(30 days)
Not Found
No
The summary describes a mechanical implant and surgical tools, with no mention of AI or ML capabilities. The performance studies focus on mechanical and biological properties, not algorithmic performance.
No.
The device is a non-absorbable implant designed to reattach soft tissue to bone, making it a surgical fixation device rather than a therapeutic device that directly treats a disease or condition. While it aids in the healing process by stabilizing tissue, its primary function is mechanical support.
No
Explanation: The device is an implantable suture anchor used for reattaching soft tissue to bone during orthopedic surgical procedures. Its purpose is mechanical fixation and support, not to perform any diagnostic function.
No
The device description clearly states it is a physical implant (anchor and suture) and a disposable inserter, which are hardware components.
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 a "non-absorbable implant" made of suture and preloaded onto an inserter. This is a physical device used for mechanical fixation within the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens.
The device described is a surgical implant used for tissue repair, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The non-absorbable implant is intended to reattach soft tissue to bone in orthopedic surgical procedures.
The devices may be used in either arthroscopic or open surgical procedures. After 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 immobilizations, throughout the healing period.
Product codes
MBI
Device Description
The CONMED Y-Knot® OneStep™ Anchors are manufactured from High Strength Flat Braided Suture and threaded with either one or two #2 (5 metric) Hi-Fi® suture strands or suture ribbon. Y-Knot® OneStep anchors are provided single-use, sterile, and preloaded onto a disposable inserter. The anchors, sutures and disposable inserter are EO Sterilized.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone (for attachment of 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
Testing has been completed to demonstrate that the Y-Knot® OneStep™ 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:
Verification Testing
- Reliability
- Fixation/Pull Out
- Displacement
- Cyclic
- Sterilization
- Pyrogen
- Biocompatibility
- Shelf-life
- Transportation
- Post Aging Functional Testing
- MR Safety Testing
Validation Testing
- User Validation
- Packaging And Labeling
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 of the U.S. Food & Drug Administration (FDA). On the left, there is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 22, 2020
ConMed Corporation Carrie Engleman Lead Regulatory Affairs Specialist 525 French Road Utica, New York 13502
Re: K193606
Trade/Device Name: Y-Knot® OneStep™ Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: December 20, 2019 Received: December 23, 2019
Dear Ms. Engleman:
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for 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,
Laura C. Rose, Ph.D. Acting 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)
K193606
Device Name Y-Knot® OneStep™ Anchor
Indications for Use (Describe)
The non-absorbable implant is intended to reattach soft tissue to bone in orthopedic surgical procedures.
The devices may be used in either arthroscopic or open surgical procedures. After 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 immobilizations, 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
I. SUBMITTER
CONMED Corporation 525 French Road Utica, New York 13502
Phone: 727-399-5574 Fax: 727-399-5264
Contact Person: Carrie Engleman Date Prepared: December 20, 2019
II. DEVICE NAME
| Device Name: | Y-Knot® OneStep™ Anchor |
|---|---|
| Classification Name: | Fastener, fixation, nondegradable, soft tissue |
| Regulatory Class: | Class II, per 21 CFR Part 888. 3040 |
| Product Codes: | MBI |
III. PREDICATE/ LEGALLY MARKETED DEVICE
| Device Name: | Y-Knot® Flex All-Suture Anchor |
|---|---|
| Company Name: | ConMed Linvatec |
| 510(k) #: | K131035 |
DEVICE DESCRIPTION IV.
The CONMED Y-Knot® OneStep™ Anchors are manufactured from High Strength Flat Braided Suture and threaded with either one or two #2 (5 metric) Hi-Fi® suture strands or suture ribbon. Y-Knot® OneStep anchors are provided single-use, sterile, and preloaded onto a disposable inserter. The anchors, sutures and disposable inserter are EO Sterilized.
V. INTENDED USE/ INDICATIONS FOR USE
The non-absorbable implant is intended to reattach soft tissue to bone in orthopedic surgical procedures.
4
The devices may be used in either arthroscopic or open surgical procedures. After 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.
COMPARISON OF THE TECHNOLOGICAL CHARACTERISTICS WITH THE VII. PREDICATE DEVICE
The following table represents a summary of the technological characteristics between the proposed and the predicate device.
| | Y-Knot® OneStep™
Anchor Proposed Device | Y-Knot® Flex All-Suture
Anchor, w/ Two #2 (5
metric) Hi-Fi Sutures,
1.8mm
Predicate Device |
|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Description | The CONMED Y-Knot®
OneStep™ Anchor System
are manufactured from High
Strength Flat Braided Suture
and threaded with either one
or two #2 (5 metric) Hi-Fi®
suture strands or suture
ribbon. Y-Knot OneStep
anchors are provided single-
use, sterile, and preloaded
onto a disposable inserter.
The anchors, sutures and
disposable inserter are EO
Sterilized. | ConMed Linvatec Y-Knot®
Flex All-Suture Anchor is
manufactured from High
Strength Flat Braided
Suture and threaded with
either one or two #2 (5
metric) Hi-Fi® suture
strands. Y-Knot anchors are
provided single-use, sterile,
and preloaded on a
disposable inserter. The
anchor, suture and
disposable inserter are EO
Sterilized. |
| Intended Use | The non-absorbable implant
is intended to reattach soft
tissue to bone in orthopedic
surgical procedures. | The non-absorbable suture
anchor is intended to
reattach soft tissue to bone
in orthopedic surgical
procedures. |
| Indication for Use | The devices may be used in
either arthroscopic or open
surgical procedures. After
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 | The devices may be used in
either arthroscopic or open
surgical procedures. After
suture is anchored to the
bone, it may be
used to reattach soft tissue,
such as ligaments, tendons,
or joint capsules to the |
| | thereby stabilizes the | bone. The suture anchor |
| | damaged soft tissue, in | systems thereby |
| | conjunction with | stabilize the damaged soft |
| | appropriate postoperative | tissue, in conjunction with |
| | immobilization, throughout | appropriate postoperative |
| | the healing period. | immobilization, throughout |
| | | the healing period. |
| Contraindications | 1. Pathological conditions
of bone which would
adversely affect Y-Knot
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 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.
8. Patients with active sepsis
or infection. | Same |
| Components | All-Suture Anchor
Disposable Inserter
Suture | All-Suture Anchor
Disposable Inserter
Suture |
5
6
| Technological
Characteristics | Flat-braid suture anchor
One or two #2 sutures or
ribbon
Pilot hole drilled with
inserter
Press-fit insertion
Expandable design
Flexible Inserter | Flat-braid suture anchor
Two #2 sutures
Pilot hole drilled with
disposable drill bit
Press-fit insertion
Expandable design
Flexible Inserter |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Single Use/
Reusable | Single-Use | Same |
| Sterilization | EtO
Sterility Assurance Level
(SAL) of 10-6 | Same |
| Biocompatibility | Materials are Biocompatible
and met the requirements of
an acceptable biological
evaluation per ISO 10993-1
and FDA Guidance | Same |
| Shelf Life | 18-months | 5-years |
PERFORMANCE DATA
Testing has been completed to demonstrate that the Y-Knot® OneStep™ 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:
Verification Testing
- Reliability ●
- Fixation/Pull Out ●
- Displacement ●
- Cyclic ●
- Sterilization ●
- Pyrogen
- Biocompatibility ●
- Shelf-life ●
- Transportation ●
- Post Aging Functional Testing ●
- MR Safety Testing ●
Validation Testing
- User Validation .
- Packaging And Labeling .
7
VIII. CONCLUSION
Y-Knot® OneStep™ Anchor is substantially equivalent in design, materials, intended use, principles of operation, and technical characteristics to the predicate Y-Knot® Flex All-Suture Anchor. Based upon the findings of our performance testing, the differences present no new issues of safety and efficacy, and the Y-Knot® OneStep™ Anchor is substantially equivalent to the Y-Knot® Flex All-Suture Anchor (K131035).