Who is the manufacturer of TruShot with Y-Knot Shallow All-Suture Anchor?

Conmed Corporation filed the 510(k) submission for TruShot with Y-Knot Shallow All-Suture Anchor (K182439).

What is the FDA product code for TruShot with Y-Knot Shallow All-Suture Anchor?

MBI. It is classified under 21 CFR 888.3040 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for TruShot with Y-Knot Shallow All-Suture Anchor?

510(k) clearance (submission type: Traditional).

What are the predicate devices for TruShot with Y-Knot Shallow All-Suture Anchor?

Mitek Mini QuickAnchor® Plus (K992487).

Who can help prepare an FDA 510(k) submission like TruShot with Y-Knot Shallow All-Suture Anchor?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

TruShot with Y-Knot Shallow All-Suture Anchor

K182439 · Conmed Corporation · MBI · Jan 8, 2019 · Orthopedic

Device Facts

Record ID	K182439
Device Name	TruShot with Y-Knot Shallow All-Suture Anchor
Applicant	Conmed Corporation
Product Code	MBI · Orthopedic
Decision Date	Jan 8, 2019
Decision	SESE
Submission Type	Traditional
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 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 systems thereby stabilize the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period.

Device Story

TruShot™ with Y-Knot® Shallow All-Suture Anchor is a sterile, single-use orthopedic fixation device. It consists of a high-strength flat braided suture preloaded on a disposable inserter with a drill bit and guide handle. During surgery, the clinician drills a pilot hole in the bone and inserts the anchor; the anchor expands to provide a press-fit fixation. The device stabilizes damaged soft tissue to bone during the healing period. Used by orthopedic surgeons in clinical settings (OR). Benefits include secure soft tissue reattachment. No software or AI components.

Clinical Evidence

Bench testing only. Performance testing included sterilization, pyrogen/endotoxin limits, reliability (ultimate fixation strength), cyclic testing, user validation, packaging/transportation, biocompatibility, shelf-life, and MR safety testing. Side-by-side testing compared the subject device to the predicate (K992487).

Technological Characteristics

Soft-body all-suture anchor; high-strength flat braided suture; disposable inserter, drill bit, and guide handle. Principle: drilled pilot hole, press-fit insertion, expandable design. EO sterilized. Single-use.

Indications for Use

Indicated for reattachment of soft tissue (ligaments, tendons, joint capsules) to bone in arthroscopic or open orthopedic surgical procedures.

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

Mitek Mini QuickAnchor® Plus (K992487)

Reference Devices

ConMed Linvatec Y-Knot™ All-Suture Anchor (K111779)
Y-Knot Flex All-Suture Anchor, w/Two #2 (5 Metric) Hi-Fi Sutures, 1.8mm (K131035)

Related Devices

K182446 — TruShot with Y-Knot All-Suture Anchor · Conmed Corporation · Dec 19, 2018
K222161 — Arthrex Knotless FiberTak Biceps Suture Anchor · Arthrex, Inc. · Aug 11, 2022
K250596 — Arthrex FiberTak Suture Anchor · Arthrex, Inc. · Mar 28, 2025
K253538 — TeKBrace Knotless Anchor · Theramicro · Mar 6, 2026
K192709 — Fixone All Suture Anchor · Aju Pharm Co., Ltd. · Dec 15, 2020

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows 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 a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and below that, the word "ADMINISTRATION" in blue. January 8, 2019 CONMED Corporation Diana L. Nader-Martone, M.S. Regulatory Affairs Specialist 525 French Road Utica, New York 13502 Re: K182439 Trade/Device Name: TruShot™ with Y-Knot® Shallow All-Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: November 16, 2018 Received: November 19, 2018 Dear Ms. Nader-Martone: 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. Laurence D. Coyne -S For Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. # DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use 510(k) Number (if known) K182439 Device Name TruShot™ with Y-Knot® Shallow All-Suture Anchor Indications for Use (Describe) Intended Use The non-absorbable suture anchors are intended to reattach soft tissue to bone in orthopedic surgical procedures. Indications for Use 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 systems thereby stabilize 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) # CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. # *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for CONMED Corporation. The logo features a stylized blue "C" shape on the left side. To the right of the "C" is the word "CONMED" in black, sans-serif font, with a horizontal blue line underneath. Below the line is the word "CORPORATION" in a smaller, sans-serif font. # 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 11311 Concept Blvd Largo, Florida 33773 Phone: 727-399-5425 Fax: 727-399-5264 Contact Person: Diana L. Nader-Martone Date Prepared: September 18, 2018 #### DEVICE NAME II. | Device Name: | TruShot™ with Y-Knot® Shallow All-Suture Anchors | |----------------------|--------------------------------------------------| | Common Name: | Nonabsorbable Suture Anchor System | | 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: | Mitek Mini QuickAnchor® Plus | |---------------|------------------------------| | Company Name: | Mitek | | 510(k) #: | K992487 | #### IV. REFERENCE DEVICE | Device Name: | ConMed Linvatec Y-Knot™ All-Suture Anchor | |---------------|-------------------------------------------| | Company Name: | ConMed Linvatec | | 510(k) #: | K111779 | #### V. ADDITIONAL REFERENCE DEVICE | Device Name: | Y-Knot Flex All-Suture Anchor, w/Two #2 (5 Metric) Hi-Fi | |---------------|----------------------------------------------------------| | | Sutures, 1.8mm | | Company Name: | ConMed Linvatec | | 510(k) #: | K131035 | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Conmed Corporation. The logo consists of a blue square on the left with a white, stylized "C" shape inside. To the right of the square is the word "CONMED" in a bold, sans-serif font, with the word "CORPORATION" in a smaller font underneath. ### VI. DEVICE DESCRIPTION The CONMED TruShot™ with Y-Knot® Shallow All-Suture Anchor is manufactured from High Strength Flat Braided Suture threaded with either one #0 (3.5 metric) or one #2-0 (3 metric) Hi-Fi® suture strand with needles. Each All-Suture Anchor is preloaded on a disposable inserter, and pre-assembled with a disposable drill bit and guide handle. The anchor, suture(s) with needles, inserter, drill bit, and guide handle are pre-assembled and provided sterile, intended for single-use. The device is EO Sterilized. ### VII. INTENDED USE/ INDICATIONS FOR USE The non-absorbable suture anchors are 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. ## COMPARISON OF THE TECHNOLOGICAL CHARACTERISTICS WITH THE VIII. PREDICATE DEVICE The following table represents a summary of the technological characteristics between the proposed and the predicate device. | | TruShot™ with Y-Knot® Shallow All-Suture Anchor Proposed Device | Mitek Mini QuickAnchor® Plus Predicate Device | ConMed Linvatec Y-Knot® All-Suture Anchor 1st Reference Device | Y-Knot Flex All-Suture Anchor, w/Two #2 (5 Metric) Hi-Fi Sutures, 1.8mm 2nd Reference Device | | |-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------| | Device Description | The non-absorbable suture anchors are intended to reattach soft tissue to bone in orthopedic surgical procedures. | Mitek Mini QuickAnchor® Plus is a sterile, disposable bone anchor supplied preloaded on an inserter with a polyester suture. | Same as proposed | Same as proposed | | | Intended Use | The non-absorbable suture anchors are intended to reattach soft tissue to bone in orthopedic surgical procedures. | N/A - Incorporated into their indications statement | Same as proposed | Same as proposed | | | Indication for Use | The system 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 | Mitek Mini QuickAnchor® Plus indications: Shoulder: Bankart repair Ankle: Midfoot Reconstructions Foot: Hallux Valgus Reconstruction | Same as proposed | Same as proposed | | | | TruShot™ with Y-Knot® Shallow All-Suture Anchor Proposed Device | Mitek Mini QuickAnchor® Plus Predicate Device | ConMed Linvatec Y- Knot® All-Suture Anchor 1st Reference Device | Y-Knot Flex All-Suture Anchor, w/Two #2 (5 Metric) Hi-Fi Sutures, 1.8mm 2nd Reference Device | | | Contraindications | bone. The suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period. 1. Reattachment of intracapsular knee ligaments (ACL & PCL). 2. Pathological conditions of bone which would adversely affect the Y-Knot anchor. 3. Pathological conditions in the soft tissue to be repaired or reconstructed which would adversely affect suture fixation. 4. Physical conditions that would eliminate, or tend to eliminate, adequate implant support or retard healing. 5. Conditions which tend to limit the patient's ability or willingness to restrict activities or follow directions during the healing period. 6. Attachment of artificial ligaments or other implants. 7. Foreign body sensitivity, known or suspected allergies to implant and/or instrument materials. 8. This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine. | Wrist: Scapholunate ligament Reconstruction Hand: Ulnar or Lateral Collateral Ligament Reconstruction Pubis: Fixation in the pubis for bladder neck suspicion to resolve stress urinary incontinence 1. Reattachment of intracapsular knee ligaments (ACL & PCL). 2. Surgical procedures other than those listed in the INDICATIONS section. 3. Pathologic conditions of bone, such as cystic changes or severe osteopenia, which would impair its ability to securely fix the Depuy Mitek Anchor, are contraindicated. 4. Pathological changes in the soft tissues sutured to the bone which would prevent its secure fixation by the suture are contraindicated. 5. Comminuted bone surface, which would militate against secure fixation of the Depuy Mitek Anchor, is contraindicated. 6. Physical conditions that would eliminate or tend to eliminate adequate implant support or retard healing, i.e., blood supply limitation, previous infections, etc. are contraindicated. 7. Conditions which tend to preempt the patient's ability or the healing period, such | 1. Pathological conditions of bone which would adversely affect the Y-Knot 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. 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. | 1. Pathological conditions of bone which would adversely affect the Y-Knot 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. 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. | | | | TruShot™ with Y-Knot® Shallow All-Suture Anchor Proposed Device | Mitek Mini QuickAnchor® Plus Predicate Device | ConMed Linvatec Y-Knot® All-Suture Anchor 1st Reference Device | Y-Knot Flex All-Suture Anchor, w/Two #2 (5 Metric) Hi-Fi Sutures, 1.8mm 2nd Reference Device | | | | 9. Patients with active sepsis or infection. | illness or alcoholism are contraindicated. 8. The Depuy Mitek Anchor is not designed for and should never be used to attach artificial ligaments or other implants. | | | | | Components | All-Suture Anchor Disposable Guide Handle Suture | Handle Shaft Anchor Suture Needles | All-Suture Anchor Disposable Driver Suture | All-Suture Anchor Disposable Driver Suture | | | | Technological Characteristics | Soft-body suture anchor One #0 or #2-0 suture Drilled pilot hole Press-fit insertion Expandable design | Hard-body suture anchor One #2/0 suture Drilled pilot hole Press-fit insertion Expandable design | Soft-body suture anchor One #2 suture Drilled pilot hole Press-fit insertion Expandable design | Soft-body suture anchor Two #2 sutures Drilled pilot hole Press-fit insertion Expandable design | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Conmed Corporation. The logo features a blue square with a white abstract shape inside, resembling a stylized "C". To the right of the square is the word "CONMED" in bold, sans-serif font. Below "CONMED" is the word "CORPORATION" in a smaller, sans-serif font. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for CONMED Corporation. The logo consists of a blue square with a white, stylized "C" inside, followed by the word "CONMED" in black, sans-serif font. Below the word "CONMED" is a thin blue line, and below that is the word "CORPORATION" in a smaller, sans-serif font. ### IX. PERFORMANCE DATA Testing has been completed to demonstrate that the TruShot™ with Y-Knot® Shallow All-Suture Anchor performs as intended and is substantially equivalent to the predicate device. Performance testing was addressed by side-by-side testing comparing the subject device to predicate K992487. Bacterial endotoxin testing was conducted and met the endotoxin limits. Completed testing includes the following: Verification Testing - Sterilization ● - Pyrogen ● - Reliability - o Ultimate Fixation Strength Side-by-Side Testing - Cyclic . - Validation Testing - User Validation ● - Packaging ● - o Transportation - Biocompatibility ● - Shelf-life ● - Post Aging Functional Testing - MR Safety Testing ### X. CONCLUSION The TruShot™ with Y-Knot® Shallow All-Suture Anchor is either substantially equivalent or identical in design, materials, intended use, principles of operation, and technical characteristics to the predicate Mitek QuickAnchor Plus device. Based upon the findings {7}------------------------------------------------ Image /page/7/Picture/1 description: The image shows the logo for CONMED Corporation. The logo features a stylized blue graphic on the left, followed by the word "CONMED" in bold, black letters. Below the word "CONMED" is the word "CORPORATION" in smaller, gray letters. of our performance testing, the differences present no new issues of safety and efficacy, and the TruShot™ with Y-Knot® Shallow All-Suture Anchor is substantially equivalent to the Mini QuickAnchor Plus (K992487) devices.