(41 days)
The Arthrex SwiveLock Suture Anchors are 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, Quadriceps Tendon Repair and Meniscal root repair (4.75 SwiveLock C only). Secondary fixation for ACL/PCL reconstruction or repair (4.75 - 5.5. SwiveLock only).
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, Radial Collament Reconstruction.
Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Unar or Radial collateral Ligament Reconstruction, Lateral Epicondylitis Repair.
Hip: Capsular Repair, acetabular labral repair
The Arthrex SwiveLock Anchor is a BioComposite 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. Arthrex cleared suture may also be provided with the device.
This document is a 510(k) premarket notification for the Arthrex SwiveLock Anchors, specifically for the addition of a meniscal root repair indication. It's a regulatory submission, not a study report per se, and it pertains to a physical medical device (suture anchors), not a software or AI-driven device.
Therefore, many of the requested fields are not applicable to this type of document or device. For example, there's no "device performance" in terms of accuracy metrics, no "test set" in the computational sense, no "ground truth" derived from expert consensus on images, no "training set," and no "AI assistance."
However, I can extract information related to the performance data provided to support the new indication.
Here's the breakdown of what can be extracted from the provided text, and where the requested information is not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Meniscal root repair (new indication) | Demonstrated that the ultimate load and displacement of the Arthrex SwiveLock are within the acceptable range for meniscal root repair. |
| Pyrogen Limit Specifications | Device meets pyrogen limit specifications. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated numerically (e.g., how many anchors were tested, how many repetitions). The document refers to "testing" performed.
- Data Provenance: The testing was conducted to demonstrate the mechanical properties and biocompatibility of the device for the new indication. It would be considered prospective testing for the purpose of this submission, performed by the manufacturer (Arthrex Inc.). Country of origin is not specified, but the manufacturer is based in Naples, Florida, USA.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Not Applicable: This relates to a physical device, not an image-based diagnostic or AI system. The "ground truth" here is objective physical and chemical testing results, not expert interpretation.
4. Adjudication Method for the Test Set
- Not Applicable: As above, this is for physical/chemical testing, not expert adjudication of diagnostic outputs. The assessment of whether the ultimate load and displacement are "within the acceptable range" would be based on predefined engineering specifications, not human adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No: This is not relevant for a physical medical device like a suture anchor. MRMC studies are typically for diagnostic imaging systems or AI products.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Not Applicable: This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
- Engineering/Mechanical Specifications and Biocompatibility Standards: The "ground truth" for the performance data involves established mechanical thresholds for ultimate load and displacement in meniscal root repair applications, as well as pyrogen limit specifications defined by standards like EP 2.6.14/USP <85>. It's based on objective physical and chemical measurements rather than expert consensus on interpretation.
8. The Sample Size for the Training Set
- Not Applicable: This is a physical device, and the concept of a "training set" for an algorithm does not apply.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable: As above, no training set for an algorithm exists here.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with "ADMINISTRATION" written below in a smaller font.
Arthrex Inc. Jessica L. Singelais Regulatory Affairs Specialist 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K192441
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 Dated: October 10, 2019 Received: October 16, 2019
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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-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, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K192441
Device Name Arthrex SwiveLock Anchors
Indications for Use (Describe)
The Arthrex SwiveLock Suture Anchors are 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, Quadriceps Tendon Repair and Meniscal root repair (4.75 SwiveLock C only). Secondary fixation for ACL/PCL reconstruction or repair (4.75 - 5.5. SwiveLock only).
· Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction.
· Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Unar 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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| Submitter | Arthrex Inc.1370 Creekside BoulevardNaples, FL34108-1945 |
|---|---|
| Contact Person | Jessica L. SingelaisRegulatory Affairs Specialist1-239-598-4302, ext. 73091Jessica.singelais@arthrex.com |
| Name of Device | Arthrex SwiveLock |
| Common Name | Suture Anchor |
| Product Code | MAI |
| Classification Name | 21 CFR 888.3030: Single/multiple component metallic bone fixation appliances and accessories |
| Regulatory Class | II |
| Predicate Device | K173845: Arthrex SwiveLock Suture AnchorK180768: Arthrex SwiveLock Suture Anchor |
| Purpose of Submission | This special 510(k) premarket notification is submitted to obtain meniscal root repair indications for the Arthrex SwiveLock C anchors cleared under K180768. |
| Device Description | The Arthrex SwiveLock Anchor is a BioComposite 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. Arthrex cleared suture may also be provided with the device. |
| Indications for Use | The Arthrex SwiveLock Suture Anchors are 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, Quadriceps Tendon Repair and Meniscal root repair (4.75 SwiveLock C only). Secondary fixation for ACL/PCL reconstruction or repair (4.75-5.5. SwiveLock 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. |
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| ComparisonSummary ofTechnologicalCharacteristics andModificationsProposed | The proposed and predicate devices (K180768) have the same technologicalcharacteristics (device design, sterilization, shelf life and biocompatibility). Theproposed device modification consists of the addition of the meniscal root repairindication. |
|---|---|
| The Arthrex BioComposite SwiveLock Suture Anchor is substantially equivalent tothe predicate device in which the design features and intended uses are thesame. Any differences between the proposed device and the predicate device areconsidered minor and do not raise questions concerning safety or effectiveness. | |
| Performance Data | Pull-out and cyclic displacement testing post 26 weeks degradation wasconducted to demonstrate that the ultimate load and displacement of theArthrex SwiveLock is within the acceptable range for meniscal root repair.Bacterial endotoxin per EP 2.6.14/USP <85> was conducted to demonstrate thatthe device meets pyrogen limit specifications. |
| Conclusion | The Arthrex SwiveLock is substantially equivalent to the predicate device in whichthe basic design features and intended uses are the same. Any differencesbetween the proposed device and the predicate device are considered minor anddo not raise questions concerning safety or effectiveness. |
| Based on the indications for use, technological characteristics, and the summaryof data submitted, Arthrex Inc. has determined that the Arthrex SwiveLock issubstantially equivalent to the currently marketed predicate device. |
§ 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.