(32 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and surgical application of a physical implant, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as an implantable bone anchor used to reattach soft tissue to bone in orthopedic surgical procedures, stabilizing damaged soft tissue to aid healing, which aligns with the definition of a therapeutic device.
No.
Explanation: The device description and intended use clearly state that it is a surgical implant designed to reattach soft tissue to bone, not to diagnose medical conditions.
No
The device description clearly states it is an implantable bone anchor made of bioabsorbable material and PEEK Optima, and includes hardware components like a driver, threaded anchor, eyelet, and suture. It is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "reattach soft tissue to bone in orthopedic surgical procedures." This is a surgical implant used directly on the patient's body during a procedure.
- Device Description: The device is described as an "implantable bone anchor." This further confirms its use within the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a patient's health. This device does not perform any such diagnostic testing on specimens.
Therefore, the Argo Knotless® GENESYS™ Anchor is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
MAI, MBI
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue to bone
Indicated Patient Age Range
Not Found
Intended User / Care Setting
orthopedic surgical procedures
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Testing (Insertion, Cyclic and Ultimate Pull Displacement Resistance)
User Validation (Cadaver Medial Collateral Ligament/Lateral Ligament)
Packaging and Labeling User Validation
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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.
1
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
2
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 Tissue |
| Fasteners, 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 SPKx |
| Argo 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.
5
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 |
| Intended | ||
| Use/Indications for | ||
| Use | Same | 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. |
| Contraindications | 1. Pathological conditions of bone
which would adversely affect the
Argo Knotless® GENESYS™ Anchor.
2. Pathological conditions in the
soft tissue to be repaired or
reconstructed which would
adversely affect suture fixation.
3. Physical conditions that would
eliminate, or tend to eliminate,
adequate implant support or
retard healing.
4. Conditions which tend to limit
the patient's ability or willingness
to restrict activities or follow | 1. Pathological conditions of bone which would
adversely affect the Argo Knotless® GENESYS™
Anchor.
2. Pathological conditions in the soft tissue to be
repaired or reconstructed which would
adversely affect suture fixation.
3. Physical conditions that would eliminate, or
tend to eliminate, adequate implant support or
retard healing.
4. Conditions which tend to limit the patient's
ability or willingness to restrict activities or
follow directions during the healing period.
5. Direct attachment of artificial ligaments or
other implants |
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| Proposed Device | Predicate Device | |
|---|---|---|
| directions during the healing | ||
| period. |
- Direct attachment of artificial
ligaments or other implants
except for bioresorbable
reinforced implants. - Foreign body sensitivity, known
or suspected allergies to implant
and/or instrument materials. - This device is not approved for
screw attachment or fixation to
the posterior elements (pedicles)
of the cervical, thoracic or lumbar
spine. | 6. Foreign body sensitivity, known or suspected
allergies to implant and/or instrument materials. - This device is not approved for screw
attachment or fixation to the posterior elements
(pedicles) of the cervical, thoracic or lumbar
spine. |
| 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 of
Operation | 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 anchor
Non-self-punching anchor
Non-self-punching, fully loaded anchor |
| Packaging | Same | Packaged as a single-unit device |
| Instrumentation | Same, with addition of reamer and
drill guide | Class 1, Exempt instrumentation for initiating a
bone hole. |
| Use with
resorbable 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.