(55 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and fixation capabilities of a suture anchor, with no mention of AI or ML.
No
The device is a suture anchor used for fixation of soft tissue to bone during surgical repairs; it does not itself provide therapy.
No
The device is described as a suture anchor for fixation of soft tissue to bone, used in surgical repairs. It does not perform any diagnostic functions like measuring physiological parameters, imaging, or analyzing data to identify a disease or condition.
No
The device description clearly indicates it is a physical suture anchor made of polyester and UHWMPE, pre-loaded on a disposable inserter. It is a hardware device for surgical fixation.
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 Knee FiberTak® Button Suture Anchor is a surgical implant used to fix soft tissue to bone during various orthopedic procedures. It is a physical device implanted into the body, not a test performed on a sample outside the body.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, diagnostic testing, or any of the typical characteristics of an IVD.
Therefore, the Arthrex Knee FiberTak® Button Suture Anchor is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Arthrex Knee FiberTak® Button 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 ligament repair, patellar tendon, posterior oblique ligament repair, iliotibial band tenodesis, joint capsule closure, medial patellofemoral ligament repair/reconstruction, and quadriceps tendon repair
· 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, ulnarradial collateral ligament reconstruction, and lateral epicondylitis repar
· Hip: Acetabular Labral Repair and gluteal tendon repair
Product codes
MBI
Device Description
The Arthrex Knee FiberTak® Button 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, Hip
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Ultimate load testing and cyclic displacement was performed on the subject device to demonstrate that the differences do not negatively impact mechanical strength.
The submitted mechanical testing data demonstrates that the Arthrex Knee FiberTak® Button Suture Anchor is substantially equivalent to that of the predicate devices for the desired indication.
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.
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.
Not Found
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 15, 2023
Image /page/0/Picture/1 description: The image contains 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 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: K232973
Trade/Device Name: Arthrex Knee FiberTak® Button 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 19, 2023 Received: September 21, 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"
1
(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 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 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.
Sara S. Thompson -S
For
Jesse Muir, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices
2
Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K232973
Device Name
Arthrex Knee FiberTak® Button Suture Anchor
The Arthrex Knee FiberTak® Button 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 ligament repair, patellar tendon, posterior oblique ligament repair, iliotibial band tenodesis, joint capsule closure, medial patellofemoral ligament repair/reconstruction, and quadriceps tendon repair
· 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, ulnarradial collateral ligament reconstruction, and lateral epicondylitis repar
· 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 | November 14, 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 Knee FiberTak® Button 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 | K231330: Arthrex FiberTak® Suture Anchor |
| Additional Predicate Device | K180768 Arthrex BioComposite SwiveLock® |
| Purpose of Submission | This Traditional 510(k) premarket notification is submitted to expand |
| indications of the Arthrex Knee FiberTak® Button Suture Anchor to | |
| include quadriceps tendon repair. | |
| Device Description | The Arthrex Knee FiberTak® Button 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 Knee FiberTak® Button 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 quadriceps tendon repair 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 |
5
| Performance Data | Ultimate load testing and cyclic displacement was performed on the
subject device to demonstrate that the differences do not negatively
impact mechanical strength. |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological Comparison | The proposed Arthrex Knee FiberTak® Button Suture Anchor device and
predicate device (K231330) have the same scientific technology,
packaging, sterility, shelf-life, and MRI safety labeling. The proposed
device modification consists of the addition of the quadriceps tendon
repair indication. The additional predicate device Arthrex BioComposite
SwiveLock® is comparable in design, intended use and inclusion of the
quadriceps tendon repair indication.
The Arthrex Knee FiberTak® Button Suture Anchor is substantially
equivalent to the predicate device in which the design features and
intended uses are identical.
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 Knee FiberTak® Button Suture Anchor is substantially
equivalent to the predicate devices cleared under K231330 in which the
basic design features and intended use are identical. Any differences
between the Arthrex Knee FiberTak® Button 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
Knee FiberTak® Button 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
predicate devices. |