(115 days)
Not Found
No
The device description and intended use focus on a mechanical anchor system for soft tissue fixation, with no mention of AI or ML capabilities.
No
The device is used for soft tissue to bone fixation, which is a repair or reconstruction purpose rather than a therapeutic (treatment) one.
No
Explanation: The Knotilus™ Anchor System is described as an implantable device for soft tissue to bone fixation, used in repair and reconstruction surgeries, rather than for diagnosing conditions.
No
The device description clearly outlines physical, implantable components (Knotilus Anchor and Knotilus Implant Loop) made of materials like UHMWPE, indicating it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "soft tissue to bone fixation in the repair of the natural ligament or tendon disruption or to assist in reconstruction surgeries." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device components (anchor and implant loop) are designed for physical implantation and fixation within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health status, diagnosis, or treatment.
IVD devices are used to perform tests on samples taken from the body, while this device is a surgical implant used to repair or reconstruct tissues within the body.
N/A
Intended Use / 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.
Product codes
MBI, LYT
Device Description
The Knotilus Anchor System consists of: • Knotilus Anchor - an implantable anchor preloaded on a disposable inserter to aid with anchor insertion into the bone. The Knotilus Anchor will be offered in outer diameters ranging from 3.5 mm to 6.0 mm and length ranging from 10 mm to 20 mm. • Knotilus Implant Loop - A non-absorbable UHMWPE (Dyneema) loop designed for fixation of soft tissue without the need of knot tying. The Knotilus Implant Loop will be offered with a total length of 470 mm and distal loop sizes of 22 mm, 25 mm and 28 mm. The Knotilus Anchor and Knotilus Implant Loop will be provided separately, sterile for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
foot, ankle, knee, hip, hand, wrist, elbow and shoulder
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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
Address: | George J. Hattub
MedicSense, USA
291 Hillside Avenue
Somerset, MA 02726
www.medicsense.com |
|-----|----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1b. | 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 |
| | Date: | February 3, 2012 |
| 2a. | Device Name: | Knotilus Anchor System |
| 2b. | Classification
Name & code: | Smooth or threaded metallic bone fixation fastener, class II device
(product code MBI ; Regulation number 21 CFR 888.3040) |
| 2c. | Subsequent
Classification
Name & code: | Single/multiple component metallic bone fixation appliances and
accessories, class II device
(product code LYT ; Regulation number 21 CFR 888.3030) |
| 3. | Predicate
Devices: | Stryker Endoscopy PEEK TWINLOOP TAC - K070882 |
| 4. | Description: | The Knotilus Anchor System consists of:
• Knotilus Anchor - an implantable anchor preloaded on a
disposable inserter to aid with anchor insertion into the bone.
The Knotilus Anchor will be offered in outer diameters ranging from
3.5 mm to 6.0 mm and length ranging from 10 mm to 20 mm.
• Knotilus Implant Loop - A non-absorbable UHMWPE (Dyneema)
loop designed for fixation of soft tissue without the need of knot
tying.
The Knotilus Implant Loop will be offered with a total length of 470
mm and distal loop sizes of 22 mm, 25 mm and 28 mm.
The Knotilus Anchor and Knotilus Implant Loop will be provided
separately, sterile for single use only. |
| 5. | 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. |
| 6. | Comparison of
Technological
Characteristics: | With respect to its indication for use, the Knotilus Anchor System is
substantially equivalent to its predicate devices. With respect to
technology, the design is similar, as confirmed by comparison, and
the performance is the same as verified by design verification.
Based upon this, T.A.G. Medical Products Corporation, Ltd. believes
that its device is safe and effective because it performs and functions
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
3
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 (800) 638-2041 or (301) 796-7100 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
4
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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