BINDER INTERVERTEBRAL BODY FUSION DEVICE

K093015 · Binder Biomedical, Inc. · MAX · Feb 25, 2010 · Orthopedic

Device Facts

• Record ID: K093015
• Device Name: BINDER INTERVERTEBRAL BODY FUSION DEVICE
• Applicant: Binder Biomedical, Inc.
• Product Code: MAX · Orthopedic
• Decision Date: Feb 25, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Binder Intervertebral Body Fusion Device ("Binder Fusion System") is intended to be used for intervertebral body fusion. The Binder Intervertebral Body Fusion Device is indicated for use in patients with degenerative disc disease (DDD) at one (1) or two (2) contiguous levels of the lumbosacral spine (L2-S1). 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 at least six (6) months of non-operative treatment. In addition, these patients may have had a previous non-fusion spinal surgery at the involved level(s) and may have had up to a Grade 1 spondylolisthesis at the involved level(s). The Binder Fusion devices are to be used with autogenous bone graft material and supplemental fixation.

Device Story

Intervertebral body fusion device; PEEK-OPTIMA spacers; designed to hold autogenous bone graft; implanted in lumbosacral spine (L2-S1) to facilitate fusion; features surface ridges to improve fixation and prevent migration; used by surgeons in clinical settings; requires supplemental fixation; provides structural support to spinal column; benefits patients by stabilizing degenerated disc levels and reducing discogenic back pain.

Clinical Evidence

Bench testing only. Mechanical performance testing conducted per ASTM F2077-03 and ASTM F2267-04. Results confirmed device functioned as intended and met all specified requirements.

Technological Characteristics

Constructed from PEEK-OPTIMA. Features superior and inferior surface ridges for fixation. Non-sterile. Mechanical testing per ASTM F2077-03 and ASTM F2267-04.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) at 1-2 contiguous levels of the lumbosacral spine (L2-S1) with discogenic back pain confirmed by history/radiography. Includes patients with prior non-fusion spinal surgery or up to Grade 1 spondylolisthesis/retrolisthesis. Requires use with autogenous bone graft and supplemental fixation. Contraindicated for patients without 6 months of prior 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

• Lumbar I/F Cage with VSP Spine System (DePuy AcroMed, Inc.)
• PATRIOT Spacers (Globus Medical, Inc.)
• Lanx Intervertebral Body Fusion Device (Lanx, Inc.)

Submission Summary (Full Text)

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

# FEB 2 5 2010

#### V. 510(K) SUMMARY

## Binder Biomedical, Inc.'s Intervertebral Body Fusion Device

### Submitted by:

Binder Biomedical, Inc. 2385 NW Executive Center Dr, Suite 100 Boca Raton, FL 33431 Phone: [phone] Facsimile: [phone] Contact Person: Lawrence Binder

Date Prepared: September 27, 2009

#### Device Name and Address of Sponsor

Binder Intervertebral Body Fusion Device Binder Biomedical, Inc. 2385 NW Executive Center Dr, Suite 100 Boca Raton, FL 33431

### Common Name

Intervertebral Body Fusion Device

#### Classification

Orthosis, Spinal Intervertebral Fusion

#### Predicate Devices

| DePuy AcroMed, Inc. | Lumbar I/F Cage with VSP Spine System |
|----------------------|----------------------------------------|
| Globus Medical, Inc. | PATRIOT Spacers |
| Lanx, Inc. | Lanx Intervertebral Body Fusion Device |

## Intended Use / Indications for Use

The Binder Intervertebral Body Fusion Device ("Binder Fusion System") is intended to be used for intervertebral body fusion.

The Binder Intervertebral Body Fusion Device is indicated for use in patients with degenerative disc disease (DDD) at one (1) or two (2) contiguous levels of the lumbosacral spine (L2-S1). DDD is

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

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 at least six (6) months of non-operative treatment. In addition, these patients may have had a previous non-fusion spinal surgery at the involved level(s) and may have had up to a Grade 1 spondylolisthesis at the involved level(s). The Binder Fusion devices are to be used with autogenous bone graft material and supplemental fixation.

#### Technological Characteristics

The Binder Fusion System is comprised of a series of PEEK-OPTIMA® spacers shaped to accommodate autogenous bone graft and anatomical variation at different spinal levels. The Binder Fusion System also has a series of ridges on its superior and inferior surfaces to improve fixation and prevent migration. The Binder Fusion System is provided non-sterile.

### Performance Data

Performance testing was conducted per ASTM F2077-03 and ASTM F2267-04. In all instances, the Binder Fusion System functioned as intended and specified requirements were met.

#### Basis of Substantial Equivalence

The Binder Fusion System is as safe and effective as the predicate devices. The Binder Fusion System has the same intended uses, indications, technological characteristics, and principles of operation as its predicate devices. The minor technological differences between the Binder Fusion System and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the Binder Fusion System is as safe and effective as the predicate devices. Thus, the Binder Fusion System is substantially equivalent.

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

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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a bird-like figure, composed of three curved lines.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

FEB 2 5 2010

Binder Biomedical, Inc. % Mr. Lawrence Binder President and CEO 2385 NW Executive Center Drive Suite 100 Boca Raton, Florida 33431

Re: K093015

Trade/Device Name: Binder Intervertebral Body Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: February 17, 2010 Received: February 19, 2010

Dear Mr. Binder:

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

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

Page 2 - Mr. Lawrence Binder

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/ReportalProblem/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Cibava buchnb

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

Enclosure

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

#### IV. INDICATIONS FOR USE STATEMENT

K093015 510(k) Number (if known):

Device Name: Binder Intervertebral Body Fusion Device

Indications for Use:

The Binder Intervertebral Body Fusion Device ("Binder Fusion System") is indicated for use in patients with degenerative disc disease (DDD) at one (1) or two (2) contiguous levels of the lumbosacral spine (L2-S1). 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 at least six (6) months of non-operative treatment. In addition, these patients may have had a previous non-fusion spinal surgery at the involved level(s) and may have had up to a Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The Binder Fusion devices are to be used with autogenous bone graft material and supplemental fixation.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ X

(Part 21 CFR 801 Subpart D)

AND/OR

(21 CFR 801 Subpart C)

Over-The-Counter Use

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

A.M.

Page 1 of 1

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

K093015 510(k) Number_