(32 days)
The biocomposite suture anchor is intended to reattach soft tissue to bone in orthopedic surgical procedures. The Argo Knotless® GENESYS™ Anchor may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. The suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization throughout the healing period.
The Argo Knotless® GENESYS™ Anchor is an implantable bone anchor, that is supplied single use, sterilized via ethylene oxide (ETO) to a SAL of 10 °. The threaded anchor is manufactured of bioabsorbable material, and the suture eyelet is manufactured of PEEK Optima material. The device features a single use driver, a threaded anchor, a PEEK-Optima eyelet, a #2 UHMWPE, non-absorbable retention suture, and loader tab. The retention suture holds the PEEK eyelet in place on the driver and can be incorporated into the repair if desired. The suture eyelet can hold up to six (6) sutures or one (1) bioresorbable reinforced implant. These anchor configurations require a pre-prepared bone hole which can be created with Class I, Exempt instrumentation.
The provided text is a 510(k) Summary for the Argo Knotless® GENESYS™ Anchor, a medical device. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and study results in the format typically found in clinical trial reports for software devices.
Based on the information provided, here's what can be extracted and what is not present:
Missing Information:
The document does not describe acceptance criteria in the typical statistical sense (e.g., specific thresholds for sensitivity, specificity, or other performance metrics). It also does not describe a study that proves the device meets these types of acceptance criteria. The performance data mentioned refers to mechanical testing and user validation, not a clinical study to establish analytical or clinical performance of an AI/software device.
Therefore, the following points cannot be answered from the provided text:
- A table of acceptance criteria and the reported device performance: Not provided in terms of statistical performance metrics.
- Sample sized used for the test set and the data provenance: Not applicable in the context of AI/software performance. The "test set" here refers to mechanical testing or cadaveric validation.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This device is a physical bone anchor, not an AI/software product that assists human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable for an AI/software performance study. For the mechanical and user validation tests, the "ground truth" would be the physical properties or user feedback.
- The sample size for the training set: Not applicable as this is not an AI/software device.
- How the ground truth for the training set was established: Not applicable.
What is present in the document about performance and validation:
The document briefly mentions "performance data" in Section VII, but this refers to mechanical and user validation for a physical medical device.
1. Acceptance Criteria and Reported Device Performance (As implied for a physical device, not statistical AI performance):
While not explicitly stated as "acceptance criteria," the document indicates that the device's performance was evaluated to demonstrate substantial equivalence to its predicate. The implied acceptance criterion is that the new device performs as intended and similarly to the predicate device in terms of mechanical properties and user experience.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Performance as intended (mechanical stability, insertion, pull-out) | Performance Testing (Insertion, Cyclic and Ultimate Pull Displacement Resistance) completed. |
| User validation for surgical procedures | User Validation (Cadaver Medial Collateral Ligament/Lateral Ligament) completed. |
| Packaging and labeling suitability | Packaging and Labeling User Validation completed. |
2. Study that proves the device meets the (implied) acceptance criteria:
The study refers to a variety of tests and validations performed:
- Performance Testing: This would typically involve laboratory tests to measure parameters like insertion force, resistance to cyclic loading, and ultimate pull-out strength. The document doesn't provide specific quantitative results but states these tests were "completed."
- User Validation (Cadaver Medial Collateral Ligament/Lateral Ligament): This indicates hands-on testing of the device's usability and effectiveness in a cadaveric model, simulating surgical conditions for the intended use (reattaching soft tissue to bone).
- Packaging and Labeling User Validation: This would involve confirming that the packaging maintains sterility and integrity, and that the labeling is clear and accurate for users.
Data Provenance and Sample Size for Test Set:
- Sample Size: The specific sample sizes for these tests (e.g., number of anchors tested, number of cadavers, number of users for validation) are not provided in this summary.
- Data Provenance: Not specified, but generally, such performance and cadaveric testing would be conducted in a laboratory or simulated surgical environment. It is not "data" in the sense of patient records from a specific country.
In summary, the provided document is a regulatory submission for a physical medical device. It does not contain the specific information requested about acceptance criteria and study design as it pertains to the performance validation of an AI/software device.
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Image /page/0/Picture/0 description: The image contains the logo for 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, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
January 28, 2025
ConMed Corporation Dionne Sanders Sr. Manager, Regulatory Affairs 525 French Road Utica, New York 13502
Re: K244025
Trade/Device Name: Argo Knotless GENESYS 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, MBI Dated: December 24, 2024 Received: December 27, 2024
Dear Dionne Sanders:
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 (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.
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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).
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 QS 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.
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-device-advicecomprehensive-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-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-regulatory
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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).
Sincerely,
CHRISTOPHER FERREIRA -S
Christopher Ferriera, MS 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)
Device Name
Argo Knotless® GENESYSTM Anchor
Indications for Use (Describe)
Argo Knotless® GENESYSTM Anchor
The biocomposite suture anchor is intended to reattach soft tissue to bone in orthopedic surgical procedures.
The Argo Knotless® GENESYS™ Anchor may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. The suture anchor system thereby stabilizes the damaged soft tissue. in conjunction with appropriate postoperative immobilization throughout the healing period.
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 Argo Knotless® GENESYS ™ Anchor
In accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92, CONMED Corporation is hereby submitting the 510(k) Summary for K244025.
l. SUBMITTER
Manufacturer: CONMED Corporation 525 French Road Utica, NY 13502
Official Contact Person: Dionne Sanders, JM, MS, CQA, RAC 525 French Road Utica, NY 13502 (O) 813-997-8126
Date Prepared: December 24, 2024
II. DEVICE NAME
III.
| Device Name: | Argo Knotless® GENESYS ™ Anchor |
|---|---|
| Classification Name: | Fasteners, Fixation, Biodegradable, Soft TissueFasteners, Fixation, Nondegradable, Soft Tissue |
| Regulatory Class: | Class II, per 21 CFR Part 888.3030; 888.3040 |
| Product Codes: | MAI, MBI |
| PREDICATE DEVICE | |
| Device Name: | Argo Knotless® GENESYS ™ SP Anchor, models SPKxArgo Knotless® GENESYS ™ Anchor, models KBCx |
| Company Name: | CONMED Corporation |
IV. DEVICE DESCRIPTION
Argo Knotless® GENESYS ™ Anchor: The Argo Knotless® GENESYS™ Anchor is an implantable bone anchor, that is supplied single use, sterilized via ethylene oxide (ETO) to a SAL of 10 °. The threaded anchor is manufactured of bioabsorbable material, and the suture eyelet is manufactured of PEEK Optima material. The device features a single use driver, a threaded anchor, a PEEK-Optima eyelet, a #2 UHMWPE, non-absorbable retention suture, and loader tab. The retention suture holds the PEEK eyelet in place on the driver and can be incorporated into the repair if desired. The suture eyelet can hold up to six (6) sutures or one (1) bioresorbable reinforced implant. These anchor configurations require a pre-prepared bone hole which can be created with Class I, Exempt instrumentation.
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V. INTENDED USE/ INDICATIONS FOR USE
Argo Knotless® GENESYS™ Anchor
The biocomposite suture anchor is intended to reattach soft tissue to bone in orthopedic surgical procedures.
The Argo Knotless® GENESYS™ Anchor may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. The suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization throughout the healing period.
VI. COMPARISON OF THE TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
A summary of the technological characteristics between the proposed and the predicate device is provided.
| Proposed Device | Predicate Device | |
|---|---|---|
| Argo Knotless® GENESYS™ Anchor | Argo Knotless® GENESYS™ Anchor | |
| 510k Number | K244025 | K240090 |
| IntendedUse/Indications forUse | Same | Argo Knotless® GENESYS™ AnchorThe biocomposite suture anchor is intended toreattach soft tissue to bone in orthopedicsurgical procedures.The Argo Knotless® GENESYS™ Anchor may beused in either arthroscopic or open surgicalprocedures. After the suture is anchored to thebone, it may be used to reattach soft tissue,such as ligaments, tendons, or joint capsules tothe bone. The suture anchor system therebystabilizes the damaged soft tissue, inconjunction with appropriate postoperativeimmobilization throughout the healing period. |
| Contraindications | 1. Pathological conditions of bonewhich would adversely affect theArgo Knotless® GENESYS™ Anchor.2. Pathological conditions in thesoft tissue to be repaired orreconstructed which wouldadversely affect suture fixation.3. Physical conditions that wouldeliminate, or tend to eliminate,adequate implant support orretard healing.4. Conditions which tend to limitthe patient's ability or willingnessto restrict activities or follow | 1. Pathological conditions of bone which wouldadversely affect the Argo Knotless® GENESYS™Anchor.2. Pathological conditions in the soft tissue to berepaired or reconstructed which wouldadversely affect suture fixation.3. Physical conditions that would eliminate, ortend to eliminate, adequate implant support orretard healing.4. Conditions which tend to limit the patient'sability or willingness to restrict activities orfollow directions during the healing period.5. Direct attachment of artificial ligaments orother implants |
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| Proposed Device | Predicate Device | |
|---|---|---|
| directions during the healingperiod.5. Direct attachment of artificialligaments or other implantsexcept for bioresorbablereinforced implants.6. Foreign body sensitivity, knownor suspected allergies to implantand/or instrument materials.7. This device is not approved forscrew attachment or fixation tothe posterior elements (pedicles)of the cervical, thoracic or lumbarspine. | 6. Foreign body sensitivity, known or suspectedallergies to implant and/or instrument materials.7. This device is not approved for screwattachment or fixation to the posterior elements(pedicles) of the cervical, thoracic or lumbarspine. | |
| How Supplied | Same | Sterile Anchor on a delivery driver |
| Single Use/Reusable | Same | Single-Use Only |
| Sterilization | Same | ETO |
| Shelf-Life | Same | 18-months |
| Principle ofOperation | Same | Soft tissue to bone fixation |
| Biocompatibility | Same | In accordance with ISO 10993-1 and FDA# G95-1 |
| Design | Non-self-punching anchor | Self-punching anchorNon-self-punching anchorNon-self-punching, fully loaded anchor |
| Packaging | Same | Packaged as a single-unit device |
| Instrumentation | Same, with addition of reamer anddrill guide | Class 1, Exempt instrumentation for initiating abone hole. |
| Use withresorbable implant | Yes | Specific SKU |
VII. PERFORMANCE DATA
Testing and analysis have been completed to demonstrate that the Argo Knotless® GENESYS™ Anchor performs as intended and is substantially equivalent to the predicate device. Additional evaluation for this modification includes the following.
- . Performance Testing (Insertion, Cyclic and Ultimate Pull Displacement Resistance)
- User Validation (Cadaver Medial Collateral Ligament/Lateral Ligament)
- Packaging and Labeling User Validation
VIII. CONCLUSION
The Argo Knotless® GENESYS™ Anchor is substantially equivalent in design, intended use, performance, and fundamental principle of operation. There are no additional questions of safety and effectiveness.
§ 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.