THE GRAPPLR AND GRAPPLR EXTENDER

K101616 · Tag Medical Corp. · MBI · Jan 6, 2011 · Orthopedic

Device Facts

• Record ID: K101616
• Device Name: THE GRAPPLR AND GRAPPLR EXTENDER
• Applicant: Tag Medical Corp.
• Product Code: MBI · Orthopedic
• Decision Date: Jan 6, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The GrappLR™ and GrappLR™ Extender are intended to provide suspension fixation for soft tissue to bone in the repair of the natural ligament or tendon disruption or assist in reconstruction surgeries and to assist in the management of reconstructive surgeries.

Device Story

GrappLR™ and GrappLR™ Extender are single-use titanium implants for soft tissue-to-bone fixation. GrappLR™ features two configurations: one with a continuous loop made of ultra-high molecular weight polyethylene (UHMWPE) in various sizes; another without a loop for custom-tied lengths. Both include a lead suture. GrappLR™ Extender provides additional button width and length. Used by surgeons in orthopedic reconstruction procedures to secure ligaments or tendons to bone. Device functions as a suspension fixation anchor; provides mechanical stability for tissue healing.

Clinical Evidence

Bench testing only.

Technological Characteristics

Titanium implant; ultra-high molecular weight polyethylene (UHMWPE) loop; single-use; metallic bone fixation fastener; Class II; product codes MBI, HWC.

Indications for Use

Indicated for patients requiring soft tissue to bone suspension fixation during ligament or tendon repair and reconstructive surgeries.

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

• Smith & Nephew EndoButton Direct (K070167)
• Smith & Nephew EndoButton Continuous Loop (K081098)
• ConMed Linvatec XO Button (K070780)

Submission Summary (Full Text)

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## 510(k) Summary of Safety & Effectiveness

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

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| 1. (a) | Submitter<br>Address: | George J. Hattub<br>MedicSense, USA<br>291 Hillside Avenue<br>Somerset, MA 02726<br>www.medicsense.com |
|--------|----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. (b) | 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: | Dan Moor |
| | Date: | May 30, 2010 |
| 2. | Device &<br>Classification<br>Name: | Smooth or threaded metallic bone fixation fastener, class II device (product<br>code MBI).<br>GrappLR™ and GrappLR™ Extender |
| 3. | Predicate Devices: | K070167- Smith & Nephew EndoButton Direct<br>K081098- Smith & Nephew EndoButton Continuous Loop<br>K070780- ConMed Linvatec XO Button |
| 4. | Description: | The GrappLR™ suspension fixation device is a single-use, titanium implant<br>used for fixation of soft tissue to bone. The GrappLR™ has two<br>configurations: One has a Continuous Loop, made of ultra high molecular<br>weight polyethylene, offered in several sizes to accommodate various bone<br>tunnel lengths. The second configuration does not have a loop, and enables<br>custom loop lengths to be tied using an appropriate material (not included).<br>Both of these configurations have a Lead Suture.<br>The GrappLR Extender™ is a single-use, titanium implant used for providing<br>additional button width and length to the GrappLR™ |
| 5. | Intended Use: | The GrappLR™ and GrappLR™ Extender are intended to provide<br>suspension fixation for soft tissue to bone in the repair of the natural<br>ligament or tendon disruption or assist in reconstruction surgeries and to<br>assist in the management of reconstructive surgeries. |
| 6. | Comparison of<br>Technological<br>Characteristics: | With respect to its indication for use, the GrappLR™ and GrappLR™<br>Extender is substantially equivalent to its predicate devices in that it<br>intended for the same clinical purpose. With respect to technology, the<br>design is similar as confirmed by comparison, and the performance is the<br>same as verified by validation. Based upon this, T.A.G. Medical Products<br>Corporation, Ltd. believes that its device is safe and effective because it<br>performs the same function in the same manner. |

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T.A.G. Medical Products Corporation Ltd. c/o Mr. George Hattub Regulatory Consultant 291 Hillside Avenue Somerset, MA 02726

JAN 6 2011

Re: K101616

Trade/Device Name: GrappLR and GrappLR Extender Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories. Regulatory Class: Class II Product Code: MBI, HWC Dated: December 21, 2010 Received: December 29, 2010

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 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

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Page 2 – Mr. George Hattub

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 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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

A. D. VS. Rh

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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## Indications for Use

510(k) Number (if known):

Device Name: GrappLR™ and GrappLR™ Extender

Indications For Use: The GrappLR™ and GrappLR™ Extender are intended to provide suspension fixation for soft tissue to bone in the repair of the natural ligament of tendon disruption or assist in reconstruction surgeries and to assist in the management of reconstructive surgeries.

Prescription Use (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)

for M. Melkersm

(Division Sign-Oft) (Division Sign-Orio), Orthopedic, Divisionative Devices

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510(k) Number K101616