(53 days)
Argo Knotless® GENESYS™ SP Anchor
The biocomposite suture anchor is intended to reattach soft tissue to bone in orthopedic surgical procedures. The Argo Knotless® GENESYS™ SP 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 damaqed soft tissue, in conjunction with appropriate postoperative immobilization throughout the healing period.
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.
Argo Knotless® GENESYS ™ SP Anchor: The Self-Punching (SP) Argo Knotless® GENESYS™ Anchor is an implantable bone anchor, that is supplied for single use, sterilized via ethylene oxide (ETO) to a SAL of 10 °. The threaded anchor is manufactured of bioabsorbable material, and the broaching tip (suture eyelet) is manufactured of titanium material. Each size features a single-use driver, the threaded anchor, a Titanium suture eyelet, a UHMWPE 1.0mm non-absorbable retention suture, and loader tab. The retention suture holds the titanium eyelet in place on the driver assembly and can be incorporated into the repair if desired. The suture eyelet can hold up to six (6) sutures.
Argo Knotless® GENESYS ™ Anchor: The Non-Self-Punching 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 anchor configuration requires a pre-prepared bone hole. The threaded anchor is manufactured of bioabsorbable material, and the suture eyelet is manufactured of PEEK material. Each size features a single use driver, a threaded anchor, a PEEK suture 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. These anchor configurations require a pre-prepared bone hole which can be created with Class I, Exempt instrumentation.
Argo Knotless® GENESYS ™ Anchor: The Preloaded 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 material. The eyelet is held on with a #2 UHMWPE, nonabsorbable retention suture and supplied with either a white/black or blue/blue colored non-absorbable Hi-Fi suture tape, a retention suture, and loader tab. These anchor configurations require a pre-prepared bone hole which can be created with Class I, Exempt instrumentation.
Principle of Operation - soft tissue to bone fixation
This document is an FDA 510(k) clearance letter and summary for a medical device (Argo Knotless GENESYS Anchor). It does not describe a study involving an AI/software as a medical device (SaMD) or diagnostic imaging. Therefore, the requested information about acceptance criteria, study design, ground truth establishment, and human-in-the-loop performance is not applicable to this document.
The document focuses on demonstrating substantial equivalence of a physical medical device (suture anchor) to a previously cleared predicate device. The "Performance Data" section lists various engineering and material tests conducted on the physical device, not clinical performance or diagnostic accuracy studies.
Here's why the questions are not applicable:
- No AI/Software Component: The device described is a physical implantable suture anchor, not an AI or software-based diagnostic tool.
- No Diagnostic Performance: The performance data mentioned (e.g., "Performance Testing," "Magnetic Resonance," "Transportation," "Corrosion Susceptibility") relate to the mechanical, material, and sterility aspects of the anchor, not its diagnostic accuracy in interpreting images or data.
- No Human Reader Interaction: There's no scenario where human readers (like radiologists) would "improve with AI vs. without AI assistance" as this is not an imaging or diagnostic AI product.
- No Ground Truth for AI: Ground truth for a physical device like a suture anchor is typically established through engineering specifications, material properties, and in-vitro or in-vivo (animal or human cadaver) biomechanical testing, not through expert consensus on images or pathology.
Therefore, I cannot populate the table or answer the specific questions related to AI/SaMD performance criteria, study design, and ground truth. The provided text simply doesn't contain that type of information.
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March 5, 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
CONMED Corporation Dionne Sanders, MS, CQA, RAC Senior Manager, Regulatory Affairs Orthopedics Division 525 French Road Utica, New York 13502
Re: K240090
Trade/Device Name: Argo Knotless GENESYS Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MAI, MBI Dated: January 10, 2024 Received: January 12, 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 (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"
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(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 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 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
Jesse Muir, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices
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Enclosure
Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
Submission Number (if known)
Device Name
Argo Knotless GENESYS Anchor
Indications for Use (Describe)
Argo Knotless® GENESYS™ SP Anchor
The biocomposite suture anchor is intended to reattach soft tissue to bone in orthopedic surgical procedures. The Argo Knotless® GENESYS™ SP 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 damaqed soft tissue, in conjunction with appropriate postoperative immobilization throughout the healing period.
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.
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 ™ SP Anchor Argo Knotless® GENESYS TM 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 of Safety and Effectiveness for 510(k) Number - K240090.
l. SUBMITTER
Manufacturer: CONMED Corporation 525 French Road Utica, NY 13502
Official Contact Person: Dionne Sanders, MS, CQA, RAC 525 French Road Utica, NY 13502 (0) 813-997-8126
Date Prepared: March 1, 2024
II. DEVICE NAME
Device Name:
Classification Name:
Regulatory Class: Product Codes:
Argo Knotless® GENESYS ™ SP Anchor, models SPKx Argo Knotless® GENESYS TM Anchor, models KBCx Fasteners, Fixation, Biodegradable, Soft Tissue Fasteners, Fixation, Nondegradable, Soft Tissue Class II, per 21 CFR Part 888.3030; 888.3040 MAI, MBI
III. PREDICATE DEVICE
| Device Name: | Argo Knotless™ SP Anchors |
|---|---|
| Company Name: | CONMED Corporation |
| 510(k) #: | K220757 |
REFERENCE DEVICE
Device Name:
CrossFT Knotless Biocomposite Suture Anchor with Disposable Driver CONMED Corporation K170501
Company Name 510(k)#:
IV. DEVICE DESCRIPTION
Argo Knotless® GENESYS ™ SP Anchor: The Self-Punching (SP) Argo Knotless® GENESYS™ Anchor is an implantable bone anchor, that is supplied for single use, sterilized via ethylene
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oxide (ETO) to a SAL of 10 °. The threaded anchor is manufactured of bioabsorbable material, and the broaching tip (suture eyelet) is manufactured of titanium material. Each size features a single-use driver, the threaded anchor, a Titanium suture eyelet, a UHMWPE 1.0mm non-absorbable retention suture, and loader tab. The retention suture holds the titanium eyelet in place on the driver assembly and can be incorporated into the repair if desired. The suture eyelet can hold up to six (6) sutures.
Argo Knotless® GENESYS ™ Anchor: The Non-Self-Punching 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 anchor configuration requires a pre-prepared bone hole. The threaded anchor is manufactured of bioabsorbable material, and the suture eyelet is manufactured of PEEK material. Each size features a single use driver, a threaded anchor, a PEEK suture 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. These anchor configurations require a pre-prepared bone hole which can be created with Class I, Exempt instrumentation.
Argo Knotless® GENESYS ™ Anchor: The Preloaded 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 material. The eyelet is held on with a #2 UHMWPE, nonabsorbable retention suture and supplied with either a white/black or blue/blue colored non-absorbable Hi-Fi suture tape, a retention suture, and loader tab. These anchor configurations require a pre-prepared bone hole which can be created with Class I, Exempt instrumentation.
Principle of Operation - soft tissue to bone fixation
V. INTENDED USE/ INDICATIONS FOR USE
Argo Knotless® GENESYS™ SP Anchor
The biocomposite suture anchor is intended to reattach soft tissue to bone in orthopedic surgical procedures.
The Argo Knotless® GENESYS™ SP 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 suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization throughout the healing period.
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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™ SP Anchor | |
| 510k Number | TBD | K220757 |
| IntendedUse/Indicationsfor Use | Argo Knotless® GENESYS™ SP AnchorThe biocomposite suture anchor isintended to reattach soft tissue tobone in orthopedic surgicalprocedures.The Argo Knotless® GENESYS™ SPAnchor may be used in eitherarthroscopic or open surgicalprocedures. After the suture isanchored to the bone, it may be usedto reattach soft tissue, such asligaments, tendons, or joint capsulesto the bone. The suture anchorsystem thereby stabilizes thedamaged soft tissue, in conjunctionwith appropriate postoperativeimmobilization throughout thehealing period.Argo Knotless® GENESYS™ AnchorThe biocomposite suture anchor isintended to reattach soft tissue tobone in orthopedic surgicalprocedures. | The non-absorbable suture anchorsare intended to reattach soft tissue tobone in orthopedic surgicalprocedures.The CONMED Argo Knotless™ SPAnchors may be used in eitherarthroscopic or open surgicalprocedures. After the suture isanchored to the bone, it may be usedto reattach soft tissue, such asligaments, tendons, or joint capsulesto the bone. The suture anchorsystem thereby stabilizes thedamaged tissue, in conjunction withappropriate postoperativeimmobilization throughout thehealing period. |
| Proposed Device | Predicate Device | |
| The Argo Knotless® GENESYS™ Anchormay be used in either arthroscopic oropen surgical procedures. After thesuture is anchored to the bone, it maybe used to reattach soft tissue, suchas ligaments, tendons, or jointcapsules to the bone. The sutureanchor system thereby stabilizes thedamaged soft tissue, in conjunctionwith appropriate postoperativeimmobilization throughout thehealing period. | ||
| How Supplied | Sterile Anchor on a delivery driver | |
| Single Use/Reusable | Single-Use Only | |
| Sterilization | Device sterilized via Ethylene Oxide Sterilization - SAL (10-6) | |
| Shelf-Life | 18-months | |
| Principle ofOperation | Soft tissue to bone fixation | |
| Biocompatibility | In accordance with ISO 10993-1 and FDA# G95-1 | |
| Dimensions(Diameter XLength) | 4.75mm X 11.5"5.5mm X 11.5" | 4.75mm X 11.5"5.5mm X 11.5" |
| Design | (1) Self-punching anchor(2) Non-self-punching anchor(3) Non-self-punching, fully loadedanchor | Self-punching anchor |
| Packaging | Packaged as a single-unit device | |
| Instrumentation | Class 1, Exempt instrumentation for initiating a bone hole. | |
| Suture | White/Blue: White Hi-Fi non-absorbable braided, UHMWPE ribbonwith polyester tracer and D&C Blue #6Black #2 Suture: UHMWPE with 1%black (D&C Black #4) colorantWhite/Blue/Black #2 Suture: WhiteUHMWPE, silicone coatedmultifilament nylon tracer with black | White UHMWPE, with polyester dyedwith D&C Blue #6 |
| Proposed Device | Predicate Device | |
| (logwood) colorant and multifilamentpolyester tracer with D&C blue no. 6colorant. | ||
| Blue/Black #2 Suture: UHMWPE withblue (chromium-cobalt aluminum-oxide) and black with D&C Black #4)colorants | ||
| White/Black Tape: White UHMWPEwith a silicone coated multifilamentnylon tracer with black (logwood)colorant. | ||
| Blue/Blue Tape: UHMWPE with D&Cblue no. 6 colorant and multifilamentpolyester tracer with D&C blue no. 6colorant. | ||
| Materials | Anchor: Bioabsorbable threadedanchor with either a PEEK, orTitanium Tip.Suture: see suture sectionDriver: Stainless SteelDriver Handle: Polycarbonate, ABS,RadelThreader: ABS, nitinol, stainless steel | Anchor: Titanium Tip; PEEKSuture: see suture sectionDriver: Stainless SteelDriver Handle: Polycarbonate, ABS,RadelThreader: ABS, nitinol, stainless steel |
| MR Compatibility | MR ConditionalMR Safe | MR Conditional |
| PerformanceTesting | ReliabilityCyclic LoadingInsertionFixation |
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VII. PERFORMANCE DATA
1
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.
| • Performance Testing | • Magnetic Resonance |
|---|---|
| • Transportation | • Corrosion Susceptibility |
| • Shelf-life | • Pyrogen (Bacterial Endotoxin) testing plan |
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| • | Biocompatibility | • Degradation |
|---|---|---|
| • | Packaging (Transportation and Shelf-life) | |
| • | Sterilization | |
| • | User Validation | |
| • | Packaging and Labeling User Validation |
VIII. CONCLUSION
The Argo Knotless® GENESYS™ Anchor is substantially equivalent in design, intended use, performance testing, transportation, packaging, biocompatibility, sterilization, shelf-life, and principle of operation. The technological differences in materials of manufacture, and the various anchor configurations do not raise any questions of safety and effectiveness and is as safe and effective as the legally marketed predicate device.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
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.(b)
Classification. Class II.