(71 days)
Not Found
No
The summary describes a mechanical device for fracture repair and ligament fixation, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is described as an adjunct in fracture repair and external/intramedullary fixation systems, providing fixation during the healing process, and does not appear to treat or prevent a disease or condition.
No
The device is described as an adjunct in fracture repair and providing fixation, indicating a therapeutic or supportive function rather than diagnosing a condition.
No
The device description explicitly states it is comprised of metal buttons and suture, which are physical components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The provided information clearly describes a surgical implant used for fixing bones and ligaments in the acromioclavicular joint. It is a physical device implanted in the body, not a test performed on a sample outside the body.
The device's function is mechanical support and fixation during the healing process, which is the opposite of an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The TightRope™ Acromioclavicular (AC) Device is intended as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as an adjunct in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting.
Specifically, the Arthrex TightRope Acromioclavicular (AC) Device is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of acromioclavicular separations due to coracoclavicular ligament disruptions.
Product codes
HTN
Device Description
The TightRope™ Acromioclavicular (AC) Device is designed as two differently sized metal buttons, both stainless steel or both titanium, and FiberWire ™ suture. The buttons are pre-threaded with FiberWire suture, looped twice through the buttonholes. Pull-through FiberWire sutures are also looped through each button.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Acromioclavicular (AC)
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)
K043248, K023294, K041356, K003227
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 3 2005
K05-2776 page 192
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS TightRope™ Acromioclavicular (AC) Device
| NAME OF SPONSOR: | Arthrex, Inc.
1370 Creekside Boulevard
Naples, Florida 34108-1945 |
|------------------|---------------------------------------------------------------------------------------------------------------------|
| 510(K) CONTACT: | Sally Foust, RAC
Regulatory Affairs Project Manager
Telephone: (239) 643-5553 ext. 125
FAX: (239) 598-5539 |
TRADE NAME: Device
TightRope™ Acromioclavicular (AC)
COMMON NAME:
Button/Suture
DEVICE PRODUCT CODE/CLASSIFICATION:
HTN: Single/multiple component metallic bone fixation appliances and accessories: 21 CFR 888.3030
PREDICATE DEVICES
K043248: TightRope Syndesmosis Device (Arthrex, Inc.) K023294: Bosworth Coraco-Clavicular Screw and Washer (Howmedica Osteonics) K041356: Tenodesis Family (Arthrex, Inc.) K003227: Bio-Absorbable Corkscrew (Arthrex, Inc.) pre-1976, Kirschner (K) Wire (Synthes)
DEVICE DESCRIPTION AND INTENDED USE
The TightRope™ Acromioclavicular (AC) Device is designed as two differently sized metal buttons, both stainless steel or both titanium, and FiberWire ™ suture. The buttons are pre-threaded with FiberWire suture, looped twice through the buttonholes. Pull-through FiberWire sutures are also looped through each button.
The TightRope™ Acromioclavicular (AC) Device is intended as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as an adjunct in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting.
1
Specifically, the Arthrex TightRope Acromioclavicular (AC) Device is intended to Opocilion in the hithing the healing process following a syndesmotic trauma, such provide intation of acromioclavicular separations due to coracoclavicular ligament disruptions.
SUBSTANTIALLY EQUIVALENCE
Arthrex has determined that the TightRope™ Acromioclavicular (AC) Device is substantially equivalent to the predicate devices where basic features and intended uses are the same. Any design differences between the Arthrex TightRope™ Acromioclavicular (AC) Device when compared to predicate devices used in the standard medical practice for the treatment of acromioclavicular separations due to coracoclavicular disruptions are considered minor and do not raise any questions concerning safety and effectiveness. Any differences have been found to have no apparent effect on the performance, function, or intended use of the device.
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three heads, representing the department's focus on health, services, and people. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle. The seal is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Sally Foust, RAC Regulatory Affairs Project Manager Arthrex, Inc. 1370 Creekside Boulevard Naples, Florida 34108-1945
DEC 1 3 2005
Re: K052776
Trade/Device Name: TightRope™ Acromioclavicular (AC) Device Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HTN Dated: September 28, 2005 Received: October 3, 2005
Dear Ms. Foust:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set 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.
3
Page 2 – Sally Foust, RAC
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Mellon
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): _
K05276
Device Name TightRope™ Acromioclavicular (AC) Device
Indications for Use:
The TightRope™ Acromioclavicular (AC) Device is intended as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as an adjunct in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting.
Specifically, the Arthrex TightRope Acromioclavicular (AC) Device is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of acromioclavicular separations due to coracoclavicular ligament disruptions.
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
signature
on Sion-Gill) Division of General, Restorative, and Neurological Devices
510(k) Number_152336