(28 days)
Not Found
No
The device description and intended use focus on mechanical fixation of soft tissue to bone using titanium implants and polyethylene loops. There is no mention of AI, ML, image processing, or data analysis capabilities.
Yes
The device is described as being used in the repair of natural ligament or tendon disruption and to assist in reconstruction surgeries, which are therapeutic interventions.
No
The device is described as an implant used for fixation of soft tissue to bone in repair or reconstruction surgeries, not for diagnosis.
No
The device description explicitly states it is a "single-use, titanium implant," which is a hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "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." This describes a surgical implant used in vivo (within the body) for structural support and repair.
- Device Description: The description details a "single-use, titanium implant" with sutures, designed for fixation of soft tissue to bone. This is consistent with a surgical device, not a diagnostic test performed in vitro (outside the body) on biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
MBI
Device Description
The G-Lok® suspension fixation device is a single-use, titanium implant used for fixation of soft tissue to bone. The G-Lok® has two configurations: One has a Continuous Loop, made of ultra high molecular weight polyethylene, offered in several sizes to accommodate various bone tunnel lengths. The second configuration does not have a loop, and enables custom loop lengths to be tied using an appropriate material (not included). Both of these configurations have a Lead Suture and an optional Flipping Suture.
The G-Lok® XL Extender is a single-use, titanium implant used for providing additional button width and length to the G-Lok®.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue to bone
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The purpose of this 510(k) was to add an optional Flipping Suture. With respect to technology, the design is similar as confirmed by comparison, and the performance is the same as verified by validation. Based upon this, T.A.G. Medical Products Corporation, Ltd. believes that its device is safe and effective because it performs the same function in the same manner.
The performance testing indicated equivalency to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
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.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a stylized emblem. The emblem depicts a stylized caduceus with three human profiles forming the staff. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
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
1
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)
Page 1 of 1
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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
Address: | George J. Hattub
MedicSense, USA
291 Hillside Avenue
Somerset, MA 02726
www.medicsense.com |
|--------|----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. (b) | Manufacturer
Address: | T.A.G. Medical Products Corporation, Ltd.
D. N. Ashrat
Kibbutz Gaaton 25130, Israel |
| | Mfg. Phone: | Tel.: 972-4-985-8400 |
| | Contact Person: | Erez Adiv RA/QA Director |
| | Date: | October 12, 2014 |
| 2. | Device &
Classification
Name: | Smooth or threaded metallic bone fixation fastener, class II device (product
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
used for fixation of soft tissue to bone. The G-Lok® has two configurations:
One has a Continuous Loop, made of ultra high molecular weight
polyethylene, offered in several sizes to accommodate various bone tunnel
lengths. The second configuration does not have a loop, and enables
custom loop lengths to be tied using an appropriate material (not included).
Both of these configurations have a Lead Suture and an optional Flipping
Suture.
The G-Lok® XL Extender is a single-use, titanium implant used for providing
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
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. |
| 6. | Comparison of
Technological
Characteristics: | With respect to its indication for use, the G-Lok® and G-Lok® XL Extender
is substantially equivalent to its predicate devices in that it intended for the
same clinical purpose. The purpose of this 510(k) was to add an optional
Flipping Suture. With respect to technology, the design is similar as
confirmed by comparison, and the performance is the same as verified by
validation. Based upon this, T.A.G. Medical Products Corporation, Ltd.
believes that its device is safe and effective because it performs the same
function in the same manner.
The following table depicts the similarities and differences between the
predicate device and the submitted device. In addition, the performance
testing indicated equivalency to the predicate device. |
4
| Feature and
Characteristic | Modified Device
The G-Lok Button and G-Lok XL
Extender | Predicate Device
The GrappLR and GrappLR
Extender |
|---------------------------------------|--------------------------------------------------------------|---------------------------------------------------------|
| Button Material | Same | Titanium |
| Button Length | Same | 13 mm |
| Button Width | Same | 3.81 mm |
| Button Thickness | Same | 2.20 mm |
| Button Hole
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
Thickness | Same | 3.3 mm |
| Extender Hole
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
used with No Loop | yes | yes |
| Suture(s) | Two Tevdek™ Polyester Sutures (for
leading and flipping) | One Tevdek™ Polyester Suture (for
leading) |
| Delivery
Mechanism | Same | Passing Pin |
| | | (not provided) |
| Deployment
Mechanism | Flip with Push Rod and/or Flip Suture | Flip with Push Rod |
| Feature and
Characteristic | Modified Device
The G-Lok Button and G-Lok XL
Extender | Predicate Device
The GrappLR and GrappLR
Extender |
|----------------------------------------------|--------------------------------------------------------------|---------------------------------------------------------|
| Surgical
Preparation
(Tunnel Drilling) | Same | Same |
| Graft Preparation | Same | Same |
| Graft Attachment
(Proximal) | Same | Same |
| Provided Single
Patient Use Sterile | yes | yes |
| 510(k) Number | Pending | K101616 |