(28 days)
Not Found
No
The device description and intended use focus on mechanical fixation components (button, anchor, suture) and do not mention any software, algorithms, or data processing capabilities indicative of AI/ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is intended to provide fixation and assist in the healing process of fractures and soft tissue separations, which are therapeutic functions.
No
Explanation: The device is described as a repair kit intended for fixation during the healing process of bone and soft tissue injuries. It is a tool for treatment, not for diagnosing conditions.
No
The device description explicitly lists physical components (metal button, bioabsorbable suture anchor, FiberWire suture), indicating it is a hardware-based medical device, not software-only.
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 description and intended use of the Mini TightRope FT Repair Kit clearly indicate it is a surgical implant used for mechanical fixation during fracture repair and soft tissue reconstruction. It is physically implanted into the body to provide stability and support during the healing process.
- Lack of IVD Characteristics: The provided information does not mention any testing of biological samples, analysis of bodily fluids, or diagnostic purposes.
Therefore, based on the provided information, the Mini TightRope FT Repair Kit is a surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Mini TightRope FT Repair Kit 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 Mini TightRope FT Repair Kit is intended to provide fixation during the healing process following:
-
- Syndesmotic trauma, such as fixation of dorsal distal radioulnar ligament (DRUL) disruptions;
-
- Tarasometatarsal (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.
Product codes (comma separated list FDA assigned to the subject device)
HTN, HWC
Device Description
The Mini TightRopeTM FT Repair Kit is designed as one metal button, one bioabsorbable suture anchor, and one FiberWireTM suture. The button and anchor are pre-threaded with FiberWire looped twice.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Dorsal distal radioulnar ligament (DRUL), Foot (Lisfranc injury, Midfoot), 1st metatarsal - 2nd metatarsal
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
K. 071978 page 12
Arthrex SPECIAL 510(k); Arthrex Mini TightFlope FT Repair Kit
AUG 1-5 2007
| 4 510(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 FT Repair Kit |
| Common Name | Button / Anchor / Suture |
| Product Code -Classification Name | HTN – Single/multiple component metallic bone fixation appliances and accessories |
| Predicate Device | Arthrex Mini TightRope Repair Kit, K061925 |
| Device Description and Intended Use | The Mini TightRopeTM FT Repair Kit is designed as one metal button, one bioabsorbable suture anchor, and one FiberWireTM suture. The button and anchor are pre-threaded with FiberWire looped twice. |
| The Mini TightRope FT Repair Kit 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 Mini TightRope FT Repair Kit is intended to provide fixation during the healing process following: |
- Syndesmotic trauma, such as fixation of dorsal distal radioulnar ligament (DRUL) disruptions:
- Tarasometatarsal (TMT) injury, such as fixation of foot soft tissue separations due to a Lisfranc injury (Midfoot Reconstruction); and |
| providing for the reduction of 1st metatarsal - 2nd metatarsal intermetatarsal angle. | |
| Substantial Equivalence Summary | The Mini TightRope™ FT Repair Kit is substantially equivalent to the predicate Mini TightRope™ Repair Kit in which the basic features and intended uses are the same. Any differences between the Mini TightRope™ FT Repair Kit and the predicate Mini TightRope™ Repair Kit is considered minor and do not raise questions concerning safety and effectiveness. Based on the information submitted, Arthrex, Inc. has determined that the new Mini TightRope™ FT Repair Kit is substantially equivalent to the currently marketed predicate device. |
1
page 12
Arthrex SPECIAL 510(k): Arthrex Mini TightfRope FT Repair Kit
:
.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all caps and is oriented to follow the curve of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 15 2007
Arthrex, Inc. % Ms. Sally Foust Regulatory Affairs Project Manager 1370 Creekside Boulevard Naples, Florida 34108-1945
K071978 Trade/Device Name: Mini TightRope FT Repair Kit Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HTN & HWC Dated: July 13, 2007 Received: July 18, 2007
Dear Ms. Foust:
Re:
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
3
Page 2 - Ms. Sally Foust
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. 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" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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/cdrh/industry/support/index.html.
Sincerely yours,
Barbene Buehup
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Arthrex SPECIAL 510(K): Arthrex Mini TightFlope FT Repair Kit
Indications for Use
510(k) Number:
Ko71978
Device Name:
Mini TightRope FT Repair Kit
The Mini TightRope FT Repair Kit 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 Mini TightRope FT Repair Kit is intended to provide fixation during the healing process following:
-
- Syndesmotic trauma, such as fixation of dorsal distal radioulnar ligament (DRUL) disruptions;
-
- Tarasometatarsal (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 18t metatarsal -2nd metatarsal intermetatarsal angle.
Prescription Use _ X_ 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
PAGE 1 of
Division of Ger estorative. and Neurological I
Mini TightRope FT Repair Kit 510(k)
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510(k) Number K671978