INTESS LUMBAR CAGE

K123100 · Kalitec Direct, LLC · MAX · Mar 28, 2013 · Orthopedic

Device Facts

• Record ID: K123100
• Device Name: INTESS LUMBAR CAGE
• Applicant: Kalitec Direct, LLC
• Product Code: MAX · Orthopedic
• Decision Date: Mar 28, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The INTESS 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). INTESS 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 INTESS 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

INTESS Lumbar Cage is an intervertebral body fusion implant designed for lumbar spinal stabilization. Device features surface ridges to prevent migration and graft windows to facilitate bony integration; includes integrated X-ray markers for post-operative visualization. Implanted by surgeons via transforaminal, open posterior, or lateral approach; requires use with autogenous bone graft and supplemental fixation. Primary function is maintaining disc space height until fusion occurs. Device is a passive implant; no active electronic or software components.

Clinical Evidence

No clinical studies were performed. Evidence is based on bench testing including static and dynamic compression, subsidence, and expulsion testing per ASTM F2077 and ASTM F2267.

Technological Characteristics

Materials: Zeniva ZA-500 PEEK (ASTM F2026) and unalloyed tantalum (ASTM F560). Form factor: Intervertebral cage with surface ridges and graft windows. Energy source: None (passive implant). Sterilization: Not specified.

Indications for Use

Indicated for skeletally mature patients with lumbar degenerative disc disease (DDD) at 1-2 contiguous levels (L2-S1) with or without Grade 1 spondylolisthesis. Requires 6 months prior non-operative treatment. Contraindicated for patients without supplemental fixation or those not requiring autogenous 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

• Lucent Straight Intervertebral Body Fusion Device (K071724/K081968)
• BRANTIGAN I/F CAGE (P960025)
• RAY THREADED LUMBAR FUSION CAGE (P950019)

Submission Summary (Full Text)

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

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

#### 1. GENERAL INFORMATION

MAR 2 8 2013.

| Date Prepared: | September 26, 2012 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------|
| Trade Name: | INTESS 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. |
| Device panel: | Orthopedic |
| Legally Marketed: | Lucent Straight Intervertebral Body Fusion Device - K071724/K081968<br>BRANTIGAN I/F CAGE - P960025 |
| Predicate Device: | RAY THREADED LUMBAR FUSION CAGE (P950019) |
| Submitter: | Dayne Popa<br>Kalitec Direct, LLC<br>555 Winderley Place - Suite 300<br>Maitland FL 32751<br>407-545-2063 Tele |
| Contact: | J.D. Webb<br>1001 Oakwood Blvd<br>Round Rock, TX 78681<br>512-388-0199 Tele<br>512-692-3699 Fax<br>e-mail: [e-mail] |

#### 2. DEVICE DESCRIPTION

The INTESS Lumbar Cage was developed as implants for the stabilization of the lumbar spinal column. The INTESS implants have ridges on both their inferior and superior surfaces to prevent migration, and graft windows which help facilitate bony integration. X-ray markers are integrated for visualization of the implants after surgery.

#### Materials:

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

#### Function:

Maintain adequate disc space until fusion occurs.

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

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

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#### 4. INTENDED USE

The INTESS 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). INTESS 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 INTESS 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. 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 INTESS Lumbar Cage is equivalent to predicate devices.

#### 6. CLINICAL TEST SUMMARY

No clinical studies were performed

#### 7. CONCLUSIONS NONCLINICAL AND CLINICAL

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

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.

Public Health Service

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

### March 28, 2013

Kalitec Direct, LLC % Mr. J.D. Webb 1001 Oakwood Boulevard Round Rock, Texas 78681

Re: K123100

Trade/Device Name: INTESS Lumbar Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: March 05, 2013 Received: March 11, 2013

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 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-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.

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# Page 2 - Mr. J.D. Webb

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

# Frin DKeith

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

Enclosure

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# INDICATIONS FOR USE

510(k) Number (if known): __ K 123100 ._______________________________________________________________________________________________________________________________________

Device Name: INTESS Lumbar Cage

Indications for Use:

The INTESS 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). INTESS 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 INTESS 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.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

#### Concurrence of CDRH, Office of Device Evaluation (ODE)

Anton E. Dmitriev, PhD Division of Orthopedic Devices