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

Conmed Corporation filed the 510(k) submission for TruShot with Y-Knot All-Suture Anchor (K182446).

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

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

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

K182446 · Conmed Corporation · MBI · Dec 19, 2018 · Orthopedic

Device Facts

Record ID	K182446
Device Name	TruShot with Y-Knot All-Suture Anchor
Applicant	Conmed Corporation
Product Code	MBI · Orthopedic
Decision Date	Dec 19, 2018
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 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 bone. The suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period.

Device Story

TruShot™ with Y-Knot® All-Suture Anchor is a non-absorbable orthopedic fixation device. It consists of a high-strength flat-braided suture anchor preloaded on a disposable inserter with a drill bit and guide handle. Used in arthroscopic or open surgery by orthopedic surgeons to reattach soft tissue (ligaments, tendons, joint capsules) to bone. The device is inserted into a drilled pilot hole; the anchor expands to provide fixation. The surgeon uses the attached sutures to secure the soft tissue, stabilizing it during the healing period. The device is provided sterile for single-use, benefiting patients by providing a secure anchor for tissue repair.

Clinical Evidence

Bench testing only. No clinical data presented. Verification testing included reliability, ultimate fixation strength, cyclic testing, sterilization, pyrogen testing, biocompatibility, shelf-life, post-aging functional testing, and MR safety. Validation testing included user validation, packaging, and transportation. Bacterial endotoxin testing met established limits.

Technological Characteristics

Non-absorbable flat-braid suture anchor system. Components: All-Suture Anchor, disposable guide handle, #2 Hi-Fi® suture strands. Principle: Press-fit insertion into a drilled pilot hole with an expandable anchor design. Sterilization: Ethylene Oxide (EO). Single-use, disposable.

Indications for Use

Indicated for patients requiring soft tissue-to-bone reattachment (ligaments, tendons, joint capsules) in orthopedic surgical procedures, including arthroscopic or open approaches. Contraindicated in patients with bone/soft tissue pathology affecting fixation, conditions limiting activity restriction, foreign body sensitivity, active sepsis/infection, or for use in posterior elements of the spine.

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

ConMed Linvatec Y-Knot™ All-Suture Anchor (K111779)

Reference Devices

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

Related Devices

K182439 — TruShot with Y-Knot Shallow All-Suture Anchor · Conmed Corporation · Jan 8, 2019
K193606 — Y-Knot OneStep Anchor · Conmed Corporation · Jan 22, 2020
K131035 — Y-KNOT FLEX ALL-SUTURE ANCHOR, W/ TWO #2 (5 METRIC) HI-FI SUTURES, 1.8MM · Linvatec Corporation D/B/A Conmed Linvatec · Jul 2, 2013
K133224 — Y-KNOT RC ALL-SUTURE ANCHOR, 2.8MM - DOUBLE LOADED AND TRIPLE LOADED W/ #2 HIFI SUTURES · Conmed Corporation · Jan 3, 2014
K221396 — Arthrex FiberTak Suture Anchor · Arthrex, Inc. · Dec 22, 2022

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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. December 19, 2018 CONMED Corporation Diana L. Nader-Martone, M.S. Regulatory Affairs Specialist 525 French Road Utica, New York 13502 Re: K182446 Trade/Device Name: TruShot™ with Y-Knot® 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 20, 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, 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 {1}------------------------------------------------ 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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 medical devices and radiation-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. # Indications for Use 510(k) Number (if known) ## K182446 Device Name TruShot™ with Y-Knot® 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 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) | |-------------------------------------------------| |-------------------------------------------------| X 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 blue square with a white abstract design on the left. To the right of the square, the word "CONMED" is written in bold, black letters. Below "CONMED", the word "CORPORATION" is written in smaller, black letters. ## 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 K182446. #### I. SUBMITTER CONMED Corporation 11311 Concept Blvd Largo, Florida 33773 Phone: 727-399-5425 Fax: 727-399-5264 Contact Persons: Diana L. Nader-Martone or Kathy Reddig Date Prepared: September 6, 2018 #### II. DEVICE NAME | Device Name: | TruShot™ with Y-Knot® 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 MARKET DEVICE | Device Name: | ConMed Linvatec Y-Knot™ All-Suture Anchor | |---------------|-------------------------------------------| | Company Name: | ConMed Linvatec | | 510(k) #: | K111779 | #### IV. 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 | #### V. DEVICE DESCRIPTION The CONMED TruShot™ with Y-Knot® All-Suture Anchor is manufactured from High Strength Flat Braided Suture threaded with either one or two #2 (5 metric) Hi-Fi® suture strands 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 {4}------------------------------------------------ Image /page/4/Picture/1 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, black letters. Below "CONMED" is the word "CORPORATION" in smaller, lighter letters, underlined with a blue line. needles, inserter, drill bit, and guide handle are pre-assembled and provided sterile, intended for single-use. The device is EO Sterilized. #### VI. INTENDED USE/ INDICATIONS FOR USE The non-absorbable suture anchors are intended to reattach soft tissue to bone in orthopedic surgical procedures. 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 bone. The suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period. ### VII. 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. | | TruShotTM with Y-Knot® All- Suture Anchor Proposed Device | ConMed Linvatec Y-Knot® All- Suture Anchor Predicate Device | Y-Knot Flex All-Suture Anchor, w/Two #2 (5 Metric) Hi-Fi Sutures, 1.8mm Reference Device | |-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|---------------------------------------------------------------------------------------------------| | Device Description | The non-absorbable suture anchors are intended to reattach soft tissue to bone in orthopedic surgical procedures. | Same | Same | | Intended Use | The non-absorbable suture anchors are intended to reattach soft tissue to bone in orthopedic surgical procedures. | Same | Same | | 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 bone. The suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period. | Same | Same | | Contraindications | 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, | Same | Same | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for CONMED Corporation. The logo features a blue square with a white, stylized "C" shape inside. To the right of the square, the word "CONMED" is written in a bold, black font. Below the word "CONMED", the word "CORPORATION" is written in a smaller, black font. | | TruShot™ with Y-Knot® All- Suture Anchor Proposed Device | ConMed Linvatec Y-Knot® All- Suture Anchor Predicate Device | Y-Knot Flex All-Suture Anchor, w/Two #2 (5 Metric) Hi-Fi Sutures, 1.8mm Reference Device | |----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|---------------------------------------------------------------------------------------------------| | | 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. | | | | Components | All-Suture Anchor Disposable Guide Handle Suture | All-Suture Anchor Disposable Driver Suture | All-Suture Anchor Disposable Driver Suture | | Technological Characteristics | Flat-braid suture anchor | Flat-braid suture anchor | Flat-braid suture anchor | | | One or two #2 sutures Drilled pilot hole | One #2 suture Drilled pilot hole | Two #2 sutures Drilled pilot hole | | | Press-fit insertion | Press-fit insertion | Press-fit insertion | | | Expandable design | Expandable design | Expandable design | #### VIII. PERFORMANCE DATA Testing has been completed to demonstrate that the TruShot™ with Y-Knot® All-Suture 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 ● - Ultimate Fixation Strength ● - Cyclic ● - Sterilization ● - Pyrogen - Biocompatibility ● - Shelf-life ● - Post Aging Functional Testing - MR Safety Testing ● Validation Testing - . User Validation - Packaging . - Transportation . {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Conmed Corporation. The logo features a blue square with a white curved shape inside on the left. To the right of the square is the word "CONMED" in a bold, sans-serif font, with a horizontal line underneath. Below the line is the word "CORPORATION" in a smaller, sans-serif font. #### IX. CONCLUSION The TruShot™ with Y-Knot® All-Suture Anchor is either substantially equivalent or identical in design, materials, intended use, principles of operation, and technical characteristics to the predicate ConMed Linvatec Y-Knot™ All-Suture Anchor. Based upon the findings of our performance testing, the differences present no new issues of safety and efficacy, and the TruShot™ with Y-Knot® All-Suture Anchor is substantially equivalent to the ConMed Linvatec Y-Knot™ All-Suture Anchor (K111779).