STALIF CTI, STALIF C

K142079 · Centinel Spine, Inc. · OVE · Oct 24, 2014 · Orthopedic

Device Facts

• Record ID: K142079
• Device Name: STALIF CTI, STALIF C
• Applicant: Centinel Spine, Inc.
• Product Code: OVE · Orthopedic
• Decision Date: Oct 24, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The STALIF C® and STALIF C® Ti devices are intended to be used as an intervertebral body fusion cage as a standalone system used with bone screws provided and requires no additional supplementary fixation systems. It is inserted between the vertebral bodies into the disc space from levels C2 to T1 for the treatment of cervical degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The device system is designed for use with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft, to facilitate fusion. STALIF C® Ti are intended to be used at one level. The cervical cage is to be used in a skeletally mature patient who has had six weeks of non-operative treatment prior to implantation of the cage.

Device Story

Intervertebral body fusion cage; standalone system; utilizes bone screws; requires no supplementary fixation. Implanted into disc space between vertebral bodies (C2-T1). Designed for use with autograft or allogenic bone graft to facilitate fusion. Used by surgeons in clinical settings. Provides structural support to vertebral bodies; promotes spinal fusion. STALIF C® Ti variant includes titanium plasma spray coating on endplates.

Clinical Evidence

No new mechanical or clinical testing performed. Evidence consists of a clinical literature review and PearlDiver reimbursement data to support the safety and efficacy of using allogenic bone graft with the device.

Technological Characteristics

Radiolucent PEEK-OPTIMA® LT1 cage; titanium alloy screws; unalloyed Tantalum X-ray markers (ASTM F-560). STALIF C® Ti includes titanium plasma spray coating on endplates. Standalone intervertebral body fusion system.

Indications for Use

Indicated for skeletally mature patients with cervical degenerative disc disease (neck pain of discogenic origin) at one level from C2 to T1, following six weeks of failed 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

• ANATOMIC PEEK™ CERVICAL FUSION SYSTEM (K130177)

Submission Summary (Full Text)

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

October 24, 2014

Centinel Spine, Incorporated % Mr. Justin Eggleton Musculoskeletal Clinical Regulatory Advisers, LLC 1331 H Street Northwest, 12th Floor Washington, District of Columbia 20005

Re: K142079

Trade/Device Name: STALIF C® and STALIF C® Ti Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVE Dated: July 30, 2014 Received: July 31, 2014

Dear Mr. Eggleton:

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

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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.

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 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 at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/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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#### Indications for Use

510(k) Number (if known) K142079

Device Name STALIF C® and STALIF C® Ti

Indications for Use (Describe)

The STALIF C® and STALIF C® Ti devices are intended to be used as an intervertebral body fusion cage as a standalone system used with bone screws provided and requires no additional supplementary fixation systems. It is inserted between the vertebral bodies into the disc space from levels C2 to T1 for the treatment of cervical degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The device system is designed for use with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft, to facilitate fusion. STALIF C® Ti are intended to be used at one level.

The cervical cage is to be used in a skeletally mature patient who has had six weeks of non-operative treatment prior to implantation of the cage.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

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FOR FDA USE ONLY

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

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# 4. 510(k) Summary

| Device Trade Name: | STALIF C® and STALIF C® Ti |
|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | Centinel Spine, Inc.<br>900 Airport Road, Suite 3B<br>West Chester, PA 19380 |
| Contact: | Mr. John Parry<br>Development Manager<br>Phone: [phone] |
| Prepared by: | Mr. Justin Eggleton<br>Musculoskeletal Clinical Regulatory Advisers, LLC<br>1331 H Street NW, 12th Floor<br>Washington, DC 20005<br>Phone: [phone]<br>[e-mail] |
| Date Prepared: | July 30, 2014 |
| Classifications: | 21 CFR §888.3080, Intervertebral Body Fusion Device |
| Class: | II |
| Product Codes: | OVE |

# Indications For Use:

The STALIF C® and STALIF C® Ti devices are intended to be used as an intervertebral body fusion cage as a standalone system used with bone screws provided and requires no additional supplementary fixation systems. It is inserted between the vertebral bodies into the disc space from levels C2 to T1 for the treatment of cervical degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The device system is designed for use with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft, to facilitate fusion. STALIF C® and STALIF C® Ti are intended to be used at one level.

The cervical cage is to be used in a skeletally mature patient who has had six weeks of non-operative treatment prior to implantation of the cage.

### Summary of Technological Characteristics:

STALIF C® is a radiolucent intervertebral body fusion cage with unicortical cancellous bone screws. It is intended to be used as an IBF cage without supplementary fixation. The cross section profile of the STALIF C® is similar to that of the vertebral body endplate

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with central cavity that can be packed with autograft or allograft. STALIF C® is manufactured from PEEK-OPTIMA® LT1 with titanium alloy screws and X-ray marker wires manufactured from unalloyed Tantalum (ASTM F-560). The STALIF C® Ti is identical to this design with a titanium plasma spray coating on the device endplates.

The purpose of the subject 510(k) was to expand the indications to include use with allograft.

## Predicate Device:

The subject STALIF C® and STALIF C® Ti intervertebral body fusion devices are substantially equivalent to predicate ANATOMIC PEEK™ CERVICAL FUSION SYSTEM (K130177) with respect to indications, design, function, and materials.

# Substantial Equivalence:

STALIF C®, STALIF C® Ti and predicate ANATOMIC PEEK™ CERVICAL FUSION SYSTEM are similar in design, material, and indicated use, and are both cleared devices. They do differ in that the ANATOMIC PEEK™ is indicated for use with allogenic bone graft. A comprehensive, clinical literature review has been conducted to investigate the risks and benefits associated with using allogenic bone graft with the STALIF C". The clinical literature suggests that there is a positive benefit associated with allograft with minimal risk.

# Performance Testing:

A comprehensive, clinical literature review and PearlDiver reimbursement data have been provided to investigate the risks and benefits associated with using allogenic bone graft with the STALIF C. No new mechanical tests were performed since there were no design changes to the device.

### Conclusion:

The Centinel Spine STALIF C® and STALIF C® Ti have been modified to expand the indications to permit use with allograft. The 510(k) demonstrates substantial equivalence to predicate devices.