OPTIMESH

K014200 · Spineology, Inc. · EZX · Nov 26, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K014200
• Device Name: OPTIMESH
• Applicant: Spineology, Inc.
• Product Code: EZX · General, Plastic Surgery
• Decision Date: Nov 26, 2003
• Decision: SESU
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

OptiMesh is intended to maintain the relative position of bone graft material (such as autograft or allograft) within a vertebral body defect (e.g. tumor) that does not impact the stability of the vertebral body and does not include the vertebral endplates.

Device Story

OptiMesh is a sterile, 3D surgical mesh container composed of knitted polyester yarn. It functions as a containment device for bone graft material (autograft or allograft) placed within vertebral body defects. The device is used by surgeons in a clinical setting to maintain the position of the graft material within the defect. It does not provide structural support. The device is terminally sterilized and supplied in various sizes to accommodate different defect dimensions.

Clinical Evidence

No clinical data provided; substantial equivalence is supported by bench testing and comparison to predicate devices.

Technological Characteristics

Sterile, 3D surgical mesh container; material: knitted polyester yarn; form factor: various sizes; packaging: double Tyvek/Mylar pouches; sterilization: terminal sterilization.

Indications for Use

Indicated for patients with vertebral body defects (e.g., tumors) that do not impact vertebral body stability and do not involve vertebral endplates. Contraindicated in patients with instability, such as resected or collapsed vertebral bodies or anterior column fractures. Not for use in interbody space fusion.

Regulatory Classification

Identification

Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.

Predicate Devices

• MacroPore OS Spinal System (K010911)
• MERSILENE Mesh (preamendment device)

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Pamela Snyder Director of Clinical and Regulatory Affairs Spineology, Inc. 1815 Northwestern Avenue Stillwater, Minnesota 55082-6500

Re: K014200 Device: OptiMesh™ Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: II Product Code: EZX Dated: July 30, 2003 Received: August 1, 2003

Dear Ms. Snyder:

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). You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. 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.

NOV 2 6 2003

The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Contraindications section of your device's labeling:

Do not use this device in patients with instability (e.g. resected or collapsed vertebral bodies or fracture of the anterior column). This device does not provide structural support.

In addition, the following warning must appear in a black box immediately below your indications for use statement of the device's labeling:

The safety and effectiveness of this device used for fusion of the interbody space has not been established.

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Page 2 - Ms. Pamela Snyder

Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.

The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling.

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 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.

If you desire specific information about the application of other labeling requirements to your device (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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/cdrh/dsma/dsmamain.html.

Sincerely yours,

Daniel Schultz, M.D Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### 510(k) Number (if known): K014200

Device Name:_OptiMesh™

FDA's Statement of the Indications For Use for device:

OptiMesh is intended to maintain the relative position of bone graft material (such as autograft or allograft) within a vertebral body defect (e.g. tumor) that does not impact the stability of the vertebral body and does not include the vertebral endplates.

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JAN-06-2004 12:36 Spineology

P.02/02

Spineology Inc. Premarket Notification: OptiMesh K014200

# 510(k) Summary

| Submitter Information | |
|-------------------------------|-----------------------------------|
| Manufacturer's Name & Address | Manufacturer's Contact Person |
| Spineology Inc. | Pamela Snyder |
| 1815 Northwestern Avenue | Director of Clinical & Regulatory |
| Stillwater, MN 55082 | Phone: [phone] |
| | Fax: [phone] |

| Device Names | |
|----------------------|-------------------------------------------------------------------------|
| Proprietary Name: | OptiMesh |
| Classification Name: | 888.3060, appliance, fixation, spinal device;<br>878.3300 surgical mesh |
| Device Product Code: | KWQ, EZX |

#### Predicate Devices

The subject device is substantially equivalent to the predicate device, MacroPore OS Spinal System, K010911, and related predicate device, MERSILENE Mesh, a preamendment device.

### Device Description

OptiMcsh is a sterile, three-dimensional surgical mesh container made of knitted polyester yarn and offered in a range of sizes. The device is packaged in double Tyvek/Mylar pouches and a cardboard carton, and terminally sterilized.

#### Intended Use

OptiMesh is intended to maintain the relative position of bone graft material (such as autograft or allograft) within a vertebral body defect (e.g. tumor) that does not impact the stability of the vertebral body and does not include the vertebral endplates.

The safety and effectiveness of this device used for fusion of the interbody space has not been established.

## Technological Characteristic Comparisons

The device was shown to be substantially equivalent to the intended use, materials and configuration of the predicate products. Where technological differences exist, performance data was provided to demonstrate that the questions raised no new concerns about safety or effectiveness.