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 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.

AI/ML Overview

This provides an analysis of the provided text regarding the Arthrex SwiveLock Anchors.

1. Table of Acceptance Criteria and Reported Device Performance

The submission for the Arthrex SwiveLock Anchors (K190728) describes a comparison to predicate devices, focusing on mechanical performance. The "acceptance criteria" can be inferred from the statement that the device performs "statistically equivalent" to the predicate.

Acceptance Criteria (inferred)	Reported Device Performance
Statistically equivalent cyclic pull-out performance to predicate devices (K180768 Arthrex SwiveLock Suture Anchor and K150768 Zimmer Biomet JuggerKnot Soft Anchor).	Cyclic pull-out testing demonstrated that the Arthrex SwiveLock Anchor performs statistically equivalent to the predicate devices.
Meets pyrogen limit specifications per EP 2.6.14/USP <85>.	Bacterial endotoxin testing per EP 2.6.14/USP <85> was conducted and demonstrated that the device meets pyrogen limit specifications.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The document does not explicitly state the numerical sample size (n) used for the cyclic pull-out testing. It only mentions that "Cyclic pull-out testing was performed."
Data Provenance: Not explicitly stated, but given it's a 510(k) submission from a U.S. company (Arthrex Inc., Naples, FL), the testing would typically be conducted in a controlled lab environment, likely in the US or by a recognized testing facility. It would be considered prospective testing for the purpose of this submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable to this type of device and study. The "ground truth" for mechanical testing of a medical device like a suture anchor is based on objective, quantifiable physical measurements (e.g., force, displacement, material properties) rather than expert opinion or diagnostic interpretation.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods (like 2+1, 3+1) are used in studies involving human interpretation (e.g., image reading) where there might be disagreement among experts. For mechanical testing, the results are typically derived from instrumentation, and judgment or adjudication in that sense is not usually employed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. MRMC studies are typically performed for diagnostic imaging devices where human readers interpret results, and the AI's impact on their performance is evaluated. This submission is for a surgical implant (suture anchor), where performance is assessed through biomechanical testing, not reader interpretation.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, a standalone performance assessment was done. The "Performance Data" section describes "Cyclic pull-out testing" and "Bacterial endotoxin testing." These are laboratory-based, objective tests conducted on the device itself without human intervention in the performance measurement process.

7. Type of Ground Truth Used

The ground truth used for the performance data is based on objective, quantitative physical and biological measurements:

Biomechanical Metrics: For cyclic pull-out testing, the "ground truth" is the measured force-displacement characteristics and failure modes, compared against established performance benchmarks of the predicate devices.
Physicochemical Analysis: For bacterial endotoxin testing, the "ground truth" is the measured endotoxin level compared against predefined pyrogen limit specifications.

8. Sample Size for the Training Set

This information is not applicable as this device does not involve an AI algorithm that requires a "training set." The device is a physical medical implant whose performance is evaluated through mechanical and biological testing, not by learned patterns from data.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable, as there is no AI algorithm or training set involved with this device.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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.

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 ( 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

Date Prepared	March 8, 2019
Submitter	Arthrex Inc.1370 Creekside BoulevardNaples, FL 34108-1945
Contact Person	Jessica L. SingelaisRegulatory Affairs Specialist1-239-598-4302, ext. 73091Jessica.singelais@arthrex.com
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 fastener21 CFR 888.3030: Single/multiple component metallic bone fixation appliancesand accessories
Regulatory Class	II
Predicate Device	K180768: Arthrex SwiveLock AnchorsK150768: Zimmer Biomet JuggerKnot Soft Anchors
Purpose of Submission	This special 510(k) premarket notification is submitted to obtain proximalhamstring indications for the Arthrex SwiveLock Anchors cleared under K180768.
Device Description	The Arthrex SwiveLock Anchor is a two-component, knotless suture anchorcomprised of an eyelet and a hollow anchor body. The SwiveLock Anchor ispremounted on a driver with the anchor body and eyelet physically separated onthe driver shaft. Arthrex 510(k) cleared suture may also be provided with thedevice.
Indications for Use	The Arthrex SwiveLock Suture Anchors are intended for fixation of suture (softtissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip inthe 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 TendonRepair, Hallux Valgus Reconstruction, Mid-foot Reconstruction,Metatarsal Ligament Repair/Tendon Repair and Bunionectomy.Knee: Medial Collateral Ligament Repair, Lateral Collateral LigamentRepair, Patellar Tendon Repair, Posterior Oblique Ligament Repair,Illiotibial Band Tenodesis and Quadriceps Tendon Repair. Secondary oradjunct fixation for ACL/PCL reconstruction or repair (4.75-5.5 SwiveLockonly).Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or RadialCollateral Ligament Reconstruction.Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar orRadial Collateral Ligament Reconstruction.Hip: Capsular repair, Acetabular Labral Repair. Proximal HamstringRepair (4.75-5.5 PEEK SwiveLock only).
Performance Data	Cyclic pull-out testing was performed on the subject device and compared to theZimmer Biomet JuggerKnot predicate device. Results demonstrate that the
	Arthrex SwiveLock Anchor performs statistically equivalent to the predicatedevices (K180768 Arthrex SwiveLock Suture Anchor and K150768 Zimmer BiometJuggerKnot Soft Anchor).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 devicesin which the basic design features and intended uses are the same. Anydifferences between the proposed device and the predicate device areconsidered minor and do 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 proposed device issubstantially equivalent to the currently marketed predicate devices.

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Regulation Number and Section

§ 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.