(100 days)
Not Found
No
The device description and intended use are purely mechanical, and there is no mention of AI, ML, or any related concepts in the provided text.
No.
Explanation: The device is intended for fixation purposes, acting as a structural component for bone-to-bone or soft tissue-to-bone repairs, rather than directly treating a disease or condition itself.
No
The device description and intended use clearly state that the Arthrex PCL TightRope is a fixation device used for purposes like ACL/PCL repair and reconstruction. It is a physical implant used for structural support, not for identifying or assessing medical conditions.
No
The device description explicitly states it consists of a suture loop and titanium buttons, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for fixation of bone to bone or soft tissue to bone and for ligament or tendon repair and reconstruction. This is a surgical device used in vivo (within the body) during a procedure.
- Device Description: The description of the device (suture loop and titanium buttons) aligns with a surgical implant or fixation device, not a diagnostic test performed in vitro (outside the body) on biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely mechanical fixation and support within the body.
N/A
Intended Use / Indications for Use
The Arthrex PCL TightRope is intended to be used for fixation of bone to bone or soft tissue to bone, and is intended as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. For example, ACL/PCL repair and reconstruction.
Product codes
HTY, GAT
Device Description
The proposed PCL TightRope consists of an adjustable non-absorbable suture loop, and 2 titanium buttons.
The proposed devices consist of a titanium button and nonabsorbable suture which is substantially equivalent to the previously cleared Arthrex ACL TightRope.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 data demonstrated that the mechanical and biomechanical testing of the proposed devices is substantially equivalent to the ultimate load and cyclic displacement of the previously cleared Arthrex BioComposite Interference Screw.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
APR 2 8 2011
K110123
1 510(k) Summary of Safety and Effectiveness
| Date Summary Prepared | January 11, 2011 |
|---|---|
| Manufacturer/Distributor/Sponsor | Arthrex, Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 USA | |
| 510(k) Contact | Courtney Smith |
| Regulatory Affairs Project Manager | |
| Arthrex, Inc. | |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 USA | |
| Telephone: 239/643.5553, ext. 1720 | |
| Fax: 239/598.5508 | |
| Email: csmith@arthrex.com | |
| Trade Name | PCL TightRope |
| Common Name | Fastener, fixation, nondegradable, soft tissue |
| Suture, Nonabsorbable, synthetic, polyethylene | |
| Product Code -Classification | |
| Name | |
| CFR | HTY, GAT |
| 21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener | |
| 21 CFR 878.5000: Nonabsorbable poly(ethylene terephthalate) surgical suture. | |
| Predicate Device | K071176: Arthrex BioComposite Interference Screw |
| K100652: Arthrex ACL TightRope | |
| Purpose of Submission | This traditional 510(k) premarket notification is submitted to |
| obtain clearance for the PCL TightRope. | |
| Device Description and Intended | |
| Use | The proposed PCL TightRope consists of an adjustable non- |
| absorbable suture loop, and 2 titanium buttons. |
The Arthrex PCL TightRope is intended to be used for
fixation of bone to bone or soft tissue to bone, and is intended
as fixation posts, a distribution bridge, or for distributing
suture tension over areas of ligament or tendon repair. For
example, ACL/PCL repair and reconstruction. |
| Substantial Equivalence
Summary | The PCL TightRope is substantially equivalent to the
previously cleared Arthrex ACL TightRope, in which the basic
features and intended use are the same. It is substantially
equivalent to the performance characteristics of the previously
cleared Arthrex BioComposite Interference Screw, which is
cleared for the same indications. Any differences between the
PCL TightRope and the predicates are considered minor and
do not raise questions concerning safety and effectiveness |
Page 1 of
1
KII DIZ 3
The proposed devices consist of a titanium button and nonabsorbable suture which is substantially equivalent to the previously cleared Arthrex ACL TightRope. The submitted data demonstrated that the mechanical and biomechanical testing of the proposed devices is substantially equivalent to the ultimate load and cyclic displacement of the previously cleared Arthrex BioComposite Interference Screw. Based on the indication for use, technological characteristics, and the comparison with the predicate devices, Arthrex, Inc. has determined that the PCL TightRope is substantially equivalent to currently marketed predicate devices.
Page 2 of 2
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 depiction of an eagle or bird-like figure with three wing-like strokes, positioned above the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". The text is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Arthrex, Inc. % Ms. Courtney Smith Regulatory Affairs Associate 1370 Creekside Boulevard Naples, Florida 34108-1945
APR 2 8 2011
Re: K110123 Trade/Device Name: Arthrex PCL TightRope Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HTY, GAT Dated: March 30, 2011 Received: April 5, 2011
Dear Ms. Smith:
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. Insting 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. Courtney Smith
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.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/RcportaProblem/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,
Ay B. Rota
for
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
510(k) Number (if known): 《 | | ○ | 乙 3
Arthrex PCL TightRope Device Name:
Indications For Use:
The Arthrex PCL TightRope is intended to be used for fixation of bone to bone or soft tissue to bone, and is intended as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. For example, ACL/PCL repair and reconstruction.
AND/OR Over-The-Counter Use __________________________________________________________________________________________________________________________________________________ Prescription Use _V (21 CFR 801 Subpart C) (Per 21 CFR 801 Subpart D)
(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
for M. Mellersor
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
5:0(k) Number K1 0123