™ Cervical IBFD is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one-disc level. DDD is defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies. The Captiva Spine TirboLOX-C™ Cervical IBFD is used to facilitate fusion in the cervical spine and is placed via an anterior approach at the C3 to C7 disc levels with autograft bone and/or allogenic bone graft composed of cancellous bone graft. Patients should have at least six weeks of non-operative to treatment with an intervertebral body fusion device. The device must be used with supplemental fixation.

Device Story

TirboLOX-C Cervical IBFD is an intervertebral body fusion device; 3D-printed titanium alloy construction; features central window for autogenous or allogenic bone graft; available in lordotic, anatomical, and parallel configurations. Used by surgeons in clinical settings to facilitate cervical spine fusion via anterior approach at C3-C7 levels. Device provides structural support to disc space; promotes bone ingrowth/fusion; requires supplemental fixation. Benefits include stabilization of cervical spine segments in patients with discogenic neck pain.

Clinical Evidence

Bench testing only. Testing included static/dynamic axial compression, shear, and torsion (ASTM F2077-14), static subsidence (ASTM 2267-04), abrasion resistance (ASTM F1978-12), wear debris (ASTM F1877-16), and expulsion testing. Results demonstrate mechanical strength sufficient for intended use.

Technological Characteristics

Titanium alloy; 3D-printed; lordotic, anatomical, and parallel configurations; central graft window. Standards: ASTM F2077-14 (mechanical testing), ASTM 2267-04 (subsidence), ASTM F1978-12 (abrasion), ASTM F1877-16 (wear debris). Provided sterile.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one-disc level (C3-C7) requiring fusion via anterior approach. Requires supplemental fixation. Patients must have failed at least six weeks of non-operative treatment.

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

• FuseLOX Cervical IBF System (K110585)
• TirboLOX-L Lumbar IBFD (K180990)
• ROI-C (K150765, K1251103, K113559)
• Renovis Tesera SC Standalone Anterior Cervical Fusion (ACF) System (K153250)
• Synthes ACIS (K120275)
• Camber Spine Technologies Coveris Cervical Cage System (K170550)

Submission Summary (Full Text)

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September 19, 2018

Image /page/0/Picture/1 description: The image contains 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.

Captiva Spine, Inc. Jackie Ferro VP Quality Assurance and Regulatory Affairs 967 N. Alternate A1A. Ste. 1 Jupiter, Florida 33477

Re: K181229

Trade/Device Name: TirboLOX-C™ Cervical IBFD Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: August 17, 2018 Received: August 21, 2018

Dear Jackie Ferro:

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 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

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

## Brent Showalter -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)

K181229

Device Name TirboLOX-CTM Cervical IBFD

## Indications for Use (Describe)

The Captiva Spine TirboLOX-C™ Cervical IBFD is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one-disc level. DDD is defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies. The Captiva Spine TirboLOX-C™ Cervical IBFD is used to facilitate fusion in the cervical spine and is placed via an anterior approach at the C3 to C7 disc levels with autograft bone and/or allogenic bone graft composed of cancellous bone graft. Patients should have at least six weeks of non-operative to treatment with an intervertebral body fusion device. The device must be used with supplemental fixation.

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

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Image /page/3/Picture/0 description: The image contains the logo for Captiva Spine. The logo features a stylized blue spine graphic on the left. To the right of the spine graphic, the words "CAPTIVA SPINE" are written in a bold, sans-serif font, with "CAPTIVA" on top of "SPINE". Below the company name, the website "captivaspine.com" is written in a smaller font.

| 510(k) Summary: TirboLOX-C TM Cervical IBFD | |
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| Manufacturer /<br>Submitter | Captiva Spine, Inc.<br>967 N. Alternate A1A Ste.1<br>Jupiter, FL 33477-3206 |
| Contact Person | Jackie Ferro<br>VP Quality Assurance & Regulatory Affairs<br>Phone: [phone] x719<br>Fax: [phone]<br>Email: [e-mail] |
| Date Prepared | September 13, 2018 |
| Trade Name | TirboLOX-CTM Cervical IBFD |
| Common Name | Intervertebral Fusion Device with Bone Graft, Cervical |
| Proposed Class | Class II |
| Classification<br>Name | Intervertebral Body Fusion Device (21 CFR §888.3080) |
| Product Code | ODP |
| Classification<br>Panel | Division of Orthopedic Devices |
| Predicate<br>Devices | Primary Predicate:<br>K110585: FuseLOX Cervical IBF System, Captiva Spine, Inc. Additional Predicates: K180990, TirboLOX-LTM Lumbar IBFD, Captiva Spine Inc. K150765, K1251103, K113559: ROI-C, LDR K153250: Renovis Tesera SC Standalone Anterior Cervical Fusion (ACF) System, Renovis Surgical Technologies, Incorporated K120275: Synthes ACIS, Synthes Spine K170550: Camber Spine Technologies Coveris Cervical Cage System, Camber Spine |
| Submission<br>Scope | The purpose of this submission is to request market clearance for a new<br>product offering of Captiva Spine, Inc. which is an intervertebral body<br>fusion device product for the cervical spine called TirboLOX-CTM Cervical<br>IBFD. |
| Device<br>Description | The Captiva Spine, Inc. TirboLOX-CTM Cervical IBFD is made from a<br>titanium alloy and is created using 3D printing technologies. The implants<br>are available in various footprints to accommodate a variety of patient<br>anatomies and is provided sterile. The device has a window in the center of<br>device to accept autogenous bone and/or allogenic bone graft. The implant<br>is available in the following configurations: lordotic, anatomically correct<br>and parallel |
| Indications for<br>Use | The Captiva Spine TirboLOX-CTM Cervical IBFD is indicated for use in<br>skeletally mature patients with degenerative disc disease (DDD) of the<br>cervical spine at one-disc level. DDD is defined as neck pain of<br>discogenic origin with the degeneration of the disc confirmed by history<br>and radiographic studies. The Captiva Spine TirboLOX-CTM Cervical<br>IBFD is used to facilitate fusion in the cervical spine and is placed via an<br>anterior approach at the C3 to C7 disc levels with autograft bone and/or<br>allogenic bone graft composed of cancellous and/or corticocancellous<br>bone graft. Patients should have at least six weeks of non-operative<br>treatment prior to treatment with an intervertebral body fusion device.<br>The device must be used with supplemental fixation. |
| Summary of the<br>Technological<br>Characteristics | The TirboLOX-CTM Cervical IBFD and its predicate devices have nearly<br>identical technological characteristics and the minor differences do not raise<br>any new issues of safety and effectiveness. Specifically, the following<br>characteristics are identical between the subject and predicates:<br>Indications for use Materials of manufacture Structural support mechanism |
| Performance<br>Data | The TirboLOX-CTM Cervical IBFD has been tested in the following test<br>modes:<br>ASTM F2077-14 Static Axial Compression Static Shear Static Torsion Dynamic Axial Compression Dynamic Shear Dynamic Torsion ASTM 2267-04 Static Subsidence ASTM F1978-12 Abrasion Resistance ASTM F1877-16 Wear Debris Additionally, expulsion testing was performed. The results of this non-<br>clinical testing show that the strength of the TirboLOX-CTM Cervical IBFD<br>is sufficient for its intended use and is substantially equivalent to legally<br>marketed predicate devices. |
| Conclusion | The overall technology characteristics and mechanical performance data lead<br>to the conclusion that the TirboLOX-CTM Cervical IBFD is substantially<br>equivalent to the predicate devices. |

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Image /page/4/Picture/0 description: The image contains the logo for Captiva Spine. The logo features a blue, stylized spine graphic on the left. To the right of the graphic, the words "CAPTIVA" and "SPINE" are stacked on top of each other in a bold, sans-serif font, also in blue. Below the word "SPINE" is the website address "captivaspine.com" in a smaller font.