TiWAVE-C™ Porous Titanium Cervical Cage

K180401 · Kalitec Direct, LLC · ODP · Jun 14, 2018 · Orthopedic

Device Facts

• Record ID: K180401
• Device Name: TiWAVE-C™ Porous Titanium Cervical Cage
• Applicant: Kalitec Direct, LLC
• Product Code: ODP · Orthopedic
• Decision Date: Jun 14, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion.

Device Story

TiWAVE-C™ is an intervertebral body fusion device used in cervical spine surgery. It is an additive manufactured (AM) porous titanium cage implanted by a surgeon to facilitate fusion at one or two contiguous levels (C2-T1). The device acts as a structural spacer to maintain disc space height while bone graft (autograft or allograft) promotes fusion. It requires supplemental fixation (e.g., plates/screws) to stabilize the segment. The device is provided sterile and is intended for use in patients with cervical degenerative disc disease who have failed conservative treatment.

Clinical Evidence

No clinical studies were performed. Safety and effectiveness were demonstrated through non-clinical bench testing, including static and dynamic axial compression, torsion, compression shear, subsidence, and expulsion testing per ASTM F2077 and ASTM F2267.

Technological Characteristics

Constructed from additive manufactured (AM) Titanium Grade 23 per ASTM F3001. Instruments made from 17-4 H900 SS or 465 SS H950 per ASTM F899. Device is a porous intervertebral cage available in various heights/lengths. Sterilized via gamma irradiation (AAMI/ANSI/ISO 11137-2).

Indications for Use

Indicated for skeletally mature patients with cervical degenerative disc disease (DDD) at one or two contiguous levels from C2 to T1. DDD defined as discogenic back pain with degeneration confirmed by history and radiography. Requires 6 weeks prior 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

• NeoFuse™ Ti3D PLIF/TLIF/Cervical Interbody (K170318)
• Cascadia™ Interbody System (K160125)

Submission Summary (Full Text)

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Image /page/0/Picture/0 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.

Kalitec Direct, LLC % Teresa Cherry Cherry Tree Consulting 1230 Show Drive Orlando, Florida 32828

Re: K180401

Trade/Device Name: TiWAVE-C™ Porous Titanium Cervical Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: May 15, 2018 Received: May 16, 2018

Dear Ms. Cherry:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

June 14, 2018

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K180401

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,

Digitally signed by Melissa Hall -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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Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2020

See PRA Statement below.

### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration.

# Indications for Use

510(k) Number (if known) K180401

#### Device Name

TiWAVE-CTM Porous Titanium Cervical Cage

#### Indications for Use (Describe)

The TiWAVE-C™ Porous Titanium Cervical Cage is intended for use in skeletally mature patients with cervical degenerative disc disease (DDD) at one level or two contiguous levels from C2 to T1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received six (6) weeks of prior non-operative treatment prior to treatment with the 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 when used as an adjunct to fusion.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| <span style="text-decoration: overline;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="text-decoration: none;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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# for the TiWAVE-C ™ Porous Titanium Cervical Cage

In accordance with 21 CFR 807.92 of the Federal Code of Regulations

| Date Prepared | Dec 15, 2017 |
|---------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitted by | Scott Winn<br>Kalitec Direct, LLC<br>618 E. South Street, Suite 500<br>Orlando, FL 32801<br>407-545-2063 Tele<br>407-358-5441 Fax |
| Primary Contact | Teresa Cherry<br>Cherry Tree Consulting<br>1230 Show Drive<br>Orlando, FL 32828<br>407-252-3295<br>e-mail: [e-mail] |
| Secondary Contact | Keith Cannan<br>1890 W. CR 419, Suite 2000<br>Oviedo, FL 32765<br>407-545-2063 Tele<br>407-358-5441 Fax<br>e-mail: [e-mail] |
| Trade Name | TiWAVE-C™ Porous Titanium Cervical Cage |
| Common Name | Intervertebral body fusion device |
| Classification Name | Intervertebral body fusion device |
| Class | II |
| Product Code | ODP |
| CFR Section | 21 CFR section 888.3080 |
| Device Panel | Orthopedic |
| Primary Predicate Device | NeoFuse™ Ti3D PLIF/TLIF/Cervical Interbody K170318 |
| Secondary Predicate Devices | Cascadia™ Interbody System K160125 |
| Device Description | The TiWAVE-C™ Porous Titanium Cervical Cages are intervertebral body<br>fusion devices made from additive manufactured (AM) Titanium Grade 23<br>per ASTM F3001. The implants are available in various heights and<br>lengths to accommodate patients' anatomy. The implants are provided<br>sterile. |
| Materials | Implants are made from additive manufactured (AM) Titanium Grade 23<br>per ASTM F3001.<br>System specific instruments are made from either 17-4 H900 SS or 465<br>SS H950 conforming to ASTM F899 |
| Intended Use | Intervertebral body fusion devices indicated for use with autograft and/or<br>allogenic bone graft comprised of cancellous and/or corticocancellous<br>bone graft when used as an adjunct to fusion. |
| Substantial Equivalence<br>Claimed to Predicate Devices | The TiWAVE-C™ Porous Titanium Cervical Cage is substantially<br>equivalent to the predicate devices in terms of intended use, design,<br>materials used, mechanical safety and performances. |
| Indications for Use | The TiWAVE-C™ Porous Titanium Cervical Cage is intended for use in<br>skeletally mature patients with cervical degenerative disc disease (DDD)<br>at one level or two contiguous levels from C2 to T1. DDD is defined as<br>discogenic back pain with degeneration of the disc confirmed by patient<br>history and radiographic studies. Patients should have received six (6)<br>weeks of prior non-operative treatment prior to treatment with the device.<br>The devices must be used with supplemental fixation and must be used<br>with autograft and/or allogenic bone graft comprised of cancellous and/or<br>corticocancellous bone graft when used as an adjunct to fusion. |
| Non-clinical Test Summary | The following tests were independently performed on the device to demonstrate safety based on current industry standards:<br>Static and dynamic axial compression (per ASTM F2077) Static and dynamic torsion (per ASTM F2077) Static compression shear (per ASTM F2077) Subsidence (per ASTM F2267) Static Expulsion The effectiveness of the gamma irradiation as a means of sterilization was validated using AAMI/ANSI/ISO 11137-2 – method VDmax25. This included: Bioburden recovery factor testing Bacteriostasis and fungistasis Bioburden Verification dose Sterility testing of the verification dose sample The effectiveness of the final ultrasonic cleaning procedure for gamma sterilization included the following process qualifications: Visual verification Bioburden testing Cytotoxicity testing UV/Vis testing Total organic carbon (TOC) Bacterial Endotoxin (LAL) The effectiveness of the packaging and shipping of sterile product included the following process qualifications: Shipping testing Peel strength testing Bubble emission testing Integrity inspections The results of these evaluations indicate that the TiWAVE-C™ Porous Titanium Cervical Cage is equivalent to predicate device. |
| Clinical Test Summary | No clinical studies were performed. |
| Conclusions: Non-clinical and Clinical | Kalitec Direct, LLC considers the TiWAVE-C™ Porous Titanium Cervical Cage to be equivalent to the predicate devices listed above. This conclusion is based upon the devices' similarities in principles of operation, technology, materials and indications for use. Based on the testing performed, it can be concluded that there are no new issues of safety or efficacy when comparing the subject device to the predicates. |

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