FOUNDATION CAGE

K073440 · Corelink, LLC · MAX · Apr 24, 2008 · Orthopedic

Device Facts

• Record ID: K073440
• Device Name: FOUNDATION CAGE
• Applicant: Corelink, LLC
• Product Code: MAX · Orthopedic
• Decision Date: Apr 24, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Foundation™ Cervical Interbody Devices 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. Foundation™ Cervical implants 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. Foundation Cervical implants 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 Foundation™ Lumbar Interbody Devices are 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. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Foundation™ Lumbar implants are to be used with autogenous bone graft and implanted via an open anterior or posterior approach..Foundation™ Lumbar implants 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

Foundation Interbody Devices are spinal implants designed for intervertebral body fusion; used in cervical (C3-C7) and lumbar (L2-S1) spine procedures. Implants restore intervertebral disc height and provide mechanical stability; facilitate fusion via autogenous bone graft. Cervical cages feature trapezoidal footprint for anterior placement; lumbar cages designed for PLIF or ALIF techniques. Used by surgeons in clinical settings; requires supplemental fixation. Benefits include stabilization of mobile vertebral segments and treatment of discogenic pain. Device is purely mechanical; no electronic or software components.

Clinical Evidence

Bench testing only. Mechanical strength testing performed according to ASTM F2077 standards to confirm the device meets required performance specifications.

Technological Characteristics

Materials: PEEK Optima conforming to ASTM F2026. Design: Intervertebral cages for cervical (trapezoidal) and lumbar (PLIF/ALIF) applications. Mechanical function: Restoration of disc height and stabilization. Testing: ASTM F2077.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C3-C7, one level) with radicular symptoms, or lumbar spine (L2-S1, one or two contiguous levels) with or without Grade I spondylolisthesis/retrolisthesis. Requires failure of 6 weeks (cervical) or 6 months (lumbar) of 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

• BAK/C Vista Interbody Fusion (P980048 S003)
• BRANTIGEN I/F CAGE (P960025)

Submission Summary (Full Text)

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## 510(k) Summary for the Foundation Interbody Devices

K073446

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

Date Prepared: February 4, 2008

- 1. Submitter: Contact Person: Corelink LLC J.D. Webb 1547 Fencorp Dr. The OrthoMedix Group, Inc. Fenton, MO 62206 1001 Oakwood Blvd Round Rock, TX 78681
- 2. Trade name: Foundation Interbody Devices Common Name: intervertebral body fusion device Classification Name: intervertebral body fusion device - cervical intervertebral body fusion device - lumbar 21 CFR 888.3080 Class II ODP MAX
- 3. Predicate or legally marketed devices which are substantially equivalent: BAK/C Vista Interbody Fusion (P980048 S003) BRANTIGEN I/F CAGE (P960025)

## 4. Description of the device:

The interbody fusion with autogenous bone graft solves and provides a logical solution for discal diseases once the movement of the vertebral segment is eliminated. The theoretical principles of the interbody cages are based on the following foundations:

- Mechanical function, allows restoration of the intervertebral disc height and immediate 1. stability of the mobile segments.
Telephone: [phone]

- Biological function, related to the autogenous bone graft introduction into and around 2. the cage, facilitates the interbody fusion.
The posterior Foundation Cage was developed as an implant for the posterior stabilization of the lumbar spinal column with the technique of Posterior Lumbar Interbody Fusion (PLIF).

The anterior Foundation Cage was developed as an implant for the posterior stabilization of the lumbar spinal column with the technique of Anterior Lumbar Interbody Fusion (ALIF),

The Foundation Cervical cage is a trapezoidal shape footprint for central placement in the vertebral body from an anterior approach.

Materials:

PEEK Optima® conforming to ASTM F2026

#### 5. Intended Use:

Foundation™ Cervical Interbody Devices 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. Foundation™ Cervical implants 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. Foundation Cervical implants are to be used with

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# APR 2 4 2008

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supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

The Foundation™ Lumbar Interbody Devices are 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. DDD is defined as discogenc ne inn with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Fourdation™ Lumbar implants are to be used with autogenous bone graft and implanted via an open anterior or posterior approach. Foundation™ Lumbar implants 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 6. devices:

The Foundation Interbody Devices are similar in design, material, and intended use to their predicate devices that have been cleared by FDA for intervertebral body fusion.

## 7. Summary of Nonclincal Tests

Tests performed according to ASTM F2077 indicate that the Foundation Interbody Devices meet required mechanical strengths.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

The OrthoMedix Group, Inc. % Mr. J.D. Webb 1001 Oakwood Blvd. Round Rock, TX 78681

APR 2 4 2008

Re: K073440

Trade/Device Name: Foundation™ Interbody Devices Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: II Product Code: MAX, ODP Dated: April 9, 2008 Received: April 21, 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 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. Millikan

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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## Indications for Use

510(k) Number (if known): K073490

Device Name: Foundation™ Interbody Devices

Indications for Use:

Foundation™ Cervical Interbody Devices 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. Foundation™ Cervical implants 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. Foundation Cervical implants 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 Foundation™ Lumbar Interbody Devices are 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. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Foundation™ Lumbar implants are to be used with autogenous bone graft and implanted via an open anterior or posterior approach..Foundation™ Lumbar implants 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.

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)

Neil R.P. Gyl for nan

and Neurological Devices

510(k) Number K073440

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