COGENT MED-LIF

K132738 · Cogent Spine, LLC · MAX · Apr 15, 2014 · Orthopedic

Device Facts

• Record ID: K132738
• Device Name: COGENT MED-LIF
• Applicant: Cogent Spine, LLC
• Product Code: MAX · Orthopedic
• Decision Date: Apr 15, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Cogent Med-LIF is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These devices are intended for intervertebral body fusion, and are intended to be used with supplemental fixation instrumentation which has been cleared by the FDA for use in the lumbar spine.

Device Story

Intervertebral body fusion device; stabilizes spinal segments to promote fusion. Comprises two PEEK spacers with axial voids for bone graft, titanium linkage, angular anti-migration teeth, and tantalum x-ray markers. Implanted via open or minimally invasive approach; placed as single unit or bilaterally in intervertebral space. Used by surgeons in clinical settings; requires supplemental fixation instrumentation. Benefits patients by providing structural support during fusion process. Non-sterile; requires end-user sterilization.

Clinical Evidence

No clinical data. Evidence consists of bench testing (static/dynamic axial compression, static/dynamic shear compression, subsidence, and expulsion testing per ASTM standards) and a cadaveric implantation study to confirm bone graft delivery.

Technological Characteristics

Materials: PEEK (ASTM F2026), titanium alloy Ti-6Al-4V (ASTM F1472), and tantalum (ASTM F560). Form factor: Two spacers with titanium linkage, angular teeth, and x-ray markers. Available in 0° and 6° lordotic options; heights 8-16mm; widths 10mm; lengths 20-30mm. Non-sterile; requires end-user sterilization.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1, including those with up to Grade I spondylolisthesis or retrolisthesis, who have failed six months 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

• Eisertech PLIF Cage (K113478)
• Stryker Spine AVS PL PEEK Spacers (K073470)
• Custom Spine Pathway Avid (K090566)
• Sapphire Medical Group A-Wedge Anterior Interbody System (K121693)

Submission Summary (Full Text)

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## APR 1 5 2014

SUBMITTER:

Submitted Bv:

| Company Name: | Cogent Spine |
|---------------|----------------------------------------------------|
| Address: | 101 N. Acacia, Suite 106<br>Solana Beach, CA 92075 |
| Telephone: | [phone] |

CONTACT PERSON: Jude Paganelli

DATE PREPARED: April 15, 2014

TRADE NAME: Cogent Med-LIF

COMMON NAME: Intervertebral Body Fusion Device

CLASSIFICATION NAME: Intervertebral Body Fusion Device (21 CFR 888.3080)

PRODUCT CODE: MAX

#### SUBSTANTIALLY EQUIVALENT TO:

The Cogent Med-LIF is substantially equivalent to the predicates in all facets including: indications, technology, method of use and performance. The predicate devices for the Cogent Med-LIF system are:

Eisertech PLIF Cage (K113478) Stryker Spine AVS PL PEEK Spacers (K073470) Custom Spine Pathway Avid (K090566) Sapphire Medical Group A-Wedge Anterior Interbody System (K121693)

### DESCRIPTION of the DEVICE:

The Cogent Med-LIF is an interbody fusion device intended to stabilize the spinal segment to promote fusion. The Cogent Med-LIF consists of two PEEK spacers with axial voids to contain bone graft material, a titanium linkage that connects the PEEK spacers, angular anti-migration teeth, and tantalum x-ray markers.

The Cogent Med-LIF is available in various sizes to accommodate varying patient anatomy. The implants come in two lordotic options, 0° (parallel)

510(K) Submission:

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#### 510(k) Summary-Continued

and 6° (lordotic). The parallel implants are available in heights ranging from 8mm to 16mm and the lordotic implants are available in heights ranging from 10mm to 16mm. All implants are 10mm wide and are available in three lengths; 20, 25 and 30mm.

The Cogent Med-LIF implants may be inserted via an open or minimally invasive approach and may be placed as a single implant or as two units bilaterally in the same intervertebral space.

The Cogent Med-LIF implants are non-sterile and are to be sterilized by the end user.

#### MATERIALS:

The Cogent Med-LIF is manufactured from polyetheretherketone (PEEK) as per ASTM F2026 and contains titanium alloy (Ti-6Al-4V) per ASTM F1472 and tantalum per ASTM F560.

### INDICATIONS FOR USE:

The Cogent Med-LIF is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These devices are intended for intervertebral body fusion, and are intended to be used with supplemental fixation instrumentation which has been cleared by the FDA for use in the lumbar spine.

#### PERFORMANCE TESTING:

Cogent Spine conducted the following bench tests:

ASTM F2077

- . Static Axial Compression
- Dynamic Axial Compression ●
- Static Shear Compression .
- Dynamic Shear Compression .

#### ASTM F2267

· Subsidence

Expulsion Testing per ASTM Draft Standard F04.25.02.02

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#### 510(k) Summary-Continued

Additionally, Cogent Spine conducted a cadaveric implantation study to confirm autogenous bone graft can be adequately delivered when compared to a legally marketed predicate.

In summary, mechanical and non-clinical testing of the Cogent Med-LIF device indicated no new risks and demonstrated substantial equivalence in performance compared to a legally marketed predicate.

### CONCLUSIONS:

The Cogent Med-LIF device has shown to be substantially equivalent to legally marketed predicates based on indications for use, technological characteristics, performance testing and comparison to predicate devices.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

April 15, 2014

Cogent Spine LLC % Mr. Jude Paganelli Cor Medical Ventures LLC 101 North Acacia Avenue, Suite 106 Solana Beach, California 92075

Re: K132738

Trade/Device Name: Cogent Med-LIF Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: February 12, 2013 Received: March 21, 2014

Dear Mr. Paganelli:

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 or any I vith 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 CI K Fall 607); adoling (21 OFF 803); good manufacturing practice requirements as set

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Page 2 - Mr. Jude Paganelli

forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

# Ronald P. Jean -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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

#### 510(k) Number (if known) K132738

Device Name Cogent Med-LIF

#### Indications for Use (Describe)

The Cogent Med-LIF is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These devices are intenertebral body fusion, and are intended to be used with supplemental fixation instrumentation which has been cleared by the FDA for use in the lumbar spine.

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

### Anton E. Dmitriev, PhD

.

Division of Orthopedic Devices

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