(98 days)
Mini TightRope, K090107
Not Found
No
The provided text describes a mechanical fixation device and does not mention any AI or ML components or functionalities.
Yes
The device is intended to provide fixation and stabilization during the healing process for various injuries and surgical reconstructions, which aligns with the definition of a therapeutic device.
No
The device is described as an adjunct for fracture repair and fixation during the healing process, and its description outlines physical components for surgical use, not diagnostic functions.
No
The device description explicitly states it consists of "two metal buttons and a pre-threaded FiberWire suture" or "one metal button, one bioabsorbable suture anchor," indicating it is a physical implantable device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The description and intended use of the Arthrex Mini TightRope and Mini TightRope FT clearly indicate that they are surgical implants used to provide mechanical support and fixation during the healing process of bone and soft tissue injuries. They are physically implanted into the body.
- Lack of Specimen Analysis: There is no mention of the device being used to analyze any biological specimens.
Therefore, the Arthrex Mini TightRope and Mini TightRope FT fall under the category of surgical devices or implants, not In Vitro Diagnostics.
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 thumb metacarpal by providing stabilization between the base of the first and second metacarpals when the trapezium has been excised due to osteoarthritis. The Mini TightRope and Mini TightRope FT are also indicated for use as adjuncts in the suspension of the thumb metacarpal during the healing process of hematoma distraction arthroplasty by providing stabilization at the base of the first and second metacarpal when the trapezium has been excised due to osteoarthritis.
Product codes (comma separated list FDA assigned to the subject device)
HTN
Device Description
The Mini TightRope devices are designed in two basic configurations: two metal buttons and a pre-threaded FiberWire suture and; one metal button, one bioabsorbable suture anchor.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Fracture repair involving metaphyseal and periarticular small bone fragments, Syndesmotic trauma (dorsal distal radioulnar ligament (DRUL)), Tarsometatarsal (TMT) injury (foot soft tissue separations due to a Lisfranc injury (Midfoot Reconstruction)), Hallux Valgus reconstruction (correction) (1st Metatarsal – 2nd metatarsal intermetatarsal angle), bone-to-bone, soft-tissue-to-bone, Carpal Metacarpal (CMC) joint, thumb metacarpal, base of the first and second metacarpals, trapezium.
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)
The submitted mechanical testing data demonstrates that the shear and tensile strength of the predicate devices are adequate for the desired proposed indication. The submitted clinical literature review demonstrates the same.
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.
Mini TightRope, K090107
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
.
| Date Summary Prepared | 29 JANUARY 2014 |
|---|---|
| Manufacturer/ | |
| Distributor/ | |
| Sponsor | Arthrex, Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 USA | |
| 510(k) Contact | Nancy Hoft |
| Regulatory Affairs | |
| Arthrex, Inc. | |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 USA | |
| Telephone: 239/643.5553, ext. 71113 | |
| Fax: 239/598.5508 | |
| Email: nancy.hoft@arthrex.com | |
| Trade Name | Mini TightRope |
| Common Name | Button / Anchor / Suture |
| Product Code, | |
| Classification Name, CFR | HTN – Single/multiple component metallic bone fixation appliances and accessories - |
| 888.3030 | |
| Predicate Device | Mini TightRope, K090107 |
| Purpose of Submission | This traditional 510(k) premarket notification is submitted to introduce to the cleared |
| Arthrex Mini TightRope devices, K090107: | |
| • A second Carpal Metacarpal (CMC) joint indication of Hematoma | |
| Distraction Arthroplasty (HDA). | |
| Device Description | The Mini TightRope devices are designed in two basic configurations: two metal |
| buttons and a pre-threaded FiberWire suture and; one metal button, one | |
| bioabsorbable suture anchor. | |
| Intended 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
thumb metacarpal by providing stabilization between the base of the first and second
metacarpals when the trapezium has been excised due to osteoarthritis. The Mini
TightRope and Mini TightRope FT are also indicated for use as adjuncts in the
suspension of the thumb metacarpal during the healing process of hematoma
distraction arthroplasty by providing stabilization at the base of the first and second
metacarpal when the trapezium has been excised due to osteoarthritis. |
| Substantial Equivalence
Summary | The Arthrex Mini TightRope family of devices is substantially equivalent to the
predicate devices, in which the basic design features and intended uses are the same. |
1
predicates are considered minor and do not raise questions concerning safety and effectiveness.
The Mini-TightRope family of devices, when used as adjuncts in the suspension of the thumb metacarpal during the healing process, provides adequate stabilization for hematoma distraction arthroplasty (HDA) at the base of the first and second metacarpal when the trapezium has been excised due to osteoarthritis. The submitted mechanical testing data demonstrates that the shear and tensile strength of the predicate devices are adequate for the desired proposed indication. The submitted clinical literature review demonstrates the same.
Based on the proposed indication for use, technological characteristics, and the summary of data submitted, Arthrex, inc., has determined that the Arthrex Mini TightRope family of devices is substantially equivalent to the currently marketed predicate devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/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 & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized graphic of what appears to be an abstract human figure.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 30, 2014
Arthrex, Incorporated Ms. Nancy Hoft Regulatory Affairs 1370 Creekside Boulevard Naples, Florida 34108
Re: K133275
Trade/Device Name: Mini TightRopes Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HTN Dated: November 6, 2013 Received: November 12, 2013
Dear Ms. Hoft:
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 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
3
Page 2 - Ms. Nancy Hoft
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Lori A. Wigqins
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
TRADITIONAL 510k: Arthrex Min1 TightRopes, 18 OCT 2013
K133275
2.4 INDICATIONS FOR USE
Indications for Use
510(k) Number (if known):
Device Name: Mini TightRopes
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) 1) 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 3) Metatarsal - 2nd metatarsal intermetatarsal angle.
The Arthrex Mini TightRope and the Mini TightRope FT, when used for fixation of bone-tobone 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 thumb metacarpal by providing stabilization between the base of the first and second metacarpals when the trapezium has been excised due to osteoarthritis. The Mini TightRope and Mini Tight Rope FT are also indicated for use as adjuncts in the suspension of the thumb metacarpal during the healing process of hematoma distraction arthroplasty by providing stabilization at the base of the first and second metacarpal when the trapezium has been excised due to osteoarthritis.
Prescription Use _ AND/OR Over-The-Counter Use _ (Per 21 CFR 801 Subpart D) (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 1
| Casey L. Hanley, Ph.D. |
|---|
| Division of Orthopedic Devices |
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