(70 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 any software-driven analysis or decision-making.
No.
A therapeutic device is one that treats a disease or condition. This device is used to fix sutures or tissue in various anatomical locations following an injury or surgical procedure, which is a supportive rather than a therapeutic function.
No
The device is a suture anchor intended for tissue fixation during surgical repairs, not for diagnosing medical conditions.
No
The device description clearly indicates it is a physical suture anchor made of polyester and UHMWPE suture, preloaded on a disposable inserter. This is a hardware 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 describes the device as being used for "suture or tissue fixation" in various anatomical locations (foot, ankle, knee, etc.). This is a surgical procedure performed directly on the patient's body.
- Device Description: The description details a physical implantable device ("all-suture" soft-tissue fixation device) made of polyester and UHMWPE suture. This is a medical device used for mechanical support and fixation within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) in vitro (outside the body) to provide information about a patient's health status, diagnosis, or treatment.
IVD devices are used to perform tests on samples taken from the body, while this device is implanted within the body to provide structural support.
N/A
Intended Use / Indications for Use
The Arthrex Knotless FiberTak Suture Anchor is intended for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip. Specific indications are listed below:
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstructions; Repair/Reconstruction of collateral ligaments; Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, Digital Tendon Transfers
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
Hip: Acetabular Labral repair
Product codes
MBI
Device Description
The Arthrex Knotless FiberTak Suture Anchor is an "all-suture" soft-tissue fixation device with an expandable push-in design. It is constructed from a hollow braid of polyester. An UHMWPE suture construct is assembled through the hollow braid coupled with a nitinol passing wire. The device comes preloaded on a disposable inserter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
foot, ankle, knee, hand, wrist, elbow, shoulder, 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)
The submitted mechanical testing data demonstrates that the tensile strength (pull-out) of the proposed devices are substantially equivalent to the predicates for the desired indications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K120155: Arthrex Knotless SutureTak, K041553: Arthrex FiberWire, K110145 Biomet JuggerKnotTM Soft Anchors
Reference Device(s)
Not Found
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
・
MAY 3 2013
Administes 510(K): ARTHREX KNOTLESS FIBERTAK SUTURE ANCHOR
2 510(k) Summary of Safety and Effectiveness
| Date Summary Prepared | February 15, 2013 |
|---|---|
| Manufacturer/Distributor/Sponsor | Arthrex, Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 USA | |
| 510(k) Contact | Christina Flores |
| Regulatory Affairs Specialist | |
| Arthrex, Inc. | |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 USA | |
| Telephone: 239-643-5553, ext. 1819 | |
| Fax: 239-569-5508 | |
| Email: Christina.flores@arthrex.com | |
| Trade Name | Knotless FiberTak Suture Anchor |
| Common Name | Soft Tissue Fixation Device |
| Product Code | MBI |
| Classification Name | Fastener, fixation, nondegradable, soft-tissue |
| CFR | 21 CFR 888.3040 |
| Predicate Device | K120155: Arthrex Knotless SutureTak |
| K041553: Arthrex FiberWire | |
| K110145 Biomet JuggerKnotTM Soft Anchors | |
| Purpose of Submission | This traditional 510(k) premarket notification is submitted to |
| obtain clearance for the Arthrex Knotless FiberTak Suture | |
| Anchor, to expand the Arthrex SutureTak family of anchors. | |
| Device Description and Intended | |
| Use | The Arthrex Knotless FiberTak Suture Anchor is an "all- |
| suture" soft-tissue fixation device with an expandable push-in | |
| design. It is constructed from a hollow braid of polyester. An | |
| UHMWPE suture construct is assembled through the hollow | |
| braid coupled with a nitinol passing wire. The device comes | |
| preloaded on a disposable inserter. |
The Arthrex Knotless FiberTak is intended for fixation in the
foot, ankle, knee, hand, wrist, elbow, shoulder, and hip.
Specific indications are listed below:
Elbow: Biceps Tendon Reattachment, Ulnar or Radial
Collateral Ligament Reconstruction
Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP
Lesion Repair, Biceps Tenodesis, Acromio-Clavicular |
1
:
.
Arthrex 510(K): ARTHREX KNOTLESS FIBERTAK SUTURE ANCHOR
:
| Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction | |
|---|---|
| Hand/Wrist : | Scapholunate Ligament Reconstruction, Carpal Ligament Reconstructions, Repair/Reconstruction of collateral ligaments; Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, Digital Tendon Transfers |
| 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 |
| Hip : | Acetabular Labral repair |
| Substantial Equivalence Summary | The Arthrex Knotless FiberTak Suture Anchor is substantially equivalent to the predicate devices, in which the basic design features and intended uses are the same. Any differences between the Arthrex Knotless FiberTak and the predicates are considered minor and do not raise questions concerning safety and effectiveness. |
| The proposed devices are comprised of polyester and UHMWPE. These materials are substantially equivalent to the materials found in the predicate devices. | |
| The submitted mechanical testing data demonstrates that the tensile strength (pull-out) of the proposed devices are substantially equivalent to the predicates for the desired indications. | |
| Based on the indication for use, technological characteristics, and the summary of data submitted, Arthrex, Inc. has determined that the Knotless FiberTak Suture Anchor is substantially equivalent to currently marketed predicate devices. |
.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 3, 2013
Arthrex, Incorporated % Ms. Christina Flores Regulatory Affairs Specialist 1370 Creekside Boulevard Naples, Florida 34108
Re: K130458
Trade/Device Name: Arthrex Knotless FiberTak Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Fastener, fixation, nondegradable, soft tissue Regulatory Class: Class II Product Code: MBI Dated: April 22, 2013 Received: April 24, 2013
Dear Ms. Flores:
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. 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 801): medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Ms. Christina Flores
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.goy/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Erin.D.Keith
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Form 1
Indications for Use
K130458 510(k) Number (if known):
Arthrex Knotless FiberTak Suture Anchor Device Name:
Indications For Use:
The Arthrex Knotless FiberTak Suture Anchor is intended for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip. Specific indications are listed below:
| Elbow: | Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament
Reconstruction |
|-------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Shoulder: | Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis,
Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or
Capsulolabral Reconstruction |
| Hand/Wrist: | Scapholunate Ligament Reconstruction, Carpal Ligament Reconstructions,
Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor
Tendons at the PIP, DIP, and MCP joints for all digits, Digital Tendon Transfers |
| 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 |
| Hip: | Acetabular Labral repair |
Prescription Use V AND/OR Over-The-Counter Use (Per 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
PAGE I of I
Image /page/4/Picture/12 description: The image contains the text "Casey L-Hanley, Ph.D Division of Orthopedic Devices". The text is arranged in a way that suggests it might be a title or heading, possibly related to a document or report. The presence of "Ph.D" indicates an academic or professional context.