(266 days)
No
The device description and performance studies focus on the mechanical properties and biological safety of a suture anchor, with no mention of AI or ML.
Yes
The device is intended for the fixation of suture to bone in various anatomical sites for procedures repairing or reconstructing damaged tissues, which aligns with the definition of a therapeutic device.
No
Explanation: The device is described as a "knotless suture anchor" used for "fixation of suture (soft tissue) to bone" in various orthopedic repair procedures. Its function is to secure tissue, not to diagnose a condition or illness.
No
The device description clearly states it is a two-component, knotless suture anchor comprised of an eyelet and a hollow anchor body, which are physical hardware components.
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 the fixation of suture to bone in various anatomical locations during surgical procedures. This is a direct surgical intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a physical implantable device (anchor) used to secure sutures. This is consistent with a surgical device, not a diagnostic one.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific markers, or providing diagnostic information about a patient's condition.
- Performance Studies: The performance studies focus on the mechanical properties of the anchor (pull-out strength) and biocompatibility (bacterial endotoxin), which are relevant to surgical implants, not diagnostic devices.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
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/Tendon Repair and Bunionectomy.
Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, and Illiotibial Band Tenodesis and Quadriceps Tendon Repair. Secondary fixation of ACL/PCL reconstruction or repair (4.75 - 5.5 SwiveLock only).
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.
Product codes
MAI, MBI
Device Description
The Arthrex SwiveLock Anchor is a two-component, knotless suture anchor comprised of an eyelet and a hollow anchor body. The SwiveLock Anchor is premounted on a driver with the anchor body and eyelet physically separated on the driver shaft. Arthrex 510(k) cleared suture may also be provided with the device.
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
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)
Static pull-out testing was conducted on the Arthrex SwiveLock Suture Anchor and the Zimmer Biomet JuggerKnot Soft Anchor. In addition, cyclic pull-out testing was performed on the subject device after 16 weeks of degradation and compared to the non-resorbable predicate device. Results demonstrate that the Arthrex SwiveLock Anchor performs statistically equivalent to the predicate device (K150768 – Zimmer Biomet JuggerKnot Soft Anchor). Bacterial endotoxin per EP 2.6.14/USP was conducted to demonstrate that the device meets pyrogen limit specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
December 14, 2018
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 in blue. Underneath the FDA logo is the word "ADMINISTRATION".
Arthrex Inc. Jessica L. Singelais Regulatory Affairs Specialist 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K180768
Trade/Device Name: Arthrex SwiveLock Anchors Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: MAI, MBI Dated: November 7, 2018 Received: November 8, 2018
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Laurence D. Coyne -S
- For Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K180768
Device Name Arthrex SwiveLock 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/Tendon Repair and Bunionectomy.
Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, and Illiotibial Band Tenodesis and Quadriceps Tendon Repair. Secondary fixation of ACL/PCL reconstruction or repair (4.75 - 5.5 SwiveLock only).
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.
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) |
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510(k) Summary or 510(k) Statement
| Date Prepared | December 14, 2018 |
|---|---|
| Submitter | Arthrex Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 | |
| Contact Person | Jessica L. Singelais |
| Regulatory Affairs Specialist | |
| 1-239-598-4302, ext. 73091 | |
| Jessica.singelais@arthrex.com | |
| Name of Device | Arthrex SwiveLock Anchor |
| Common Name | Suture Anchor |
| Product Code | MAI, MBI |
| Classification Name | 21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener |
| 21 CFR 888.3030: Single/multiple component metallic bone fixation appliances | |
| and accessories | |
| Regulatory Class | II |
| Predicate Device | K151342: Arthrex SwiveLock Anchors |
| K171141: Arthrex SwiveLock Anchors | |
| K150768: Zimmer Biomet JuggerKnot Soft Anchors | |
| Purpose of Submission | This traditional 510(k) premarket notification is submitted to obtain quadriceps |
| tendon repair indications for the Arthrex SwiveLock Anchors originally cleared | |
| under K151342 and K171141. | |
| Device Description | The Arthrex SwiveLock Anchor is a two-component, knotless suture anchor |
| comprised of an eyelet and a hollow anchor body. The SwiveLock Anchor is | |
| premounted on a driver with the anchor body and eyelet physically separated on | |
| the driver shaft. Arthrex 510(k) cleared suture may also be provided with the | |
| device. | |
| Indications for Use | The Arthrex SwiveLock Suture 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, | |
| Illiotibial Band Tenodesis, and Quadriceps Tendon Repair. Secondary or | |
| adjunct fixation for ACL/PCL reconstruction or repair (4.75-5.5 SwiveLock | |
| only). 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. | |
| Performance Data | Static pull-out testing was conducted on the Arthrex SwiveLock Suture Anchor |
| and the Zimmer Biomet JuggerKnot Soft Anchor. In addition, cyclic pull-out | |
| testing was performed on the subject device after 16 weeks of degradation and | |
| compared to the non-resorbable predicate device. Results demonstrate that the | |
| Arthrex SwiveLock Anchor performs statistically equivalent to the predicate | |
| device (K150768 – Zimmer Biomet JuggerKnot Soft Anchor). | |
| Bacterial endotoxin per EP 2.6.14/USP was conducted to demonstrate that | |
| the device meets pyrogen limit specifications. | |
| Conclusion | The Arthrex SwiveLock Anchor is substantially equivalent to the predicate device |
| in which the basic design features and intended uses are the same. Any | |
| differences between the proposed device and the predicate device are | |
| considered minor and do not raise questions concerning safety or 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 devices. |
4