STINGRAY CERVICAL CAGE; SHARK IMPLANT (PLIF); BULL SHARK IMPLANT(PLIF); TIGER IMPLANT (TLIF); GREAT WHITE IMPLANTS(ALIF)

K102322 · Omni Surgical, L.P. · MAX · Jan 7, 2011 · Orthopedic

Device Facts

• Record ID: K102322
• Device Name: STINGRAY CERVICAL CAGE; SHARK IMPLANT (PLIF); BULL SHARK IMPLANT(PLIF); TIGER IMPLANT (TLIF); GREAT WHITE IMPLANTS(ALIF)
• Applicant: Omni Surgical, L.P.
• Product Code: MAX · Orthopedic
• Decision Date: Jan 7, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Spine 360 Lumbar Interbody Fusion System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Spine 360 Lumbar Interbody Fusion System implants are to be used with autogenous bone graft. The Spine 360 Lumbar Interbody Fusion System implants are to be used with supplemental fixation. Patients should have at least (6) months of non-operative treatment prior to treatment with an intervertebral cage. Patients with previous nonfusion spinal surgery at involved level may be treated with the device.

Device Story

Spine 360 Interbody Fusion System comprises PEEK-OPTIMA LT1 polymer implants for lumbar interbody fusion. Available in various geometries: SHARK (PLIF, rectangular, tapered/conical nose), TIGER (TLIF, banana-shaped), and GREAT WHITE (ALIF, oval, lordotic). Implants feature hollow centers/windows for autogenous bone graft placement to facilitate fusion. Used by surgeons in spinal procedures; requires supplemental fixation. Provides structural support to intervertebral space; promotes fusion in DDD patients. Non-sterile; requires hospital steam sterilization.

Clinical Evidence

No clinical studies were performed. Evidence is based on bench testing, including static and dynamic compression testing per ASTM F2077 and subsidence testing per ASTM F2267.

Technological Characteristics

Materials: PEEK-OPTIMA LT1 polymer (ASTM F2026) and tantalum (ASTM F560) X-ray markers. Configurations: PLIF (rectangular), TLIF (banana), ALIF (oval/lordotic). Energy: None (mechanical implant). Sterilization: Non-sterile, hospital steam sterilization. Connectivity: None.

Indications for Use

Indicated for skeletally mature patients with lumbar degenerative disc disease (DDD) at one or two contiguous levels (L2-S1). Includes patients with up to Grade 1 spondylolisthesis or retrolisthesis and those with prior non-fusion spinal surgery. Requires 6 months of failed non-operative treatment. Must be used with autogenous bone graft and supplemental fixation.

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

• BRANTIGAN I/F CAGE (P960025)
• Lucent Straight Intervertebral Body Fusion Device (K072120)

Reference Devices

• Crystal Cervical Cage (K073351)
• BAK/C Vista (P980048 S3)

Submission Summary (Full Text)

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K 102 322

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## 510(k) Summary for the Spine 360 Interbody Fusion System

JAN - 7 2011

In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for the Spine 360 Interbody Fusion System.

Date Prepared: December 2, 2010

- 1. Submitter: Contact Person: J.D. Webb Spine 360 5000 Plaza on the Lake, Suite 305 The OrthoMedix Group, Inc. Austin, TX 78746 1001 Oakwood Blvd Round Rock, TX 78681 Telephone: [phone]
- 2. Trade name: Spine 360 Interbody Fusion System Common Name: intervertebral body fusion device Classification Name: intervertebral body fusion device - lumbar 21 CFR section 888.3080 MAX Class II

### ന് Predicate or legally marketed devices which are substantially equivalent:

- Spine 360 Interbody Fusion System is substantially equivalent to the following devices.
- BRANTIGAN I/F CAGE (P960025) .
- . Lucent Straight Intervertebral Body Fusion Device (K072120)

#### 4. Description of the device:

The SHARK implant (PLIF) consists of rectangular blocks with a tapered nose. The BULLSHARK implant (PLIF) is rectangular in shape with a conical nose. Both devices have parallel configurations of various heights.

The TIGER implant (TLIF) consists of banana shaped blocks in a parallel configuration of various heights. Large bone graft windows are located through the body of the device to allow for placement of bone graft and facilitate fusion.

The GREAT WHITE implants (ALIF) are oval shaped blocks, which are available in a two lordotic configurations (7° and 13°) of various heights. The hollow cylinders allow for placement of bone graft and facilitate fusion.

### Materials:

PEEK-OPTIMA LT1 polymer (ASTM F2026 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications) and tantalum according to ASTM F560.

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### 5. Substantial equivalence claimed to predicate devices

JAN - 7 2911

Spine 360 Cervical Interbody Fusion System is substantially equivalent to the predicate devices in terms of intended use, design, materials used, mechanical safety and performances. The table below compares the features and characteristics of the Spine 360 Cervical Interbody Fusion System to these predicate devices.

| Device | Spine 360 | Crystal Cervical<br>Cage | BAK/C Vista | BRANTIGAN | Lucent |
|----------------------|-------------------------------------------------------------|-------------------------------------------------------------|------------------------------------------------------------|---------------------------------------------------------------------------------------------------|-------------------------------------------------------------|
| 510(k) number | -- | K073351 | P980048 S3 | P960025 | K072120 |
| Intended use | Per 888.3080 | Per 888.3080 | Per 888.3080 | Per 888.3080 | Per 888.3080 |
| Bone graft<br>cavity | Yes | Yes | Yes | Yes | Yes |
| Ridges | Yes | Yes | Yes | Yes | Yes |
| X-ray markers | Yes | Yes | Yes | Yes | Yes |
| Raw material | PEEK Optima<br>LT1 | PEEK Optima<br>LT1 | carbon-fiber<br>reinforced PEEK-<br>OPTIMA® LT1<br>polymer | 70% (poly ether<br>ketone ether<br>ketone ketone)<br>(PEKEKK), 30%<br>polyacrylonitrile<br>carbon | PEEK Optima<br>LT1 |
| Sterility | Provided non-<br>sterile<br>Steam sterilized<br>at hospital | Provided non-<br>sterile<br>Steam sterilized<br>at hospital | Provided<br>gamma<br>sterilized | Provided<br>gamma<br>sterilized | Provided non-<br>sterile<br>Steam sterilized<br>at hospital |

### 6. Intended Use:

The Spine 360 Lumbar Interbody Fusion System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Spine 360 Lumbar Interbody Fusion System implants are to be used with autogenous bone graft. The Spine 360 Lumbar Interbody Fusion System implants are to be used with supplemental fixation. Patients should have at least (6) months of non-operative treatment prior to treatment with an intervertebral cage. Patients with previous nonfusion spinal surgery at involved level may be treated with the device.

### 7. Non-clinical Test Summary:

The following tests were conducted:

- Static and dynamic compression testing per ASTM F2077 "Test Methods for Intervertebral Body . Fusion Devices"
- Subsidence per ASTM F2267 "Measuring Load Induced Subsidence of Intervertebral Body Fusion . Device Under Static Axial Compression".

### 8. Clinical Test Summary

- No clinical studies were performed
- Comparison of the technological characteristics of the device to predicate and legally marketed devices: த் Spine 360 Interbody Fusion System is substantially equivalent to the predicate devices in terms of indications for use, design, material, and function.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with outstretched wings, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002

Spine 360 % The Orthomedix Group, Inc. Mr. J.D. Webb 1001 Oakwood Boulevard Round Rock, Texas 78681

JAN - 7 201

Re: K102322

Trade/Device Name: Spine 360 Lumbar Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: December 02, 2010 Received: December 07, 2010

Dear Mr. Webb:

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

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Page 2 – Mr. J.D. Webb

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.

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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Sincerely yours,

Mark A. Milliman

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

K102322 510(k) Number (if known):

JAN - 7 2011

Device Name: Spine 360 Lumbar Interbody Fusion System

The Spine 360 Lumbar Interbody Fusion System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Spine 360 Lumbar Interbody Fusion System implants are to be used with autogenous bone graft. The Spine 360 Lumbar Interbody Fusion System implants are to be used with supplemental fixation. Patients should have at least (6) months of non-operative treatment prior to treatment with an intervertebral cage. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

K102322 510(k) Number_