(59 days)
The Arthrex TensionLok™ for fixation of bone to bone or soft tissue to bone is intended as a fixation post, a distribution bridge, or for distributing suture tension, intended as a fixation pool, a dicinemation of the summer will be offering this for ACL repair.
The Arthrex TensionLok™is a Titanium button per F136 available with pre-threaded FiberWire® suture.
The provided text is a 510(k) summary for the Arthrex TensionLok™ device, a medical device for bone fixation. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not include any information about acceptance criteria, a study proving the device meets those criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.
Therefore, I cannot provide the requested table and information as it is not present in the given text.
No information regarding acceptance criteria or a study proving the device meets acceptance criteria is present in the provided document.
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DEC 1 2 2005
VIII. 510(k) SUMMARY OF SAFETY AND EFFECTIVE
ARTHREX TENSIONLOK™
| MANUFACTURER / SPONSOR | Arthrex, Inc.1370 Creekside BoulevardNaples, Florida 34108-1945 |
|---|---|
| 510(K) CONTACT: | Ann Waterhouse, RACRegulatory Affairs Project ManagerTelephone: (239) 643-5553 ext. 1179FAX: (239) 598-5539 |
| TRADE NAME: | TensionLok TM |
| COMMON NAME: | Plate, Fixation, Bone |
| PRODUCT CODE /CLASSIFICATION NAME | HWG/21 CFR 888.3020 |
HWC/ 21 CFR 888.3030 Plate, Fixation, Bone
GAT/ 21 CFR 878.5000 Suture. Nonabsorbable Synthetic Polyethylene
PREDICATE DEVICE:
FiberWire Button Repair Kit: K031666
DEVICE DESCRIPTION AND INTENDED USE:
The Arthrex TensionLok™is a Titanium button per F136 available with pre-threaded FiberWire® suture.
The Arthrex TensionLok™ for fixation of bone to bone or soft tissue to bone is intended as a fixation post, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. Specifically, Arthrex will be offering this for ACL repair.
SUBSTANTIAL EQUIVALENCE SUMMARY
The Arthrex TensionLok™ is substantially equivalent to the predicate Arthrex FiberWire Button Repair Kit/ACL Retroconstruction™ Button Kit in which the basic features and intended uses are the same. Any differences between the Arthrex TensionLok™and the predicate Arthrex FiberWire Button Repair Kit/ACL Retroconstruction™ Button Kit are considered minor and do not raise questions concerning safety and effectiveness. Based on the information submitted, Arthrex, Inc. has determined that the TensionLok ™ is substantially equivalent to the currently marketed predicate device.
Image /page/0/Picture/13 description: The image shows the number 000 and what appears to be the number 4. The numbers are in bold font. The image is black and white.
05 2901
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" around the perimeter. Inside the circle is a stylized symbol of three human figures connected by flowing lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 2 2005
Ms. Ann Waterhouse, RAC Regulatory Affairs Project Manager Arthrex Inc. 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K052901
Trade/Device Name: Arthrex TensionLok™ Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories
Regulatory Class: II Product Code: HRS, GAT Dated: November 28, 2005 Received: November 29, 2005
Dear Ms. Waterhouse:
We have reviewed your Section 510(k) premarket notification of intent to market the device indicati we nave reviewed your Section > ro(t) premised is substantially equivalent (for the indications felerenced above and have determined we arredicate devices marketed in interstate for use stated in the encrosite) to regally manative provide Americal Device Amendments, or to commerce prior to May 28, 1776, the enacements with the provisions of the Federal Food, Drug, devices that have been recults in access approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket a Act - T and Cosment Act (Act) that to not require approvial controls provisions of the Act. The You may, therefore, market the act include requirements for annual registration, listing of general controls provisions of the free free labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is Classifica (Sec above) into 5. Existing major regulations affecting your device
it may be subject to such additional controls. Existing major collection It may be subject to such additional controlsi matther of the 21, Parts 800 to 898. In addition, FDA can be found in the Oode of Features concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that TDA s issuation of a cadewice complies with other requirements of the Act that I DA has made a determination administered by other Federal agencies. You must or any irederal statutes and regulations and limited to: registration and listing (21 comply with an the 7ter 31equirements (1); good manufacturing practice requirements as set
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Page 2 -- Ms. Waterhouse
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic 1011111 the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (over device as described in your Section 510(k) I ms letter will anow you to oegin manteening your antial equivalence of your device to a legally premarket notification: "The PDF Interestion for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific at not at (240) 276-0120. Also, please note the regulation entitled, Colliact the Office of Comphanes in (21 notification" (21CFR Part 807.97). You may obtain Misolallums by reference to promantee no promantee for Act from the Division of Small other general international and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
S Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Form III.
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Arthrex TensionLokI™
Indications for Use:
The Arthrex TensionLok™ for fixation of bone to bone or soft tissue to bone is intended as a fixation post, a distribution bridge, or for distributing suture tension, intended as a fixation pool, a dicinemation of the summer will be offering this for ACL repair.
メ Prescription Use_ (Per 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 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
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number_LOS 2901
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.