Who is the manufacturer of Arthrex 3.9 mm SwiveLock Anchor?

Arthrex, Inc. filed the 510(k) submission for Arthrex 3.9 mm SwiveLock Anchor (K230435).

What is the FDA product code for Arthrex 3.9 mm SwiveLock Anchor?

MAI. It is classified under 21 CFR 888.3030 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for Arthrex 3.9 mm SwiveLock Anchor?

510(k) clearance (submission type: Special).

What are the predicate devices for Arthrex 3.9 mm SwiveLock Anchor?

Arthrex SwiveLock Anchor (K192532); Arthrex SwiveLock Anchor (K203495).

Who can help prepare an FDA 510(k) submission like Arthrex 3.9 mm SwiveLock Anchor?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Arthrex 3.9 mm SwiveLock Anchor

K230435 · Arthrex, Inc. · MAI · Mar 17, 2023 · Orthopedic

Device Facts

Record ID	K230435
Device Name	Arthrex 3.9 mm SwiveLock Anchor
Applicant	Arthrex, Inc.
Product Code	MAI · Orthopedic
Decision Date	Mar 17, 2023
Decision	SESE
Submission Type	Special
Regulation	21 CFR 888.3030
Device Class	Class 2
Attributes	Therapeutic, Pediatric

Intended Use

The Arthrex SwiveLock Anchor is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip in skeletally mature pediatric and adult patients for the following procedures: Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis Capsulolabral Reconstruction, Acromio-Clavicular Separation Repair, Capsular Shift or Capsulo labral Reconstruction. Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament/Tendon Repair, and Bunionectomy Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, and MPFL Repair Reconstruction Hand/Wrist: Scapholunate Ligament Reconstruction and Ulnar/Radial Collateral Ligament Reconstruction Elbow: Biceps Tendon Reattachment, Ulnar/Radial Collateral Ligament Reconstruction, and Lateral Epicondvlitis repair Hip: Capsular Repair and Acetabular labral repair.

Device Story

Sterile two-component suture anchor consisting of eyelet and hollow anchor body; pre-mounted on driver with components separated on shaft. Used by surgeons in orthopedic procedures to fixate soft tissue to bone. Device facilitates suture tensioning and secure attachment; benefits patient through stable tissue repair. Used in clinical settings (OR).

Clinical Evidence

Bench testing only. Packaging validation performed per ISO 11607; 5-year accelerated aging shelf-life testing completed. Bacterial Endotoxins Test (BET) performed per ANSI/AAMI ST72:2011/(R)2016, USP <161>, USP <85>, and EP 2.6.14.

Technological Characteristics

Two-component metallic bone fixation appliance; includes eyelet and hollow anchor body. Packaged in PETG blister tray with Tyvek lid and outer poly/Tyvek pouch. Sterility maintained via validated packaging.

Indications for Use

Indicated for soft tissue-to-bone fixation in shoulder, foot/ankle, knee, hand/wrist, elbow, and hip procedures in skeletally mature pediatric and adult patients.

Regulatory Classification

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.

Predicate Devices

Arthrex SwiveLock Anchor (K192532)
Arthrex SwiveLock Anchor (K203495)

Related Devices

K201749 — Arthrex SwiveLock Anchor · Arthrex, Inc. · Aug 21, 2020
K192532 — Arthrex SwiveLock Anchor · Arthrex, Inc. · Oct 19, 2019
K151342 — Arthrex SwiveLock Anchors · Arthrex, Inc. · Mar 24, 2016
K193503 — Arthrex SwiveLock Suture Anchor · Arthrex, Inc. · Jan 15, 2020
K190728 — Arthrex SwiveLock Anchors · Arthrex, Inc. · Apr 17, 2019

Submission Summary (Full Text)

{0}------------------------------------------------ March 17, 2023 Image /page/0/Picture/1 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 and 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 ADMINISTRATION' in blue text. Arthrex, Inc. Stacy Valdez, M.S. Sr. Regulatory Affairs Specialist 370 Creekside Boulevard Naples, Florida 34113 Re: K230435 Trade/Device Name: Arthrex 3.9 mm SwiveLock Anchor Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: MAI, HWC Dated: February 14, 2023 Received: February 17, 2023 Dear Ms. Valdez: 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 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. # Sara S. Thompson -S For Laurence D. Coyne. Ph.D. 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 {2}------------------------------------------------ ### Indications for Use Submission Number (if known) K230435 Device Name Arthrex 3.9 mm SwiveLock Anchor Indications for Use (Describe) The Arthrex SwiveLock Anchor is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip in skeletally mature pediatric and adult patients for the following procedures: Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis Capsulolabral Reconstruction, Acromio-Clavicular Separation Repair, Capsular Shift or Capsulo labral Reconstruction. Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament/Tendon Repair, and Bunionectomy Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, and MPFL Repair Reconstruction Hand/Wrist: Scapholunate Ligament Reconstruction and Ulnar/Radial Collateral Ligament Reconstruction Elbow: Biceps Tendon Reattachment, Ulnar/Radial Collateral Ligament Reconstruction, and Lateral Epicondvlitis repair Hip: Capsular Repair and 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## 510(k) Summary | Date Prepared | February 14, 2023 | |-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter | Arthrex Inc. 1370 Creekside Boulevard Naples, FL 34108-1945 | | Contact Person | Stacy Valdez Senior Regulatory Affairs Specialist 1-239-643-5553, ext. 72010 stacy.valdez@arthrex.com | | Name of Device | Arthrex 3.9 mm SwiveLock Anchor | | Common Name | Suture Anchor | | Product Code | MAI, HWC | | Classification Name | 21 CFR 888.3030: Single/multiple component metallic bone fixation appliances and accessories (Primary) 21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener | | Regulatory Class | II | | Primary Predicate Device | K192532: Arthrex SwiveLock Anchor | | Additional Predicate Device | K203495: Arthrex SwiveLock Anchor | | Purpose of Submission | This Special 510(k) premarket notification is submitted to obtain clearance for the Arthrex 3.9 mm SwiveLock Anchor | | Device Description | The proposed Arthrex 3.9 mm SwiveLock Anchor is a sterile two- component suture anchor comprised of an eyelet and a hollow anchor body. The Arthrex 3.9 mm SwiveLock Anchor is pre-mounted on a driver with the anchor body and eyelet physically separated on the driver shaft. The Arthrex 3.9 mm SwiveLock Anchor can be used with Arthrex 510(k) cleared suture. | | Indications for Use | The Arthrex SwiveLock Anchor is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip in skeletally mature pediatric and adult patients for the following procedures: Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis Capsulolabral Reconstruction, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulo labral Reconstruction. Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament/Tendon Repair, and Bunionectomy. Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, and MPFL Repair/Reconstruction. Hand/Wrist: Scapholunate Ligament Reconstruction and Ulnar/Radial Collateral Ligament Reconstruction. Elbow: Biceps Tendon Reattachment, Ulnar/Radial Collateral Ligament Reconstruction, and Lateral Epicondylitis Repair. Hip: Capsular Repair, Acetabular labral repair. | {4}------------------------------------------------ | Performance Data | Packaging validation and 5-year accelerated aging shelf-life testing was performed to demonstrate that the packaging configurations are capable of maintaining and protecting the product and sterility of the device throughout the shipping and handling environment. The packaging configuration met all the packaging testing acceptance criteria in conformance to ISO 11607 and applicable standards. Bacterial Endotoxins Test (BET) was performed on the representative samples utilizing the Kinetic Chromogenic Method in accordance with ANSI/AAMI ST72:2011/(R)2016, USP <161>, USP <85>, EP 2.6.14 to demonstrate that the proposed device meets pyrogen limit specifications. | |--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Technological Comparison | The Arthrex 3.9 mm SwiveLock Anchor is substantially equivalent to the predicate devices cleared under K192532 and K203495 in which the overall design, intended use, indications, materials, design, sterility, shelf- life, surgical technique, and MRI safety labeling is identical. The Arthrex 3.9 mm SwiveLock Anchor will be packaged in inner PETG blister tray with Tyvek lid and outer poly/Tyvek pouch. The predicate devices cleared under K192532 and K203495 are packaged in an inner PETG blister tray with Tyvek lid and outer foil pouch. Any differences between the Arthrex 3.9 mm SwiveLock Anchor and the predicate devices are considered minor and do not raise different questions of safety or effectiveness. | | Conclusion | The Arthrex 3.9 mm SwiveLock Anchor is substantially equivalent to the predicate devices in which the basic design features and intended use are the same. Any differences between the proposed Arthrex 3.9 mm SwiveLock Anchor and the predicate devices are considered minor and do not result in new or different questions of 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 device. |