VAULT-C INTERVERTEBRAL BODY FUSION DEVICE

K132029 · Spinal USA · OVE · Nov 25, 2013 · Orthopedic

Device Facts

• Record ID: K132029
• Device Name: VAULT-C INTERVERTEBRAL BODY FUSION DEVICE
• Applicant: Spinal USA
• Product Code: OVE · Orthopedic
• Decision Date: Nov 25, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Vault-C Standalone Cervical Interbody Fusion System is a standalone cervical interbody device intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C3-T1) at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The Vault-C implants are used with two titanium alloy screws and filled with autogenous bone graft material to facilitate fusion in the cervical spine. The device is placed via an anterior approach at the C-3 to T-1 disc levels. Patients should have at least six weeks of non-operative treatment with an intervertebral fusion device.

Device Story

Vault-C is a standalone cervical interbody fusion system; consists of PEEK-OPTIMA cage, titanium alloy plate, and titanium bone screws. Used for intervertebral body fusion in cervical spine (C3-T1). Surgeon implants device via anterior approach; fills cage with autogenous bone graft to facilitate fusion; secures with two titanium screws. Device provides structural support to vertebral bodies. Intended for patients with degenerative disc disease. Benefits include stabilization of spinal segment and promotion of fusion. Used in clinical/surgical settings by orthopedic or neurosurgeons.

Clinical Evidence

Bench testing only. No clinical data provided. Mechanical testing included static and dynamic axial compression, compression-shear, torsion, and subsidence testing per ASTM F-2077 and ASTM F-2267 standards.

Technological Characteristics

Materials: PEEK-OPTIMA (ASTM F2026), titanium alloy (ASTM F136), tantalum (ASTM F560-05). Components: PEEK cage, titanium plate, titanium screws. Mechanical fixation via screws. No software or electronic components.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C3-T1) at one disc level, defined as discogenic pain with degeneration confirmed by history and radiography, following at least 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

• Centinel Spine Stalif C System (K120819)
• Biomet Spine Solitaire-C System (K113796)
• LDR Spine ROI-C (K091088, K113559)
• Life Spine, Inc. Pro-Link Stand-Alone Cervical System (K121151)
• Globus Medical, Inc. COALITION Spacer (K083389)

Submission Summary (Full Text)

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# 5.510(K) SUMMARY

| Submitter's Name: | Spinal USA, Inc. |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter's Address: | 2050 Executive Drive<br>Pearl. MS 39208 |
| Submitter's Telephone: | 601-420-4244 |
| Contact Person: | Meredith L. May, MS<br>Empirical Testing Corp.<br>719.337.7579 |
| Date Summary was<br>Prepared: | 28 June 2013 |
| Trade or Proprietary Name: | Vault-C Standalone Cervical Interbody Fusion System |
| Common or Usual Name: | Intervertebral body fusion device. |
| Classification: | Class II per 21 CFR §888.3080 |
| Product Code: | OVE |
| Classification Panel: | Orthopedic and Rehabilitation Devices Panel |
| Predicate Devices: | Centinel Spine Stalif C System (K120819)<br>Biomet Spine. Solitaire-C System (K113796)<br>LDR Spine ROI-C (K091088, K113559)<br>Life Spine, Inc. Pro-Link Stand-Alone Cervical System (K121151)<br>Globus Medical. Inc COALITION Spacer (K083389) |

## DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

The Vault-C consists of a spacer assembly including a PEEK cage with a titanium alloy plate and titanium bone screws for intervertebral body fusion. Screws are available in a variety of diameter-length combinations. The titanium and PEEK spacers are available in a variety of depths, widths and heights. Fixation is achieved by inserting bone screws through the openings in the spacer into the vertebral bodies of the cervical spine.

## INDICATIONS FOR USE

The Vault-C Standalone Cervical Interbody Fusion System is a standalone cervical interbody device intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C3-TI) at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The Vault-C implants are used with two titanium alloy screws and filled with autogenous bone graft material to facilitate fusion in the cervical spine. The device is placed via an anterior approach at the C-3 to T-1 disc levels.

Spinal USA Vault-C Standalone Cervical Interbody Fusion System

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Patients should have at least six weeks of non-operative treatment with an intervertebral fusion device.

The indication for use for the Spinal USA Vault-C is similar to that of the Centinel Spine Stalif C System (K120819). Biomet Spine Solitaire-C System (K113796). LDR Spine ROI-C (K091088, K 113559), Life Spine, Inc. Pro-Link Stand-Alone Cervical System (K121151) and Globus Medical. Inc. COALITION Spacer (K083389).

#### TECHNICAL CHARACTERISTICS

The spacers are manufactured from PEEK-OPTIMA® (ASTM F2026), titanium alloy (ASTM F136), and tantalum (ASTM F560-05). The predicate devices are manufactured from the same or similar materials. 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:

- . Indications for Use
- Materials of manufacture �
- t Structural support mechanism

## PERFORMANCE DATA

The Vault-C has been tested in the following test modes:

- Static Axial Compression (ASTM F-2077) .
- . Static Compression-Shear (ASTM F-2077)
- Static Torsion (ASTM F-2077) . ●
- Dynamic Axial Compression (ASTM F-2077) ●
- Dynamic Compression-Shear (ASTM F-2077) .
- . Dynamic Torsion (ASTM F-2077)
- Subsidence (ASTM F-2267 and ASTM F-2077)

The results of this non-clinical testing show that the strength of the Vault-C 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 Vault-C is substantially equivalent to the predicate device.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, superimposed over three horizontal bars. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

November 25, 2013

Spinal USA % Ms. Meredith May Partnership Manager Empirical Testing Corporation 4628 Northpark Drve Colorado Springs, Colorado 80918

Re: K132029

Trade/Device Name: Vault-C Standalone Cervical Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVE Dated: October 8, 2013 Received: October 18, 2013

Dear Ms. May:

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 - Ms. Meredith May

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.

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/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 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 Nielkerson -S

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

Enclosure

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| | DEPARTMENT OF HEALTH AND HUMAN SERVICES<br>Food and Drug Administration | Form Approved: OMB No. 0910-0120<br>Expiration Date: December 31, 2013 | |
|-------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| | Indications for Use | See PRA Statement on last page. | |
| 510(k) Number (if known) | | | |
| K132029 | | | |
| Device Name<br>Vault-C Standalone Cervical Interbody Fusion System | | | |
| Indications for Use (Describe) | | | |
| intervertebral fusion device | The Vault-C Standalone Cervical Interbody Fusion System is a standalone cervical interbody<br>the disc confirmed by history and radiographic studies. The Vault-C implants are used with two<br>titanium alloy screws and filled with autogenous bone graft material to facilitate fusion in the<br>cervical spine. The device is placed via an anterior approach at the C-3 to T-1 disc levels.<br>Patients should have at least six weeks of non-operative treatment with an | device intended for use in skeletally mature patients with degenerative disc disease (DDD) of the<br>cervical spine (C3-T1) at one disc level. DDD is defined as discogenic pain with degeneration of | |
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| Type of Use (Select one or both, as applicable)<br>Prescription Use (Part 21 CFR 801 Subpart D) | | Over-The-Counter Use (21 CFR 801 Subpart C) | |
| | PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. | | |
| FOR FDA USE ONLY | | | |
| Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) | | | |
| | Anton E. Dmitriev, PhD | | |
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| | Division of Orthopedic Devices | | |
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| FORM FDA 3881 (9/13) | Page 1 of 2 | PSC Publishing Bervices (301) 443-8 | |

Spinal USA Vault-C Standalone Cervical Interbody Fusion System

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