Iconix® Anchor

K241577 · Riverpoint Medical · MBI · Jul 3, 2024 · Orthopedic

Device Facts

• Record ID: K241577
• Device Name: Iconix® Anchor
• Applicant: Riverpoint Medical
• Product Code: MBI · Orthopedic
• Decision Date: Jul 3, 2024
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Iconix® Anchors are intended to be used for soft-tissue to bone fixation in the foot, ankle, knee, hip, hand, wrist, elbow and shoulder. Specific indications are listed below. Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Repair Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction, Repair/ Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, Digital Tendon Repair Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valqus Reconstruction, Digital Tendon Transfers, Mid-foot Reconstruction Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Medial Patellofemoral Ligament (MPFL) Repair/ Reconstruction, Quadriceps Tendon Repair Hip: Capsular Repair, Acetabular Labral Repair, Gluteal Tendon Repair, Proximal Hamstring Repair

Device Story

Iconix® Anchor is a soft-tissue to bone fixation device; consists of braided polyester anchor body with working sutures; preloaded on disposable metallic shaft inserter with over-molded handle. Used in surgical settings by surgeons for orthopedic repairs (e.g., rotator cuff, ligament reconstruction). Device implanted into bone to secure soft tissue; provides mechanical fixation. Benefits patient by restoring anatomical attachment of tendons/ligaments to bone. Single-use; sterilized via ethylene oxide.

Clinical Evidence

Bench testing only. Included shelf-life, sterilization validation, biocompatibility (ISO 10993-1), packaging stability (ISO 11607-1), and usability engineering (EN 62366). Mechanical performance (insertion, cyclic, pullout testing) compared to predicate demonstrated comparable fixation strength.

Technological Characteristics

2.3mm anchor size; braided polyester anchor body; metallic shaft inserter with over-molded handle. Non-absorbable sutures (USP compliant except diameter). Sterilization: Ethylene oxide. Single-use. No software or electronic components.

Indications for Use

Indicated for soft-tissue to bone fixation in adults for orthopedic procedures in the foot, ankle, knee, hip, hand, wrist, elbow, and shoulder, including tendon and ligament repairs/reconstructions.

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

• All-Suture Anchor (K231078)

Reference Devices

• Iconix Anchor (K233468)
• Iconix Knotless Anchor (K240213)

Submission Summary (Full Text)

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July 3, 2024

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Riverpoint Medical Bianca Silva de Sousa Regulatory Associate II 825 NE 25th Ave Portland, Oregon 97232

Re: K241577

Trade/Device Name: Iconix® Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: May 31, 2024 Received: June 3, 2024

Dear Mrs. Silva de Sousa:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-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 ([e-mail]) or phone [phone] or 301-796-7100).

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Sincerely,

Robert M. Stefani -S 2024.07.03 09:14:23 -04'00'

For: Jesse Muir, 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

Submission Number (if known)

K241577

Device Name

Iconix(R) Anchor

Indications for Use (Describe)

The Iconix() Anchors are intended to be used for soft-tissue to bone fixation in the foot, ankle, knee, hip, hand, wrist, elbow and shoulder. Specific indications are listed below.

Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction

Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Repair

Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction, Repair/ Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, Digital Tendon Repair

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valqus Reconstruction, Digital Tendon Transfers, Mid-foot Reconstruction

Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Medial Patellofemoral Ligament (MPFL) Repair/ Reconstruction, Quadriceps Tendon Repair

Hip: Capsular Repair, Acetabular Labral Repair, Gluteal Tendon Repair, Proximal Hamstring 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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Image /page/4/Picture/0 description: The image contains the logo for Riverpoint. The logo consists of the letters "RP" in white on a green rounded square. To the right of the square is the word "RIVERPOINT" in green sans-serif font.

# 510(k) SUMMARY

# Iconix® Anchor

# Submitter Information

| Submitter's Name: | Riverpoint Medical |
|----------------------|-----------------------------------------|
| Address: | 825 NE 25th Ave.<br>Portland, OR 97232 |
| Phone Number: | [phone] |
| Fax Number: | [phone] |
| Registration Number: | 3006981798 |
| Contact Person: | Bianca Silva de Sousa<br>[phone] |
| Date of Preparation: | July 2, 2024 |

### Device Name

| Trade Name: | Iconix® Anchor |
|------------------------|------------------------------------------------------------------------|
| Common or Usual Names: | Fastener, Fixation, Nondegradable, Soft Tissue |
| Classification Name: | 21 CFR 888.3040: Smooth or Threaded Metallic Bone<br>Fixation Fastener |

### Device Classification

| FDA Class: | II |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Classification: | 888.3040: Smooth or Threaded Metallic Bone Fixation<br>Fastener |
| Classification Code: | MBI |
| Review Panel: | Orthopedic |
| Premarket Review | Center for Device and Radiological Health<br>Office of Health Technology (OHT6: Orthopedic Devices)<br>Division of Health Technology 6C Restorative, Repair and<br>Trauma Devices |

# Predicate Device

K231078 – All-Suture Anchor

#### Reference Devices

K233468 - Iconix Anchor

K240213 - Iconix Knotless Anchor

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### Device Description

The Iconix® Anchors are soft-tissue to bone fixation devices, provided preloaded on a disposable inserter. The device is composed of a braided polyester anchor body that contains one or more working sutures. Sutures supplied meet United States Pharmacopeia (USP) requirements for nonabsorbable suture except for diameter. Suture dyes are FDA approved (K100006 and K190817). The standard and the self-punching inserters are comprised of metallic shaft with over molded handle. The device is sterilized by ethylene oxide gas and is provided sterile for single use. The Iconix® Anchors size is 2.3mm. The anchors will be sold sterile for single use with no components or accessories. The product is intended to be used with the same accessories used to implant the predicate device. The device is intended for use in a hospital/clinic/surgical setting, and it is intended for adults only.

The classification for the Iconix® Anchor is FDA Class II device with product classification 21 CFR &888.3040: Smooth or threaded metallic bone fixation fastener, Product Code MBI.

#### Intended Use and Indications for Use

The Iconix® Anchors are intended to be used for soft-tissue to bone fixation in the foot, ankle, knee, hip, hand, wrist, elbow and shoulder. Specific indications are listed below.

Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction

Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Repair

Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, Digital Tendon Repair

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus Reconstruction, Digital Tendon Transfers, Mid-foot Reconstruction

Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Medial Patellofemoral Ligament (MPFL) Repair/ Reconstruction, Quadriceps Tendon Repair

Hip: Capsular Repair, Acetabular Labral Repair, Gluteal Tendon Repair, Proximal Hamstring Repair

#### Performance Data

The sutures used to construct the Iconix® Anchor meet requirements established by the United

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Image /page/6/Picture/0 description: The image shows the logo for Riverpoint. The logo consists of the letters "RP" in a green rounded square, followed by the word "RIVERPOINT" in green sans-serif font. The logo is simple and modern, and the green color suggests growth and stability.

States Pharmacopeia (USP), except for diameter. The UHMWPE sutures are tested per USP performance requirements for tensile strength.

FDA Guidance "Bone Anchors - Premarket Notification (510(k)) Submissions Guidance for Industry and Food and Drug Administration Staff" and FDA Guidance "Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA" were followed during the preparation of this submission.

Non-clinical performance testing for the Iconix® Anchor included shelf-life testing, sterilization adoption validation, biocompatibility testing per ISO10993- 1:2018 - Biological Evaluation of Medical Devices, stability testing on the product packaging per ISO 11607-1:2006 - Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems, usability engineering validation with simulated use in a cadaveric models performed per EN62366: 2015- Medical devices - Application of usability engineering to medical devices.

Non-clinical mechanical testing was performed to verify the fixation strength of the Iconix® Anchor using insertion, cyclic and pullout testing as compared to the predicate device. Results of performance testing for the Iconix® Anchor device concluded that the device performed comparably to the predicate device in insertion, cyclic and pullout testing and the validations performed demonstrated that the Iconix® Anchor met all requirements for its intended use.

### Substantial Equivalence and Comparison of Technical Characteristics

The Iconix® Anchor is substantially equivalent to the previously cleared All-Suture Anchor per K231078 "predicate device." The Iconix® Anchor has the same intended use, same principles of operation, and similar technological characteristics as the predicate device. Both the Iconix® Anchor and the predicate device have the same anchor geometry and method of fixation of suture to anchor. They're also packaged using the same packaging materials and sterilized using the same processes. The only difference between Iconix® Anchor subject device and the predicate device is in technological characteristics, specifically in (i) range of suture size – the subject device contains sutures size 1.2mm and 2.2mm, while the predicate device has 1.2mm and #2. (ii) anchor materials - the anchor of the subject device does not contain a coating. However, the technological characteristics are within the range of currently marketed devices, as seen in the reference devices Iconix Knotless Anchor (K240213) and Iconix Anchors (K233468), and they have been assessed through risk analysis, not raising any new questions of effectiveness. Therefore, the Iconix® Anchor "subject device" is substantially equivalent to the "predicate device" and does not raise any new issues of safety or effectiveness.

### Conclusion

The information provided in this Special 510(k) demonstrates that the Iconix® Anchor is substantially equivalent to the predicate device.