Cortina™ Lumbar Cage System

K171914 · Neurostructures, Inc. · MAX · Oct 25, 2017 · Orthopedic

Device Facts

• Record ID: K171914
• Device Name: Cortina™ Lumbar Cage System
• Applicant: Neurostructures, Inc.
• Product Code: MAX · Orthopedic
• Decision Date: Oct 25, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Cortina™ Lumbar Cage System is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion combined with supplemental fixation. The interior of the Cortina™ Lumbar Cage System should be packed with autogenous bone graft (i.e. autograft). DDD is defined as back pain of discogenic origin 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.

Device Story

Intervertebral body fusion device; used in lumbar spine (L2-S1) for degenerative disc disease; requires supplemental fixation; packed with autogenous bone graft. Implanted by surgeons during spinal fusion procedures. Provides structural support to disc space to facilitate fusion. Device design accommodates various patient anatomies.

Clinical Evidence

Bench testing only. Performed static/dynamic axial compression (ASTM F2077-11), static subsidence (ASTM F2267-04), and static expulsion (ASTM DRAFT F-04.25.02.02). Results demonstrate mechanical strength sufficient for intended use.

Technological Characteristics

Medical grade PEEK with titanium markers. Intervertebral fusion device. Mechanical testing per ASTM F2077-11 and ASTM F2267-04. No software or electronic components.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 requiring interbody fusion with supplemental fixation; requires six months of prior 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

• PLIF Cage (K113478)
• OPAL Spacer (K072791)
• AccuLIF® TL and PL Cage (K141217)
• Lucent Cage (K071724)
• AccuLiF® TL-PEEK Cage (K112095)
• AccuLiF® TL and P (K123281, K123752)

Submission Summary (Full Text)

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October 25, 2017

NeuroStructures, Inc. % Kenneth C. Maxwell II Regulatory and Quality Specialist Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, Colorado 80918

#### Re: K171914

Trade/Device Name: Cortina™ Lumbar Cage System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: October 10, 2017 Received: October 10, 2017

Dear Mr. Maxwell:

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 (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.

U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.qov

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free 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 Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

# Mark N. Melkerson -S

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

Enclosure

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# Indications for Use

510(k) Number (if known) K171914

Device Name Cortina™ Lumbar Cage System

#### Indications for Use (Describe)

The Cortina™ Lumbar Cage System is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion combined with supplemental fixation. The interior of the Cortina™ Lumbar Cage System should be packed with autogenous bone graft (i.e. autograft). DDD is defined as back pain of discogenic origin 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.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--------------------------|
| Prescription Use (Part 21 CFR 801 Subpart D) | <input type="checkbox"/> |
| Over-The-Counter Use (21 CFR 801 Subpart C) | <input type="checkbox"/> |

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510(K) SUMMARY

| Submitter's Name | Neurostructures, Inc. |
|------------------------------|------------------------------------------------------------------------------------------------------|
| Submitter's Address | 16 Technology Drive, Suite 165<br>Irvine, CA 92618 |
| Company Contact Person | Kathleen Wong<br>[e-mail]<br>949.370.4497 |
| Contact Person | Kenneth C. Maxwell II<br>Empirical Testing Corp.<br>719.291.6874<br>[e-mail] |
| Date Summary was<br>Prepared | 21 June 2017 |
| Trade or Proprietary Name | Cortina™ Lumbar Cage System |
| Common or Usual Name | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Classification | Class II per 21 CFR §888.3080 Device Classification |
| Product Code | MAX |
| Classification Panel | Division of Orthopedic Devices |

### DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION

The Cortina™ Lumbar Cage System is an intervertebral fusion device made from medical grade PEEK with titanium markers. The subject device is offered in a variety of styles and sizes to accommodate various patient anatomies.

## INDICATIONS FOR USE

The Cortina™ Lumbar Cage System is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion combined with supplemental fixation. The interior of the Cortina™ Lumbar Cage System should be packed with autogenous bone graft (i.e. autograft). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of nonoperative treatment.

The indications for use for the Cortina™ Lumbar Cage System is similar to that of the predicates noted in Table 5-1: Predicate Devices.

### TECHNOLOGICAL CHARACTERISTICS

The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically the following characteristics are identical between the subject and predicates:

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- Principles of Operation ●
- Indications for Use .
- Implant Materials
- Implant Sizes ●
- Surgical Approach ●

| 510k Number | Trade or Proprietary or Model<br>Name | Manufacturer | Predicate<br>Type |
|-----------------|---------------------------------------|----------------|-------------------|
| K113478 | PLIF Cage | Eisertech | Primary |
| K072791 | OPAL Spacer | Synthes | Additional |
| K141217 | AccuLIF® TL and PL Cage | Stryker | Additional |
| K071724 | Lucent Cage | Spinal Element | Additional |
| K112095 | AccuLiF® TL-PEEK Cage and | CoAlign | Additional |
| K123281 K123752 | AccuLiF® TL and P | Innovation | Additional |

#### Table 5-1: Predicate Devices

## Performance Data

The Cortina™ Lumbar Cage System has been tested in the following test modes:

- Static axial compression per ASTM F2077-11 ●
- . Dynamic axial compression per ASTM F2077-11
- . Static subsidence per ASTM F2267-04
- Static expulsion per ASTM DRAFT F-04.25.02.02 ●

The results of this non-clinical testing show that the strength of the Cortina™ Lumbar Cage System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.

### CONCLUSION

The overall technology characteristics and mechanical performance data lead to the conclusion that the Cortina™ Lumbar Cage System is substantially equivalent to the predicate devices.