(57 days)
No
The device description and intended use focus on a mechanical suture anchor and its materials. There is no mention of AI, ML, image processing, or data analysis that would indicate the use of such technologies.
No.
The document describes the device as a suture anchor for orthopedic repairs, not as a device that delivers a therapeutic effect itself; it is a fixation device.
No
The device is a suture anchor intended for fixation of suture to bone during surgical repairs, not for diagnosing medical conditions.
No
The device description clearly states it is an 'all-suture' soft-tissue device constructed from polyester and UHWMPE, pre-loaded on a disposable inserter. This describes a physical, implantable medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "fixation of suture (soft tissue) to bone" in various anatomical locations. This is a surgical procedure performed in vivo (within the body), not a test performed in vitro (outside the body) on biological samples to diagnose or monitor a condition.
- Device Description: The description details a physical implantable device (suture anchor) and its components, not reagents, instruments, or software used for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no indication of providing diagnostic information about a patient's health status.
The device is a surgical implant used to facilitate tissue repair, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Arthrex FiberTak Suture Anchor is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip in the following procedures:
· Shoulder: Rotator cuff repair, Bankart repair, biceps tenodesis, acromio-clavicular separation repair, deltoid repair, capsular shift or capsulolabral reconstruction
· Foot/Ankle: Lateral stabilization, medial stabilization, achilles tendon repair, mid-foot reconstruction, hallux valgus reconstruction, metatarsal ligament repair, and digital tendon transfers
· Knee: Medial collateral ligament repair, lateral ligament repair, patellar tendon, posterior oblique ligament repair, iliotibial band tenodesis, and joint capsule closure, medial patellofemoral ligament repair/reconstruction, and anterolateral ligament repair/reconstruction
• Hand/Wrist: Scapholunate ligament reconstructions, repair/reconstructions, repair/reconstruction of collateral ligaments digital tendon transfers, and carpometacarpal joint arthroplasty (basal thumb joint arthroplasty)
· Elbow: Biceps tendon reattachment, ulnar/radial collateral ligament reconstruction, and lateral epicondy.itis repair
· Hip: Acetabular labral repair and gluteal tendon repair
Product codes (comma separated list FDA assigned to the subject device)
MBI
Device Description
The Arthrex FiberTak suture anchor is an 'all-suture' soft-tissue device intended to be used for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip.
The anchor is constructed from a hollow braid of polyester with a single loaded suture component composed of UHWMPE or a polyblend of UHMWPE and polyester.
The anchor is pre-loaded on a disposable inserter and will be sold sterile for single-use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, foot/ankle, knee, hand/wrist, elbow, and hip
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Mechanical testing demonstrated that the pull-out (tensile) strength of the proposed Arthrex FiberTak Suture Anchor met the criteria established by published literature for anterolateral ligament repair/reconstruction.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K231113: Arthrex FiberTak Suture Anchor
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K221364 MITEK TIGHT-N™ Tendon Docking Anchor
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
November 3, 2023
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Arthrex Inc. Kristi Frisch Regulatory Affairs Specialist, Principal 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K232742
Trade/Device Name: Arthrex FiberTak Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: September 6, 2023 Received: September 7, 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 (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.
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).
1
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 OS 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.
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-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 Digitally signed by
Jesse Muir Jesse Muir -S -5 Date: 2023.11.03 11:13:44 -04'00' 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
2
Enclosure
3
Indications for Use
510(k) Number (if known) K232742
Device Name Arthrex FiberTak Suture Anchor
Indications for Use (Describe)
The Arthrex FiberTak Suture Anchor is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip in the following procedures:
· Shoulder: Rotator cuff repair, Bankart repair, biceps tenodesis, acromio-clavicular separation repair, deltoid repair, capsular shift or capsulolabral reconstruction
· Foot/Ankle: Lateral stabilization, medial stabilization, achilles tendon repair, mid-foot reconstruction, hallux valgus reconstruction, metatarsal ligament repair, and digital tendon transfers
· Knee: Medial collateral ligament repair, lateral ligament repair, patellar tendon, posterior oblique ligament repair, iliotibial band tenodesis, and joint capsule closure, medial patellofemoral ligament repair/reconstruction, and anterolateral ligament repair/reconstruction
• Hand/Wrist: Scapholunate ligament reconstructions, repair/reconstructions, repair/reconstruction of collateral ligaments digital tendon transfers, and carpometacarpal joint arthroplasty (basal thumb joint arthroplasty)
· Elbow: Biceps tendon reattachment, ulnar/radial collateral ligament reconstruction, and lateral epicondy.itis repair
· Hip: Acetabular labral repair and gluteal tendon repair
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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4
510(k) Summary
| Date Prepared | September 6, 2023 |
|---|---|
| Submitter | Arthrex Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 | |
| Contact Person | Kristi Frisch |
| Regulatory Affairs Specialist, Principal | |
| Tel 239-598-4302 x73849 | |
| Kristi.Frisch@Arthrex.com | |
| Trade Name | Arthrex FiberTak Suture Anchor |
| Common Name | Suture Anchor |
| Product Code | MBI |
| Classification Name | 21 CFR 888.3040: Smooth or threaded metallic bone fastener |
| Regulatory Class | II |
| Primary Predicate Device | K231113: Arthrex FiberTak Suture Anchor |
| Reference Device(s) | K221364 MITEK TIGHT-N™ Tendon Docking Anchor |
| Purpose of Submission | This Special 510(k) premarket notification is submitted to expand |
| indications of the 2.6 mm FiberTak Suture Anchor to include | |
| Anterolateral Ligament Repair/Reconstruction. | |
| Device Description | The Arthrex FiberTak suture anchor is an 'all-suture' soft-tissue device |
| intended to be used for fixation of suture (soft tissue) to bone in the | |
| shoulder, foot/ankle, knee, hand/wrist, elbow, and hip. | |
| The anchor is constructed from a hollow braid of polyester with a single | |
| loaded suture component composed of UHWMPE or a polyblend of | |
| UHMWPE and polyester. | |
| The anchor is pre-loaded on a disposable inserter and will be sold sterile | |
| for single-use. | |
| Indications for Use | The Arthrex FiberTak Suture Anchor is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip in the following procedures: |
| Shoulder: Rotator cuff repair, Bankart repair, SLAP lesion repair, biceps tenodesis, acromio-clavicular separation repair, deltoid repair, capsular shift or capsulolabral reconstruction Foot/Ankle: Lateral stabilization, medial stabilization, achilles tendon repair, mid-foot reconstruction, hallux valgus reconstruction, metatarsal ligament repair, and digital tendon transfers Knee: Medial collateral ligament repair, lateral collateral ligament repair, patellar tendon, posterior oblique ligament repair, iliotibial band tenodesis, joint capsule closure, medial patellofemoral ligament repair/reconstruction, and anterolateral ligament repair/reconstruction Hand/Wrist: Scapholunate ligament reconstruction, carpal ligament reconstructions, repair/reconstruction of collateral ligaments digital tendon transfers, and carpometacarpal joint arthroplasty (basal thumb joint arthroplasty Elbow: Biceps tendon reattachment, ulnar/radial collateral ligament reconstruction, and lateral epicondylitis repair Hip: Acetabular Labral Repair and gluteal tendon repair |
5
| Performance Data | Mechanical testing demonstrated that the pull-out (tensile) strength of
the proposed Arthrex FiberTak Suture Anchor met the criteria
established by published literature for anterolateral ligament
repair/reconstruction. |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological Comparison | The proposed Arthrex Suture Anchor device and predicate device
(K231113) have the same scientific technology, packaging, sterility,
shelf-life, and MRI safety labeling. The proposed device modification
consists of the addition of the anterolateral ligament
repair/reconstruction indication. The reference device DePuy Synthes
Mitek Sports Medicine MITEK TIGHT-N Tendon Docking Anchor is
comparable in design, intended use and inclusion of the anterolateral
ligament repair/reconstruction indication.
The Arthrex FiberTak Suture Anchor is 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 device
are considered minor and do not raise questions concerning safety or
effectiveness. |
| Conclusion | The Arthrex FiberTak Suture Anchor is substantially equivalent to the
predicate devices cleared under K231113 in which the basic design
features and intended use are the same. Any differences between the
Arthrex FiberTak Suture Anchor and the predicate devices are
considered minor and do not raise different questions of safety or
effectiveness.
The submitted mechanical testing data demonstrates that the Arthrex
FiberTak Suture Anchor is substantially equivalent to that of the
predicate devices for the desired indication.
Based on the indications for use, technological characteristics, and the
summary of data submitted, Arthrex Inc. has determined that the
proposed device is substantially equivalent to the currently marketed |