Who is the manufacturer of CrossFT Knotless Deep Thread Suture Anchor with Disposable Driver?

Conmed Corporation filed the 510(k) submission for CrossFT Knotless Deep Thread Suture Anchor with Disposable Driver (K182621).

What is the FDA product code for CrossFT Knotless Deep Thread Suture Anchor with Disposable Driver?

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

What is the regulatory pathway for CrossFT Knotless Deep Thread Suture Anchor with Disposable Driver?

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

Who can help prepare an FDA 510(k) submission like CrossFT Knotless Deep Thread Suture Anchor with Disposable Driver?

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.

CrossFT Knotless Deep Thread Suture Anchor with Disposable Driver

K182621 · Conmed Corporation · MBI · Jan 4, 2019 · Orthopedic

Device Facts

Record ID	K182621
Device Name	CrossFT Knotless Deep Thread Suture Anchor with Disposable Driver
Applicant	Conmed Corporation
Product Code	MBI · Orthopedic
Decision Date	Jan 4, 2019
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 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.

Device Story

CrossFT™ Knotless Deep Thread Suture Anchor is a threaded, screw-in orthopedic implant used to reattach soft tissue to bone. Device consists of a PEEK anchor, disposable driver, and threader; some models include preloaded Hi-Fi® suture. Used by orthopedic surgeons in arthroscopic or open surgical procedures. Surgeon inserts anchor into bone using disposable driver; suture secures soft tissue to anchor, stabilizing tissue during healing. Provides mechanical fixation for ligament/tendon repairs. Benefits include stable soft tissue-to-bone reattachment and knotless fixation. Device is provided sterile (EO).

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, MR safety, user validation, packaging, and transportation testing.

Technological Characteristics

Material: PolyEtherEtherKetone (PEEK). Design: Threaded, screw-in, knotless suture anchor. Components: Non-absorbable anchor, disposable driver, threader, optional Hi-Fi® suture. Sterilization: Ethylene Oxide (EO).

Indications for Use

Indicated for reattaching soft tissue (ligaments, tendons, joint capsules) to bone in arthroscopic or open orthopedic procedures. Contraindicated in patients with pathological bone/soft tissue conditions affecting fixation, physical conditions preventing healing or activity restriction, foreign body sensitivity, active sepsis/infection, or for use in posterior elements (pedicles) 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

CrossFT™ Knotless Suture Anchor with Disposable Driver (K163258)

Reference Devices

ConMed Linvatec Soft Tissue to Bone System (K091549)

Related Devices

K170501 — CrossFT Knotless Biocomposite Suture Anchor with Disposable Driver · Conmed Corporation · Mar 17, 2017
K253895 — Arthrex SwiveLock Suture Anchor, 3.5 x 10 mm · Arthrex, Inc. · Dec 30, 2025
K163258 — CrossFT Knotless Suture Anchor with Disposable Driver · Conmed Corporation · Jan 25, 2017
K180101 — HEALIX ADVANCE KNOTLESS BR Anchor · Medos International SARL · May 10, 2018
K180594 — Knotless SutureTak Anchors · Arthrex, Inc. · Jun 22, 2018

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. January 4, 2019 ConMed Corporation Diana Nader-Martone Regulatory Affairs Specialist 525 French Road Utica, New York 13502 Re: K182621 Trade/Device Name: CrossFT™ Knotless Deep Thread Suture Anchor with Disposable Driver Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: November 30, 2018 Received: December 6, 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/cdrl/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 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.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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}------------------------------------------------ ### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ## Indications for Use 510(k) Number (if known) ### K182621 Device Name CrossFTM Knotless Deep Thread Suture Anchor with Disposable Driver # 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) | | |-------------------------------------------------|--| |-------------------------------------------------|--| > 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/0 description: The image shows the logo for CONMED Corporation. The logo features a blue square on the left side with a white curved shape inside. To the right of the square, the word "CONMED" is written in a bold, black font, with a horizontal line underneath. Below the line, the word "CORPORATION" is written in a smaller, lighter 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 K182621 #### 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 21, 2018 #### II. DEVICE NAME | Device Name: | CrossFT™ Knotless Deep Thread Suture Anchor with Disposable Driver | |----------------------|-----------------------------------------------------------------------| | 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: | CrossFT™ Knotless Suture Anchor with Disposable Driver | |---------------|--------------------------------------------------------| | Company Name: | ConMed | | 510(k)#: | K163258 | #### IV. REFERENCE/ LEGALLY MARKET DEVICE | Device Name: | ConMed Linvatec Soft Tissue to Bone System | |---------------|--------------------------------------------| | Company Name: | ConMed Linvatec | | 510(k) #: | K091549 | #### V. DEVICE DESCRIPTION The CONMED CrossFT™ Knotless Deep Thread Suture Anchors are manufactured from stable PolyEtherEtherKetone (PEEK). The CrossFT Knotless Deep Thread Anchors are a threaded screw-in suture anchor design. The CrossFT™ Knotless Deep Thread Suture Anchors are provided sterile, preloaded on a single-use driver and some include a preloaded sliding #2 (5 metric) Hi-Fi® Suture. The device is EO sterilized. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for CONMED Corporation. The logo features a stylized blue graphic on the left, resembling a curved shape. To the right of the graphic is the company name, "CONMED," in bold, black letters. Below the company name is the word "CORPORATION" in smaller, black letters. #### INTENDED USE/ INDICATIONS FOR USE VI. The non-absorbable suture anchor 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. ### 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. | | CrossFT™ Knotless Deep Thread Suture Anchor with Disposable Driver Proposed Device | CrossFT™ Knotless Suture Anchor with Disposable Driver Predicate Device | ConMed Linvatec Soft Tissue to Bone System (CrossFT™ Suture Anchor with Disposable Driver) Reference | |----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------| | Device Description | The CONMED CrossFT™ Knotless Deep Thread Suture Anchors are manufactured from stable PolyEtherEtherKetone (PEEK). The CrossFT Knotless Deep Thread Anchors are a threaded screw-in suture anchor design. The CrossFT™ Knotless Deep Thread Suture Anchors are provided sterile, preloaded on a single-use driver and some include a preloaded sliding #2 (5 metric) Hi-Fi® Suture. The device is EO sterilized. | The CONMED CrossFT™ Knotless Deep Thread Suture Anchors are manufactured from stable PolyEtherEtherKetone (PEEK). The CrossFT Knotless Deep Thread Anchors are a threaded screw- in suture anchor design. The CrossFT™ Knotless Deep Thread Suture Anchors are provided sterile, preloaded on a single-use driver and some include a preloaded sliding #2 (5 metric) Hi-Fi® Suture. The device is EO sterilized. | Reference | | 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 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. | Same | Same | | | CrossFT™ Knotless Deep Thread Suture Anchor with Disposable Driver Proposed Device | CrossFT™ Knotless Suture Anchor with Disposable Driver Predicate Device | ConMed Linvatec Soft Tissue to Bone System (CrossFT™ Suture Anchor with Disposable Driver) Reference | | Contraindications | 1. Pathological conditions of bone which would adversely affect the CrossFT™ Knotless Deep Thread 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 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 | Same | | Components | Non-absorbable Anchor Disposable Driver Threader Suture (some catalog numbers) | Non-absorbable Anchor Disposable Driver Threader Suture (some catalog numbers) Suture Tape (some catalog numbers) | Non-absorbable Anchor Disposable Driver Suture | | Technological Characteristics | Non-absorbable, PolyEtherEtherKetone (PEEK) Anchor Screw-in, Knotless Anchor Design Threader Disposable Driver | Same | Non-absorbable, PolyEtherEtherKetone (PEEK) Anchor Screw-in Anchor Design Disposable Driver | {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 is the word "CONMED" in black, sans-serif font, with a horizontal line underneath. Below the line is the word "CORPORATION" in smaller, sans-serif font. ### PERFORMANCE DATA Testing has been completed to demonstrate that the CrossFT™ Knotless Deep Thread 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: {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the Conmed Corporation logo. 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 black, with the word "CORPORATION" in smaller blue letters underneath. K182621 Page 4 of 4 Verification Testing - Reliability ● - Ultimate Fixation Strength ● - Cyclic ● - Sterilization ● - Pyrogen ● - Biocompatibility - Shelf-life - Post Aging Functional Testing ● - MR Safety Testing ● ## VIII. CONCLUSION The CrossFTTM Knotless Deep Thread Suture Anchor with Disposable Driver is either substantially equivalent or identical in design, materials, intended use, principles of operation, and technical characteristics to the predicate ConMed CrossFT™ Knotless Suture Anchor with Disposable Driver. Based upon the findings of our performance testing, the differences present no new issues of safety and efficacy, and the CrossFTM Knotless Deep Thread Suture Anchor with Disposable Driver is substantially equivalent to the ConMed CrossFT™ Knotless Suture Anchor with Disposable Driver (K163258). ## Validation Testing - User Validation ● - Packaging ● - Transportation ●