(183 days)
Not Found
No
The device description and intended use clearly define the device as suture anchors for soft tissue to bone fixation, with no mention of any computational or analytical capabilities that would involve AI or ML. The performance studies focus on mechanical properties.
Yes
The device is used for fixation of soft tissue to bone in various repair and reconstruction procedures across multiple joints, which directly addresses medical conditions and aims to improve patient health outcomes.
No
The device, Arthrex Corkscrew and SwiveLock Suture Anchors, is described as being used for "fixation of suture (soft tissue) to bone" in surgical procedures, indicating a therapeutic or reconstructive function rather than a diagnostic one. The descriptions of "Intended Use / Indications for Use" and "Device Description" strictly outline its use as an implantable medical device for repair, not for identifying or assessing medical conditions.
No
The device description clearly states that the devices are "cannulated anchors manufactured from polyetheretherketone (PEEK) or Titanium" and are "pre-loaded on a handled inserter." These are physical hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description and Intended Use: The description and intended use clearly state that these are suture anchors used for fixing soft tissue to bone within the body during surgical procedures. They are implants used for mechanical support and repair.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, performing tests on specimens, or providing diagnostic information based on laboratory analysis.
Therefore, the Arthrex Corkscrew and SwiveLock suture anchors are surgical implants, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The Arthrex Corkscrew suture anchors are intended to be used for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, hip, knee, hand/wrist, and elbow 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, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair and Bunionectomy. Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, and Illiotibial Band Tenodesis. Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction. Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis repair. Hip: Capsular repair, acetabular labral repair, gluteus medius repair.
The Arthrex SwiveLock anchors are 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, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair and Bunionectomy. Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, and Illiotibial Band Tenodesis. Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction. Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis repair. Hip: Capsular repair, acetabular labral repair, gluteus medius repair.
Product codes (comma separated list FDA assigned to the subject device)
MBI
Device Description
The Arthrex Corkscrew and SwiveLock Suture Anchors consist of cannulated anchors manufactured from polyetheretherketone (PEEK) or Titanium with an integral or separate eyelet. They are pre-loaded on a handled inserter. Suture, with or without needles, and a suture threader may also be provided.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulder, foot/ankle, hip, knee, hand/wrist, elbow
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 insertion testing, static pull-out testing, fatigue testing, and suture abrasion testing data demonstrates that the proposed devices are substantially equivalent to the predicates.
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 2, 2015
Arthrex, Incorporated Mr. David Rogers Regulatory Affairs Associate 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K143745
Trade/Device Name: Arthrex Corkscrew and SwiveLock Suture Anchors Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: May 12, 2015 Received: May 14, 2015
Dear Mr. Rogers,
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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/ResourcesforYou/Industry/default.htm. 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
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,
Lori A. Wiggins -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name Arthrex Corkscrew Suture Anchors
Indications for Use (Describe)
The Arthrex Corkscrew suture anchors are intended to be used for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, hip, knee, hand/wrist, and elbow 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, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair and Bunionectomy.
Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, and Illiotibial Band Tenodesis.
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction.
Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis repair.
Hip: Capsular repair, acetabular labral repair, gluteus medius 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) |
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."
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Indications for Use
510(k) Number (if known)
Device Name Arthrex SwiveLock Suture Anchors
Indications for Use (Describe)
The Arthrex SwiveLock anchors are 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, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair and Bunionectomy.
Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, and Illiotibial Band Tenodesis.
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction.
Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis repair.
Hip: Capsular repair, acetabular labral repair, gluteus medius 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."
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510K SUMMARY OF SAFETY AND EFFECTIVENESS
| Date Summary Prepared | June 30, 2015 |
|---|---|
| Manufacturer/ | |
| Distributor/ | Arthrex, Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 USA | |
| Sponsor | 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 Corkscrew and SwiveLock Suture Anchors |
| Common Name | Suture Anchor |
| Product Code, | MBI |
| Classification Name, CFR | 21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener |
| Predicate Device | K113294: HEALICOIL PK Suture Anchor |
| K101823: Arthrex SwiveLock 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 Corkscrew and SwiveLock Suture Anchors for gluteus medius repair in | |
| the hip. | |
| Device Description | The Arthrex Corkscrew and SwiveLock Suture Anchors consist of cannulated |
| anchors manufactured from polyetheretherketone (PEEK) or Titanium with an | |
| integral or separate eyelet. They are pre-loaded on a handled inserter. Suture, | |
| with or without needles, and a suture threader may also be provided. | |
| Intended Use | The Arthrex Corkscrew suture anchors are intended to be used for fixation of |
| suture (soft tissue) to bone in the shoulder, foot/ankle, hip, knee, hand/wrist, and | |
| elbow 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, Hallux Valgus Reconstruction, Mid-foot Reconstruction, | |
| Metatarsal Ligament Repair/Tendon Repair and Bunionectomy. Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament | |
| Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, | |
| Posterior Oblique Ligament Repair, and Illiotibial Band Tenodesis. Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial | |
| Collateral Ligament Reconstruction. Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or | |
| Radial Collateral Ligament Reconstruction, Lateral Epicondylitis repair. Hip: Capsular repair, acetabular labral repair, gluteus medius repair. | |
| The Arthrex SwiveLock anchors are 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, Hallux Valgus Reconstruction, Mid-foot Reconstruction, | |
| Metatarsal Ligament Repair/Tendon Repair and Bunionectomy. Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament | |
| Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, and | |
| Illiotibial Band Tenodesis. | |
| • | Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial |
| Collateral Ligament Reconstruction. | |
| • | Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or |
| Radial Collateral Ligament Reconstruction, Lateral Epicondylitis repair. | |
| • | Hip: Capsular repair, acetabular labral repair, gluteus medius repair. |
| Substantial | |
| Equivalence Summary | The Arthrex Corkscrew and SwiveLock 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 Corkscrew and SwiveLock Suture | |
| Anchors and the predicates are considered minor and do not raise questions | |
| concerning safety and effectiveness. | |
| The submitted insertion testing, static pull-out testing, fatigue testing, and suture | |
| abrasion testing data demonstrates that the proposed devices are substantially | |
| equivalent to the predicates. | |
| Based on the indication for use, technological characteristics, and the summary of | |
| data submitted, Arthrex, Inc. has determined that the Arthrex Corkscrew and | |
| SwiveLock Suture Anchors is substantially equivalent to currently marketed | |
| predicate devices. |
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