Arthrex SwiveLock Anchors

K190728 · Arthrex, Inc. · MBI · Apr 17, 2019 · Orthopedic

Device Facts

• Record ID: K190728
• Device Name: Arthrex SwiveLock Anchors
• Applicant: Arthrex, Inc.
• Product Code: MBI · Orthopedic
• Decision Date: Apr 17, 2019
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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, Siceps 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 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. Hip: Capsular repair, acetabular labral repair. Proximal Hamstring Repair (4/75-5.5 PEEK SwiveLock only).

Device Story

Two-component, knotless suture anchor; consists of eyelet and hollow anchor body. Premounted on driver with components separated on shaft. Used by surgeons in orthopedic procedures to secure soft tissue to bone. Operates via mechanical fixation; provides stable attachment point for sutures. Benefits patient by facilitating tissue healing through secure anatomical fixation.

Clinical Evidence

Bench testing only. Cyclic pull-out testing compared subject device to predicate (K150768), demonstrating statistical equivalence. Bacterial endotoxin testing per EP 2.6.14/USP <85> confirmed compliance with pyrogen limit specifications.

Technological Characteristics

Two-component knotless suture anchor (eyelet and hollow body). Materials include PEEK (for specific sizes). Mechanical fixation principle. Supplied sterile.

Indications for Use

Indicated for soft tissue-to-bone fixation in shoulder, foot/ankle, knee, hand/wrist, elbow, and hip orthopedic procedures. Includes specific repairs for ligaments, tendons, and capsular structures across these joints. Proximal hamstring repair indicated for 4.75-5.5 PEEK SwiveLock only.

Regulatory Classification

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.

Predicate Devices

• Arthrex SwiveLock Anchors (K180768)
• Zimmer Biomet JuggerKnot Soft Anchors (K150768)

Submission Summary (Full Text)

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April 17, 2019

Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services and the U.S. Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Arthrex Inc. Jessica Singelais Regulatory Affairs Specialist 1370 Creekside Boulevard Naples, Florida 34108-1945

Re: K190728

Trade/Device Name: Arthrex SwiveLock Anchors Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: March 8, 2019 Received: March 21, 2019

Dear Jessica 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

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Shumaya Ali -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) K190728

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, Siceps 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 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.

Hip: Capsular repair, acetabular labral repair. Proximal Hamstring Repair (4/75-5.5 PEEK SwiveLock only).

| Type of Use ( <i>Select one or both, as applicable</i> ) |
|----------------------------------------------------------------------------------------------------------|
| <span style="unicode-bidi:embed; text-align:left;">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> |
| <span style="unicode-bidi:embed; text-align:left;">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> |

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## 510(k) Summary

| Date Prepared | March 8, 2019 |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter | Arthrex Inc.<br>1370 Creekside Boulevard<br>Naples, FL 34108-1945 |
| Contact Person | Jessica L. Singelais<br>Regulatory Affairs Specialist<br>1-239-598-4302, ext. 73091<br>[e-mail] |
| Name of Device | Arthrex SwiveLock Anchor |
| Common Name | Suture Anchor |
| Product Code | MBI |
| Classification Name | 21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener<br>21 CFR 888.3030: Single/multiple component metallic bone fixation appliances<br>and accessories |
| Regulatory Class | II |
| Predicate Device | K180768: Arthrex SwiveLock Anchors<br>K150768: Zimmer Biomet JuggerKnot Soft Anchors |
| Purpose of Submission | This special 510(k) premarket notification is submitted to obtain proximal<br>hamstring indications for the Arthrex SwiveLock Anchors cleared under K180768. |
| Device Description | The Arthrex SwiveLock Anchor is a two-component, knotless suture anchor<br>comprised of an eyelet and a hollow anchor body. The SwiveLock Anchor is<br>premounted on a driver with the anchor body and eyelet physically separated on<br>the driver shaft. Arthrex 510(k) cleared suture may also be provided with the<br>device. |
| Indications for Use | The Arthrex SwiveLock Suture Anchors are intended for fixation of suture (soft<br>tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip in<br>the following procedures:<br>Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair,<br>Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair,<br>Capsular Shift or Capsulolabral Reconstruction.Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon<br>Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction,<br>Metatarsal Ligament Repair/Tendon Repair and Bunionectomy.Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament<br>Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair,<br>Illiotibial Band Tenodesis and Quadriceps Tendon Repair. Secondary or<br>adjunct fixation for ACL/PCL reconstruction or repair (4.75-5.5 SwiveLock<br>only).Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial<br>Collateral Ligament Reconstruction.Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or<br>Radial Collateral Ligament Reconstruction.Hip: Capsular repair, Acetabular Labral Repair. Proximal Hamstring<br>Repair (4.75-5.5 PEEK SwiveLock only). |
| Performance Data | Cyclic pull-out testing was performed on the subject device and compared to the<br>Zimmer Biomet JuggerKnot predicate device. Results demonstrate that the |
| | Arthrex SwiveLock Anchor performs statistically equivalent to the predicate<br>devices (K180768 Arthrex SwiveLock Suture Anchor and K150768 Zimmer Biomet<br>JuggerKnot Soft Anchor).<br>Bacterial endotoxin per EP 2.6.14/USP <85> was conducted to demonstrate that |
| | the device meets pyrogen limit specifications. |
| Conclusion | The Arthrex SwiveLock Anchor is substantially equivalent to the predicate devices<br>in which the basic design features and intended uses are the same. Any<br>differences between the proposed device and the predicate device are<br>considered minor and do not raise questions concerning safety or effectiveness. |
| | Based on the indications for use, technological characteristics, and the summary<br>of data submitted, Arthrex Inc. has determined that the proposed device is<br>substantially equivalent to the currently marketed predicate devices. |
| | |

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