(203 days)
No
The document describes a mechanical fixation device and does not mention any AI or ML components or functionalities.
Yes
Explanation: The device is intended to provide fixation during the healing process following syndesmotic trauma, tarsometatarsal injury, and Hallux Valgus reconstruction, and for fixation of bone-to-bone or soft-tissue-to-bone, which directly supports the body's healing or provides therapy.
No
The device is described as providing fixation during the healing process following injury and in reconstruction, and is designed as metal buttons with pre-threaded sutures. These functions are therapeutic, not diagnostic.
No
The device description explicitly states it is comprised of metal buttons, a bioabsorbable suture anchor, and FiberWire suture, which are physical components, not software.
Based on the provided information, 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 (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description and intended use of the Arthrex Mini TightRope and Mini TightRope FT clearly indicate they are surgical implants used for fracture repair, ligament reconstruction, and stabilization of bones and soft tissues within the body. They are physical devices used in surgical procedures, not for testing samples outside the body.
The information provided focuses on the mechanical function and surgical application of the device, which is characteristic of a non-IVD medical device.
N/A
Intended Use / Indications for Use
The Arthrex Mini TightRope and Mini TightRope FT are intended as adjuncts in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as adjuncts in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting.
Specifically, the Arthrex Mini TightRope and the Mini TightRope FT are intended to provide fixation during the healing process following:
- Syndesmotic trauma, such as fixation of dorsal distal radioulnar ligament (DRUL) disruptions;
- Tarsometatarsal (TMT) injury, such as fixation of foot soft tissue separations due to a Lisfranc injury (Midfoot Reconstruction); and
- Hallux Valgus reconstruction (correction) by providing for the reduction of 1st metatarsal -2nd metatarsal intermetatarsal angle.
The Arthrex Mini TightRope and the Mini TightRope FT, when used for fixation of bone-to-bone or soft-tissue-to-bone, are intended as fixation posts, distribution bridges, or for distributing suture tension over areas of ligament or tendon repair. Specifically, the Arthrex Mini TightRope and the Mini TightRope FT are indicated for Carpal Metacarpal (CMC) joint arthroplasty as an adjunct in the healing process of the reconstruction of the ligament at the base of the thumb metacarpal by providing stabilization between the base of the first and second metacarpal when the trapezium has been excised due to osteoarthritis.
Product codes
HTN, HWC
Device Description
The Mini TightRope is designed as either two metal buttons with a pre-threaded FiberWire suture or as one metal button, one bioabsorbable suture anchor with one pre-threaded FiberWire suture.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
metaphyseal and periarticular small bone fragments, syndesmotic trauma (dorsal distal radioulnar ligament), Tarsometatarsal (TMT) injury (foot soft tissue separations, Lisfranc injury, Midfoot Reconstruction), Hallux Valgus, bone-to-bone, soft-tissue-to-bone, ligament or tendon repair, Carpal Metacarpal (CMC) joint (ligament at the base of the thumb metacarpal, first and second metacarpal)
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)
Mini TightRope Repair Kit, K061925, Mini TightRope FT Repair Kit, K071978, ACL RetroConstruction Button Kit, K031666
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.
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5 I 0(k) Summary of Safety and Effectiveness
| Manufacturer/
Distributor/
Sponsor | Arthrex, Inc.
1370 Creekside Boulevard
Naples, FL 34108-1945 USA |
|-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact | Sally Foust, RAC
Regulatory Affairs Project Manager
Arthrex, Inc.
1370 Creekside Boulevard
Naples, FL 34108-1945 USA
Telephone: 239/643.5553, ext. 1251
Fax: 239/598.5508
Email: sfoust@arthrex.com |
| Trade Name | Mini TightRope |
| Common Name | Button / Anchor / Suture |
| Product Code -
Classification
Name | HTN - Single/multiple component metallic bone fixation appliances
and accessories |
| Predicate Device | Mini TightRope Repair Kit, K061925
Mini TightRope FT Repair Kit, K071978
ACL RetroConstruction Button Kit, K031666 |
| Device
Description and
Intended Use | The Mini TightRope is designed as either two metal buttons with a
pre-threaded FiberWire suture or as one metal button, one
bioabsorbable suture anchor with one pre-threaded FiberWire suture. |
| | The Arthrex Mini TightRope and Mini TightRope FT are intended as
adjuncts in fracture repair involving metaphyseal and periarticular
small bone fragments where screws are not indicated, and as adjuncts
in external and intramedullary fixation systems involving plates and
rods, with fracture braces and casting. |
| | Specifically, the Arthrex Mini TightRope and the Mini TightRope
FT are intended to provide fixation during the healing process
following: |
| | 1) Syndesmotic trauma, such as fixation of dorsal distal radioulnar
ligament (DRUL) disruptions; |
| | 2) Tarsometatarsal (TMT) injury, such as fixation of foot soft tissue
separations due to a Lisfranc injury (Midfoot Reconstruction);
and |
| | 3) Hallux Valgus reconstruction (correction) by providing for the
reduction of 1st metatarsal -2nd metatarsal intermetatarsal angle. |
| | The Arthrex Mini TightRope and the Mini TightRope FT, when used
for fixation of bone-to-bone or soft-tissue-to-bone, are intended as
fixation posts, distribution bridges, or for distributing suture tension |
| | over areas of ligament or tendon repair. Specifically, the Arthrex
Mini TightRope and the Mini TightRope FT are indicated for Carpal |
| | Metacarpal (CMC) joint arthroplasty as an adjunct in the healing
process of the reconstruction of the ligament at the base of the thumb
metacarpal by providing stabilization between the base of the first
and second metacarpal when the trapezium has been excised due to
osteoarthritis. |
| Substantial | The Mini TightRope with expanded indications is substantially |
| Equivalence | equivalent to the predicate Mini TightRope devices and the AC |
| Summary | RetroConstruction Button Kit in which the basic features are
identical and the intended uses are very similar. Any differences
between the Mini TightRope with expanded indications and the
predicate devices are considered minor and do not raise questions
concerning safety and effectiveness. Based on the information
submitted, Arthrex, Inc. has determined that the Mini TightRope with
expanded indications is substantially equivalent to the currently
marketed predicate devices. |
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Arthrex, Inc. % Ms. Sally Foust Regulatory Affairs Project Manager 1370 Creekside Boulevard Naples, Florida 34108
AUG 0 6 2009
Re: K090107
Trade/Device Name: Mini TightRope Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HTN, HWC Dated: July 27, 2009 Received: July 29, 2009
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 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 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 -- Ms. Sally Foust
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/CDRH/CDRHOffices/ucm11.5809.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/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark M Millken
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
690107
K090107 510(k) Number (if known:
Mini TightRope Device Name:
Indications For Use:
The Arthrex Mini TightRope and Mini TightRope FT are intended as adjuncts in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as adjuncts in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting.
Specifically, the Arthrex Mini TightRope and the Mini TightRope FT are intended to provide fixation during the healing process following:
-
- Syndesmotic trauma, such as fixation of dorsal distal radioulnar ligament (DRUL) disruptions;
-
- Tarsometatarsal (TMT) injury, such as fixation of foot soft tissue separations due to a Lisfranc injury (Midfoot Reconstruction); and
-
- Hallux Valgus reconstruction (correction) by providing for the reduction of 185 metatarsal -2nd metatarsal intermetatarsal angle.
The Arthrex Mini TightRope and the Mini TightRope FT, when used for fixation of bone-to-bone or soft-tissue-to-bone, are intended as fixation posts, distribution bridges, or for distributing suture tension over areas of ligament or tendon repair. Specifically, the Arthrex Mini TightRope and the Mini TightRope FT are indicated for Carpal Metacarpal (CMC) joint arthroplasty as an adjunct in the healing process of the reconstruction of the ligament at the base of the thumb metacarpal by providing stabilization between the base of the first and second metacarpal when the trapezium has been excised due to osteoarthritis.
× Prescription Use (Per 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (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) | |
|---|---|
| (Division Sign-Off) | |
| Division of Surgical, Orthopedic, and Restorative Devices |
K090107510(k) Number _