(230 days)
Not Found
No
The description focuses on the mechanical function and materials of a suture anchor, with no mention of AI or ML capabilities.
No
The device is described as a two-component, knotless suture anchor used for fixation of suture to bone, not to treat or cure a disease or condition.
No
Explanation: The device description and intended use clearly state that the Arthrex SwiveLock is a surgical implant (suture anchor) used for fixation of soft tissue to bone during repair procedures. It is not described as being used for diagnosis or detection of medical conditions.
No
The device description clearly states it is a physical, two-component suture anchor made of PEEK, pre-mounted on a driver. 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's function as a surgical anchor for fixing suture to bone in various anatomical locations. This is a surgical procedure performed in vivo (within the body).
- Device Description: The description details a physical implantable device (anchor) used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo during surgical procedures.
N/A
Intended Use / Indications for Use
The Arthrex SwiveLock is intended to be used for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, hip, knee, hand/wrist, elbow, and hip in the following procedures:
· Shoulder: · Rotator Cuff 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, Midfoot reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy.
· Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis. Secondary fixation for ACL/PCL reconstruction or repair (4.75 -5.5. SwiveLock only). Meniscal root repair (4.75 PEEK SwiveLock C only)
· Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, 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
MBI
Device Description
The Arthrex SwiveLock Anchor is a PEEK two-component, knotless suture anchor comprised of an eyelet and a hollow anchor body. The SwiveLock Anchor is pre-mounted on a driver with the anchor body and eyelet physically separated on the driver shaft.
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
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
Pull-out and cyclic displacement testing was conducted to demonstrate that the ultimate load and displacement of the Arthrex SwiveLock is within the acceptable range for meniscal root repair.
Bacterial endotoxin per EP 2.6.14/USP was conducted to demonstrate that the device meets pyrogen limit specifications.
Key Metrics
Not Found
Predicate Device(s)
K151342: Arthrex SwiveLock 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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The Department of Health and Human Services logo features a stylized human figure, while the FDA part includes the acronym "FDA" in a blue square, followed by "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
August 6, 2018
Arthrex Inc. David Rogers Project Manager, Regulatory Affairs 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K173845
Trade/Device Name: Arthrex SwiveLock Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: June 27, 2018 Received: June 29, 2018
Dear David 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. 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 mediation-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.
Mark N. Melkerson -S
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) K173845
Device Name Arthrex SwiveLock
Indications for Use (Describe)
The Arthrex SwiveLock is intended to be used for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, hip, knee, hand/wrist, elbow, and hip in the following procedures:
· Shoulder: · Rotator Cuff 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, Midfoot reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy.
· Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis. Secondary fixation for ACL/PCL reconstruction or repair (4.75 -5.5. SwiveLock only). Meniscal root repair (4.75 PEEK SwiveLock C only)
· Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, 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) | ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ||
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
| Date Prepared | June 27, 2018 |
|---|---|
| Submitter | Arthrex Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 | |
| Contact Person | David L Rogers |
| Regional Manager, Regulatory Affairs | |
| 1-239-643-5553, ext. 71924 | |
| david.rogers@arthrex.com | |
| Name of Device | Arthrex SwiveLock |
| Common Name | Suture Anchor |
| Product Code | MBI |
| Classification Name | 21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener |
| Regulatory Class | II |
| Predicate Device | K151342: Arthrex SwiveLock Anchors |
| Purpose of | |
| Submission | This traditional 510(k) premarket notification is submitted to obtain meniscal |
| root repair indications for the Arthrex SwiveLock C anchor cleared under K15342. | |
| Device Description | The Arthrex SwiveLock Anchor is a PEEK two-component, knotless suture anchor |
| comprised of an eyelet and a hollow anchor body. The SwiveLock Anchor is pre- | |
| mounted on a driver with the anchor body and eyelet physically separated on the | |
| driver shaft. | |
| Indications for Use | The Arthrex SwiveLock is intended to be used for fixation of suture (soft tissue) to |
| bone in the shoulder, foot/ankle, hip, knee, hand/wrist, elbow, and hip in the | |
| following procedures: | |
| • Shoulder: Rotator Cuff Repairs, 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, Bunionectomy. | |
| • Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament | |
| Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, | |
| Iliotibial Band Tenodesis. Secondary fixation for ACL/PCL reconstruction | |
| or repair (4.75 – 5.5. SwiveLock only). Meniscal root repair (4.75 PEEK | |
| SwiveLock C only) | |
| • Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial | |
| Collateral Ligament Reconstruction, 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 | Pull-out and cyclic displacement testing was conducted to demonstrate that the |
| ultimate load and displacement of the Arthrex SwiveLock is within the acceptable | |
| range range for meniscal root repair. | |
| Bacterial endotoxin per EP 2.6.14/USP was conducted to demonstrate that | |
| the device meets pyrogen limit specifications. | |
| Conclusion | The Arthrex SwiveLock is substantially equivalent to the predicate device in which |
| the basic design features and intended uses are the same. Any differences |
4
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 Arthrex SwiveLock is substantially equivalent to the currently marketed predicate device.