(59 days)
Not Found
No
The summary describes a mechanical fixation device (Titanium button with suture) and does not mention any software, algorithms, or data processing related to AI/ML.
No.
The intended use describes the device as a fixation post or distribution bridge for ACL repair, indicating it is an implant for mechanical support rather than a device used for treating disease or maintaining health.
No
The device is described as a fixation device (Titanium button with suture) used for bone to bone or soft tissue to bone fixation, specifically mentioning ACL repair. Its intended use is for fixation and distributing suture tension, not for diagnosing conditions.
No
The device description explicitly states it is a "Titanium button per F136 available with pre-threaded FiberWire® suture," indicating it is a physical hardware device, not software only.
Based on the provided information, the Arthrex TensionLok™ is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device for fixation of bone to bone or soft tissue to bone in surgical procedures, specifically mentioning ACL repair. This is a surgical implant/device used directly on the patient's body.
- Device Description: The description of a Titanium button with pre-threaded suture further supports its role as a surgical implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) in vitro (outside the body) to provide information about a patient's health status, diagnose, monitor, or screen for diseases.
IVD devices are used to perform tests on samples taken from the body, while the Arthrex TensionLok™ is a device implanted within the body to provide structural support and fixation.
N/A
Intended Use / 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 over areas of ligament or tendon repair. Specifically, Arthrex will be offering this for ACL repair.
Product codes (comma separated list FDA assigned to the subject device)
HWG, HWC, GAT, HRS
Device Description
The Arthrex TensionLok™is a Titanium button per F136 available with pre-threaded FiberWire® suture.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone, soft tissue, ligament, tendon, ACL
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): 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
§ 888.3030 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.
0
DEC 1 2 2005
VIII. 510(k) SUMMARY OF SAFETY AND EFFECTIVE
ARTHREX TENSIONLOK™
| MANUFACTURER / SPONSOR | Arthrex, Inc.
1370 Creekside Boulevard
Naples, Florida 34108-1945 |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| 510(K) CONTACT: | Ann Waterhouse, RAC
Regulatory Affairs Project Manager
Telephone: (239) 643-5553 ext. 1179
FAX: (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
1
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
2
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
3
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