(170 days)
No
The device description and performance studies focus on mechanical properties and biocompatibility of surgical implants, with no mention of AI/ML algorithms or data processing.
No.
The device is described as a fixation device for bone-to-bone or soft tissue-to-bone, specifically for ACL/PCL repair and reconstruction, distributing suture tension. It does not perform any diagnostic or therapeutic action itself to treat a condition or disease directly, but rather provides mechanical support or fixation.
No.
The device is described as an implant used for fixation of bone to bone or soft tissue to bone, specifically for ACL/PCL repair and reconstruction. Its function is to provide mechanical support rather than to diagnose medical conditions.
No
The device description clearly states the device is comprised of physical components like suture loops, passing sutures, and a metallic button made of titanium. This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the fixation of bone to bone or soft tissue to bone, specifically for ACL/PCL repair and reconstruction. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is comprised of sutures and a metallic button, designed for physical fixation within the body.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze samples and provide diagnostic information. This device is used in vivo (inside the body) for surgical repair and reconstruction.
N/A
Intended Use / Indications for Use
The Arthrex ACL TightRope®, PCL TightRope®, and TightRope® II devices are intended to be used for fixation of bone to bone or soft tissue to bone, and are intended as fixation bridge, or for distributing suture tension over areas of ligament or tendon repair. Specifically, Arthrex will be offering these devices for ACL/PCL repair and reconstruction for the adult and pediatric patient population.
Product codes
MAI, MBI
Device Description
The Arthrex ACL TightRope®, PCL TightRope®, and TightRope® II devices are comprised of a suture loop that may include passing sutures and/or metallic button. The suture loop and passing sutures are braided nonabsorbable surgical sutures. The button is made of titanium with holes to permit suture passage and assembly with Arthrex sutures.
The proposed devices are available in various device models referred to as TightRope® ABS, Implant; TightRope®, PCL; ACL TightRope® RT; ACL TightRope® II RT; ACL TightRope® II RT, Double Loaded Passing Sutures; BTB TightRope® II; BTB TightRope® II, Double Loaded Passing Sutures; and TightRope® II ABS, Implant Open.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone, ligament, tendon
Indicated Patient Age Range
adult and pediatric patient population
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
Ultimate load testing and cyclic displacement was performed on the proposed devices and compared to the predicate device. The test results demonstrate that the proposed and predicate devices are equivalent.
Bacterial endotoxin per EP 2.6.14/USP was conducted to demonstrate that the device meets pyrogen limit specifications.
Clinical literature was provided on the subject devices involving the proposed patient population of pediatric patients. The reviewed literature shows the device is effective when used in the proposed patient population.
Real World Data/evidence is provided from the Surgical Outcomes System registry. Based on the patient outcomes, there are no statistical differences in patients less than 22 years of age versus patients greater than 22 years of age.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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October 5, 2022
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with an abstract design. To the right of the seal, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG" are written in blue, with the word "ADMINISTRATION" written in a smaller font size below.
Lai Saeteurn Regulatory Affairs Specialist II 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K221128
Trade/Device Name: Arthrex ACL TightRope®, PCL TightRope®, and TightRope® II Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: MAI, MBI Dated: April 14, 2022 Received: April 18, 2022
Dear Lai Saeteurn:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 and Part 809; medical device reporting of medical device-related adverse events) (21 CFR
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- for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For:
Laura C. Rose, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair, and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K221128
Device Name Arthrex ACL TightRope®, PCL TightRope®, and TightRope® II
Indications for Use (Describe)
The Arthrex ACL TightRope®, PCL TightRope®, and TightRope® II devices are intended to be used for fixation of bone to bone or soft tissue to bone, and are intended as fixation bridge, or for distributing suture tension over areas of ligament or tendon repair. Specifically, Arthrex will be offering these devices for ACL/PCL repair and reconstruction for the adult and pediatric patient population.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
| Date Prepared | October 5, 2022 |
|---|---|
| Submitter | Arthrex Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 | |
| Contact Person | Lai Saeteurn |
| Regulatory Affairs Specialist II | |
| 1-239-598-4302, ext. 71764 | |
| Lai.Saeteurn@Arthrex.com | |
| Name of Device | Arthrex ACL TightRope®, PCL TightRope®, and TightRope® II |
| Common Name | Smooth or threaded metallic bone fixation fastener |
| Product Code | MAI – Single/Multiple component metallic bone fixation appliances and accessories |
| MBI – Smooth or threaded metallic bone fixation fastener | |
| Classification Name | 21 CFR 888.3040: Smooth or threaded metallic bone fastener |
| 21 CFR 888.3030: Single/multiple component metallic bone fixation appliances and accessories | |
| Regulatory Class | II |
| Predicate Device | K202581: Arthrex TightRope II |
| K112990: ACL TightRope | |
| K110123: PCL TightRope | |
| Reference Device | K130217: Orthopediatrics ACL Reconstructive System |
| K201522: Arthrex Syndesmosis TightRope XP Buttress Plate Implant System | |
| Purpose of Submission | This Traditional 510(k) premarket notification is submitted to obtain pediatric indications for the Arthrex ACL TightRope®, PCL TightRope®, and TightRope® II devices cleared under K112990, K110123, and K202581. |
| Device Description | The Arthrex ACL TightRope®, PCL TightRope®, and TightRope® II devices are comprised of a suture loop that may include passing sutures and/or metallic button. The suture loop and passing sutures are braided nonabsorbable surgical sutures. The button is made of titanium with holes to permit suture passage and assembly with Arthrex sutures. |
The proposed devices are available in various device models referred to as TightRope® ABS, Implant; TightRope®, PCL; ACL TightRope® RT; ACL TightRope® II RT; ACL TightRope® II RT, Double Loaded Passing Sutures; BTB TightRope® II; BTB TightRope® II, Double Loaded Passing Sutures; and TightRope® II ABS, Implant Open. |
| Comparison Summary of Technological Characteristics and Modifications Proposed | The proposed devices have the same technological characteristics (device design, material, sterilization method, and biocompatibility profile). The proposed device modification is the addition of the pediatric patient population.
The Arthrex ACL TightRope®, PCL TightRope®, and TightRope® II devices are substantially equivalent to the predicate device in which the design features and intended uses are the same. Any differences between the proposed device and the predicate devices are considered minor and do not result in new or different questions concerning safety or effectiveness |
| Indications for Use | The Arthrex ACL TightRope®, PCL TightRope®, and TightRope® II devices are
intended 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 devices for ACL/PCL repair and reconstruction for the adult and
pediatric patient population. |
| Performance Data | Ultimate load testing and cyclic displacement was performed on the proposed
devices and compared to the predicate device. The test results demonstrate
that the proposed and predicate devices are equivalent.
Bacterial endotoxin per EP 2.6.14/USP was conducted to demonstrate
that the device meets pyrogen limit specifications. |
| Clinical Literature | Clinical literature was provided on the subject devices involving the proposed
patient population of pediatric patients. The reviewed literature shows the
device is effective when used in the proposed patient population. |
| Real World
Data/Evidence | Real World Data/evidence is provided from the Surgical Outcomes System
registry. Based on the patient outcomes, there are no statistical differences in
patients less than 22 years of age versus patients greater than 22 years of age. |
| Conclusion | The Arthrex ACL TightRope®, PCL TightRope®, and TightRope® II devices are
substantially equivalent to the predicate devices in which the basic design
features and intended use are the same. Any differences between the
proposed device and the predicate devices are considered minor and do not
result in new or different questions concerning safety or effectiveness. Based
on the indications for use, technological characteristics, and the summary of
data submitted, Arthrex has determined that the proposed devices are
substantially equivalent to the currently marketed predicate device. |
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