(46 days)
No
The summary describes a mechanical fixation device and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is used for fixation of bone or soft tissue to bone and for distributing suture tension over areas of ligament or tendon repair in knee reconstruction, which are therapeutic medical procedures.
No
The device description and intended use clearly state that it is for "fixation of bone or soft tissue to bone" and for "repair and reconstruction" of various knee ligaments. These are therapeutic and surgical functions, not diagnostic ones.
No
The device description explicitly states the device is comprised of a suture loop and a metallic button, indicating it is a physical 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 examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states the Arthrex TightRope II devices are used for the fixation of bone or soft tissue to bone during surgical procedures like ACL/PCL repair and reconstruction. This is a surgical implant/device used within the body, not for testing samples outside the body.
- No Mention of Specimen Testing: The provided information does not mention any use of the device for analyzing biological specimens.
Therefore, based on the provided information, the Arthrex TightRope II is a surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Arthrex TightRope II devices are intended to be used for fixation of 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; and MCL, POL, LCL repair and reconstruction, IBT, and PRT for the adult population only.
Product codes
MBI
Device Description
The Arthrex 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone, soft tissue, ligament, tendon, knee (ACL/PCL, MCL, POL, LCL, IBT, PRT)
Indicated Patient Age Range
Adult and pediatric patient population (for ACL/PCL repair and reconstruction); adult population only (for MCL, POL, LCL repair and reconstruction, IBT, and PRT).
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)
Based on cyclic displacement and strength testing, the proposed Arthrex TightRope II device is equivalent to the predicate Zimmer-Biomet ToggleLoc™ device. This predicate equivalence supports the inclusion of the proposed indications for soft tissue repairs and reconstructions in the knee for the proposed Arthrex TightRope II devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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.
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August 8, 2023
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 the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" surrounding a graphic. To the right of the seal, there is a blue square with the letters "FDA" in white. Next to the blue square, the text "U.S. FOOD & DRUG ADMINISTRATION" is written in blue.
Arthrex Inc. Kristi Frisch Regulatory Affairs, Principal 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K231857
Trade/Device Name: Arthrex TightRope II Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: June 21, 2023 Received: June 23, 2023
Dear Kristi Frisch:
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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) 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 (OS) 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,
Jesse Muir -S
Jesse Muir, 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
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known)
Device Name Arthrex TightRope II
Indications for Use (Describe)
The Arthrex TightRope II devices are intended to be used for fixation of 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; and MCL, POL, LCL repair and reconstruction, IBT, and PRT for the adult population only.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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510(k) Summary
| Date Prepared | June 21, 2023 |
|---|---|
| Submitter | Arthrex Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 | |
| Contact Person | Name: Kristi Frisch |
| Title: Regulatory Affairs, Principal | |
| Phone: 1-239-598-4302, ext. 73849 | |
| Email: Kristi.Frisch@Arthrex.com | |
| Trade Name | Arthrex TightRope II |
| Common Name | Smooth or threaded metallic bone fixation fastener |
| Product Code | MBI- Fastener, Fixation, Nondegradable, Soft Tissue |
| Classification Name | 21 CFR 888.3040: Smooth or threaded metallic bone |
| fastener | |
| Regulatory Class | II |
| Primary Predicate Device | K130033 Zimmer Biomet ToggleLoc™ |
| Reference Devices | K221128 Arthrex® TightRope II |
| K202581 Arthrex® TightRope II | |
| Purpose of Submission | This Traditional 510(k) premarket notification is |
| submitted to expand the device indications to include | |
| (for the adult population only): |
- Medial Collateral Ligament (MCL) Repair and
Reconstruction; - Posterior Oblique Ligament (POL) Repair and
Reconstruction; - Lateral Collateral Ligament (LCL) Repair and
Reconstruction; - Iliotibial Band Tenodesis (IBT); and
- Patella Tendon Repair (PTR) for the Arthrex
TightRope II devices cleared under K202581 and
K221128 |
| Device Description | The Arthrex 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. |
| Indications for Use | The Arthrex 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; and MCL,
POL, LCL repair and reconstruction, IBT, and PRT for the
adult population only. |
| Performance Data | Based on cyclic displacement and strength testing, the
proposed Arthrex TightRope II device is equivalent to
the predicate Zimmer-Biomet ToggleLoc™ device. This
predicate equivalence supports the inclusion of the
proposed indications for soft tissue repairs and
reconstructions in the knee for the proposed Arthrex
TightRope II devices. |
| Technological Comparison | The proposed Arthrex TightRope II devices have similar
technological characteristics as the predicate devices.
The proposed device is comprised of multiple sutures
manufactured using the same materials as the
reference predicate. |
| Conclusion | Therefore, based on the intended use, fundamental
scientific technology, and the data provided in this
Special 510(k), Arthrex has determined that the
proposed Arthrex TightRope II devices in this
submission are substantially equivalent to the reference
predicate Arthrex TightRope II devices and the
performance of the Zimmer-Biomet ToggleLoc
predicate devices. |
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