WAVE O CAGE

K121330 · Advanced Medical Technologies AG · MAX · Jun 29, 2012 · Orthopedic

Device Facts

• Record ID: K121330
• Device Name: WAVE O CAGE
• Applicant: Advanced Medical Technologies AG
• Product Code: MAX · Orthopedic
• Decision Date: Jun 29, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The WAVE O Cage is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via an open or a minimally invasive unilateral posterior approach. Alternatively, these implants may also be implanted via a transforaminal approach. These implants are to be used with autogenous bone graft. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine.

Device Story

WAVE O Cage is an expandable PEEK intervertebral body fusion device; designed for lumbar or lumbosacral vertebral support during fusion surgery. Device features hollow geometry for packing with autogenous bone graft. Implanted by surgeons via open, minimally invasive unilateral posterior, or transforaminal approaches. Used in conjunction with FDA-cleared supplemental lumbar fixation instrumentation. Provides structural support and correction for discogenic back pain associated with DDD and Grade 1 Spondylolisthesis. Benefits include stabilization of the spinal column to facilitate fusion.

Clinical Evidence

No clinical studies were performed.

Technological Characteristics

Expandable cage manufactured from PEEK-OPTIMA LT1 polymer (ASTM F2026) and Tantalum (ISO 13782 / ASTM F560). Mechanical performance validated via dynamic compression testing (ASTM F1717) and finite element analysis.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1, including those with up to Grade 1 Spondylolisthesis, who have failed six months 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

• Distractable WAVE Cage (K083626)

Submission Summary (Full Text)

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K121330 Page 12

JUN 2 9 2012

# 510(k) Summary for the WAVE O Cage

In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for the WAVE O Cage

#### GENERAL INFORMATION 1.

Date Prepared: April 17, 2012

Trade Name: WAVE O Cage

Common Name: intervertebral body fusion device

Classification

Name: Intervertebral body fusion device - lumbar

Class: []

Product Code: MAX

CFR section: 21 CFR section 888.3080

Device panel: Orthopedic

Legally Marketed Predicate Device: Distractable WAVE Cage - K083626

- Submitter: Advanced Medical Technologies AG Kasteler Strasse 11 66620 Nonnweiler-Braunshausen Germany
- Contact: J.D. Webb 1001 Oakwood Blvd Round Rock, TX 78681 512-388-0199 Tele 512-692-3699 Fax e-mail: [e-mail]

# 2. DEVICE DESCRIPTION

The WAVE O cage is an expandable PEEK cage of various widths and heights, which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone graft.

## Materials:

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

Tantalum (ISO 13782 / ASTM F560)

### Function:

The WAVE-O Cage was developed as an implant for the posterior stabilization of the lumbar spinal column.

### 3. SUBSTANTIAL EQUIVALENCE CLAIMED TO PREDICATE DEVICES

The WAVE-O Cage is substantially equivalent to the predicate devices in terms of intended use, design, materials used, mechanical safety and performances.

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# 4. INTENDED USE

The WAVE O Cage is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via an open or a minimally invasive unilateral posterior approach. Alternatively, these implants may also be implanted via a transforaminal approach. These implants are to be used with autogenous bone graft. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine.

# 5. NON-CLINICAL TEST SUMMARY

Dynamic compression per ASTM F1717 Finite element analysis

The results of this testing indicate that the WAVE O Cage is equivalent to predicate devices.

#### 6. CLINICAL TEST SUMMARY

No clinical studies were performed

# 7. CONCLUSIONS NONCLINICAL AND CLINICAL

This summary includes the conclusions drawn from the nonclinical tests (discussed above) that demonstrate that WAVE O Cage is as safe and performs as well as the predicate device(s).

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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 features a stylized eagle with three lines forming its body and wings. The eagle is enclosed within a circle of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

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

JUN 2 9 2012

Re: K121330 Trade/Device Name: WAVE O Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: April 27, 2012 Received: May 3, 2012

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.

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Page 2- Mr. J.D. Webb

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); 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.

1211 Mark N. Melkers 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

510(k) Number (if known):

Device Name: WAVE O Cage

Indications for Use:

The WAVE O Cage is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via an open or a minimally invasive unilateral posterior approach. Alternatively, these implants may also be implanted via a transforaminal approach. These implants are to be used with autogenous bone graft. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine.

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 Sign-Off) Division of Surgical Orthopedic, Vand Restorative Devices

K121330 510(k) Number_