Navagio Lumbar Cage

K220902 · Kalitec Medical, LLC · MAX · May 27, 2022 · Orthopedic

Device Facts

• Record ID: K220902
• Device Name: Navagio Lumbar Cage
• Applicant: Kalitec Medical, LLC
• Product Code: MAX · Orthopedic
• Decision Date: May 27, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Navagio 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 or retrolisthesis at the involved level(s). Navagio Lumbar Cage implants are to be used with autogenous bone graft and implanted via a transforaminal approach, or an open posterior or lateral approach. The Navagio Lumbar Cage implants are to be used with supplemental fixation. Patients should have at least (6) months of non-operative treatment prior to treatment with an intervertebral cage. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.

Device Story

Lumbar intervertebral body fusion device; stabilizes lumbar spinal column. Implant features surface ridges to prevent migration; graft windows for bone graft integration; integrated X-ray markers for post-operative visualization. Available in various sizes to match patient anatomy. Implanted by surgeons via transforaminal, open posterior, or lateral approach. Used in conjunction with autogenous bone graft and supplemental fixation to facilitate fusion in DDD patients. Benefits include spinal stabilization and potential reduction of discogenic back pain.

Clinical Evidence

No clinical studies were performed. Substantial equivalence is supported by non-clinical bench testing including static and dynamic compression (ASTM F2077), subsidence (ASTM F2267), and expulsion testing.

Technological Characteristics

Constructed from Zeniva ZA-500 PEEK (ASTM F2026) and unalloyed tantalum (ASTM F560) for X-ray markers. Features surface ridges and graft windows. Mechanical testing performed per ASTM F2077 and ASTM F2267. No software or electronic components.

Indications for Use

Indicated for skeletally mature patients with lumbar degenerative disc disease (DDD) at one or two contiguous levels (L2-S1) with discogenic back pain; may include up to Grade 1 spondylolisthesis or retrolisthesis. Requires 6 months of prior non-operative treatment. Used with autogenous bone graft and supplemental 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

• InTess Lumbar Cage - Kalitec Direct (K123100)
• Lucent Lumbar Interbody System- Spinal Elements (K152011)

Submission Summary (Full Text)

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May 27, 2022

Kalitec Medical, LLC % J.D. Webb President The OrthoMedix Group, Inc. 4313 West 3800 South West Haven, Utah 84401

Re: K220902

Trade/Device Name: Navagio Lumbar Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: March 23, 2022 Received: March 28, 2022

Dear J.D. 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 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

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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) for devices or postmarketing safety reporting (21 CFR 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 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-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,

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

Enclosure

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

# Indications for Use

Form Approved: 0MB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known) K220902

Device Name Navagio Lumbar Cage

Indications for Use (Describe)

The Navagio 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 or retrolisthesis at the involved level(s).

Navagio Lumbar Cage implants are to be used with autogenous bone graft and implanted via a transforaminal approach, or an open posterior or lateral approach. The Navagio Lumbar Cage implants are to be used with supplemental fixation. Patients should have at least (6) months of non-operative treatment prior to 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) □ Over-The-Counter Use (21 CFR 801 Subpart C) 区 Prescription Use (Part 21 CFR 801 Subpart D)

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## 510(k) Summary for the Navagio Lumbar Cage

In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for the Navagio Lumbar Cage

#### 1. GENERAL INFORMATION

| Date Prepared: | March 23, 2022 |
|----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name: | Navagio 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 Legally Marketed Predicate Device: | InTess Lumbar Cage - Kalitec Direct (K123100) |
| Secondary Legally Marketed Predicate Devices | Lucent Lumbar Interbody System- Spinal Elements (K152011) |
| Submitter: | Kalitec Direct, LLC doing business as Kalitec Medical<br>618 E. South Street, Suite 500<br>Orlando, FL 32801<br>407-545-2063 Tele<br>407-358-5441 Fax |
| Contact: | J.D. Webb<br>4313 W. 3800 S.<br>West Haven, UT 84401<br>512-590-5810 Tele<br>e-mail: [e-mail] |

#### 2. DEVICE DESCRIPTION

The Navagio Lumbar Cage was developed as an implant for the stabilization of the lumbar spinal column. The Navagio implants have ridges on both their inferior and superior surfaces to prevent migration, and graft windows to receive bone graft, which helps facilitate bony integration. X-ray markers are integrated for visualization of the implants after surgery. The components are available in a variety of sizes to more closely match the patient's anatomy.

#### Materials:

Zeniva® ZA-500 PEEK conforming to ASTM F2026. Unalloyed tantalum (ASTM F560)

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#### 3. SUBSTANTIAL EQUIVALENCE CLAIMED TO PREDICATE DEVICES

The Navagio Lumbar Caqe is substantially equivalent to the predicate devices in terms of intended use, design, materials used, mechanical safety and performances.

#### 4. INTENDED USE

The Navagio 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 contiquous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with deqeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis at the involved level(s).

Navaqio Lumbar Cage implants are to be used with autogenous bone graft and implanted via a transforaminal approach, or an open posterior or lateral approach. The Navagio Lumbar Cage implants are to be used with supplemental fixation. Patients should have at least (6) months of non-operative treatment prior to treatment with an intervertebral cage. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.

#### 5. SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS COMPARED TO PREDICATE

#### Intended use

The Navagio Lumbar Cage was developed as an implant for the stabilization of the lumbar spinal column, same as the predicates.

#### Indications for Use

All of the devices comply with the indications for use specified in 21 CFR section 888.3080 for lumbar intervertebral body fusion device.

#### Material

The Navagio Lumbar Cage uses the same material as the predicate devices.

#### Design

The Navagio Lumbar Cage and the predicates are equivalent in terms of shape, material, and operating principles.

Sizes

The Navagio Lumbar Cage and the predicates are equivalent in their dimensions.

#### 6. NON-CLINICAL TEST SUMMARY

The following tests were conducted:

- Static and dynamic compression per ASTM F2077 ●
- Subsidence per ASTM F2267 ●
- Expulsion ●

The results of this testing indicate that the Navagio Lumbar Cage is substantially equivalent to predicate devices.

#### 7. CLINICAL TEST SUMMARY

No clinical studies were performed

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### 8. CONCLUSIONS NONCLINICAL AND CLINICAL

Kalitec Medical considers the Navagio Lumbar Cage to be substantially equivalent to the predicate devices listed above. This conclusion is based upon the device's similarities in principles of operation, technology, materials and indications for use.