(29 days)
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, and Medial Patellofemoral 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
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
This document is a 510(k) Premarket Notification for the Arthrex FiberTak Suture Anchor. It primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device (K203268) to expand its indications for use to include Medial Patellofemoral Ligament Repair/Reconstruction.
Therefore, the "study" described is mechanical testing rather than a typical clinical study involving human readers or AI algorithms as would be the case for medical imaging devices.
Here's the information based on the provided document:
Acceptance Criteria and Device Performance for Arthrex FiberTak Suture Anchor
Type of Device: Suture Anchor (Class II Medical Device)
Purpose of Submission: Expansion of Indications for Use to include Medial Patellofemoral Ligament Repair/Reconstruction.
This submission relies on mechanical performance testing to demonstrate substantial equivalence for the expanded indication, rather than a clinical study involving human readers or AI performance.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (What was measured) | Reported Device Performance |
|---|---|
| Pull-out (Tensile) Strength for Medial Patellofemoral Ligament Repair/Reconstruction | "Mechanical testing demonstrated that the pull-out (tensile) strength of the proposed Arthrex FiberTak Suture Anchor met the criteria established by published literature for Medial Patellofemoral Ligament Repair/Reconstruction." (Specific numerical values for acceptance criteria or performance are not provided in this summary, but the statement confirms that the device met the pre-defined standards derived from literature for this specific application.) |
2. Sample Size and Data Provenance
- Sample Size for Test Set: Not explicitly stated as a number of "cases" or "patients" in this summary. The "test set" here refers to the samples used in the mechanical testing. The standard practice for such testing involves a sufficient number of devices/constructs to achieve statistical significance.
- Data Provenance: The study is reported as "Mechanical testing", implying it was conducted as laboratory-based testing. Country of origin and retrospective/prospective nature are not applicable in the typical sense for this type of testing (it's not patient data).
3. Number of Experts and Qualifications for Ground Truth
- Not Applicable (N/A): This submission pertains to a physical medical device (suture anchor) and its mechanical properties, not a diagnostic or AI-driven imaging device that would require expert-established ground truth from clinical data. The "acceptance criteria" here are based on established engineering and biomechanical literature for sufficient tensile strength in the context of ligament repair.
4. Adjudication Method for the Test Set
- N/A: As this is mechanical testing, there is no adjudication process involving multiple human reviewers. The results are quantitative measurements of physical properties.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No: An MRMC comparative effectiveness study was not performed as this is not an imaging or diagnostic device. The study is focused on the mechanical performance of the suture anchor.
6. Standalone Performance (Algorithm Only)
- N/A: This is not an algorithm or AI device.
7. Type of Ground Truth Used
- Literature-established Mechanical/Biomechanical Criteria: The "ground truth" for success in this context is the fulfillment of established criteria for pull-out (tensile) strength, derived from published literature relevant to Medial Patellofemoral Ligament Repair/Reconstruction.
8. Sample Size for Training Set
- N/A: No "training set" is applicable as this is not a machine learning model.
9. How Ground Truth for Training Set was Established
- N/A: No "training set" is applicable.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and 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. Kristi Frisch Regulatory Affairs Specialist, Principal 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K231113
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: April 17, 2023 Received: April 19, 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
{1}------------------------------------------------
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerelv.
Yu-chieh Chiu -S
Digitally signed by Yuchieh Chiu -S Date: 2023.05.17 20:21:18 -04'00'
Yu-Chieh Chiu, Ph.D. Acting 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
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K231113
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, and Medial Patellofemoral Ligament Repair/Reconstruction
• Hand/Wrist: Scapholunate ligament reconstruction, carpal ligament reconstruction of collateral ligaments digital tendon transfers, and carpometacarpal joint arthroplasty (basal thumb joint arthroplasty)
· Elbow: Biceps tendon reattachment, ulnarradial collateral ligament reconstruction, and lateral epicondy.itis repar
· Hip: 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
510(k) Summary
| Date Prepared | May 18, 2023 |
|---|---|
| Submitter | Arthrex Inc.1370 Creekside BoulevardNaples, FL 34108-1945 |
| Contact Person | Kristi FrischRegulatory Affairs Specialist, PrincipalTel 239-598-4302 x73849Kristi.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 | K203268: Arthrex FiberTak Suture Anchor |
| Reference Device(s) | K201749: Arthrex SwiveLok Suture Anchor |
| Purpose of Submission | This Special 510(k) premarket notification is submitted to expandindications of the 2.6 mm FiberTak Suture Anchor to include MedialPatellofemoral Ligament Repair/Reconstruction. |
| Device Description | The Arthrex FiberTak suture anchor is an 'all-suture' soft-tissue deviceintended to be used for fixation of suture (soft tissue) to bone in theshoulder, foot/ankle, knee, hand/wrist, elbow, and hip.The anchor is constructed from a hollow braid of polyester with a singleloaded suture component composed of UHWMPE or a polyblend ofUHMWPE and polyester.The anchor is pre-loaded on a disposable inserter and will be sold sterilefor 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, deltoidrepair, capsular shift or capsulolabral reconstruction Foot/Ankle: Lateral stabilization, medial stabilization, achillestendon repair, mid-foot reconstruction, hallux valgusreconstruction, metatarsal ligament repair, and digital tendontransfers Knee: Medial collateral ligament repair, lateral collateral ligamentrepair, patellar tendon, posterior oblique ligament repair, iliotibialband tenodesis, joint capsule closure, and Medial PatellofemoralLigament Repair/Reconstruction Hand/Wrist: Scapholunate ligament reconstruction, carpal ligamentreconstructions, repair/reconstruction of collateral ligamentsdigital tendon transfers, and carpometacarpal joint arthroplasty(basal thumb joint arthroplasty Elbow: Biceps tendon reattachment, ulnar/radial collateralligament reconstruction, and lateral epicondylitis repair |
{4}------------------------------------------------
| Performance Data | Mechanical testing demonstrated that the pull-out (tensile) strength ofthe proposed Arthrex FiberTak Suture Anchor met the criteriaestablished by published literature for Medial Patellofemoral LigamentRepair/Reconstruction. |
|---|---|
| Technological Comparison | The proposed Arthrex Suture Anchor device and predicate device(K203268) have the same technological characteristics (device design,sterilization and biocompatibility). The proposed device modificationconsists of the addition of the Medial Patellofemoral LigamentRepair/Reconstruction indication.The Arthrex FiberTak Suture Anchor is substantially equivalent to thepredicate device in which the design features and intended uses are thesame.Any differences between the proposed device and the predicate deviceare considered minor and do not raise questions concerning safety oreffectiveness. |
| Conclusion | The Arthrex FiberTak Suture Anchor is substantially equivalent to thepredicate devices cleared under K203268 in which the basic designfeatures and intended use are the same. Any differences between theArthrex FiberTak Suture Anchor and the predicate devices areconsidered minor and do not raise different questions of safety oreffectiveness. |
| Conclusion | The submitted mechanical testing data demonstrates that the ArthrexFiberTak Suture Anchor is substantially equivalent to that of thepredicate devices for the desired indication. |
| Conclusion | Based on the indications for use, technological characteristics, and thesummary of data submitted, Arthrex Inc. has determined that theproposed device is substantially equivalent to the currently marketedpredicate devices. |
§ 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.