SHELL CAGE, WAVE CAGE, LOOP CAGE

K080401 · Advanced Medical Technologies AG · MAX · May 9, 2008 · Orthopedic

Device Facts

• Record ID: K080401
• Device Name: SHELL CAGE, WAVE CAGE, LOOP CAGE
• Applicant: Advanced Medical Technologies AG
• Product Code: MAX · Orthopedic
• Decision Date: May 9, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

SHELL 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. SHELL 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. SHELL Cages are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment with an intervertebral cage. The WAVE/LOOP 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 at the involved level. WAVE implants are to be used with autogenous bone graft and implanted via an open posterior approach. The WAVE Cage is to be used with supplemental fixation. Patients should have at least six (6) months of nonoperative treatment prior to treatment with an intervertebral cage.

Device Story

AMT Interbody Fusion Devices (SHELL, WAVE, LOOP) are spinal implants designed to facilitate intervertebral body fusion. SHELL is a lordotic, trapezoidal cervical cage with x-ray pins for rotational fixation. LOOP is a banana-shaped lumbar cage with an integrated swivel joint and radial fixation teeth. WAVE is a rectangular, trapezoidal lumbar cage implanted in pairs. Devices are manufactured from PEEK-OPTIMA LT1. Implants are placed by surgeons during spinal fusion procedures to stabilize the spine and promote bone growth. Clinical benefit includes stabilization of the spinal segment in patients with degenerative disc disease.

Clinical Evidence

Bench testing only. Mechanical strength testing performed according to ASTM F2077 and ASTM F2267 standards to verify structural integrity.

Technological Characteristics

Materials: PEEK-OPTIMA LT1 polymer (ASTM F2026). Design: SHELL (cervical, lordotic, trapezoidal), LOOP (lumbar, banana-shaped, swivel joint), WAVE (lumbar, rectangular, trapezoidal). Energy source: None (mechanical implant). Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) at one level. SHELL: cervical spine (C3-C7) with radicular symptoms; requires 6 weeks non-operative treatment. WAVE/LOOP: lumbar spine (L2-S1) with discogenic back pain, including up to Grade I spondylolisthesis or retrolisthesis; requires 6 months non-operative treatment. All require supplemental fixation and autograft/autogenous bone graft.

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 peek-optima It1, Zimmer Spine, Inc (P980048 S003)
• BRANTIGEN I/F CAGE, DePuy Spine Inc, (P960025)
• PARAMOUNT INTERVERTEBRAL BODY FUSION DEVICE (K072120)

Submission Summary (Full Text)

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K080401

## 510(k) Summary for the AMT Interbody Fusion Devices

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

Date Prepared: February 12, 2008

- 1. Submitter:
Advanced Medical Technologies AG Kasteler Strasse 11 66620 Nonnweiler-Braunhausen Germany

Contact Person: J.D. Webb The OrthoMedix Group, Inc. 1001 Oakwood Blvd Round Rock, TX 78681 Telephone: [phone]

| 2. | Trade name: | SHELL/WAVE/LOOP 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 |

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

- BAK/C Vista Interbody Fusion peek-optima It1, Zimmer Spine, Inc (P980048 S003) �
- . BRANTIGEN I/F CAGE, DePuy Spine Inc, (P960025)
- . PARAMOUNT INTERVERTEBRAL BODY FUSION DEVICE (K072120)

#### 4. Description of the device:

The SHELL was especially adapted to the local anatomy in order to secure the surgical result as possible. Its caudal side is flat, its cranial side is domed and the implant is formed conically from anterior to posterior. In the lateral view, the implant has a slightly lordotic form. The A/P view is trapezoidal. There are x-ray pins at the four edges, which slightly protrude the cage in order to maximize rotational fixation.

The LOOP is a banana-shaped implant with optimized tip design and an integrated swivel joint for the instrument fixation. Both factors facilitate the implantation. The radial orientated fixation teeth define the direction of implantation and secure the implant position. LOOP is shaped with a 6° lordosis.

The WAVE is rectangular in shape. Cross section is trapezoidal with the lateral side 1mm higher than the medial. WAVE has a neutral and a 6° lordosis. The posterior end has a threaded hole for attaching insertion instruments, while the other end is solid and tapered. The WAVE cages are implanted in pairs.

### Materials:

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

### Function:

The SHELL Cage was developed as an intercorporal implant for anterior cervical spondylodesis.

The WAVE 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 LOOP Cage was developed as an implant for the posterior stabilization of the lumbar spinal column with the technique of Transforaminal Lumbar Interbody Fusion (T-LIF).

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Page 2 of 2

## Intended Use:

SHELL 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. SHELL 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. SHELL Cages are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment with an intervertebral cage.

The WAVE/LOOP 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 at the involved level. WAVE implants are to be used with autogenous bone graft and implanted via an open posterior approach. The WAVE Cage is to be used with supplemental fixation. Patients should have at least six (6) months of nonoperative treatment prior to treatment with an intervertebral cage.

- Comparison of the technological characteristics of the device to predicate and legally marketed devices: പ്പ The AMT Interbody Fusion devices have the same indications and material, and similar designs as
previously cleared devices.

### Summary of Nonclinical Tests 6.

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

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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 three stripes representing the three branches of government. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## MAY - 9 2008

Advanced Medical Technologies, AG % Mr. J.D. Webb 1001 Oakwood Blvd Round Rock, TX 78681

Re: K080401

Trade/Device Name: SHELL, WAVE and LOOP Cages Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: II Product Code: MAX, ODP Dated: February 12, 2008 Received: February 14, 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. Millican

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): K08040

Device Name:

Indications for Use:

The WAVE 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. WAVE implants are to be used with autogenous bone graft and implanted via an open posterior approach. The WAVE 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)

Neil RP Ogden for rkn
Division Sign Off

Division of General. Restora and Neurological Devices

**510(k) Number** k040401

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# Indications for Use

510(k) Number (if known): _ KO8040 B

Device Name: LOOP Cage

Indications for Use:

The LOOP 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. LOOP implants are to be used with autogenous bone graft and implanted via an open posterior approach. The LOOP 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)

Neil R. Oslen for mam

Division of General, Restora and Neurological Device

**510(k) Number** K080401

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## Indications for Use

510(k) Number (if known): _ K080 40

Device Name:

Indications for Use:

SHELL 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. SHELL 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. SHELL 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)

Yuil R.P. Ogden for mkm

Division of General, Restorative. and Neurological Devices

510(k) Number