Who is the manufacturer of All-Suture Anchor?

Riverpoint Medical, LLC filed the 510(k) submission for All-Suture Anchor (K231078).

What is the FDA product code for All-Suture Anchor?

MBI. It is classified under 21 CFR 888.3040 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for All-Suture Anchor?

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

What are the predicate devices for All-Suture Anchor?

ICONIX XBraid TT Suture Anchor (K173074).

Who can help prepare an FDA 510(k) submission like All-Suture 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.

All-Suture Anchor

K231078 · Riverpoint Medical, LLC · MBI · Oct 5, 2023 · Orthopedic

Device Facts

Record ID	K231078
Device Name	All-Suture Anchor
Applicant	Riverpoint Medical, LLC
Product Code	MBI · Orthopedic
Decision Date	Oct 5, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3040
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Iconix® HA+™ 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 of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, Digital Tendon Repar 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 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® HA+™ Anchor is a soft-tissue to bone fixation device; consists of a cylindrical suture sleeve (braided polyester and bioceramics) and non-absorbable braided UHMWPE working sutures. Used in surgical settings (hospital/clinic) by orthopedic surgeons. Principle of operation: surgeon prepares pilot hole, manually inserts anchor via metallic shaft/polymer handle inserter, and deploys anchor to secure soft tissue. Device provides mechanical fixation for various orthopedic repairs (e.g., rotator cuff, ligament reconstruction). Benefits include secure soft-tissue reattachment to bone, facilitating healing. Provided sterile for single use.

Clinical Evidence

Bench testing included insertion, cyclic, and pullout mechanical testing compared to predicate; sterilization validation; biocompatibility (ISO 10993-1); packaging stability (ISO 11607-1); usability engineering (EN 62366); and endotoxin/pyrogenicity testing (ANSI/AAMI ST72, USP <161>, <151>, <85>). An animal study was conducted to evaluate biological safety and in vivo performance, demonstrating substantial equivalence.

Technological Characteristics

Anchor: braided polyester and bioceramics cylindrical sleeve. Suture: braided UHMWPE (USP compliant except diameter). Inserter: stainless steel shaft with over-molded polymer handle. Sterilization: Ethylene Oxide (EtO). Sizes: 1.4mm and 2.3mm. Connectivity: None (mechanical device).

Indications for Use

Indicated for soft-tissue to bone fixation in foot, ankle, knee, hip, hand, wrist, elbow, and shoulder for patients requiring tendon/ligament repair or reconstruction.

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

ICONIX XBraid TT Suture Anchor (K173074)

Reference Devices

EVOL® -SI Joint Fusion System (K190025)
Promimic Dental Implant (K101225)
EVOS Lumbar Interbody System (K150321)
TWINFIX HA suture anchors (K112526)

Related Devices

K241577 — Iconix® Anchor · Riverpoint Medical · Jul 3, 2024
K243203 — OC JuggerKnotless Soft Anchor; OC JuggerLoop Soft Anchor · Riverpoint Medical · Oct 29, 2024
K252144 — Iconix Speed Anchor; Iconix Speed HA+ Anchor · Riverpoint Medical · Jul 30, 2025
K980103 — ACUMED SUTURE ANCHOR · Acu Med, Inc. · Mar 16, 1998
K231113 — Arthrex FiberTak Suture Anchor · Arthrex, Inc. · May 18, 2023

Submission Summary (Full Text)

{0}------------------------------------------------ October 5, 2023 Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services-USA. To the right, the FDA logo is displayed in blue, with the words "U.S. FOOD & DRUG ADMINISTRATION" written in a clear, sans-serif font. The overall design is clean and professional, reflecting the organization's role in public health and safety. Riverpoint Medical, LLC Edwin Anderson Vice President Regulatory Affairs 815 NE 25th Ave Portland, Oregon 97232 Re: K231078 Trade/Device Name: All-Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: September 7, 2023 Received: April 17, 2023 Dear Edwin Anderson: 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). {1}------------------------------------------------ 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, ## Sara S. Thompson -S 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 {2}------------------------------------------------ Enclosure {3}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K231078 Device Name Iconix® HA+TM Anchor #### Indications for Use (Describe) The Iconix® HA+™ 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 of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, Digital Tendon Repar 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 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) | | |-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------| | <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> | #### 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." ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ {4}------------------------------------------------ K231078 # ERPOINT ### 510(k) SUMMARY #### Iconix® HA+TM Anchor #### Submitter Information | Submitter's Name: | Riverpoint Medical | |----------------------|----------------------------------------| | Address: | 825 NE 25th Ave. Portland, OR 97232 | | Phone Number: | (503) 517-8001 | | Fax Number: | (503) 517-8002 | | Registration Number: | 3006981798 | | Contact Person: | Edwin Anderson (503) 517-8001 | | Date of Preparation: | April 14, 2023 | #### Device Name | Trade Name: | Iconix® HA+TM Anchor | |------------------------|----------------------------------------------------| | Common or Usual Names: | Fastener, Fixation, Nondegradable, Soft Tissue | | Classification Name: | Smooth or Threaded Metallic Bone Fixation Fastener | #### Device Classification | FDA Class: | II | |-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product Classification: | 888.3040: Smooth or Threaded Metallic Bone Fixation Fastener | | Classification Code: | MBI | | Review Panel | Orthopedic | | Premarket Review | Center for Device and Radiological Health Office of Health Technology (OHT6: Orthopedic Devices) Division of Health Technology 6C Restorative, Repair and Trauma Devices | #### Predicate Device K173074 – ICONIX XBraid TT Suture Anchor ### Reference Devices - K190025 EVOL® -SI Joint Fusion System K101225 - Promimic Dental Implant K150321 - EVOS Lumbar Interbody System K112526 - TWINFIX HA suture anchors {5}------------------------------------------------ ### Device Description The Iconix® HA*TM Anchor is comprised of a suture sleeve structure and working suture. Nonabsorbable braided ultra-high molecular weight polyethylene (UHMWPE) sutures are spliced through a suture anchor sleeve comprised of non-absorbable braided polyester and bioceramics. Up to two non- absorbable round or flat braided UHMWPE working sutures can be added inside the suture anchor sleeve. The UHMWPE sutures are available undyed (white) and black. Sutures supplied meet United States Pharmacopeia (USP) requirements for non-absorbable suture except for diameter. Suture dyes are FDA approved. The inserter is comprised of a metallic shaft with over molded handle. The device is sterilized by ethylene oxide gas and is provided sterile for single use. Iconix® HA*M Anchors are available in common sizes and lengths and will be sold sterile for single use with no components or accessories. The device is intended for use in a hospital/clinic/surgical setting. The classification for the Iconix® HA*™ 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® HA*TM 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® HA*™ Anchor meet requirements established by the United States Pharmacopeia (USP), except for diameter. The UHMWPE sutures are tested per USP performance requirements for tensile strength. {6}------------------------------------------------ # RIVERPOINT 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® HA+TM Anchor included a 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 I: 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. Endotoxin/pyrogenicity testing was performed per ANSI/AAMI ST72:2019, USP <161>, USP <151> and USP <85>. Non-clinical mechanical testing was performed to verify the fixation strength of the Iconixe HA+1M Anchor using insertion, cyclic and pullout testing as compared to the predicate device. Results of performance testing for the Iconix® HA*™ Anchor device concluded that the device performed comparably to the predicate device and to other currently marketed All-Suture anchor devices in insertion, cyclic and pullout testing and the validations performed demonstrated that the Iconix® HA*1M Anchor met all requirements for its intended use. An animal study was performed to evaluate the biological safety associated with the Iconix® HA*TM Anchor. The animal study demonstrated substantially equivalent biological safety and in vivo performance. #### Substantial Equivalence and Comparison of Technical Characteristics The Iconix® HA *TM Anchor is substantially equivalent to the previously cleared ICONIX XBraid TT Suture Anchor cleared per K173074 "predicate device." The Iconix® HA*110 Anchor has the same intended use, same principles of operation, and similar technological characteristics as the predicate device. The Iconix® HA+™ Anchor "subject device" contains slight technological differences and indications statement from the predicate device but are within the range of currently marketed devices, and they have been assessed through risk analysis, not raising any new questions of safety or effectiveness. Therefore, the Iconix® HA*™ Anchor "subject device" is substantially equivalent to the predicate device in both technological characteristics and intended use and does not raise any issues of safety or effectiveness. | | Riverpoint Medical Iconix® HA+TM Anchor "Subject Device" | Stryker ICONIX XBraid TT Suture Anchor "Predicate Device" (K173074) | |------------------------|-----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------| | Intended Use | The Iconix® HA+TM Anchors are indicated for use in soft tissue to bone fixation. | The Stryker ICONIX Xbraid TT with needles devices are intended to be used for soft-tissue to bone fixation. | | Principle of Operation | Preparation of pilot hole, manual insertion of inserter and deployment of anchor. | Preparation of pilot hole, manual insertion of inserter and deployment of anchor. | | Suture Materials | UHMWPE | UHMWPE | {7}------------------------------------------------ # RPOINT | | Riverpoint Medical Iconix® HA+TM Anchor "Subject Device" | Stryker ICONIX XBraid TT Suture Anchor "Predicate Device" (K173074) | |----------------------------------------------|----------------------------------------------------------------------|---------------------------------------------------------------------------| | Range of Suture Size | For the 1.4mm anchor: 1.2mm, #2 For the 2.3mm anchor: 1.8mm or #2 | For the 1.4mm anchor: 1.2mm, #2 For the 2.3mm anchor: 1.8mm or #2 | | Anchor Materials | Polyester with bioceramics | Polyester | | Anchor Geometry | Cylindrical sleeve | Cylindrical sleeve | | Anchor Sizes | 1.4mm and 2.3mm | 1.4mm and 2.3mm | | Method of Fixation of Suture to Anchor | Splicing of suture through anchor | Splicing of suture through anchor | | Inserter Material | Stainless steel with polymer handle | Stainless steel with polymer handle | | Regulation Number | 888.3040 | 888.3040 | | Regulatory Class | II | II | | Prescription or OTC | Prescription | Prescription | | Product Code | MBI | MBI | | Packaging | Tyvek/Poly Pouch | Tyvek/Poly Pouch | | Sterilization | EtO Sterilization | EtO Sterilization | ### Conclusion The information provided in this Traditional 510(k) demonstrates that the Iconix® HA+TM Anchor is substantially equivalent to the predicate device.