EPICAGE INTERBODY FUSION DEVICE

K092901 · R Tree Innovations · MAX · Apr 28, 2010 · Orthopedic

Device Facts

• Record ID: K092901
• Device Name: EPICAGE INTERBODY FUSION DEVICE
• Applicant: R Tree Innovations
• Product Code: MAX · Orthopedic
• Decision Date: Apr 28, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Epicage Interbody Fusion Device is intended for interbody fusion procedures and is indicated for use 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. Patients should have received 6 months of non-operative treatment prior to treatment with the device is intended to be used with supplemental posterior fixation. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be used with autograft bone.

Device Story

Epicage Interbody Fusion Device is a PEEK implant providing mechanical support to lumbar spine during biologic fusion. Device features openings for bone growth and ribs for flexure during insertion. Available in two lengths and four heights (8mm-14mm). Used in interbody fusion procedures by surgeons; requires supplemental posterior fixation. Provides mechanical stability in lumbar disc space to facilitate fusion; benefits patients with discogenic back pain.

Clinical Evidence

Bench testing only. Static axial compression, static compression shear, static torsion, dynamic axial compression, dynamic torsion (ASTM F2077-03), subsidence (ASTM F2267-04), and expulsion testing performed to demonstrate substantial equivalence.

Technological Characteristics

PEEK implant; dimensions include two lengths and heights from 8mm to 14mm in 2mm increments; features openings for bone growth and ribs for flexure. Testing performed per ASTM F2077-03 and ASTM F2267-04.

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 I spondylolisthesis or retrolisthesis. Requires 6 months prior non-operative treatment. Must be used with supplemental posterior fixation and autograft bone.

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 Interbody Fusion Device (P950002)
• Ray Threaded Fusion Cage (P950019)
• Brantigan Lumbar I/F Cage (P960025)
• ROI-T device (K082262)

Submission Summary (Full Text)

{0}------------------------------------------------

# 4. 510(k) Summary according to 807.92(c)

APR 2 8 2010

| Contact: | Jay Finster |
|-----------------|----------------------------------------------------------|
| | R Tree Innovations, LLC |
| | 5956 Timber Ridge Drive |
| | Suite 101 |
| | Prospect, KY 40059 |
| | 502-689-4483 |
| Trade Name: | Epicage Interbody Fusion Device |
| Product Class: | Class II |
| Classification: | 21 CFR \$888.3080 Orthosis, intervertebral fusion device |
| Product Codes: | MAX |
| Panel Code: | 87 |

## Indications for Use:

The Epicage Interbody Fusion Device is intended for interbody fusion procedures and is indicated for use 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. Patients should have received 6 months of non-operative treatment prior to treatment with the device is intended to be used with supplemental posterior fixation. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be used with autograft bone.

### Device Description:

The Epicage Interbody Fusion Device is a PEEK implant that is designed to provide mechanical support to the lumbar spine while biologic fusion takes place. The device is designed with openings for bone growth and fusion. The rib allow for flexure of the device during insertion.

The device is available in two lengths to accommodate various patients' anatomy. Each of these sizes is available in 4 heights ranging from 8mm to 14mm in 2mm increments.

### Predicate Device(s):

The Epicage Interbody Fusion Device was shown to be substantially equivalent to previously cleared devices and has the same indications for use, design, function, and materials used. The predicate devices include the BAK Interbody Fusion Device (Spine-Tech, P950002), the Ray Threaded Fusion Cage (P950019), the Brantigan Lumbar I/F Cage (P960025) and the ROI-T device from LDR (K082262)

{1}------------------------------------------------

#### Performance Testing:

Static axial compression, static compression shear, static torsion, dynamic axial compression and dynamic torsion were completed following ASTM F2077-03. Subsidence was tested following ASTM F2267-04. Expulsion testing was conducted following a recognized protocol to allow comparison evaluation of intervertebral body fusion device assemblies, and characterize their resistance to expulsion. The above pre-clinical testing performed on the Epicage Interbody Fusion Device indicated that the Epicage Interbody Fusion Device is substantially equivalent to the predicate devices and is adequate for the intended use.

#### Summary:

The Epicage Interbody Fusion Device and predicate devices have the same intended use, to provide mechanical stability in the lumbar disc space to facilitate biologic fusion. The indications for use of the Epicage Interbody Fusion Device contain no new language that is not already included in at least one of the predicate devices. Moreover, the device is very similar in its size to the predicate devices. The materials used are also the same as in some predicate devices. There are no significant differences in technological characteristics compared to the predicates, and the minor differences that do exist do not raise any new types of safety or efficacy issues. Furthermore, bench testing demonstrates that these differences do not adversely impact device performance, as discussed below.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling an emblem. The emblem is a stylized depiction of an eagle, with its wings spread, symbolizing protection and service.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

APR 2 8 2010

R Tree Innovations, LLC % Dr. Richard Jansen Silver Pine Consulting 13540 Guild Avenue Apple Valley, Minnesota 55124

Re: K092901

Trade/Device Name: Epicage Interbody Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: April 17, 2010 Received: April 20, 2010

Dear Dr. Jansen:

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

{3}------------------------------------------------

Page 2 – Dr. Richard Jansen

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,

Barbace Buchud

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

Enclosure

{4}------------------------------------------------

# 3. Statement of Indications for Use

510(k) Number (if known): _K092901

Indications for Use:

The Epicage Interbody Fusion Device is intended for interbody fusion procedures and is indicated for use 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. Patients should have received 6 months of non-operative treatment prior to treatment with the device is intended to be used with supplemental posterior fixation. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be used with autograft bone.

Prescription Use V (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)

h

(Division Sign-Off) (Division of Surgical, Orthopedic, and Restorative Devices

K092901 510(k) Number_

Concurrence of CDRH, Office of Device Evaluation (ODE)