(118 days)
No
The device description and intended use focus on the physical properties and surgical applications of sutures, with no mention of AI or ML technologies. The performance studies are mechanical tests, not related to algorithmic performance.
Yes.
This device is intended to treat or alleviate a disease, injury, or condition by providing fixation and repair during the healing process following various injuries and surgeries, which aligns with the definition of a therapeutic device.
No
Explanation: The device is a non-absorbable cerclage suture intended for soft tissue approximation and ligation, and for fixation during the healing process following various injuries and surgical procedures. It is used as a surgical implant to provide mechanical support, not to diagnose a condition.
No
The device description clearly states the device is composed of physical materials (sutures made of UHMWPE, polyester, nylon, Bismuth Trioxide, and assembled on an ABS loader) and is intended for physical surgical procedures. There is no mention of software as a component or the primary function of the device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for soft tissue approximation, ligation, and bone fixation cerclage in various surgical procedures. This involves direct interaction with the patient's body during surgery.
- Device Description: The device is described as a braided suture made of specific materials, designed to be implanted or used within the body.
- Lack of IVD Characteristics: An In Vitro Diagnostic device is used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a patient's health. The description and intended use of this device do not involve any such testing of specimens.
Therefore, the Arthrex FiberTape and Tiger Tape Cerclage sutures and Arthrex Radiopaque FiberTape Cerclage sutures are surgical devices, not IVDs.
N/A
Intended Use / Indications for Use
Arthrex FiberTape and Tiger Tape Cerclage sutures and 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
Product codes
JDQ, GAT
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Not Found
Summary of Performance Studies
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). These predicate equivalences support the inclusion of the proposed indications for the subject Arthrex Radiopaque FiberTape Cerclage and Arthrex FiberTape & TigerTape Cerclage sutures.
Bacterial endotoxin per EP 2.6.14/USP was conducted to demonstrate that the devices meet pyrogen limit specifications.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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.
1
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
2
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 Boulevard | |
| Naples, FL 34108-1945 | |
| Contact Person | Name: Emmarie Halteman |
| Title: Senior Regulatory Affairs Specialist | |
| Phone: 1-239-643-5553 | |
| Email: emmarie.halteman@arthrex.com | |
| Trade Name | Arthrex FiberTape and TigerTape Cerclage sutures |
| Arthrex Radiopaque FiberTape Cerclage sutures | |
| Common Name | Bone Fixation Cerclage |
| Product Code | Primary: JDQ |
| Additional: GAT | |
| Classification Name | 21 CFR 888.3010: Bone Fixation Cerclage |
| 21 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 to |
| expand and align the indications for Arthrex Radiopaque FiberTape | |
| Cerclage Sutures and Arthrex FiberTape & TigerTape Cerclage | |
| Sutures. | |
| Device Description | 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. |
| Indications for Use | Arthrex FiberTape and Tiger Tape Cerclage sutures and 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 |
| Performance Data | 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). These predicate equivalences support the
inclusion of the proposed indications for the subject Arthrex
Radiopaque FiberTape Cerclage and Arthrex FiberTape & TigerTape
Cerclage sutures. |
| | Bacterial endotoxin per EP 2.6.14/USP was conducted to
demonstrate that the devices meet pyrogen limit specifications. |
| Technological Comparison | 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. |
| | The subject devices will include the addition of spinal applications
cleared via K181749, and acromioclavicular (AC) indication cleared
via K232755 to the indications for use.
Based on the intended use, fundamental scientific technology, and
the data provided in this Traditional 510(k), Arthrex has
determined that the subject Arthrex Radiopaque FiberTape
Cerclage and Arthrex FiberTape & TigerTape Cerclage sutures are
substantially equivalent to the predicate devices cleared under
Kinamed SuperCable Iso-Elastic Cerclage System (K181749) and
Arthrex FiberTape and TigerTape Cerclages Sutures (K232755). Any
differences between the subject and predicate devices are
considered minor and do not raise new or different questions
concerning safety and effectiveness. |
| Conclusion | The Arthrex Radiopaque FiberTape Cerclage and Arthrex FiberTape
& TigerTape Cerclage sutures are substantially equivalent to the
predicate devices in which the intended use and basic design
features are the same. Any differences between the subject
devices and the predicate devices are considered minor and do not
raise questions concerning safety or effectiveness. Based on the
indications for use, technological characteristics, and the summary
of data submitted, Arthrex Inc. has determined that the subject
devices are substantially equivalent to the currently marketed
predicate 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.
6
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.