ORACLE LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEM

K121567 · Accel Spine · MAX · Sep 26, 2012 · Orthopedic

Device Facts

• Record ID: K121567
• Device Name: ORACLE LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEM
• Applicant: Accel Spine
• Product Code: MAX · Orthopedic
• Decision Date: Sep 26, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Cezanne Lumbar Interbody Fusion Cage System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels 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 1 spondylolisthesis or retrolisthesis at the involved level(s).This device is to be used with autogenous bonegraft. Cezanne Lumbar Interbody Fusion Cage System 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.

Device Story

Cezanne Lumbar Interbody Fusion Cage System; intervertebral body fusion implant; used in lumbar spine (L2-S1). Device consists of PEEK-OPTIMA CTI body with tantalum marker pins; various heights and lordotic configurations; open architecture for bone graft packing. Used by surgeons in clinical settings to provide intervertebral support during fusion procedures. Requires supplemental fixation. Benefits patients by stabilizing vertebral segments in degenerative disc disease cases.

Clinical Evidence

Bench testing only. Testing included Static and Dynamic Axial Compression (ASTM F2077), Static and Dynamic Compression-Shear (ASTM F2077), Static and Dynamic Torsion (ASTM F2077), Expulsion (ASTM F2077), and Static Subsidence (ASTM F2267).

Technological Characteristics

Materials: PEEK-OPTIMA CTI (ASTM F2026) and tantalum marker pins (ASTM F560). Design: Intervertebral cage with open architecture for bone graft. Mechanical testing per ASTM F2077 and ASTM F2267.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1, including those with up to Grade 1 spondylolisthesis or retrolisthesis. Requires 6 months of prior 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.

Predicate Devices

• L&K BIOMED: VENUS Lumbar Intervertebral Body Fusion Cage System (K110783, K120063, K121096)
• GS Medical: Any Plus PEEK Cage (K100516)
• STRYKER SPINE: AVS PEEK Spacer System (K083661, K090816, K093704)
• Solco Biomedical: 4CIS PEEK PLIF Cage System (K092162)
• Nuvasive: NuVasive CoRoent System (K043405, K052210, K071795, K081611)
• Spine Art: JULIET OL, DYNAMIK Intervertebral body fusion device (K081888, K101720)
• Medtronic Sofamor Danek: CLYDESDALE Spinal System (K100175, K112405, K113528)

Submission Summary (Full Text)

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# 510(k) SUMMAR

The following 510(k) summary is being submitted as required by 21 CFR 807.92(a):

| 1. | Submitter: | AccelSpine LLC |
|----|-----------------|------------------------------------------|
| | | 14850 Quorum Dr.Suite220Dallas, TX 75254 |
| | Contact Person: | Daniel Chon |
| | | Telephone. [phone] |
| | | FAX .[phone] |
| | | [e-mail] |
| | Date Prepared | May 22, 2012 |
| | | |

### 2. Device Identification

| Trade Name | Cezanne Lumbar Interbody Fusion Cage System |
|-------------------|-----------------------------------------------------|
| Common/Usual Name | Intervertebral Fusion Device |
| Regulation Name | Intervertebral body fusion device (21 CFR 888.3080) |
| Regulatory Class | Class II |
| Product Code | MAX |

### 3. Description of the Device

The Cezanne Lumbar Interbody Fusion Cage System is intended to help provide support in the intervertebral body space during fusion of vertebral bodies in the lumbar spine. This system is intended to be used with supplemental fixation. The Cezanne Lumbar Interbody Fusion Cage System consists of implants available in various heights and lordotic configurations with an open architecture to accept packing of bone graft material. The Implants are made of PEEK-OPTIMA CTI (ASTM F2026) body with the tantalum(ASTM F560) marker pins.

#### 4. Indications for Use

Cezanne Lumbar Interbody Fusion Cage System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels 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 1 spondylolisthesis or retrolisthesis at the involved level(s).This device is to be used with autogenous bonegraft. Cezanne Lumbar Interbody Fusion Cage System 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.

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K121567
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# SACCES

#### 5. Non-clinical Testing

The Cezanne Lumbar Interbody Fusion Cage System has been tested Static and Dynamic Axial Compression(ASTM F2077), Static and Dynamic Compression-Shear (ASTM F2077), Static and Dynamic Torsion (ASTM F2077), Expulsion (ASTM F2077), Static Subsidence (ASTM F 2267)

#### 6. Summary of technology characteristics

The Cezanne Lumbar Interbody Fusion Cage System shares technological characteristics similar to the predicate devices. These characteristics include similar design, the same materials and the same intended use.

## 7. Predicate or legally marketed devices which are substantially equivalent The design feature and indications for use for the subject Cezanne Lumbar Interbody Fusion

Cage System is substantially equivalent to the following predicates:

- ··· L&K BIOMED: VENUS Lumbar Intervertebral Body Fusion Cage System (K110783, K120063, K121096)
- ··· GS Medical: Any Plus PEEK Cage (K100516)
- ··· STRYKER SPINE :AVS PEEK Spacer System (K083661,K090816,K093704)
- ··· Solco Biomedical : 4CIS PEEK PLIF Cage System (K092162)
- ··· Nuvasive: NuVasiveCoRoent System (K043405,K052210 K071795, K081611)
- ·· Spine Art : JULIET OL , DYNAMIK Intervertebral body fusion device (K081888, K101720)
- ••• Medtronic SofamorDanek: CLYDESDALE Spinal System (K100175,K112405,K113528)

#### 8. Conclusion

The Cezanne Lumbar Interbody Fusion Cage System is substantially equivalent to the device referenced above and is therefore safe and effective for its intended use.

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Image /page/2/Picture/0 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized representation of a human figure embracing another, symbolizing care and support. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the emblem in a circular fashion.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Accel Spine LLC % L & K Biomed Company, Limited Ms. Ki Hyang Kim Vice President 1104-ho, 145, Gasandigital 1-ro, Geumcheon-gu Seoul. 153-787. Korea

Re: K121567

Trade/Device Name: Cezanne Lumbar Interbody Fusion Cage System Regulation Number: 21 CFR 888.3080 Regulation Name: Invertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: August 22, 2012 Received: September 04, 2012

Dear Ms. Kim:

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.

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

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## Page 2 - Ms. Ki Hyang Kim

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 vours.

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

Enclosure

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# CACCESPINE

# Indications for Use

510(k) Number : K121567

Device Name : Cezanne Lumbar Interbody Fusion Cage System

Indications for Use :

Cezanne Lumbar Interbody Fusion Cage System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels 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 1 spondylolisthesis or retrolisthesis at the involved level(s).This device is to be used with autogenous bone graft. Cezanne Lumbar Interbody Fusion Cage System 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 801 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 of Surgical, Orthopedic,
and Restorative Devices

K121567 510(k) Number_

Cezanne Lumbar Interbody Fusion Cage System 510(K)

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