← Product Code [MBI](/productcode/MBI) · K262677 # Iconix Knotless T (K262677) _Riverpoint Medical · MBI · Aug 27, 2026 · Orthopedic · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K262677 ## Device Facts - **Applicant:** Riverpoint Medical - **Product Code:** [MBI](/productcode/MBI.md) - **Decision Date:** Aug 27, 2026 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 888.3040 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Indications for Use The Iconix Knotless T is 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 ReconstructionShoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral RepairHand/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 RepairFoot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus Reconstruction, Digital Tendon Transfers, Mid-foot ReconstructionKnee: 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 RepairHip: Capsular Repair, Acetabular Labral Repair, Gluteal Tendon Repair, Proximal Hamstring Repair ## Device Story Soft-tissue to bone fixation device; push-in design; preloaded on disposable inserter. Composed of braided polyester anchor body; contains working repair strand and shuttle strand for tissue manipulation. Used in hospital/clinic/surgical settings by surgeons. Inserter features metallic shaft with over-molded handle. Device facilitates secure attachment of tendons/ligaments to bone; aids in orthopedic repairs (e.g., rotator cuff, ligament reconstruction). Benefits patient through stable fixation during healing process. ## Clinical Evidence Bench testing only. Included shelf-life, sterilization validation, biocompatibility (ISO 10993-1:2025), packaging stability (ISO 11607-1:2019), and usability engineering (EN 62366-1:2015/AMD1:2020) in cadaveric models. Mechanical testing (insertion, cyclic, pullout) demonstrated performance comparable to predicate device. ## Technological Characteristics Push-in anchor; braided polyester anchor body; UHMWPE sutures (USP compliant except diameter). Sizes: 1.4mm or 2.3mm. Inserter: metallic shaft with over-molded handle. Sterilization: ethylene oxide gas. Single-use. Mechanical fixation principle. ## Regulatory 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 - Knotless Suture Anchor ([K231278](/device/K231278.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} **U.S. FOOD & DRUG** ADMINISTRATION August 27, 2026 Riverpoint Medical Brice Biggins Regulatory Affairs Associate 825 NE 25th Ave. Portland, Oregon 97232 Re: K262677 Trade/Device Name: Iconix Knotless T Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: July 30, 2026 Received: July 30, 2026 Dear Brice Biggins: 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" U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K262677 - Brice Biggins Page 2 (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). Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3). 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 (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-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (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. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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). {2} K262677 - Brice Biggins Page 3 Sincerely, Christopher Ferreira, M.S. 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 {3} | Indications for Use | | | | --- | --- | --- | | Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K262677 | ? | | Please provide the device trade name(s). | | ? | | Iconix Knotless T | | | | Please provide your Indications for Use below. | | ? | | The Iconix Knotless T is 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 ReconstructionShoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral RepairHand/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 RepairFoot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus Reconstruction, Digital Tendon Transfers, Mid-foot ReconstructionKnee: 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 RepairHip: Capsular Repair, Acetabular Labral Repair, Gluteal Tendon Repair, Proximal Hamstring Repair | | | | Please select the types of uses. | Prescription Use (21 CFR 801 Subpart D)Over-The-Counter Use (21 CFR 801 Subpart C) | ? | | Please select the age group(s) for which the device(s) is to be used. | Neonates/Newborns (Birth to < 29 days old)Infants (29 days old to < 2 years old)Children (2 years old to < 12 years old)Adolescents (12 years old to < 22 years old)Adults (22 years old and greater) | ? | {4} K262677 Page 1 of 3 RP RIVERPOINT ### 510(k) SUMMARY ### Iconix Knotless T ### 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: Brice Biggins (503) 517-8001 Date of Preparation: July 30, 2026 ### Device Name Trade Name: Iconix Knotless T Common or Usual Names: Fastener, Fixation, Nondegradable, Soft Tissue. Classification Name: 21 CFR 888.3040: 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 K231278 – Knotless Suture Anchor No reference devices were used in this submission. {5} K262677 Page 2 of 3 **RP RIVERPOINT** ## Device Description The Iconix Knotless T is a soft-tissue to bone fixation device with a push-in design, provided preloaded on a disposable inserter. The Iconix Knotless T is composed of a braided polyester anchor body that contains one working suture, also referred to as the repair strand, and a shuttle strand that is used to shuttle the repair strand around tissue and through the braided anchor body. Sutures supplied meet United States Pharmacopeia (USP) requirements for non-absorbable suture except for diameter. Suture dyes are FDA approved. The 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 size of the anchor of the Subject Device is either 1.4mm or 2.3mm. Iconix Knotless T 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 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 Knotless T is 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 Knotless Anchor meet requirements established by the {6} K262677 Page 3 of 3 RP RIVERPOINT United 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 Knotless T included shelf-life testing, sterilization adoption validation, biocompatibility testing in compliance with ISO10993- 1:2025 - Biological Evaluation of Medical Devices, stability testing on the product packaging per ISO 11607-1:2019 - 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 EN62366-1:2015/AMD1:2020- 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 Knotless 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 Knotless Anchor met all requirements for its intended use. ### Substantial Equivalence and Comparison of Technical Characteristics The Iconix Knotless T is substantially equivalent to the previously cleared Knotless Suture Anchor per K231278 “Predicate Device.” The Iconix Knotless T has the same intended use, indications for use and same principles of operation as the Predicate Device. Both the Iconix Knotless T and the Predicate Device are packaged using the same packaging materials and sterilized using the same processes. The only difference between the subject device and the predicate device is in technological characteristics, specifically in materials of construction. However, the technological characteristics 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 Knotless T “Subject Device” is substantially equivalent to the “predicate device” and does not raise any issues of safety or effectiveness. ### Conclusion The information provided in this Special 510(k) demonstrates that the Iconix Knotless T is substantially equivalent to the predicate device. --- **Source:** [https://fda-staging.innolitics.com/device/K262677](https://fda-staging.innolitics.com/device/K262677) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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