ZEUS SMALL CERVICAL CAGE AND LARGE, EXTRA LARGE, CURVED AND STRAIGHT LUMBAR CAGES

K081614 · Interbody Innovations, Llp · ODP · Sep 5, 2008 · Orthopedic

Device Facts

• Record ID: K081614
• Device Name: ZEUS SMALL CERVICAL CAGE AND LARGE, EXTRA LARGE, CURVED AND STRAIGHT LUMBAR CAGES
• Applicant: Interbody Innovations, Llp
• Product Code: ODP · Orthopedic
• Decision Date: Sep 5, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Zeus Small Cervical Cages are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Zeus Cervical Cages are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at the C3 to C7 disc levels using autograft bone. Zeus Cervical Cages are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage. The Zeus Lumbar Cages are indicated for intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from 12-51. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level. Zeus implants are to be used with autogenous bone graft and implanted via an anterior/transforaminal/posterior approach. The Zeus Lumbar Cages are to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

Device Story

Zeus Intervertebral Fusion Devices consist of PEEK-OPTIMA LT1 polymer cages designed for spinal fusion. Cervical cages are trapezoidal with a central window; lumbar cages (Anterior, Curved/T-LIF, Straight/PLIF) feature surface ridges to prevent migration and large windows for bone graft integration. Implants are placed surgically by physicians to stabilize the spinal column and facilitate fusion. Devices are used with autogenous bone graft and supplemental fixation. Benefit includes stabilization of the spinal segment and promotion of bony fusion in patients with degenerative disc disease.

Clinical Evidence

Bench testing only. Mechanical strength testing performed in accordance with ASTM F2077 and ASTM F2267 standards to verify performance requirements.

Technological Characteristics

Materials: PEEK-OPTIMA LT1 polymer (ASTM F2026). Design: Trapezoidal (cervical) or rectangular/curved (lumbar) cages with graft windows and surface ridges. Energy source: None (passive implant). Sterilization: Not specified. Connectivity: None.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) at one level (cervical C3-C7 or lumbar L2-S1). Lumbar patients may have up to Grade I spondylolisthesis or retrolisthesis. Requires autograft/autogenous bone graft and supplemental fixation. Contraindicated for patients without prior non-operative treatment (6 weeks for cervical, 6 months for lumbar).

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.

Submission Summary (Full Text)

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## 510(k) Summarv for the Interbody Innovation Zeus Intervertebral Fusion Devices

In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for the Interbody Innovation Zeus Intervertebral Fusion Devices.

Date Prepared: June 5, 2008

| 1. | Submitter: | Contact Person: |
|----|------------------------------------|----------------------------|
| | Interbody Innovations | J.D. Webb |
| | 303 Veterans Park Lane, Suite 1101 | The OrthoMedix Group, Inc. |
| | Midland, TX 79705 | 1001 Oakwood Blvd |
| | | Round Rock, TX 78681 |
| | | Telephone: [phone] |

| 2. | Trade name: | Interbody Innovation Zeus Intervertebral Fusion Devices |
|----|----------------------|---------------------------------------------------------|
| | Common Name: | intervertebral body fusion device |
| | Classification Name: | intervertebral body fusion device - cervical |
| | | Intervertebral body fusion device - lumbar |
| | | 21 CFR section 888.3080 |
| | | ODP/MAX |
| | | Class II |

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

The Interbody Innovations Zeus Intervertebral Fusion Devices are substantially equivalent to similar previously cleared cervical and lumbar intervertebral body fusion devices.

#### 4. Description of the device:

The Zeus Small Cervical Cage was developed as an intercorporal implant for anterior cervical spondylodesis. The top view is trapezoidal with a trapezoidal window for bone graft. The Zeus Cervical Cage has a flat top and bottom.

The Zeus Large/Extra Large Lumbar Cage was developed as an implant for the posterior stabilization of the lumbar spinal column using an Anterior Lumbar Interbody Fusion (ALIF) technique. To eliminate migration, ridges are incorporated on both the superior and inferior surfaces. Two large windows allow bony growth to form.

The Zeus Curved Large Lumbar Cage was developed as an implant for the posterior stabilization of the lumbar spinal column using a Transforaminal Lumbar Interbody Fusion (T-LIF) technique. The Zeus Curved implant has ridges on both its inferior and superior surfaces to prevent migration, and two large graft windows which help facilitate bony integration. It is a curved shape to facilitate insertion using a T-LF approach.

The Zeus Straight Lumbar Cage was developed as an implant for the posterior stabilization of the lumbar spinal column using a Posterior Lumbar Interbody Fusion (PLIF) technique and is used in pairs. The Zeus Straight implant incorporates ridges on both its superior and inferior surfaces to help eliminate migration. A large rectangular graft space help facilitate bony integration once implanted..

### Materials:

PEEK-OPTIMA LT1 polymer (ASTM F2026 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications)

### 5. Intended Use:

Zeus Small Cervical Cage s are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is

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defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Zeus Cervical Cages are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at the C3 to C7 disc levels using autograft bone. Zeus Cervical Cages are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

The Zeus Lumbar Cages are indicated for intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from 12-51. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level. Zeus implants are to be used with autogenous bone graft and implanted via an anterior/transforaminal/posterior approach. The Zeus Lumbar Cages are to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

- Comparison of the technological characteristics of the device to predicate and legally marketed devices: 6. The Interbody Innovations Zeus Intervertebral Fusion Devices have indications and material, and similar designs as previously cleared devices.
#### 7. Summary of Non-clinical Tests

Tests performed according to ASTM F2077/F2267 indicate that the Interbody Zeus Innovations Intervertebral Fusion Devices meet required mechanical strengths. Some of the predicate devices have a different geometry than the Interbody Innovations Zeus Intervertebral Fusion Devices and do not have some test results reported in their PMA summaries, therefore, additional acceptance values for testing have been utilized.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

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 with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The logo is black and white and appears to be a simple, vectorized design.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## SEP - 5 2008

SEP - 5 2008

Interbody Innovations, LLP % Mr. J.D. Wcbb The Orthomedix Group, Inc. 1001 Oakwood Blvd

Re: K081614

Round Rock, Texas 78681

Trade/Device Name: Zeus Small Cervical Cage, Zeus Anterior Lumbar Cage, Zeus Curved Lumbar Cage, Zeus Straight Lumbar Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP, MAX Dated: June 5, 2008 Received: June 9, 2008

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. Iisting 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 such 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); 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 - Mr. J.D. Webb

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Mullinax

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): _K08)614

Device Name: Zeus Small Cervical Cages

Indications for Use:

Zeus Small Cervical Cages are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Zeus Cervical Cages are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at the C3 to C7 disc levels using autograft bone. Zeus Cervical Cages are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

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)

FOR MNIM

Division of General, Restorative, and Neurological Devices

510(k) Number K080614

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રેજી દાપ 510(k) Number (if known):

Device Name: Zeus Anterior Lumbar Cage

Indications for Use:

The Zeus Anterior Lumbar Cage is indicated for intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level. Zeus implants are to be used with autogenous bone graft and implanted via an anterior approach. The Zeus Anterior Cage is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

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)

FOR MNM

510(K) L

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KORIBIT 510(k) Number (if known):

Device Name: Zeus Curved Lumbar Cage

Indications for Use:

The Zeus Curved Lumbar Cage is indicated for intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level. Zeus implants are to be used with autogenous bone graft and implanted via a transforaminal approach. The Zeus Curved Cage is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

Prescription Use × (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)

FOR MNM

(Division Sign-Off Division of General, Restorative, and Neurological Devices

**510(k) Number** L081614

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kosibili 510(k) Number (if known):

Device Name: ___ Zeus Straight Lumbar Cage

Indications for Use:

The Zeus Straight Lumbar Cage is indicated for intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from 12-51. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level. Zeus implants are to be used with autogenous bone graft and implanted via a posterior approach. The Zeus Straight Cage is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

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)

FOR MNM

and Neurological

510(k) Number K080614