INTEGRA CERVICAL AND PETRA PLIF LUMBAR CAGES

K082260 · Calvary Spine, LLC · MAX · Oct 17, 2008 · Orthopedic

Device Facts

• Record ID: K082260
• Device Name: INTEGRA CERVICAL AND PETRA PLIF LUMBAR CAGES
• Applicant: Calvary Spine, LLC
• Product Code: MAX · Orthopedic
• Decision Date: Oct 17, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Integra Cervical Cage is 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 history and radiographic studies. Integra Cervical Cage implants are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at the C-3 to T-1 disc levels using autograft bone. Integra Cervical implant is 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 Petra PLF Cage 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). Petra PLIF Cage implants are to be used with autogenous bone graft and implanted via an open posterior approach. The Petra PLIF Cages 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.

Device Story

Intervertebral body fusion cages (Integra Cervical and Petra PLIF Lumbar) designed for spinal stabilization; Integra used for anterior cervical spondylodesis; Petra used for posterior lumbar interbody fusion (PLIF). Implants feature surface teeth or ridges to prevent migration and windows to facilitate bony integration; Integra includes tantalum x-ray markers; Petra features curved, wedged configuration for insertion. Implants are placed by surgeons in clinical settings to facilitate fusion; used in conjunction with autogenous bone graft and supplemental fixation. Benefit: stabilization of spinal segments and promotion of fusion in patients with degenerative disc disease.

Clinical Evidence

No clinical data. Bench testing performed according to ASTM F2077 and ASTM F2267 to verify mechanical strength requirements.

Technological Characteristics

Materials: PEEK-OPTIMA LT1 polymer (ASTM F2026). Integra Cervical Cage: anterior approach, teeth for migration prevention, tantalum x-ray markers. Petra PLIF Lumbar Cage: posterior approach, ridges for migration prevention, curved/wedged geometry. Both devices feature graft windows for bony integration. Mechanical testing per ASTM F2077/F2267.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C3-T1, one level) with radicular symptoms, or lumbar spine (L2-S1, one or two contiguous levels) with discogenic back pain, including up to Grade 1 spondylolisthesis or retrolisthesis. Requires failure of 6 weeks (cervical) or 6 months (lumbar) of 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.

Submission Summary (Full Text)

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K0822.60-ivf 2

## 510(k) Summary for the Calvary Spine Intervertebral Body Fusion Cages

In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for the Calvary Spine Intervertebral Body Fusion Cages

Date Prepared: August 5, 2008

| 1. | Submitter: | Contact Person: |
|----|-------------------|----------------------------|
| | Calvary Spine LLC | J.D. Webb |
| | 308 North Wind Rd | The OrthoMedix Group, Inc. |
| | Towson, MD 21204 | 1001 Oakwood Blvd |
| | | Round Rock, TX 78681 |
| | | Telephone: [phone] |

| 2. Trade name: | Integra Cervical and Petra PLIF Lumbar Cages |
|----------------------|----------------------------------------------|
| 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 |

#### 3. Predicate or legally marketed devices which are substantially equivalent:

The Calvary Spine Intervertebral Body Fusion Cages are substantially equivalent to similar previously cleared cervical and lumbar intervertebral body fusion devices.

#### 4. Description of the device:

The Integra Cervical Cage was developed as an intercorporal implant for anterior cervical spondylodesis. To prevent migration, the Integra Cervical Cage has teeth on its superior and inferior surfaces. A large window allows bony growth to form. It has two tantalum x-ray markers.

The Petra PLF Lumbar Cage was developed as an implant for the posterior stabilization of the lumbar spinal column using a Posterior Lumbar Interbody Fusion (PLIF) technique. The Petra PLIF 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 PLIF approach. The design is a wedged configuration for ease of insertion.

### Materials:

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

#### റ്റ് Intended Use:

The Integra Cervical Cage is 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 history and radiographic studies. Integra Cervical Cage implants are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at the C-3 to T-1 disc levels using autograft bone. Integra Cervical implant is 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 Petra PLF Cage 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). Petra PLIF Cage implants are to be used with

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autogenous bone graft and implanted via an open posterior approach. The Petra PLIF Cages 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.

- Comparison of the technological characteristics of the device to predicate and legally marketed devices: റ. The Calvary Spine Intervertebral Body Fusion Cages have indications and material, and similar designs as previously cleared devices.
### 7. Summary of Nonclincal Tests

Tests performed according to ASTM F2077/F2267 indicate that the Interbody Calvary Spine Intervertebral Body Fusion Cages meet required mechanical strengths.

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Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circular border, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the border.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Calvary Spine, LLC % The Orthomedix Group, Inc. Mr. J.D. Webb Official Correspondent 1001 Oakwood Boulevard Round Rock, Texas 78681

OCT 1 7 2008

Re: K082260

Trade/Device Name: Integra Cervical Cage Petra PLIF Lumbar Cage Regulation Number: 21 CFR 888.3080 Regulation Names: Intervertebral body fusion device. Regulatory Class: II Product Code: MAX, ODP Dated: August 5, 2008 Received: August 8, 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, 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 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 the reporting 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 the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark N. Millerson

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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K082260-1 of 2

## Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name:

Indications for Use:

The Integra Cervical Cage is 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 history and radiographic studies. Integra Cervical Cage implants are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at the C-3 to T-1 disc levels using autogenous bone graft. Integra Cervical implant is 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)

Nilfne Oden for mxm

Division of General. Restorative, and Neurological Devices

082260 510(k) Number

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KU82260 - 2 of 2

# Indications for Use

K-082260 510(k) Number (if known): _

Device Name: Petra PLIF Lumbar Cage

Indications for Use:

The Petra PLIF Cage 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). Petra PLF Cage implants are to be used with autogenous bone graft and implanted via an open posterior approach. The Petra PLIF Cages 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.

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)

Mitree Dyke for mxm

Division of General, Restorative and Neurological Devic

510(k) Number K082260