(22 days)
No
The device description and performance studies focus on the mechanical properties and equivalence to predicate devices, with no mention of AI or ML.
Yes.
The device is a medical implant (suture anchor) used for fixation of soft tissue to bone to repair injuries or reconstruct ligaments/tendons, which are therapeutic procedures.
No
The device is an orthopedic implant (suture anchor) used for fixation of soft tissue to bone, not for diagnosis.
No
The device description clearly states it is a physical 'all-suture' soft-tissue device constructed from polyester and UHWMPE, preloaded on a disposable inserter. It is a hardware medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The Arthrex FiberTak Suture Anchor is a physical device intended for surgical implantation to fix soft tissue to bone. It is used in vivo (within the living body) during surgical procedures.
- Lack of Diagnostic Function: The device does not perform any tests on biological samples to provide diagnostic information. Its function is purely mechanical and structural.
Therefore, the Arthrex FiberTak Suture Anchor falls under the category of a surgical implant or medical device used for fixation, not an in vitro diagnostic device.
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:
· Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
· Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
• Hand/Wrist: Scapholunate Ligament Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, digital tendon transfers, Carpal Ligament Reconstruction and Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty)
• Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction
• Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Joint Capsule Closure
· Hip: Capsular repair, Acetabular labral repair, Gluteal Tendon Repair.
Product codes
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 preloaded 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)
Cyclic pull-out testing was performed on the subject device and compared to the Arthrex FiberTak predicate device. Results demonstrate that the Arthrex FiberTak Anchor performs statistically equivalent to the predicate device. Results were compared to K133671: Stryker Iconix All Suture Anchor System and K171020: Arthrex SutureTak Suture Anchor to show suitability for the gluteal tendon repair and joint capsule closure (knee) indications, respectively.
Bacterial endotoxin per EP 2.6.14/USP was conducted on a representative device to demonstrate that the device meets pyrogen limit specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 27, 2020
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 the FDA logo, which consists of a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below that.
Arthrex Inc. Jessica L. Singelais Senior Regulatory Affairs Specialist 1370 Creekside Boulevard Naples. Florida 34108
Re: K203268
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: October 30, 2020 Received: November 5, 2020
Dear Ms. Singelais:
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).
Sincerely,
Laura C. Rose, 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
Enclosure
2
Special 510ßEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
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:
· Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
· Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
• Hand/Wrist: Scapholunate Ligament Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, digital tendon transfers, Carpal Ligament Reconstruction and Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty)
• Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction
• Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior
Oblique Ligament Repair, Iliotibial Band Tenodesis, Joint Capsule Closure · Hip: Capsular repair, Acetabular labral repair, Gluteal Tendon Repair.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 201 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 201 Subpart C) |
| > Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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3
510(k) Summary
| Date Prepared | November 19, 2020 |
|---|---|
| Submitter | Arthrex Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 | |
| Contact Person | Jessica L. Singelais |
| Senior Regulatory Affairs Specialist | |
| 1-239-598-4302, ext. 73091 | |
| Jessica.singelais@arthrex.com | |
| Name of Device | Arthrex FiberTak Suture Anchor |
| Common Name | Smooth or threaded metallic bone fixation fastener |
| Product Code | MBI |
| Classification Name | 21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener |
| Regulatory Class | II |
| Predicate Device | K200341: Arthrex Self-punching FiberTak Suture Anchor |
| K171020: Arthrex SutureTak Suture Anchor | |
| Reference Device(s) | K133671: Stryker ICONIX All Suture Anchor System |
| K143745: Arthrex Corkscrew and SwiveLock Suture Anchors | |
| K191226: Arthrex SwiveLock Suture Anchor | |
| Purpose of Submission | This Special 510(k) premarket notification is submitted to expand indications for the |
| Arthrex FiberTak Suture Anchor devices cleared under K200341 to include Gluteal | |
| Tendon Repair, Capsular Repair (Hip), and Joint Capsule Closure (Knee). | |
| 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 preloaded 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: | |
| Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction Hand/Wrist: Scapholunate Ligament Reconstruction, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, digital tendon transfers, Carpal Ligament Reconstruction and Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty) Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Joint Capsule Closure Hip: Capsular repair, Acetabular labral repair, Gluteal Tendon Repair. |
4
| Comparison
Summary of
Technological
Characteristics and
Modifications
Proposed | The proposed device is a line extension to the predicate device. The proposed and
predicate device (K200341) have the same basic design, intended use, packaging,
shelf life, biocompatibility profile and sterilization method. Proposed modifications
consist of a minor dimensional change to the self-bunching mechanism and the
addition of gluteal tendon and joint capsule closure (knee) indications. Any
differences between the proposed device and the predicate device are considered
minor and do not raise questions concerning safety or effectiveness. |
|-----------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance Data | Cyclic pull-out testing was performed on the subject device and compared to the
Arthrex FiberTak predicate device. Results demonstrate that the Arthrex FiberTak
Anchor performs statistically equivalent to the predicate device. Results were
compared to K133671: Stryker Iconix All Suture Anchor System and K171020: Arthrex
SutureTak Suture Anchor to show suitability for the gluteal tendon repair and joint
capsule closure (knee) indications, respectively.
Bacterial endotoxin per EP 2.6.14/USP was conducted on a representative
device to demonstrate that
the device meets pyrogen limit specifications. |
| Conclusion | The Arthrex FiberTak Suture Anchor is substantially equivalent to the predicate device
in which the basic design features and intended use are the same. Any differences
between the Arthrex proposed device and the predicate device are considered minor
and do not raised questions concerning safety and effectiveness. 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 predicate device. |