TiWAVE-L Porous Titanium Lumbar Cage

K182210 · Kalitec Medical, LLC · MAX · Jan 7, 2019 · Orthopedic

Device Facts

• Record ID: K182210
• Device Name: TiWAVE-L Porous Titanium Lumbar Cage
• Applicant: Kalitec Medical, LLC
• Product Code: MAX · Orthopedic
• Decision Date: Jan 7, 2019
• 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 allograft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion.

Device Story

TiWAVE-L Porous Titanium Lumbar Cage is an intervertebral body fusion device; additive manufactured (AM) from Titanium Grade 23. Implanted in lumbar spine (L2-S1) via transforaminal or open posterior approach; used with autogenous or allograft bone graft and supplemental fixation. Provides structural support to facilitate spinal fusion in patients with degenerative disc disease. Used by surgeons in clinical settings. Benefits include stabilization of spinal segments and promotion of fusion.

Clinical Evidence

No clinical studies were performed. Substantial equivalence is supported by non-clinical bench testing including static/dynamic axial compression, static torsion, static/dynamic compression shear, subsidence, and static expulsion testing per ASTM standards.

Technological Characteristics

Material: Additive manufactured Titanium Grade 23 (ASTM F3001). Instruments: Stainless steel (ASTM F899) or Ti6Al4V ELI (ASTM F136). Form factor: Lumbar intervertebral cage in various heights/lengths. Sterilization: Provided sterile. Connectivity: None.

Indications for Use

Indicated for intervertebral body fusion in skeletally mature patients with lumbar degenerative disc disease (DDD) at one or two contiguous levels (L2-S1). DDD defined as discogenic back pain with degeneration confirmed by history/radiographic studies. Patients may have up to Grade 1 spondylolisthesis or retrolisthesis. Used with autogenous/allograft bone graft via transforaminal or open posterior approach. Requires supplemental fixation. Patients must have failed 6 months of non-operative treatment. Suitable for patients with prior non-fusion spinal surgery at the involved level.

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, HT Medical, LLC (K170318)
• Cascadia™ Interbody System, K2M, Inc. (K160125/ K162264/ K172009/ K172941/ K170318)
• BAK/L Interbody Fusion System, Zimmer (P950002)
• Brantigan I/F Cage, DePuy Spine, Inc. (P960025)
• InTess Lumbar Cage System, Kalitec Direct, LLC (K133815)
• InTess Cervical Cage System, Kalitec Direct, LLC (K123100)

Submission Summary (Full Text)

{0}------------------------------------------------

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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath in a smaller font.

January 7, 2019

Kalitec Medical, LLC % J.D. Webb Authorized Contact Person The OrthoMedix Group, Inc. 1001 Oakwood Blvd Round Rock, Texas 78681

Re: K182210

Trade/Device Name: TiWAVE-L™ Porous Titanium Lumbar Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: August 13, 2018 Received: August 15, 2018

Dear Mr. Webb:

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 mav, 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 avare 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

{1}------------------------------------------------

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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.

# Melissa Hall -S

For Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Expiration Date: 06/30/2020

See PRA Statement below.

Form Approved: OMB No. 0910-0120

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

## Indications for Use

510(k) Number (if known)

K182210

#### Device Name

TiWAVE-L™ Porous Titanium Lumbar Cage

#### Indications for Use (Describe)

The TiWAVE-L™ Porous Titanium Lumbar Cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis at the involved level(s). TiWAVE-L™ Porous Titanium Lumbar Cage implants are to be used with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft and implanted via a transforaminal approach or an open posterior approach. The TIWAVE-L™ Porous Titanium Lumbar Cage implants are to be used with supplemental fixation. Patients should have at least (6) months of non-operative treatment with an intervertebral cage. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.

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

Y Prescription Use (Part 21 CFR 801 Subpart D)

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

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

# for the TiWAVE

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

| Date Prepared | December 6, 2018 |
|-----------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitted by | Scott Winn<br>Kalitec Medical, LLC<br>618 E. South Street, Suite 500<br>Orlando, FL 32801<br>407-545-2063 Tele<br>407-358-5441 Fax |
| Primary Contact | J.D. Webb<br>OrthoMedix Group<br>1001 Oakwood Blvd<br>Round Rock, TX 78681<br>512-388-0199 Tele<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-L™ Porous Titanium Lumbar Cage |
| Common Name | Intervertebral body fusion device |
| Classification Name | Intervertebral body fusion device - lumbar |
| Class | II |
| Product Code | MAX |
| CFR Section | 21 CFR section 888.3080 |
| Device Panel | Orthopedic |
| Primary Predicate<br>Device | NeoFuse™ Ti3D PLIF/TLIF/Cervical Interbody, HT Medical, LLC (K170318) |
| Additional Predicate<br>Devices | Cascadia™ Interbody System, K2M, Inc. (K160125/ K162264/ K172009/ K172941/<br>K170318)<br>BAK/L Interbody Fusion System, Zimmer (P950002)<br>Brantigan I/F Cage, DePuy Spine, Inc. (P960025)<br>InTess Lumbar Cage System, Kalitec Direct, LLC (K133815)<br>InTess Cervical Cage System, Kalitec Direct, LLC (K123100) |
| Device Description | The TiWAVE-L Porous Titanium Lumbar Cages are lumbar intervertebral body fusion<br>devices made from additive manufactured (AM) Titanium Grade 23 per ASTM F3001.<br>The implants are available in various heights and lengths to accommodate patients'<br>anatomy. The implants are provided sterile. |
| Materials | Implants are made from additive manufactured (AM) Titanium Grade 23 per ASTM<br>F3001.<br>System specific instruments are made from either stainless steel conforming to ASTM<br>F899 or Ti6Al4V ELI titanium alloy conforming to ASTM F136. |
| Intended Use | Intervertebral body fusion devices indicated for use with autograft and/or allograft<br>comprised of cancellous and/or corticocancellous bone graft when used as an adjunct<br>to fusion. |
| Substantial Equivalence<br>Claimed to Predicate<br>Devices | The TiWAVE-L Porous Titanium Lumbar Cage is substantially equivalent to the<br>predicate devices in terms of intended use, design, materials used, mechanical safety<br>and performances. |
| Indications for Use | The TiWAVE-L Porous Titanium Lumbar Cage is indicated for intervertebral body<br>fusion procedures in skeletally mature patients with degenerative disc disease (DDD)<br>of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc<br>disease is defined as discogenic back pain with degeneration of the disc confirmed by<br>history and radiographic studies. These DDD patients may have up to Grade 1<br>spondylolisthesis or retrolisthesis at the involved level(s). TiWAVE-L Porous Titanium<br>Lumbar Cage implants are to be used with autogenous bone graft and/or allograft<br>comprised of cancellous and/or corticocancellous bone graft implanted via a<br>transforaminal approach or an open posterior approach. The TiWAVE-L Porous<br>Titanium Lumbar Cage implants are to be used with supplemental fixation. Patients<br>should have at least (6) months of non-operative treatment prior to treatment with an<br>intervertebral cage. Patients with previous non-fusion spinal surgery at involved level<br>may be treated with the device |
| Summary of the<br>technological<br>characteristics<br>compared to predicate | Intended Use<br>The TiWAVE-L Porous Titanium Lumbar Cage and all the predicates have similar<br>intended uses.<br>Materials<br>The TiWAVE-L Porous Titanium Lumbar Cage is composed of the same material as<br>the predicate device.<br>Design Features/Functions<br>The TiWAVE-L Porous Titanium Lumbar Cage and cited predicate devices share<br>similar basic design features and functions.<br>Dimensions<br>The TiWAVE-L Porous Titanium Lumbar Cage is dimensionally similar to cited<br>predicate devices.<br>Sterilization<br>The TiWAVE-L Porous Titanium Lumbar Cage is provided sterile and cited predicate<br>devices are packaged sterile for single use only.<br>Performance Specification<br>Mechanical testing confirmed the TiWAVE-L Porous Titanium Lumbar Cage<br>demonstrated equivalent performance to the cited predicate device under the same<br>test conditions. |
| Non-clinical Test<br>Summary | The following tests were independently performed on the TiWAVE-L Porous<br>Titanium Lumbar Cage to demonstrate substantial equivalence based on current<br>industry standards:<br>> Static and dynamic axial compression (per ASTM F2077)<br>> Static torsion (per ASTM F2077)<br>> Static and dynamic compression shear (per ASTM F2077)<br>> Subsidence (per ASTM F2267)<br>> Static Expulsion (per ASTM draft standard F04.25.02.02)<br>> Bacterial Endotoxin (BET)<br>The results of these evaluations indicate that the TiWAVE-L Porous Titanium<br>Lumbar Cage is substantially equivalent to the predicate devices. |
| Clinical Test Summary | No clinical studies were performed. |
| Conclusions: Non-<br>clinical and Clinical | Kalitec Medical considers the TiWAVE-L Porous Titanium Lumbar Cage system to<br>be substantially equivalent to the predicate devices listed above. This conclusion is<br>based upon the devices' similarities in principles of operation, technology,<br>materials, and indications for use. Based on the testing performed, it can be<br>concluded that there are no new issues of safety or efficacy when comparing the<br>subject device to the predicates. |

{4}------------------------------------------------

# K182210
Page 2 of 2