ABSORBATACK AND APPLICATOR

K071061 · Sorbx, LLC · GDW · May 16, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K071061
• Device Name: ABSORBATACK AND APPLICATOR
• Applicant: Sorbx, LLC
• Product Code: GDW · General, Plastic Surgery
• Decision Date: May 16, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4750
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AbsorbaTack™ and Applicator are indicated for fixation of prosthetic material to soft tissue in various minimally invasive and open general surgical procedures, such as hernia repair.

Device Story

AbsorbaTack™ and Applicator is a surgical fixation device used to secure prosthetic mesh to soft tissue. The system consists of an applicator tool and absorbable tacks. Used by surgeons in both minimally invasive and open general surgical procedures, such as hernia repair. The device functions by deploying tacks through the mesh into the underlying tissue to provide mechanical fixation. This replaces or supplements traditional suturing techniques, potentially reducing procedure time and improving mesh stability. The tacks are designed to be absorbed by the body over time, eliminating the need for permanent foreign body retention in the fixation site.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on bench testing and comparison to legally marketed predicate devices.

Technological Characteristics

Implantable fixation device (staple/tack). Materials are absorbable. Designed for use with an applicator tool. Class II device under 21 CFR 878.4750.

Indications for Use

Indicated for fixation of prosthetic material to soft tissue during minimally invasive and open general surgical procedures, including hernia repair, in patients requiring surgical mesh placement.

Regulatory Classification

Identification

An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 16 2007

Sorbx, LLC % Ms. Mary Lee Willetts P.O. Box 3614 Ponte Vedra Beach, Florida 32004

Re: K071061

Trade/Device Name: AbsorbaTack™ and Applicator Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: II Product Code: GDW Dated: May 1, 2007 Received: May 2, 2007

Dear Ms. Willetts:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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Page 2 - Ms. Mary Lee Willetts

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

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson
Director

Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

K071061 510(k) Number (if known):

Not known

## Device Name:

AbsorbaTack™ and Applicator

## Indications for Use:

The AbsorbaTack™ and Applicator are indicated for fixation of prosthetic material to soft tissue in various minimally invasive and open general surgical procedures, such as hernia repair.

Prescription Use > Yes

AND/OR

Over-the-Counter Use_

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

Concurrence of CDRH, Offise of Device Evaluation (ODE)

**(Division Sign-Off)**
Division of General, Restorative,
and Neurological Devices

510(k) Number /L071061

Indications for Use rev 1