(85 days)
The Arthrex TightRope™ Syndesmosis 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™ Syndesmosis Device is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of syndesmosis (syndesmosis disruptions) in connection with Weber B and C ankle fractures.
The TightRope™ Syndesmosis 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. A long straight needle with pull-through FiberWire suture is also looped through the leading button.
The provided text does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.
This document is a 510(k) Summary of Safety and Effectiveness for the Arthrex TightRope™ Syndesmosis Device, dated February 16, 2005. The primary purpose of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, rather than to establish specific performance acceptance criteria through a dedicated study.
Here's why and what information is present in the document:
- Substantial Equivalence: The document explicitly states that Arthrex determined the TightRope™ Syndesmosis Device is "substantially equivalent to the predicate devices where basic features and intended uses are the same." This means its safety and effectiveness are established by showing it is as safe and effective as a device already on the market, not by meeting predefined performance targets in a primary clinical study.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and a study as the provided text does not include this information.
The document does contain:
- Device Name: TightRope™ Syndesmosis Device
- Sponsor: Arthrex, Inc.
- Regulatory Information: Product codes, classifications, and identified predicate devices.
- Device Description: What the device is made of and how it works.
- Intended Use: The medical conditions and procedures for which the device is designed.
- FDA Clearance Letter: Confirmation of the 510(k) clearance based on substantial equivalence.
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K043248 pge f^{2}
Pages 11-12
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS TightRope™ Syndesmosis Device
FEB 1 6 2005
| NAME OF SPONSOR: | Arthrex, Inc.1370 Creekside BoulevardNaples, Florida 34108-1945 |
|---|---|
| 510(K) CONTACT: | Sally Foust, RACSr. Regulatory Affairs SpecialistTelephone: (239) 643-5553 extension 1251FAX: (239) 598-5539 |
| TRADE NAME: | TightRope™ Syndesmosis Device |
| COMMON NAME: | Button/Suture |
DEVICE PRODUCT CODE/CLASSIFICATION:
HWC: Single/multiple component metailic bone fixation appliances and accessories: 21 CFR 888.3030
MBI: Fastener, Fixation, Nondegradable, Soft Tissue Smooth or threaded metallic bone fixation fastener: 21 CFR 888.3040
GAT: Nonabsorbable poly (ethylene terephthalate) surgical suture: 21 CFR 878.5000
PREDICATE DEVICES
K033717: TranSet™ Fracture Fixation System (Bonutti) K963172: 4.0 / 4.5 mm Screw (Synthes) K003077: SmartScrew™. Bionx Implants, Ltd. (Linvatec) K030900, OTPS™ Biodegradable Fixation System (Inion Ltd.) K984550, EndoButton (Smith & Nephew) pre-1976, Kirschner (K) Wire (Synthes)
DEVICE DESCRIPTION AND INTENDED USE
The TightRope™ Syndesmosis 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. A long straight needle with pull-through FiberWire suture is also looped through the leading button.
The Arthrex TightRope™ Syndesmosis 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.
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page 2 of 2
Specifically, the Arthrex TightRope™ Syndesmosis Device is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of syndesmosis (syndesmosis disruptions) in connection with Weber B and C ankle fractures.
SUBSTANTIALLY EQUIVALENCE
Arthrex has determined that the TightRope™ Syndesmosis Device is substantially equivalent to the predicate devices where basic features and intended uses are the same. Any design differences between the Arthrex TightRope™ Syndesmosis Device when compared to predicate devices used in the standard medical practice for the treatment of syndesmosis 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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
FEB I & 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Sally Foust, RAC Sr. Regulatory Affairs Specialist Arthrex, Inc. 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K043248
Trade/Device Name: Arthrex TightRope™ Syndesmosis Devices Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HTN Dated: February 7, 2005 Received: February 8, 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.
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Page 2 - Mrs. Foust
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 may be obtained 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 addresshttp://www.fda.gov/cdrb/industry/support/index.html
Sincerely yours.
Sincerely yours,
Mark N. Wilkinson
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 10
510(k) Number (if known): ___________________________________________________________________________________________________________________________________________________
Device Name: Arthrex TightRope™ Syndesmosis Device
Indications for Use:
The Arthrex TightRope™ Syndesmosis 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™ Syndesmosis Device is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of syndesmosis (syndesmosis disruptions) in connection with Weber B and C ankle fractures.
| Prescription Use(Per 21 CFR 801 Subpart D) | Yes |
|---|---|
| AND/OR Over-The-Counter Use(21 CFR 801 Subpart C) | No |
(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 General, Restorative, and Neurological Devices
| 510(k) Number | K043248 |
|---|---|
| Page | 1 of 1 |
§ 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.