(74 days)
Not Found
No
The device description and intended use focus on mechanical fixation components (suture loops, buttons, wedge) for ligament repair. There is no mention of AI/ML terms, image processing, or data-driven performance metrics.
No
The device is intended for fixation of bone to bone or soft tissue to bone, specifically for ACL/PCL repair and reconstruction, acting as fixation posts, a distribution bridge, or for distributing suture tension, which are structural support and mechanical functions rather than therapeutic interventions.
No
The device is described as being used for fixation of bone to bone or soft tissue to bone, specifically for ACL/PCL repair and reconstruction. This is a therapeutic or reconstructive function, not a diagnostic one.
No
The device description explicitly states it consists of physical components like suture loops, titanium buttons, and a PEEK Femoral Wedge, indicating it is a hardware 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 examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The description clearly states the device is 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." This is a surgical implant used directly within the body.
- Intended Use: The intended use is for "ACL/PCL repair and reconstruction," which is a surgical procedure.
- Lack of IVD Characteristics: The description does not mention analyzing biological samples, providing diagnostic information based on those samples, or any of the typical components or processes associated with IVDs (reagents, analyzers, etc.).
The device described is a surgical implant used for musculoskeletal repair, not a diagnostic tool that analyzes samples outside the body.
N/A
Intended Use / Indications for Use
The ACL TightRope and ACL TightRope Double Bundle are to be used for fixation of bone to bone or soft tissue to bone, and are intended as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. Specifically, Arthrex will be offering these for ACL/PCL repair and reconstruction.
Product codes
HTY, GAT
Device Description
The ACL TightRope consists of an adjustable nonabsorbable suture loop and titanium button. The ACL TightRope Double Bundle consists of nonabsorbable suture loops, titanium button, and a PEEK Femoral Wedge. The ACL TightRope and ACL TightRope Double Bundle is 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. Specifically, Arthrex will be offering this for Anterior Cruciate Ligament (ACL) and Posterior Cruciate Ligament (PCL) Repair and Reconstruction.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Anterior Cruciate Ligament (ACL) and Posterior Cruciate Ligament (PCL)
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
Bench testing was conducted to determine the tensile load to failure strength of the ACL TightRope devices.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing was conducted to determine the tensile load to failure strength of the ACL TightRope devices. Based on the information submitted, Arthrex, Inc. has determined that the ACL TightRope and ACL TightRope Double Bundle with expanded indications are substantially equivalent to the currently marketed predicate devices.
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
K112990 (pg. 1 of 2)
Arthrex S TRADITIONAL 510(k): Arthrex ACL TightRope Devices, expand indications to include POL
510(k) Summary of Safety and Effectiveness
| Date Summary Prepared | October 4, 2011 |
|---|---|
| Manufacturer/Distributor/Sponsor | Arthrex, Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 USA | |
| 510(k) Contact | Christina Flores |
| Regulatory Affairs Specialist | |
| Arthrex, Inc. | |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 USA | |
| Telephone: 239/643.5553, ext. 1819 | |
| Fax: 239/598.5508 | |
| Email: Christina.flores@arthrex.com | |
| Trade Name | ACL TightRope; ACL TightRope Double Bundle |
| Common Name | Pin, fixation, smooth |
| Suture, Nonabsorbable, synthetic, polyethylene | |
| Product Code -Classification | |
| Name | |
| CFR | 21 CFR 888.3040: Smooth or threaded metallic bone |
| fixation fastener | |
| HTY - Smooth or threaded metallic bone fixation | |
| fastener | |
| 21 CFR 878.5000: Nonabsorbable poly(ethylene | |
| terephthalate) surgical suture | |
| GAT - Nonabsorbable poly(ethylene terephthalate) | |
| surgical suture | |
| Predicate Device | K100652Arthrex ACL TightRope |
| K101837Arthrex ACL TightRope Double Bundle | |
| K110123Arthrex PCL TightRope | |
| Purpose of Submission | This traditional 510(k) premarket notification is |
| submitted to obtain clearance for the addition of the | |
| PCL indication to the ACL TightRope and the ACL | |
| TightRope Double Bundle. | |
| Device Description and Intended | |
| Use | The ACL TightRope consists of an adjustable |
| nonabsorbable suture loop and titanium button. | |
| The | |
| ACL TightRope Double Bundle consists of | |
| nonabsorbable suture loops, titanium button, and a | |
| PEEK Femoral Wedge. The ACL TightRope and | |
| ACL TightRope Double Bundle is 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. Specifically, Arthrex will be offering |
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K112990 (pg. 2 of 2)
this for Anterior Cruciate Ligament (ACL) and Posterior Cruciate Ligament (PCL) Repair and Reconstruction. ---------Substantial Equivalence The ACL TightRope and ACL TightRope Double Summary Bundle with expanded indications are substantially equivalent to the existing ACL TightRope and ACL TightRope Double Bundle as no changes have been made to the devices. The ACL TightRope and ACL TightRope Double Bundle with expanded indications are substantially equivalent to the PCL TightRope device in which the basic design features and intended uses are very similar. Any design differences between the subject devices (ACL TightRope and ACL TightRope Double Bundle with expanded indications) to the PCL TightRope are considered minor and do not raise questions concerning safety and effectiveness. Bench testing was conducted to determine the tensile load to failure strength of the ACL TightRope devices. Based on the information submitted, Arthrex, Inc. has determined that the ACL TightRope and ACL TightRope Double Bundle with expanded indications are substantially equivalent to the currently marketed predicate devices.
Arthrex. 6 TRADITIONAL 510(k): Arthrex ACL TightRope Devices, expand indications to include PCL
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 eagle or bird symbol with three wing-like shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002
Arthrex, Incorporated % Ms. Christina Flores Regulatory Affairs Specialist 1370 Creekside Boulevard Naples, Florida 34108
DEC 1 9 2011
Re: K112990
Trade/Device Name: ACL TightRope and ACL Tightrope Double Bundle Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HTY, GAT Dated: October 4, 2011 Received: October 6, 2011
Dear Ms. Flores:
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.
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Page 2 - Ms. Christina Flores
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/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
For Ploth
KEI L.U.M
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Arthreat B TRADITIONAL 510(k): Arthrex ACL TightRope Devices, expand indications to include PCL
2 Indications for Use Form
| 510(k) Number: | K112990 |
|---|---|
| Device Name: | ACL TightRope and ACL Tightrope Double Bundle |
The ACL TightRope and ACL TightRope Double Bundle are to be used for fixation of bone to bone or soft tissue to bone, and are intended as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. Specifically, Arthrex will be offering these for ACL/PCL repair and reconstruction.
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 (ODE)
l of l
Muhel Idsm
fur
(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K112990
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