Arthrex Radiopaque FiberTape Cerclage sutures

K230976 · Arthrex, Inc. · JDQ · Aug 24, 2023 · Orthopedic

Device Facts

• Record ID: K230976
• Device Name: Arthrex Radiopaque FiberTape Cerclage sutures
• Applicant: Arthrex, Inc.
• Product Code: JDQ · Orthopedic
• Decision Date: Aug 24, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Arthrex Radiopaque FiberTape sutures are intended for use in soft tissue approximation and or ligation. These sutures may be incorporated, as components, into surgeries where constructs including those with allograft or autograft tissues are used for repair. When used as bone fixation cerclage the sutures are intended for: · Trochanteric reattachment after trochanteric osteotomy following total hip arthroplasty) · Sternotomy indications including the "rewiring" of osteomized sternums · Trauma surgery indications including olecranon, ankle, patella and some shoulder fracture rewiring Treatment of anterior glenoid bone loss using the Latarjet or bone block procedure (allograft or autograft) · Repair of long bone fractures due to trauma or reconstruction

Device Story

Non-absorbable braided suture device; manufactured from UHMWPE polyblend incorporating Bismuth Trioxide (radiopaque agent) and polyester. Assembled on ABS loader with nitinol wire for knot passage. Used by surgeons in orthopedic/trauma procedures for bone fixation and soft tissue approximation. Provides mechanical stabilization of bone fragments or soft tissue constructs. Radiopacity allows visualization under imaging. Benefits include secure fixation and compatibility with existing surgical techniques.

Clinical Evidence

Bench testing only. Performance data includes tensile strength, cyclic displacement, and creep displacement testing demonstrating equivalence to predicate K143716. Bacterial Endotoxins Test (BET) performed per EP 2.6.14/USP <85> to confirm compliance with pyrogen limits.

Technological Characteristics

Non-absorbable braided suture; materials: UHMWPE, polyester, and Bismuth Trioxide (Bi2O3). Form factor: suture on ABS loader with nitinol wire. Sterilization: not specified. Connectivity: none.

Indications for Use

Indicated for soft tissue approximation, ligation, and bone fixation cerclage in patients requiring surgical repair of fractures (e.g., olecranon, ankle, patella, shoulder, long bone), trochanteric reattachment, sternotomy rewiring, or anterior glenoid bone loss treatment (Latarjet/bone block procedures).

Regulatory Classification

Identification

A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.

Predicate Devices

• Arthrex FiberTape and TigerTape Cerclage Sutures (K221485)
• DSM Biomedical DRP Cable (K143716)

Reference Devices

• Arthrex FiberTape Cerclage (K170206)
• Arthrex SutureTape (K193575)

Submission Summary (Full Text)

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August 24, 2023

Arthrex, Inc Stacy Valdez Senior Regulatory Affairs Specialist 1370 Creekside Boulevard Naples, Florida 34108-1945

Re: K230976

Trade/Device Name: Arthrex Radiopaque FiberTape Cerclage sutures Regulation Number: 21 CFR 888.3010 Regulation Name: Bone Fixation Cerclage Regulatory Class: Class II Product Code: JDQ, GAT Dated: July 24, 2023 Received: July 25, 2023

Dear Stacy Valdez:

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

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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 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 (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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Brent Showalter -S

Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal 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) K230976

#### Device Name

Arthrex Radiopaque FiberTape cerclage sutures

#### Indications for Use (Describe)

Arthrex Radiopaque FiberTape sutures are intended for use in soft tissue approximation and or ligation. These sutures may be incorporated, as components, into surgeries where constructs including those with allograft or autograff tissues are used for repair.

When used as bone fixation cerclage the sutures are intended for:

- · Trochanteric reattachment after trochanteric osteotomy following total hip arthroplasty)
- · Sternotomy indications including the "rewiring" of osteomized sternums
- · Trauma surgery indications including olecranon, ankle, patella and some shoulder fracture rewiring
- Treatment of anterior glenoid bone loss using the Latarjet or bone block procedure (allograft or autograft)
- · Repair of long bone fractures due to trauma or reconstruction

| 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 | 07/24/2023 |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter | Arthrex Inc.<br>1370 Creekside Boulevard<br>Naples, FL 34108-1945 |
| Contact Person | Stacy Valdez<br>Senior Regulatory Affairs Specialist<br>1-239-643-5553, ext. 72010<br>[e-mail] |
| Name of Device | Arthrex Radiopaque FiberTape Cerclage sutures |
| Common Name | Bone Fixation Cerclage |
| Product Code | JDQ (Primary), GAT |
| Classification Name | 21 CFR 888.3010: Bone Fixation Cerclage (Primary)<br>21 CFR 878.5000: Nonabsorbable Poly(ethylene) Terephthalate |
| Regulatory Class | II |
| Predicate Device | K221485: Arthrex FiberTape and TigerTape Cerclage Sutures |
| Additional Predicate Device | K143716: DSM Biomedical DRP Cable |
| Reference Device(s) | K170206: Arthrex FiberTape Cerclage<br>K193575: Arthrex SutureTape |
| Purpose of Submission | This Traditional 510(k) premarket notification is submitted to obtain<br>clearance for the Arthrex Radiopaque FiberTape Cerclage Sutures. |
| Device Description | The Arthrex Radiopaque FiberTape Cerclage sutures are non-absorbable<br>braided sutures assembled on an ABS loader. The Radiopaque FiberTape<br>Cerclage implant is hitched around the post of the ABS loader which<br>allows the nitinol wire to pass through the knot. The devices are<br>manufactured from a polyblend of Ultra High Molecular Weight<br>Polyethylene (UHMWPE) which incorporates Bismuth Trioxide (Bi2O3),<br>and polyester materials. |
| Indications for Use | Arthrex Radiopaque FiberTape cerclage sutures are intended for use in<br>soft tissue approximation and or ligation. These sutures may be<br>incorporated, as components, into surgeries where constructs including<br>those with allograft or autograft tissues are used for repair. |
| | When used as bone fixation cerclage the sutures are intended for:<br>• Trochanteric reattachment after trochanteric osteotomy following<br>total hip arthroplasty)<br>• Sternotomy indications including the “rewiring” of osteomized<br>sternums<br>• Trauma surgery indications including olecranon, ankle, patella and<br>some shoulder fracture rewiring<br>- Treatment of anterior glenoid bone loss using the Latarjet or bone<br>block procedure (allograft or autograft)<br>• Repair of long bone fractures due to trauma or reconstruction |
| Performance Data | The submitted testing data, tensile strength, cyclic displacement, and<br>creep displacement, demonstrates that the Arthrex Radiopaque<br>FiberTape Cerclage sutures are substantially equivalent to the additional<br>predicate device DSM Biomedical DRP Cable (K143716). |
| | Bacterial Endotoxins Test (BET) was performed on the Arthrex<br>Radiopaque FiberTape Cerclage Sutures per EP 2.6.14/USP <85> to |
| | |
| | demonstrate that the device meets pyrogen limit specifications. |
| Technological Comparison | Compared to the primary predicate device Arthrex FiberTape and<br>TigerTape Cerclage Sutures (K221485) and additional predicate device<br>DSM Biomedical DPR Cable (K143716), the proposed Arthrex<br>Radiopaque FiberTape Cerclage sutures have the same fundamental<br>scientific technology, design, packaging, sterility, shelf-life, and MRI<br>safety labeling. The proposed Arthrex Radiopaque FiberTape Cerclage<br>sutures contain UHMWPE which incorporates Bismuth Trioxide (Bi2O3);<br>whereas the primary predicate device Arthrex FiberTape and TigerTape<br>Cerclage sutures (K221485) do not contain Bismuth Trioxide (Bi2O3).<br>However, the Cerclage sutures cleared under additional predicate device<br>DSM Biomedical DPR Cable (K143716) contain UHMWPE which<br>incorporates Bismuth Trioxide (Bi2O3). |
| | Any differences between the proposed devices and the predicate<br>devices are considered minor and do not raise new or different<br>questions concerning safety or effectiveness. |
| Conclusion | The Arthrex Radiopaque FiberTape Cerclage sutures are substantially<br>equivalent to the predicate device in which the basic design features<br>and intended use are the same. Any differences between the proposed<br>device and the predicate device are considered minor and do not raise<br>questions concerning safety and effectiveness. Based on the indications<br>for use, technological characteristics, and the summary of data<br>submitted, Arthrex Inc. has determined that the proposed device is<br>substantially equivalent to the currently marketed predicate device. |

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