Y-Knotless™ Flex Anchors

K253763 · Conmed Corporation · MBI · Jan 29, 2026 · Orthopedic

Device Facts

• Record ID: K253763
• Device Name: Y-Knotless™ Flex Anchors
• Applicant: Conmed Corporation
• Product Code: MBI · Orthopedic
• Decision Date: Jan 29, 2026
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The non-absorbable suture anchors are intended to reattach soft tissue to bone in orthopedic surgical procedures. The Y-Knotless™ Flex Anchors 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 systems thereby stabilize the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period. The Y-Knotless™ Flex Anchors may be used in the following orthopedic procedures: 1. Shoulder Labrum 2. MPFL Reconstruction 3. Foot and Ankle 4. Biceps 5. Meniscal Root Repair

Device Story

Non-absorbable, all-suture, knotless implant for soft tissue-to-bone fixation. Composed of UHMWPE flat braided suture anchor, #2 Hi-Fi repair suture, and #2-0 Hi-Fi shuttle suture. Pre-loaded on disposable driver (304 SS shaft, ABS handle). Used in arthroscopic or open orthopedic procedures; requires 1.8mm pre-drilled bone hole. Surgeon inserts anchor into bone; knotless splice loop mechanism secures soft tissue. Stabilizes tissue during healing. Used in hospitals, clinics, and surgery centers. Benefits include secure soft tissue reattachment and stabilization.

Clinical Evidence

Bench testing only. Performance testing included ASTM F3960 testing (insertion, ultimate pull displacement resistance, cyclic loading), biocompatibility per ISO 10993-1, sterilization validation (SAL 10^-6), shelf-life testing, and packaging/transportation validation. No clinical data provided.

Technological Characteristics

Materials: UHMWPE (suture), 304 Stainless Steel (driver shaft), ABS (driver handle). Principle: All-suture, knotless splice loop anchor. Dimensions: 1.8mm width. Sterilization: Ethylene Oxide (ETO). Connectivity: None. Software: None.

Indications for Use

Indicated for reattachment of soft tissue (ligaments, tendons, joint capsules) to bone in orthopedic procedures including shoulder labrum, MPFL reconstruction, foot/ankle, biceps, and meniscal root repair. Contraindicated in patients with bone/soft tissue pathology affecting fixation, conditions limiting healing or activity restriction, foreign body sensitivity, active sepsis/infection, or for posterior spinal element fixation.

Regulatory Classification

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.

Predicate Devices

• Y-Knot® Flex All-Suture Anchor, w/two #2 (5 metric) Hi-Fi Sutures, 1.8mm (K131035)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

January 29, 2026

Conmed Corporation
Mirela Gjini
Sr. Specialist Regulatory Affairs
525 French Rd.
Utica, New York 13502

Re: K253763
Trade/Device Name: Y-Knotless™ Flex Anchors
Regulation Number: 21 CFR 888.3040
Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener
Regulatory Class: Class II
Product Code: MBI
Dated: November 25, 2025
Received: January 15, 2026

Dear Mirela Gjini:

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.

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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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 (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-reporting-combination-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-devices/device-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

CHRISTOPHER FERREIRA -S

Christopher Ferreira, M.S.
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 | | |
| --- | --- | --- |
| Please type in the marketing application/submission number, if it is known. This
textbox will be left blank for original applications/submissions. | K253763 | ? |
| Please provide the device trade name(s). | | ? |
| Y-Knotless™ Flex Anchors | | |
| Please provide your Indications for Use below. | | ? |
| The non-absorbable suture anchors are intended to reattach soft tissue to bone in orthopedic surgical
procedures.

The Y-Knotless™ Flex Anchors 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 systems thereby stabilize the damaged soft tissue, in conjunction
with appropriate postoperative immobilization, throughout the healing period.

The Y-Knotless™ Flex Anchors may be used in the following orthopedic procedures:
1. Shoulder Labrum
2. MPFL Reconstruction
3. Foot and Ankle
4. Biceps
5. Meniscal Root Repair | | |
| Please select the types of uses (select one or both, as
applicable). | ☑ Prescription Use (21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? |

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510(k) SUMMARY

CONMED Corporation
Y-Knotless™ Flex Anchors

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 K253763

I. SUBMITTER

Manufacturer:
CONMED Corporation
525 French Road
Utica, NY 13502

Official Contact Person:
Mirela Gjini
525 French Road
Utica, NY 13502
(O) 727-509-6143

Date Prepared: January 15, 2026

II. DEVICE NAME

Device Name: Y-Knotless™ Flex Anchors
Common Name: Fastener, Fixation, Nondegradable, Soft tissue
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: Y-Knot® Flex All-Suture Anchor, w/two #2 (5 metric) Hi-Fi Sutures, 1.8mm
Company Name: Linvatec Corp. d/b/a ConMed Linvatec
510(k) #: K131035

IV. DEVICE DESCRIPTION

The Y-Knotless™ Flex Anchors are a non-absorbable, all-suture, knotless implant, that are supplied single use, sterilized via ethylene oxide (ETO) to a SAL of 10-6. The implant anchors are composed of a white flat braided ultra-high molecular weight polyethylene (UHMWPE) suture anchor, a tapered #2 Hi-Fi® repair suture either white/black or green/white/black, and a #2-0 Hi-Fi® shuttle suture, blue and black. The implants are pre-loaded on a disposable driver with sutures cleated to the handle. The anchors require a 1.8 mm pre-drilled bone hole created using Class I, exempt instrumentation.

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V. INTENDED USE/INDICATIONS FOR USE

The non-absorbable suture anchors are intended to reattach soft tissue to bone in orthopedic surgical procedures.

The Y-Knotless™ Flex Anchors 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 systems thereby stabilize the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period.

The Y-Knotless™ Flex Anchors may be used in the following orthopedic procedures:

1. Shoulder Labrum
2. MPFL Reconstruction
3. Foot and Ankle
4. Biceps
5. Meniscal Root Repair

VI. COMPARISON OF THE TECHNOLOGICAL CHARACTERISTICS WITH THE 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 | Linvatec Corp. d/b/a ConMed Linvatec |
| Device Name | Y-Knotless™ Flex Anchors | Y-Knot® Flex All-Suture Anchor, W/Two #2 (5 Metric) Hi-Fi Sutures, 1.8mm |
| 510k Number | K253763 | K131035 |
| Intended Use/Indications for Use | The non-absorbable suture anchors are intended to reattach soft tissue to bone in orthopedic surgical procedures.
The Y-Knotless™ Flex Anchors 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 systems thereby stabilize the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period. | The device is intended to reattach soft tissue to bone in orthopedic surgical procedures.
The device 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. |

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| | Proposed Device | Predicate Device |
| --- | --- | --- |
| | The Y-Knotless™ Flex Anchors may be used in the following orthopedic procedures:
1. Shoulder Labrum
2. MPFL Reconstruction
3. Foot and Ankle
4. Biceps
5. Meniscal Root Repair | |
| **Contraindications** | 1. Pathological conditions of bone which would adversely affect Y-Knotless™ Flex 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. Foreign body sensitivity, known or suspected allergies to implant and/or instrument materials.
6. This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.
7. Patients with active sepsis or infection. | 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. |
| **How Supplied** | Same | Sterile Anchor w/Delivery System (1ea) |
| **Single Use /Reusable** | Same | Single-Use Only |
| **Sterilization** | Same | Ethylene Oxide (10^{-6}) |
| **Shelf-Life** | 3-Years | 5-Years |
| **Principle of Operation** | Suture anchors for soft tissue to bone fixation | Suture anchors for soft tissue to bone fixation |
| **Biocompatibility** | In accordance with ISO 10993-1 | In accordance with ISO 10993-1 and FDA# G95-1 |

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| | Proposed Device | Predicate Device |
| --- | --- | --- |
| Materials | **Implant/Anchor:**
White (natural) UHMWPE flat suture
**Implant Suture:**
Round Tapered #2
UHMWPE (Green/White/Black or White/Black)
**Non-Implant Shuttle Suture:**
Shuttle, 2-0, Blue and Black
UHMWPE
**Driver:**
Shaft - 304 SS
Handle – ABS | **Implant/Anchor:**
Natural UHMWPE flat suture
**Implant Suture:**
Two #2 suture strands, UHMWPE (blue/white, black/white)

**Driver:**
Shaft - 304 SS
Handle - ABS |
| Packaging | Same | Packaged as a single-unit device |
| Design | Folded flat suture, push-in, knotless splice loop. Assembled and packed with non-absorbable, ultra-high molecular weight polyethylene suture a tapered #2 (5 metric) Hi-Fi® repair suture, and a #2-0 (3 metric) Hi-Fi® shuttle suture | Folded flat suture, push-in. Assembled and packed with two non-absorbable braided #2 ultra-high molecular weight polyethylene suture |
| Dimensions: | Same | 1.8mm width x 13mm length x .47mm thickness |
| Compatibility w/ environment | Same | Designed to operate in normal operating room environments. |
| Where used | Same | Hospitals, clinics, and surgery centers. |
| MR Compatibility | Same | MR Safe |
| Instrumentation | Same | Drill Guides
Drill Bit
Obturators |
| Performance Testing | Same | Cyclic Loading
Insertion
Fixation/Pull out |

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# VII. PERFORMANCE DATA

Testing has been completed to demonstrate that Y-Knotless™ Flex Anchors performs as intended and is substantially equivalent to the predicate device. Completed testing includes the following:

- Performance Testing (ASTM F3960)
- Insertion
- Ultimate Pull Displacement Resistance
- Cyclic

- Validation
- User Validation
- Packaging (Transportation and Shelf-life)
- Packaging and Labeling User Validation
- Sterilization
- Transportation and Post Transportation

- Well-established Method Testing
- Pyrogen (Bacterial Endotoxin)
- Biocompatibility
- Shelf-life
- Post Shelf-Life Functional Test

# VIII. CONCLUSION

The Y-Knotless™ Flex Anchors are substantially equivalent in design, materials, intended use, principles of operation, and technical characteristics to the predicate Y-Knot® Flex All-Suture Anchor, w/two #2 (5 metric) Hi-Fi Sutures, 1.8mm. Based upon the findings of the performance testing, the differences present no new issues of safety and effectiveness, and the Y-Knotless™ Flex Anchors are substantially equivalent to the predicate device (K131035).