(118 days)
Arthrex FiberTape and Tiger Tape Cerclage sutures and Arthrex Radiopaque FiberTape Cerclage 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
- · Provide fixation during the healing process following syndesmotic trauma. such as fixation of acromioclavicular separation due to coracoclavicular ligament
- · Spinal applications including sublaminar and intrafacet wiring of the spinal column
The Arthrex Radiopaque FiberTape Cerclage sutures are non-absorbable braided sutures composed of Ultra High Molecular Weight Polyethylene (UHMWPE) which incorporates Bismuth Trioxide (Bi2O3), and Polyester yarns over a core of suture also made with Ultra High Molecular Weight Polyethylene (UHMWPE) with Bismuth Trioxide (Bi2O3), and Polyester. Dyes include D&C Blue No. 6. The UHMWPE is naturally yellow due to the addition of Bismuth Trioxide (Bi2O3). The sutures are assembled on an ABS loader. The sutures may also contain a FiberLink shuttling suture that is used for passing only.
The Arthrex FiberTape and TigerTape Cerclage Sutures are non-absorbable braided sutures composed of Ultra High Molecular Weight Polyethylene, polyester, and possibly nylon yarns over a core of FiberWire or TigerWire Suture (each made of UHMWPE and polyester). FiberTape differs from TigerTape in color and materials. FiberTape is blue/white suture consisting of UHMWPE and polyester. TigerTape suture is white/black consisting of UHMWPE, polyester, and nylon. Additional materials include cyanoacrylate at the suture ends which are cut off during the procedure. Dyes include D&C Blue No. 6 and Logwood Black. For the loop assembly the looped end of the suture is tied as a hitch over a sheath that secures a double loop or tied over the post of an ABS loader.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Arthrex FiberTape and TigerTape Cerclage Sutures and Arthrex Radiopaque FiberTape Cerclage Sutures:
Device: Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage Sutures
The provided document is a 510(k) Premarket Notification summary, indicating a submission to expand and align the indications for the Arthrex Radiopaque FiberTape Cerclage Sutures and Arthrex FiberTape & TigerTape Cerclage Sutures. The primary purpose of this submission is to demonstrate substantial equivalence to previously cleared predicate devices.
Based on the available text, the study presented focuses on demonstrating mechanical equivalence and biocompatibility, not clinical performance with human-in-the-loop for diagnostic accuracy. Therefore, several of the requested sections (e.g., MRMC studies, expert qualifications, adjudication methods, training set details) are not applicable or cannot be extracted from this document, as they pertain to AI/diagnostic device performance studies.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (What the device must achieve) | Reported Device Performance (How the device performed) |
|---|---|
| Mechanical Performance: Dynamic Tensile Fatigue Testing (5 million cycles in fluid) | "The submitted testing data, dynamic tensile fatigue testing in fluid for 5 million cycles, demonstrates that the Arthrex Radiopaque FiberTape Cerclage and Arthrex FiberTape & TigerTape Cerclage sutures are substantially equivalent to the primary predicate Kinamed SuperCable Iso-Elastic Cerclage System (K181749) and secondary predicate Arthrex FiberTape and TigerTape Cerclage sutures (K232755)." |
| Biocompatibility/Pyrogenicity: Meet pyrogen limit specifications | "Bacterial endotoxin per EP 2.6.14/USP <85> was conducted to demonstrate that the devices meet pyrogen limit specifications." |
| Equivalence to Predicates: Same intended use, materials, fundamental scientific technology, design, packaging, sterility, shelf-life, and MRI safety labeling. | "Compared to the secondary predicate Arthrex FiberTape and TigerTape Cerclage sutures (K232755), and reference device Arthrex Radiopaque FiberTape Cerclage sutures (K230976), the subject Arthrex Radiopaque FiberTape Cerclage and Arthrex FiberTape & TigerTape Cerclage sutures have the same intended use, materials, fundamental scientific technology, design, packaging, sterility, shelf-life, and MRI safety labeling." |
2. Sample Size Used for the Test Set and Data Provenance
The document describes mechanical testing and biocompatibility testing, not a clinical study on patient data.
- Mechanical Testing: The sample size for dynamic tensile fatigue testing is not explicitly stated in terms of the number of sutures tested, only the duration/cycles (5 million cycles). The provenance of the "test set" (i.e., the sutures themselves) would be from the manufacturer (Arthrex Inc.).
- Biocompatibility (Bacterial Endotoxin): The sample size for this testing is also not explicitly stated (e.g., how many units were tested), only the method.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is a surgical suture, not a diagnostic device requiring expert interpretation of results to establish ground truth from a test set. The validation relies on engineering and biological testing standards.
4. Adjudication Method for the Test Set
Not applicable. There is no "test set" in the context of diagnostic interpretation requiring adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a surgical suture, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a surgical suture, not an algorithm.
7. The Type of Ground Truth Used
- Mechanical Performance: The "ground truth" is defined by established engineering standards for suture performance (e.g., ability to withstand 5 million fatigue cycles) and substantial equivalence to predicate devices with a known safety and effectiveness profile. This is typically determined by physical measurements and adherence to pre-defined mechanical property specifications.
- Biocompatibility/Pyrogenicity: The ground truth is defined by established biological safety standards (e.g., EP 2.6.14/USP <85> pyrogen limits) to ensure the device does not cause adverse biological reactions.
8. The Sample Size for the Training Set
Not applicable. This device is a physical medical device, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. As above, no AI model or training set is applicable here.
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February 20, 2025
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Arthrex Inc. Emmarie Halteman Sr. Regulatory Affairs Specialist 1370 Creekside Boulevard Naples, Florida 34108
Re: K243344
Trade/Device Name: Arthrex FiberTape and TigerTape Cerclage Sutures; 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: January 17, 2025 Received: January 21, 2025
Dear Emmarie Halteman:
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 (the 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 available 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.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-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-regulatory
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assistance/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,
CHRISTOPHER EERREIRA -S
Christopher Ferreira, M.S. 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
Submission Number (if known)
Device Name
Arthrex FiberTape and TigerTape Cerclage Sutures;
Arthrex Radiopaque FiberTape Cerclage Sutures
Indications for Use (Describe)
Arthrex FiberTape and Tiger Tape Cerclage sutures and Arthrex Radiopaque FiberTape Cerclage 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
- · Provide fixation during the healing process following syndesmotic trauma. such as fixation of acromioclavicular separation due to coracoclavicular ligament
- · Spinal applications including sublaminar and intrafacet wiring of the spinal column
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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Image /page/4/Picture/0 description: The image shows the Arthrex logo. The logo consists of the word "Arthrex" in a bold, sans-serif font, followed by a stylized image of surgical scissors. The scissors are positioned to the right of the text, with the blades open.
510(k) Summary
| Date Prepared | February 20, 2025 |
|---|---|
| Submitter | Arthrex Inc.1370 Creekside BoulevardNaples, FL 34108-1945 |
| Contact Person | Name: Emmarie HaltemanTitle: Senior Regulatory Affairs SpecialistPhone: 1-239-643-5553Email: emmarie.halteman@arthrex.com |
| Trade Name | Arthrex FiberTape and TigerTape Cerclage suturesArthrex Radiopaque FiberTape Cerclage sutures |
| Common Name | Bone Fixation Cerclage |
| Product Code | Primary: JDQAdditional: GAT |
| Classification Name | 21 CFR 888.3010: Bone Fixation Cerclage21 CFR 878.5000: Nonabsorbable Poly(ethylene) Terephthalate |
| Regulatory Class | II |
| Primary Predicate Device | K181749: Kinamed SuperCable® Iso-Elastic™ Cerclage System |
| Additional Predicate Devices | K232755: Arthrex FiberTape and TigerTape Cerclage sutures |
| Reference Devices | K230976: Arthrex Radiopaque FiberTape Cerclage sutures |
| Purpose of Submission | This Traditional 510(k) premarket notification is submitted toexpand and align the indications for Arthrex Radiopaque FiberTapeCerclage Sutures and Arthrex FiberTape & TigerTape CerclageSutures. |
| Device Description | The Arthrex Radiopaque FiberTape Cerclage sutures are non-absorbable braided sutures composed of Ultra High MolecularWeight Polyethylene (UHMWPE) which incorporates BismuthTrioxide (Bi2O3), and Polyester yarns over a core of suture alsomade with Ultra High Molecular Weight Polyethylene (UHMWPE)with Bismuth Trioxide (Bi2O3), and Polyester. Dyes include D&CBlue No. 6. The UHMWPE is naturally yellow due to the addition ofBismuth Trioxide (Bi2O3). The sutures are assembled on an ABSloader. The sutures may also contain a FiberLink shuttling suturethat is used for passing only.The Arthrex FiberTape and TigerTape Cerclage Sutures are non-absorbable braided sutures composed of Ultra High MolecularWeight Polyethylene, polyester, and possibly nylon yarns over acore of FiberWire or TigerWire Suture (each made of UHMWPE andpolyester). FiberTape differs from TigerTape in color and materials.FiberTape is blue/white suture consisting of UHMWPE andpolyester. TigerTape suture is white/black consisting of UHMWPE,polyester, and nylon. Additional materials include cyanoacrylate atthe suture ends which are cut off during the procedure. Dyesinclude D&C Blue No. 6 and Logwood Black. For the loop assembly |
| the looped end of the suture is tied as a hitch over a sheath thatsecures a double loop or tied over the post of an ABS loader. | |
| Indications for Use | Arthrex FiberTape and Tiger Tape Cerclage sutures and RadiopaqueFiberTape Cerclage sutures are intended for use in soft tissueapproximation and or ligation. These sutures may be incorporated,as components, into surgeries where constructs including thosewith allograft or autograft tissues are used for repair. |
| When used as bone fixation cerclage the sutures are intended for:• Trochanteric reattachment after trochanteric osteotomyfollowing total hip arthroplasty)• Sternotomy indications including the “rewiring” of osteomizedsternums | |
| • Trauma surgery indications including olecranon, ankle, patellaand some shoulder fracture rewiring• Treatment of anterior glenoid bone loss using the Latarjet orbone block procedure (allograft or autograft)• Repair of long bone fractures due to trauma or reconstruction• Provide fixation during the healing process following syndesmotictrauma, such as fixation of acromioclavicular separation due tocoracoclavicular ligament• Spinal applications including sublaminar and intrafacet wiring ofthe spinal column | |
| Performance Data | The submitted testing data, dynamic tensile fatigue testing in fluidfor 5 million cycles, demonstrates that the Arthrex RadiopaqueFiberTape Cerclage and Arthrex FiberTape & TigerTape Cerclagesutures are substantially equivalent to the primary predicateKinamed SuperCable Iso-Elastic Cerclage System (K181749) andsecondary predicate Arthrex FiberTape and TigerTape Cerclagesutures (K232755). These predicate equivalences support theinclusion of the proposed indications for the subject ArthrexRadiopaque FiberTape Cerclage and Arthrex FiberTape & TigerTapeCerclage sutures. |
| Bacterial endotoxin per EP 2.6.14/USP <85> was conducted todemonstrate that the devices meet pyrogen limit specifications. | |
| Technological Comparison | Compared to the secondary predicate Arthrex FiberTape andTigerTape Cerclage sutures (K232755), and reference deviceArthrex Radiopaque FiberTape Cerclage sutures (K230976), thesubject Arthrex Radiopaque FiberTape Cerclage and ArthrexFiberTape & TigerTape Cerclage sutures have the same intendeduse, materials, fundamental scientific technology, design,packaging, sterility, shelf-life, and MRI safety labeling. |
| The subject devices will include the addition of spinal applicationscleared via K181749, and acromioclavicular (AC) indication clearedvia K232755 to the indications for use.Based on the intended use, fundamental scientific technology, andthe data provided in this Traditional 510(k), Arthrex hasdetermined that the subject Arthrex Radiopaque FiberTapeCerclage and Arthrex FiberTape & TigerTape Cerclage sutures aresubstantially equivalent to the predicate devices cleared underKinamed SuperCable Iso-Elastic Cerclage System (K181749) andArthrex FiberTape and TigerTape Cerclages Sutures (K232755). Anydifferences between the subject and predicate devices areconsidered minor and do not raise new or different questionsconcerning safety and effectiveness. | |
| Conclusion | The Arthrex Radiopaque FiberTape Cerclage and Arthrex FiberTape& TigerTape Cerclage sutures are substantially equivalent to thepredicate devices in which the intended use and basic designfeatures are the same. Any differences between the subjectdevices and the predicate devices are considered minor and do notraise questions concerning safety or effectiveness. Based on theindications for use, technological characteristics, and the summaryof data submitted, Arthrex Inc. has determined that the subjectdevices are substantially equivalent to the currently marketedpredicate devices. |
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Image /page/5/Picture/0 description: The image shows the logo for Arthrex. The logo consists of the word "Arthrex" in a sans-serif font, followed by a stylized image of a surgical instrument. The logo is simple and modern, and it is likely used to represent the company's brand.
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Image /page/6/Picture/0 description: The image shows the Arthrex logo. The logo consists of the word "Arthrex" in a sans-serif font, with a stylized image of a surgical instrument replacing the "x". The surgical instrument appears to be a type of clamp or forceps.
§ 888.3010 Bone fixation cerclage.
(a)
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.(b)
Classification. Class II.