STALIF X

K130461 · Centinel Spine, Inc. · OVD · Aug 28, 2013 · Orthopedic

Device Facts

• Record ID: K130461
• Device Name: STALIF X
• Applicant: Centinel Spine, Inc.
• Product Code: OVD · Orthopedic
• Decision Date: Aug 28, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The STALIF X™ is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to L5. 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. Patients with previous non-fusion spinal surgery at the treated level may be treated. These implants may be implanted via a laparoscopic or an open lateral approach. The STALIF X™ is required to be used with supplementary fixation systems (e.g., pedicle screws) that have been cleared for use in the lumbar spine. The STALIF X™ system should be used with bone grafting material (autograft only).

Device Story

STALIF X is a radiolucent intervertebral body fusion device; used for spinal fusion in lumbar region. Device implanted via laparoscopic or open lateral approach; requires concurrent use of supplemental fixation (e.g., pedicle screws) and autogenous bone graft. Provides structural support to disc space to facilitate fusion; benefits patients with discogenic back pain and DDD. Operated by surgeons in clinical/OR settings.

Clinical Evidence

Bench testing only. No clinical data provided. Mechanical testing included static compression, static compression-shear, dynamic compression, dynamic torsion, dynamic compression-shear, expulsion, and subsidence per ASTM F2077, F2267, and F-04.25.02.02.

Technological Characteristics

Intervertebral body fusion device. Materials: PEEK Optima LT-1 or Zeniva ZA PEEK (ASTM F2026) and titanium alloy Ti6Al4V (ASTM F136). Radiolucent design with unicortical cancellous bone screws. Mechanical testing performed per ASTM F2077, F2267, and F-04.25.02.02.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-L5), including those with up to Grade I spondylolisthesis or retrolisthesis, who have failed six months of non-operative treatment. Includes patients with prior non-fusion spinal surgery at the treated level.

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

• STALIF devices (K073109, K101301)
• Integra Vu aPOD-L (K112986)
• Pinnacle Infill (K121733, K103729)

Submission Summary (Full Text)

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# 510(k) Summary

| Contact: | Mr. Justin Eggleton<br>Musculoskeletal Clinical & Regulatory Advisers, LLC<br>1331 H Street NW, 12th Floor<br>Washington, DC 20005<br>202.552.5800 | |
|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Date Prepared: | August 23, 2013 | AUG 2 8 2013 |
| Device Trade Name: | STALIF XTM | |
| Manufacturer: | Centinel Spine, Inc<br>900 Airport Road, Suite 3B<br>West Chester, PA 19380 | |
| Classification: | 21 CFR §888.3080, Intervertebral body fusion device | |
| Class: | . II | |
| Product Code: | . OVD | |

#### Indications For Use:

The STALIF X™ is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to L5. 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. Patients with previous non-fusion spinal surgery at the treated level may be treated. These implants may be implanted via a laparoscopic or an open lateral approach.

The STALIF X™ is required to be used with supplementary fixation systems (e.g., pedicle screws) that have been cleared for use in the lumbar spine.

The STALIF X™ system should be used with bone grafting material (autograft only).

#### Device Description:

The STALIF XTM is a radiolucent intervertebral body fusion device and unicortical cancellous bone screws intended to be used with supplemental fixation. The device is manufactured from PEEK Optima LT-1 or Zeniva ZA PEEK per ASTM F2026 and titanium alloy (Ti6Al4V) per ASTM F136.

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### K130461

## Predicate Device(s):

STALIF X™ was shown to be substantially equivalent to the previously cleared STALIF devices (K073109, K101301), Integra Vu aPOD-L (K112986), and Pinnacle Infill (K121733, K103729). The subject device has similar indications for use, design, function, and materials used.

## Performance Standards:

. .

Testing performed indicate that the STALIF X™ is as mechanically sound as predicate devices. Testing included static compression, static compression-shear, dynamic compression, dynamic torsion, dynamic compression-shear, expulsion, and subsidence per ASTM F2077, F2267, and F-04.25.02.02.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the department's name encircling an abstract symbol. The symbol resembles a stylized caduceus, featuring a staff with a snake winding around it, representing health and medicine. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

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

August 28, 2013

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

Re: K130461

Trade/Device Name: STALIF X TM Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD Dated: July 30, 2013 Received: July 31, 2013

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

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# Page 2 - Mr. Justin Eggleton

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.

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/Resourcesfor You/Industry/default.htm. 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/ReportalProblem/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,

# Erin I. Keith

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): K130461

Device Name: STALIF XTM

The STALIF XTM is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to LS. 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. Patients with previous non-fusion spinal surgery at the treated level may be treated. These implants may be implanted via a laparoscopic or an open lateral approach.

The STALIF XTM is required to be used with supplementary fixation systems (e.g., pedicle screws) that have been cleared for use in the lumbar spine.

The STALIF X™ system should be used with bone grafting material (autograft only).

Prescription Use > Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use (21 CFR 801 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