G-Lok and G-Lok XL Extender

K142653 · T.A.G. Medical Products Corporation, Ltd. · MBI · Oct 16, 2014 · Orthopedic

Device Facts

• Record ID: K142653
• Device Name: G-Lok and G-Lok XL Extender
• Applicant: T.A.G. Medical Products Corporation, Ltd.
• Product Code: MBI · Orthopedic
• Decision Date: Oct 16, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The G-Lok® and G-Lok® XL 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

G-Lok and G-Lok XL Extender are single-use titanium implants for soft tissue-to-bone fixation; used in ligament/tendon repair and reconstructive surgeries. Device configurations include a continuous ultra-high molecular weight polyethylene loop or a no-loop version for custom lengths. Features lead and optional flipping sutures for deployment. Used by surgeons in clinical settings; implanted via bone tunnels. Provides mechanical suspension fixation to secure grafts; facilitates surgical reconstruction. Benefits include stable fixation for soft tissue healing.

Clinical Evidence

Bench testing only; no clinical data provided. Performance testing verified equivalency to the predicate device.

Technological Characteristics

Materials: Titanium (button/extender), ultra-high molecular weight polyethylene (loop), polyester (sutures). Form factor: Metallic bone fixation fastener with optional extender. Deployment: Flip mechanism via push rod and/or flipping suture. Single-use, sterile.

Indications for Use

Indicated for patients requiring soft tissue to bone suspension fixation during ligament or tendon repair or 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

• GrappLR™ and GrappLR™ Extender (K101616)

Submission Summary (Full Text)

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

October 16, 2014

T.A.G. Medical Products Corporation, Limited % George J. Hattub, RAC, CQE MedicSense, USA 291 Hillside Avenue Somerset, Massachusetts 02726

Re: K142653

Trade/Device Name: G-Lok® and G-Lok® XL Extender Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: September 11, 2014 Received: September 18, 2014

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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

## Ronald DAJean -S for

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

Enclosure

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## Indications for Use

510(k) Number (if known): K142653

Device Name: The G-Lok® and G-Lok® XL Extender

Indications For Use: The G-Lok® and G-Lok® XL 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.

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)

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## Special 510(k) Summary of Safety & Effectiveness

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

| 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: | Erez Adiv RA/QA Director |
| | Date: | October 12, 2014 |
| 2. | Device &<br>Classification<br>Name: | Smooth or threaded metallic bone fixation fastener, class II device (product<br>code MBI). |
| | | G-Lok® and G-Lok® XL Extender |
| 3. | Predicate Devices: | K101616- GrappLR™ and GrappLR™ Extender |
| 4. | Description: | The G-Lok® suspension fixation device is a single-use, titanium implant<br>used for fixation of soft tissue to bone. The G-Lok® has two configurations:<br>One has a Continuous Loop, made of ultra high molecular weight<br>polyethylene, offered in several sizes to accommodate various bone tunnel<br>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 and an optional Flipping<br>Suture.<br>The G-Lok® XL Extender is a single-use, titanium implant used for providing<br>additional button width and length to the G-Lok®. |
| 5. | Intended Use: | The G-Lok® and G-Lok® XL Extender are intended to provide suspension<br>fixation for soft tissue to bone in the repair of the natural ligament or tendon<br>disruption or assist in reconstruction surgeries and to assist in the<br>management of reconstructive surgeries. |
| 6. | Comparison of<br>Technological<br>Characteristics: | With respect to its indication for use, the G-Lok® and G-Lok® XL Extender<br>is substantially equivalent to its predicate devices in that it intended for the<br>same clinical purpose. The purpose of this 510(k) was to add an optional<br>Flipping Suture. With respect to technology, the design is similar as<br>confirmed by comparison, and the performance is the same as verified by<br>validation. Based upon this, T.A.G. Medical Products Corporation, Ltd.<br>believes that its device is safe and effective because it performs the same<br>function in the same manner.<br>The following table depicts the similarities and differences between the<br>predicate device and the submitted device. In addition, the performance<br>testing indicated equivalency to the predicate device. |

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| Feature and<br>Characteristic | Modified Device<br>The G-Lok Button and G-Lok XL<br>Extender | Predicate Device<br>The GrappLR and GrappLR<br>Extender |
|---------------------------------------|--------------------------------------------------------------|---------------------------------------------------------|
| Button Material | Same | Titanium |
| Button Length | Same | 13 mm |
| Button Width | Same | 3.81 mm |
| Button Thickness | Same | 2.20 mm |
| Button Hole<br>Diameter(s) | 1.5 mm and 1.2 mm | 1.5 mm |
| Optional Extender | yes | yes |
| Extender Material | Same | Titanium |
| Extender Length | 19.8 mm | 19 mm |
| Extender Width | Same | 5.0 mm |
| Extender<br>Thickness | Same | 3.3 mm |
| Extender Hole<br>Diameter(s) | 1.5 mm and 1.5 mm | 1.5 mm |
| Loop Size | Same | 15-50 mm |
| Loop Material | Same | Braided Polyethylene |
| Capability to be<br>used with No Loop | yes | yes |
| Suture(s) | Two Tevdek™ Polyester Sutures (for<br>leading and flipping) | One Tevdek™ Polyester Suture (for<br>leading) |
| Delivery<br>Mechanism | Same | Passing Pin |
| | | (not provided) |
| Deployment<br>Mechanism | Flip with Push Rod and/or Flip Suture | Flip with Push Rod |

| Feature and<br>Characteristic | Modified Device<br>The G-Lok Button and G-Lok XL<br>Extender | Predicate Device<br>The GrappLR and GrappLR<br>Extender |
|----------------------------------------------|--------------------------------------------------------------|---------------------------------------------------------|
| Surgical<br>Preparation<br>(Tunnel Drilling) | Same | Same |
| Graft Preparation | Same | Same |
| Graft Attachment<br>(Proximal) | Same | Same |
| Provided Single<br>Patient Use Sterile | yes | yes |
| 510(k) Number | Pending | K101616 |