KNOTILUS ANCHOR SYSTEM

K113297 · T.A.G. Medical Products Corporation, Ltd. · MBI · Mar 2, 2012 · Orthopedic

Device Facts

• Record ID: K113297
• Device Name: KNOTILUS ANCHOR SYSTEM
• Applicant: T.A.G. Medical Products Corporation, Ltd.
• Product Code: MBI · Orthopedic
• Decision Date: Mar 2, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Knotilus Anchor System is intended for use in soft tissue to bone fixation in the repair of the natural ligament or tendon disruption or to assist in reconstruction surgeries. Specific indications are: foot, ankle, knee, hip, hand, wrist, elbow and shoulder.

Device Story

Knotilus Anchor System consists of implantable anchor preloaded on disposable inserter and non-absorbable UHMWPE (Dyneema) loop; designed for soft tissue to bone fixation without knot tying. Used by surgeons in orthopedic procedures (foot, ankle, knee, hip, hand, wrist, elbow, shoulder). Anchor inserted into bone; loop secures soft tissue. Provided sterile for single use.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Implantable anchor (3.5-6.0 mm diameter, 10-20 mm length) and UHMWPE (Dyneema) loop (470 mm total length). Disposable inserter included. Sterile, single-use.

Indications for Use

Indicated for soft tissue to bone fixation in ligament or tendon repair or reconstruction surgeries in the foot, ankle, knee, hip, hand, wrist, elbow, and shoulder.

Regulatory Classification

Identification

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• Stryker Endoscopy PEEK TWINLOOP TAC - K070882

Submission Summary (Full Text)

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K113297(pg1/z)

MAR - 2 2012

## 510(k) Summary of Safety & Effectiveness

Pursuant to CFR 807.92, the following 510(k) Summary is provided:

| 1a. | Submitter<br>Address: | George J. Hattub<br>MedicSense, USA<br>291 Hillside Avenue<br>Somerset, MA 02726<br>www.medicsense.com |
|-----|----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1b. | Manufacturer<br>Address: | T.A.G. Medical Products Corporation, Ltd.<br>D. N. Ashrat<br>Kibbutz Gaaton 25130, Israel |
| | Mfg. Phone: | Tel.: [phone] |
| | Contact Person: | Erez Adiv |
| | Date: | February 3, 2012 |
| 2a. | Device Name: | Knotilus Anchor System |
| 2b. | Classification<br>Name & code: | Smooth or threaded metallic bone fixation fastener, class II device<br>(product code MBI ; Regulation number 21 CFR 888.3040) |
| 2c. | Subsequent<br>Classification<br>Name & code: | Single/multiple component metallic bone fixation appliances and<br>accessories, class II device<br>(product code LYT ; Regulation number 21 CFR 888.3030) |
| 3. | Predicate<br>Devices: | Stryker Endoscopy PEEK TWINLOOP TAC - K070882 |
| 4. | Description: | The Knotilus Anchor System consists of:<br>• Knotilus Anchor - an implantable anchor preloaded on a<br>disposable inserter to aid with anchor insertion into the bone.<br>The Knotilus Anchor will be offered in outer diameters ranging from<br>3.5 mm to 6.0 mm and length ranging from 10 mm to 20 mm.<br><br>• Knotilus Implant Loop - A non-absorbable UHMWPE (Dyneema)<br>loop designed for fixation of soft tissue without the need of knot<br>tying.<br>The Knotilus Implant Loop will be offered with a total length of 470<br>mm and distal loop sizes of 22 mm, 25 mm and 28 mm.<br><br>The Knotilus Anchor and Knotilus Implant Loop will be provided<br>separately, sterile for single use only. |
| 5. | Intended Use: | The Knotilus Anchor System is intended for use in soft tissue to bone<br>fixation in the repair of the natural ligament or tendon disruption or to<br>assist in reconstruction surgeries.<br>Specific indications are: foot, ankle, knee, hip, hand, wrist, elbow and<br>shoulder. |
| 6. | Comparison of<br>Technological<br>Characteristics: | With respect to its indication for use, the Knotilus Anchor System is<br>substantially equivalent to its predicate devices. With respect to<br>technology, the design is similar, as confirmed by comparison, and<br>the performance is the same as verified by design verification.<br><br>Based upon this, T.A.G. Medical Products Corporation, Ltd. believes<br>that its device is safe and effective because it performs and functions<br>in the same manner. |

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread. The eagle is facing to the right and has three lines representing its wings.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

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

T.A.G. Medical Products Corportation, Ltd. % MedicSense, USA Mr. George J. Hattub 291 Hillside Ave. Somerset, MA 02726

MAR - 2 2012

Re: K113297

Trade/Device Name: Knotilus Anchor System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: February 3, 2012 Received: February 27, 2012

Dear Mr. Hattub:

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 I that FDA has made a determination that your device complies with other requirements of the Act that I Dri has made a cond regulations administered by other Federal agencies. You must or any I caelar stututes and regulaments, including, but not limited to: registration and listing (21 Comply with an the Fict of Net 810 ); medical device reporting (reporting of medical CITY art 807); abonny (21 CFR 803); good manufacturing practice requirements as set

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Page - 2 - Mr. George J. Hattub

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/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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Eric Keith

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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K113297(pg 1/1)

## Indications for Use

510(k) Number (if known): K113297

Device Name: Knotilus™ Anchor System

Indications For Use: The Knotilus™ Anchor System is intended for use in soft tissue to bone fixation in the repair of the natural ligament or tendon disruption or to assist in reconstruction surgeries.

Specific indications are: foot, ankle, knee, hip, hand, wrist, elbow and shoulder.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Michael Chavis

lvision Sign-Off) ision of Surgical, Orthopedic, nd Restorative Devices

**§10(k) Number** K113297

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