SeaSpine Cabo ACP (Anterior Cervical Plate) System

K173521 · SeaSpine Orthopedics Corporation · KWQ · Jan 24, 2018 · Orthopedic

Device Facts

• Record ID: K173521
• Device Name: SeaSpine Cabo ACP (Anterior Cervical Plate) System
• Applicant: SeaSpine Orthopedics Corporation
• Product Code: KWQ · Orthopedic
• Decision Date: Jan 24, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SeaSpine Cabo ACP (Anterior Cervical Plate) System is intended for anterior cervical fixation (C2-T1) for the following indications: Degenerative Disc Disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), Spondylolisthesis, Trauma (i.e., fracture or dislocation), Spinal Stenosis, Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), Tumor, Pseudoarthrosis, and failed previous fusion.

Device Story

The SeaSpine Cabo ACP System is a spinal intervertebral body fixation orthosis used by surgeons for anterior cervical stabilization. The device consists of titanium alloy bone plates and screws. During surgery, the surgeon attaches the plate to the cervical vertebral bodies (C2-T1) using bone screws. The system features preassembled locking pins that cover screw heads to prevent back-out. The device provides mechanical stabilization to the cervical spine to facilitate fusion. It is intended for use in clinical settings by trained orthopedic or neurosurgeons. The system is supported by associated surgical instruments for implantation.

Clinical Evidence

No clinical data. Substantial equivalence is based on non-clinical bench testing, including static axial compression, torsion, and dynamic axial compression testing performed in accordance with ASTM F1717.

Technological Characteristics

Materials: Titanium alloy (ASTM F136). Components: Bone plates, screws, and preassembled locking pins. Principle: Spinal intervertebral body fixation. Sterility: Not specified. Connectivity: None (mechanical device).

Indications for Use

Indicated for anterior cervical fixation (C2-T1) in patients with degenerative disc disease, spondylolisthesis, trauma (fracture/dislocation), spinal stenosis, spinal deformities (scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, or failed previous fusion.

Regulatory Classification

Identification

A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.

Predicate Devices

• Transom Cervical Plate System (K142060)

Submission Summary (Full Text)

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January 24, 2018

SeaSpine Orthopedics Corporation Gina Flores Sr. Regulatory Specialist 5770 Armada Drive Carlsbad, California 92008

Re: K173521

Trade/Device Name: SeaSpine Cabo ACP (Anterior Cervical Plate) System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: November 27, 2017 Received: November 28, 2017

Dear Ms. Flores:

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 (OS) 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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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.

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/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,

# Katherine D. Kavlock -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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## Indications for Use

510(k) Number (if known)

K173521

Device Name

SeaSpine Cabo ACP (Anterior Cervical Plate) System

Indications for Use (Describe)

The SeaSpine Cabo ACP (Anterior Cervical Plate) System is intended for anterior cervical fixation (C2-T1) for the following indications:

· Degenerative Disc Disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies),

- · Spondylolisthesis,
- · Trauma (i.e., fracture or dislocation),
- · Spinal Stenosis,
- · Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis).
- · Tumor,
- · Pseudoarthrosis,
- · and failed previous fusion

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/1 description: The image contains the logo for SeaSpine. The logo consists of a stylized graphic of three curved lines in shades of blue, resembling waves or a spine. To the right of the graphic is the company name, "SeaSpine," in orange, with a small trademark symbol next to it. The text is in a sans-serif font and appears to be the primary element of the logo.

## 510(k) Summary

#### Contact Details

| Applicant Name: | SeaSpine Orthopedics Corporation | |
|-----------------|----------------------------------------|--|
| Address: | 5770 Armada Drive, Carlsbad CA | |
| Phone number: | [phone] | |
| Fax number: | [phone] | |
| Contact person: | Gina Flores, Sr. Regulatory Specialist | |
| Email address: | [e-mail] | |
| Date Prepared: | January 10, 2018 | |

#### Device Name

| Trade Name: | SeaSpine Cabo ACP (Anterior Cervical Plate) System |
|----------------------|----------------------------------------------------|
| Common Name: | Cervical Plate |
| Classification Name: | Spinal intervertebral body fixation orthosis |
| Classification: | 21 CFR 888.3060 |
| Class: | II |
| Product Code: | KWQ |

## Legally Marketed Predicate Device

| 510(k)<br>Number | Product<br>Code | Trade Name | Manufacturer |
|------------------|-----------------|----------------------------------|-----------------------|
| K142060 | KWQ | Transom Cervical Plate<br>System | Neurostructures, Inc. |

#### Device Description

The SeaSpine Cabo ACP (Anterior Cervical Plate) System consists of a variety of bone plates and screws. Fixation is achieved by inserting bone screws through the openings in the plate into the vertebral bodies of the cervical spine. The Cabo plates include locking pins that cover the heads of the bone screws to reduce the potential for screw back-out. The locking pins come preassembled to the plate. The Cabo ACP (Anterior Cervical Plate) System implant components are made from titanium alloy per ASTM F136. Associated instruments are available to facilitate the implantation of the device.

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SeaSpine

#### Intended Use/Indications for Use

The SeaSpine Cabo ACP (Anterior Cervical Plate) System is intended for anterior cervical fixation (C2-T1) for the following indications:

- . Degenerative Disc Disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies),
- . Spondylolisthesis.
- Trauma (i.e., fracture or dislocation), ●
- Spinal Stenosis,
- Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
- Tumor,
- Pseudoarthrosis, ●
- and failed previous fusion.

## Summary of Technological Characteristics

The SeaSpine Cabo ACP (Anterior Cervical Plate) System is equivalent to the cited predicate device in regard to components, device description, intended use/indications for use, technological characteristics (operating principle, design, materials, sterility, manufacturing, etc.) and performance (mechanical).

## Non-Clinical Testing

The SeaSpine Cabo ACP (Anterior Cervical Plate) System demonstrated equivalent performance to the predicate system through engineering analysis of static axial compression and torsion, and dynamic axial compression per ASTM F1717.

## Clinical Testing

Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data.

## Conclusions

The submitted data demonstrate that the SeaSpine Cabo ACP (Anterior Cervical Plate) System is substantially equivalent to the cited legally marketed predicate device.