VAULT ALIF SYSTEM

K103369 · Spinal USA · OVD · Apr 4, 2011 · Orthopedic

Device Facts

• Record ID: K103369
• Device Name: VAULT ALIF SYSTEM
• Applicant: Spinal USA
• Product Code: OVD · Orthopedic
• Decision Date: Apr 4, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Vault ALIF System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion. One device is used per intervertebral space. The Vault ALIF System is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used with autogenuos bone graft. Patients should have at least six months of non-operative treatment prior to treatment with a lumbar intervertebral fusion device. The Vault ALIF System is a stand-alone system intended to be used with the bone screws provided and requires no additional supplementary fixations.

Device Story

Vault ALIF System is a stand-alone intervertebral body fusion device; used for lumbar spine fusion (L2-S1). System comprises PEEK implants of varying dimensions and bone screws; eliminates need for supplementary fixation. Implanted by surgeons during spinal fusion procedures to treat degenerative disc disease with spondylolisthesis. Device facilitates fusion using autograft. Mechanical stability provided by integrated screw fixation. Benefits include stabilization of spinal segments and promotion of arthrodesis.

Clinical Evidence

Bench testing only. No clinical data provided. Mechanical testing performed per ASTM F2077 (axial/shear compression), ASTM F2267 (subsidence), and expulsion testing. Cyclical axial and shear compression testing conducted to 5,000,000 cycles.

Technological Characteristics

Intervertebral body fusion device; material: medical grade polyetheretherketone (PEEK LTI). Stand-alone design with integrated bone screws. Mechanical testing performed per ASTM F2077 and F2267. Supplied non-sterile.

Indications for Use

Indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) and up to Grade I spondylolisthesis at one or two contiguous lumbar levels (L2-S1). Requires six months of prior non-operative treatment. Contraindicated in patients without skeletal maturity or those not meeting DDD criteria.

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

• Spinal USA Interbody Fusion Device (K092193)
• Solitare Anterior Spinal System (K081501)
• STALIF TT Intervertebral Body Fusion System (K073109)

Submission Summary (Full Text)

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K103369 Page 1/2

Atlachment F

APR - 4 20il

## 510 (k) Summary of Safety and Effectiveness

#### Date Summary Prepared: November 11, 2010 Submitter Information: Spinal USA 2050 Executive Drive Pearl, MS 39208 Contact Name: Linda Polk Phone: [phone] Fax: [phone] ·[e-mail] E-mail: Device Trade Name: Vault ALIF System Intervertebral Body Fusion Device Common Name: Regulatory Number: 888.3080 Classification: Class II OVD Product Code:

INTENDED USE: The Vault ALIF System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion. One device is used per intervertebral space.

The Vault ALIF System is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used with autogenuos bone graft. Patients should have at least six months of non-operative treatment prior to treatment with a lumbar intervertebral fusion device.

The Vault ALIF System is a stand-alone system intended to be used with the bone screws provided and requires no additional supplementary fixations.

#### DEVICE DESCRIPTION:

The Vault ALIF System consists of implants with various widths, heights, lengths and bone screws to accommodate individual patient anatomy and graft material size. All components are manufactured from medical grade polyetheretherketone (Peek LTI). The products are supplied clean and "NON-STERILE".

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Attachment F

### MECHANICAL TESTING:

The Vault ALIF System was mechanically tested per ASTM F2077, F2267 and Expulsion. The objectives of this test battery were to mechanically test the Vault ALIF System using the following test methods:

Static testing in a load to failure mode in axial compression

Static testing in a load to failure mode in shear compression

Static testing in subsidence

Static testing in expulsion

Cyclical axial compression testing to estimate the maximum run out load value at 5.000.000 cycles

Cyclical shear compression testing to estimate the maximum run out load value at 5.000.000 cycles

Mechanical Test Conclusion:

The Vault system is as safe as the predicates based on the following:

- 1) The design of the Vault system is similar to the predicates in height, width, length and lordotic angle.
- 2) The materials used in the Vault system are the same as used in the predicate systems.
- 3) The mechanical strength of the Vault system is greater than the predicate based on mechanical test results

The Vault system is as effective as the predicate based on the following:

- 1) The intended use of the Vault system is the same as the predicates.
- 2) The indication for use of the Vault system is the same as the predicates.
- 3) The bone port opening of the Vault system is equivalent to its predicates.

The Vault system is as safe and effective as its predicates.

#### EQUIVALENT DEVICE:

Documentation was provided which demonstrated the Vault ALIF System to be substantially equivalent to previously cleared devices. The substantial equivalence is based upon equivalence in intended use, indications, anatomic sites, performance and material of manufacture.

#### Predicate Devices:

Spinal USA Interbody Fusion Device (K092193) Solitare Anterior Spinal System (K081501) STALIF TT Intervertebral Body Fusion System (K073109)

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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 consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

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

Letter dated: January 23, 2013

Spinal USA % Ms. Linda Polk 2050 Executive Drive Pearl, Mississippi 39208

Re: K103369

Trade/Device Name: Spinal USA Vault ALIF System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD Dated: March 14, 2011 Received: March 17, 2011

Dear Ms. Polk:

This letter corrects our substantially equivalent letter of April 4, 2011.

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 (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.

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 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.

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Page 2 - Ms. Linda Polk

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Mark N. Melkerson

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

. K103369 510(k) Number (if known):

Device Name: Vault ALIF System

Indications for Use:

The Vault ALIF System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion. One device is used per intervertebral space.

The Vault ALIF System is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used with autogenuos bone graft. Patients should have at least six months of non-operative treatment prior to treatment with a lumbar intervertebral fusion device.

The Vault ALIF System is a stand-alone system intended to be used with the bone screws provided and requires no additional supplementary fixations.

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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign Off

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

K103369 510(k) Number.

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