(259 days)
Not Found
No
The device description and intended use are purely mechanical/material-based, and there is no mention of any software, algorithms, or data processing that would suggest the use of AI/ML. The performance studies focus on mechanical properties.
Yes
The device is described as "suture (soft tissue) fixation to bone" for repairing various injuries and conditions, which falls under the definition of a therapeutic device.
No
Explanation: The device is described as suture anchors intended for soft tissue fixation to bone for orthopedic repairs. It is a surgical implant, not a device used to diagnose a medical condition.
No
The device description explicitly states the anchors are composed of physical materials (PEEK, PLDLA/βTCP) and are preloaded on a driver, indicating a physical medical device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Description and Intended Use: The Arthrex SutureTak Suture Anchors are described as devices used for "suture (soft tissue) fixation to bone" in various anatomical locations. They are physical implants used within the body during surgical procedures.
The information provided clearly indicates that this device is a surgical implant used for mechanical fixation within the body, not for performing diagnostic tests on samples.
N/A
Intended Use / Indications for Use
The Arthrex SutureTak Suture Anchors are intended to be used for suture (soft tissue) fixation to bone in the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip.
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clabicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
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 Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, digital tendon transfers
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
Hip: Capsular repair, Acetabular Labral repair
Product codes
MAI, MBI
Device Description
The Arthrex SutureTak Suture Anchors share the same design features, materials, and intended use as the predicates. The anchors are composed of Polyetheretherketone (PEEK), or PLDLA/βTCP and are preloaded on a driver with nonabsorbable suture. The anchors range from 2.0mm – 3.0mm in diameter and 4.9mm – 14.5mm in length.
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
The submitted tensile testing, fatigue testing, and degradation testing data demonstrates that the performance of the proposed devices meets or exceeds the predicate device for the desired indications.
Key Metrics
Not Found
Predicate Device(s)
K112237, K110660, K091844, K061863
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads in profile, facing right. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 18, 2014
Arthrex. Incorporated Mr. David L. Rodgers Regulatory Affairs 1370 Creekside Boulevard Naples, Florida 34108
Re: K140855
Trade/Device Name: Arthrex SutureTak Suture Anchors Regulation Number: 21 CFR 888.3080 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: MAI, MBI Dated: November 17, 2014 Received: November 19, 2014
Dear Mr. Rodgers:
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
1
Page 2 - Mr. David L. Rodgers
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 Industry and Consumer Education at its toll-free 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Image /page/2/Picture/0 description: The image shows the Arthrex logo, which includes the company name and a graphic of scissors cutting a suture. Next to the logo, the text "TRADITIONAL 510(K): ARTHREX SUTURETAK SUTURE ANCHORS" is displayed. This text indicates that the product, Arthrex SutureTak Suture Anchors, has received traditional 510(k) clearance.
2.4 INDICATIONS FOR USE
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K140855
Device Name
Arthrex SutureTak Suture Anchors
Indications for Use (Describe)
The Arthrex SutureTak Suture Anchors are intended to be used for suture (soft tissue) fixation to bone in the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip.
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clabicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
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 Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, digital tendon transfers
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
Hip: Capsular repair, Acetabular Labral repair
Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)
□ Over-The-Counter Use (21 CFR 801 Subpart C)
Form Approved: OMB No. 0910-0120
Expiration Date: December 31, 2013
See PRA Statement on last page.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
PSC Publishing Services (301) 443-674
3
1.1510K SUMMARY OF SAFETY AND EFFECTIVENESS
| Date Summary Prepared | December 12, 2014 |
|---|---|
| Manufacturer/ | |
| Distributor/ | |
| Sponsor | Arthrex, Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 USA | |
| 510(k) Contact | David L Rogers |
| Regulatory Affairs | |
| Arthrex, Inc. | |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 USA | |
| Telephone: 239/643.5553, ext. 71924 | |
| Fax: 239/598.5508 | |
| Email: david.rogers@arthrex.com | |
| Trade Name | Arthrex SutureTak Suture Anchors |
| Common Name | Suture Anchor |
| Product Code, | MAI, MBI |
| Classification Name, CFR | 21 CFR 888.3030: Single/multiple component metallic bone fixation appliances |
| and accessories | |
| Predicate Device | K112237: Arthrex MicroSuture Anchors |
| K110660: Arthrex BioComposite SutureTak | |
| K091844: Arthrex Bio-Composite SutureTak Suture Anchors | |
| K061863: Arthrex Corkscrew, Corkscrew FT, Bio-Corkscrew, and Bio Corkscrew FT | |
| Suture Anchors | |
| Purpose of Submission | This traditional 510(k) premarket notification is submitted to obtain clearance for |
| the Arthrex SutureTak Suture Anchors for indications in the foot, ankle, knee, | |
| hand, wrist, elbow, shoulder, and hip. | |
| Device Description | The Arthrex SutureTak Suture Anchors share the same design features, materials, |
| and intended use as the predicates. The anchors are composed of | |
| Polyetheretherketone (PEEK), or PLDLA/βTCP and are preloaded on a driver with | |
| nonabsorbable suture. The anchors range from 2.0mm – 3.0mm in diameter and | |
| 4.9mm – 14.5mm in length. | |
| Intended Use | The Arthrex SutureTak suture anchors are intended to be used for suture (soft |
| tissue) fixation to bone in the foot, ankle, knee, hand, wrist, elbow, shoulder, and | |
| hip. |
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps
Tenodesis, Acromio-Clabicular Separation Repair, Deltoid Repair, Capsular Shift
or Capsulolabral Reconstruction
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
Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal 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
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament
Reconstruction
Hip: Capsular repair, Acetabular Labral repair |
| Substantial
Equivalence Summary | The Arthrex SutureTak Suture Anchors is substantially equivalent to the predicate
devices, in which the basic design features and intended uses are the same. Any
differences between the Arthrex SutureTak Suture Anchors and the predicates
are considered minor and do not raise questions concerning safety and
effectiveness. |
| The submitted tensile testing, fatigue testing, and degradation testing data
demonstrates that the performance of the proposed devices meets or exceeds the
predicate device for the desired indications. | |
| Based on the indication for use, technological characteristics, and the summary of
data submitted, Arthrex, Inc. has determined that the Arthrex SutureTak Suture
Anchors is substantially equivalent to currently marketed predicate devices. | |
4