(59 days)
Not Found
No
The document describes a mechanical suture anchor and does not mention any software, algorithms, or data processing related to AI/ML.
No
The device is described as a non-absorbable suture anchor intended to reattach soft tissue to bone, stabilize damaged tissue, and aid in healing. This function is structural and mechanical, supporting the body's natural healing processes rather than treating a disease or condition itself.
No
The device is described as a non-absorbable suture anchor intended to reattach soft tissue to bone in orthopedic surgical procedures. It is a fixation device, not one that identifies or analyzes medical conditions.
No
The device description clearly states it is a physical device made of titanium and PEEK materials, intended for surgical implantation. It is 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 for structural support and fixation.
- Device Description: The description details a physical implant made of titanium and PEEK, designed for mechanical fixation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are typically used in laboratories or point-of-care settings to analyze biological samples. This device is clearly a surgical tool and implant.
N/A
Intended Use / Indications for Use
The non-absorbable suture anchor is intended to reattach soft tissue to bone in orthopedic surgical procedures.
The Argo Knotless™ 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 damaged tissue, in conjunction with appropriate postoperative immobilization throughout the healing period.
Product codes (comma separated list FDA assigned to the subject device)
MBI
Device Description
The Argo Knotless™ SP Anchor is a soft tissue to bone fixation device that consists of a titanium tip with an eyelet to thread suture through, and a threaded anchor body, manufactured of PEEK material. The anchor design includes a 1.0mm UHMWPE Hi-Fi™ retention ribbon which secures the titanium tip to the delivery system and to the retention suture cleat.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone (for reattaching soft tissue)
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 Reliability Ultimate Fixation Strength Insertion Torque Cyclic Testing
Validation User Validation Packaging and Transportation Labeling Sterilization
Well-established Method Testing Pyrogen (Bacterial Endotoxin) Biocompatibility Shelf-life MR Safety Testing
The Argo Knotless™ SP Anchor is either substantially equivalent or identical in intended use, principles of operation, performance testing results, packaging, sterilization method, and biocompatibility as the predicate CrossFT Knotless Suture Anchors. Based upon the findings of our performance testing, the differences present no new issues of safety and effectiveness, and the Argo Knotless™ SP Anchors are substantially equivalent to the predicate device, CrossFT Knotless Suture Anchors (K163248).
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
May 13, 2022
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
CONMED Corporation Dionne Sanders, MS, CQA, RAC Senior Manager, Regulatory Affairs 525 French Road Utica, New York 13502
Re: K220757
Trade/Device Name: Argo Knotless™ SP Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: March 10, 2022 Received: March 15, 2022
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 (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 located 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.
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 803) for
1
devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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.
For:
Laura C. Rose, 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
Enclosure
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Indications for Use
510(k) Number (if known) K220757
Device Name Argo Knotless™ SP Anchor
Indications for Use (Describe)
The non-absorbable suture anchor is intended to reattach soft tissue to bone in orthopedic surgical procedures.
The Argo Knotless™ 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 damaged 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
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 K220757.
I. SUBMITTER
Manufacturer: CONMED Corporation 525 French Road Utica, NY 13502
Official Contact Person: Dionne Sanders, MS, CQA, RAC 525 French Road Utica, NY 13502 (O) 813-997-8126
Date Prepared: May 13, 2022
II. DEVICE NAME
| Device Name: | Argo Knotless™ SP Anchor |
|---|---|
| Classification Name: | Smooth Or Threaded Metallic Bone Fixation Fastener |
| Regulatory Class: | Class II, per 21 CFR Part 888.3040 |
| Product Codes: | MBI |
III. PREDICATE/ LEGALLY MARKETED DEVICE
| Device Name: | CrossFT Knotless Suture Anchor |
|---|---|
| Company Name: | CONMED Corporation |
| 510(k) #: | K163258 |
IV. DEVICE DESCRIPTION
The Argo Knotless™ SP Anchor is a soft tissue to bone fixation device that consists of a titanium tip with an eyelet to thread suture through, and a threaded anchor body, manufactured of PEEK material. The anchor design includes a 1.0mm UHMWPE Hi-Fi™ retention ribbon which secures the titanium tip to the delivery system and to the retention suture cleat.
V. INTENDED USE/ INDICATIONS FOR USE
The non-absorbable suture anchor is intended to reattach soft tissue to bone in orthopedic surgical procedures.
The Argo Knotless™ 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
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stabilizes the damaged tissue, in conjunction with appropriate postoperative immobilization throughout the healing period.
COMPARISON OF THE TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE
The following table represents a summary of the technological characteristics between the proposed and the predicate device.
| Proposed Device | Predicate Device | |
|---|---|---|
| Manufacturer | CONMED | CONMED |
| Device Name | Argo KnotlessTM SP Anchor | CrossFT Knotless Suture Anchor |
| 510k Number | TBD | K163258 |
| Intended | ||
| Use/Indications | ||
| for Use | The non-absorbable suture | |
| anchor is intended to reattach | ||
| soft tissue to bone in | ||
| orthopedic surgical procedures. |
The Argo KnotlessTM 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 damaged tissue,
in conjunction with
appropriate postoperative
immobilization throughout the
healing period. | The CrossFT Knotless Suture Anchor
with Disposable Driver is intended to
reattach soft tissue to bone in
orthopedic surgical procedures.
The device may be used in either
arthroscopic or open 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 KnotlessTM SP
anchors.
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 | 1. Pathological conditions of bone
which would adversely affect the
CrossFT Knotless Suture 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 |
| | willingness to restrict activities
or follow directions during the
healing period.
5. Attachment of artificial
ligaments or other implants.
6. Foreign body sensitivity,
known or suspected allergies
to implant and/or instrument
materials.
7. This device is not approved
for screw attachment or
fixation to the posterior
elements (pedicles) of the
cervical, thoracic or lumbar
spine. | directions during the healing
period.
5. Attachment of artificial ligaments
or other implants.
6. Foreign body sensitivity, known or
suspected allergies to implant
and/or instrument materials.
7. This device is not approved for
screw attachment or fixation to the
posterior elements (pedicles) of the
cervical, thoracic or lumbar spine. |
| How Supplied | Sterile Anchor w/Delivery System (1ea) | |
| Single Use
/Reusable | Single-Use Only | |
| Sterilization | Device sterilized via Ethylene Oxide Sterilization - SAL (10-6) | |
| Shelf-Life | 18-months | |
| Principle of
Operation | Non-absorbable suture anchors for soft tissue to bone fixation | |
| Biocompatibility | In accordance with ISO 10993-1 and FDA# G95-1 | |
| Packaging | Packaged as a single unit device | |
| Instrumentation | Reusable Bone Punch
Sterile Disposable Bone Punch
Drill Bit | |
| Suture | White UHMWPE, with
polyester dyed with D&C Blue
#6 | Black suture, Nylon with
logwood extract Blue suture, polyester per with
D&C Blue #6, silicone coating Blue Suture, UHMWPE, dyed
with D&C Blue #6 |
| Materials | Anchor: Titanium Tip; PEEK
Suture: White, UHMWPE
with polyester dyed with D&C
Blue #6
Driver: Stainless Steel
Driver Handle: Polycarbonate,
ABS, Radel
Threader: ABS, nitinol,
stainless steel | Anchor: PEEK
Suture: UHMWPE, Nylon, polyester
Driver Shaft and Tip: 17-7 Stainless
Steel; 465 Stainless Steel
Handle and Knob: Polycarbonate
Threader: Polycarbonate, Nitinol |
| MR
Compatibility | MR Conditional | MR Safe |
| Performance
Testing | Reliability | |
| | Cyclic Loading | |
| | Insertion | |
| | Fixation | |
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VII. PERFORMANCE DATA
Testing has been completed to demonstrate that the Argo Knotless™ SP Anchor performs as intended and is substantially equivalent to the predicate device. Bacterial endotoxin testing was conducted and met the endotoxin limits. Completed testing includes the following:
Performance Testing Reliability Ultimate Fixation Strength Insertion Torque Cyclic Testing
Validation User Validation Packaging and Transportation Labeling Sterilization
Well-established Method Testing Pyrogen (Bacterial Endotoxin) Biocompatibility Shelf-life MR Safety Testing
VIII. CONCLUSION
The Argo Knotless™ SP Anchor is either substantially equivalent or identical in intended use, principles of operation, performance testing results, packaging, sterilization method, and biocompatibility as the predicate CrossFT Knotless Suture Anchors. Based upon the findings of our performance testing, the differences present no new issues of safety and effectiveness, and the Argo Knotless™ SP Anchors are substantially equivalent to the predicate device, CrossFT Knotless Suture Anchors (K163248).