(65 days)
No
The 510(k) summary describes a mechanical suture anchor and driver, with no mention of AI or ML in the intended use, device description, or performance studies.
No.
The device is described as a suture anchor system used to reattach soft tissue to bone, stabilizing damaged soft tissue during healing. While it aids in the healing process, it is a fixation device rather than one that directly treats a disease or condition through therapeutic action.
No
The device is intended to reattach soft tissue to bone in orthopedic surgical procedures and stabilizes damaged soft tissue. It is a surgical implant for repair, not a device used to diagnose a medical condition.
No
The device description clearly states that the device is a physical implant (suture anchor) made of PEEK and a disposable driver, indicating it is a hardware medical device.
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 in vivo (within the body) to provide mechanical support and facilitate healing.
- Device Description: The device is a "Knotless Suture Anchor with Disposable Driver" made of PEEK. This is a physical implant and delivery system.
- Lack of IVD Characteristics: An IVD is a medical device used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of biological specimens.
The device is clearly intended for direct surgical intervention within the body, which is the opposite of an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The CrossFT™ Knotless Anchor with Disposable Driver 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 sutured 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 appropriative immobilization, throughout the healing period.
Product codes
MBI
Device Description
The CrossFT™ Knotless Suture Anchors with Disposable Driver are sterile, single use devices. The CrossFT™ Knotless Suture Anchors are manufactured from PolyEtherEtherKetone (PEEK™). The anchors are provided sterile, single use and preloaded on a disposable driver. The anchors are available in three sizes and nine configurations.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue to bone
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 CrossFT™ Knotless Suture Anchor with Disposable Driver performs as intended and is substantially equivalent to the predicate device. The bacterial endotoxin testing was conducted and met the endotoxin limits.
Completed testing includes the following:
- Reliability
- Packaging
- Ultimate Fixation Strength
- Cyclic
- Sterilization
- Pyrogenicity
- Verification Testing
- Transportation
- Biocompatibility
- User Validation
- Shelf-life
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 25, 2017
ConMed Corporation Ms. Nyrobia Freeman Regulatory Affairs Specialist 525 French Road Utica, New York 13502
Re: K163258
Trade/Device Name: CrossFT10 Knotless 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: December 29, 2016 Received: January 5, 2017
Dear Ms. Freeman:
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. 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 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K163258
Device Name
CrossFTTM Knotless Suture Anchor with Disposable Driver
Indications for Use (Describe)
The CrossFT™ Knotless Anchor with Disposable Driver 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 sutured 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 appropriative 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.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Image /page/3/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 black, with the word "CORPORATION" in smaller, blue letters underneath.
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 K163258.
I. SUBMITTER
CONMED Corporation 11311 Concept Blvd Largo, Florida 33773
Phone: 727-399-5416 Fax: 727-399-5264
Contact Person: Nyrobia Freeman Date Prepared: November 18, 2016
II. DEVICE NAME
| Device Name: | CrossFT™ Knotless Suture Anchor with Disposable Driver |
|---|---|
| Common Name: | Nonabsorbable Suture Anchor |
| Classification Name: | Fastener, Fixation, Non-degradable, Soft-Tissue |
| Regulatory Class: | Class II, per 21 CFR Part 888. 3040 |
| Product Codes: | MBI |
III. PREDICATE/ LEGALLY MARKET DEVICE
| Device Name: | CrossFTTM Suture Anchor with Disposable Drive |
|---|---|
| Company Name: | CONMED Linvatec |
| 510(k) #: | K091549 |
IV. DEVICE DESCRIPTION
The CrossFT™ Knotless Suture Anchors with Disposable Driver are sterile, single use devices. The CrossFT™ Knotless Suture Anchors are manufactured from PolyEtherEtherKetone (PEEK™). The anchors are provided sterile, single use and preloaded on a disposable driver. The anchors are available in three sizes and nine configurations. (See table 1)
| Catalog Number | Description |
|---|---|
| CFK-40 | CrossFTTM Knotless 4.0 mm Suture Anchor |
| CFK-40TA | CrossFTTM Knotless 4.0 mm Suture Anchor with one 2 mm Hi-Fi ® Tape (Blue) |
Table 1: CrossFT™ Knotless Suture Anchors with Disposable Driver sizes and configurations
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Image /page/4/Picture/0 description: The image shows the logo for CONMED Corporation. The logo consists of a blue square with a white abstract shape on the left, and the word "CONMED" in black capital letters on the right. Below the word "CONMED" is the word "CORPORATION" in smaller black capital letters, underlined by a thin blue line. The logo is clean and professional, and the colors are simple and effective.
| CFK-40TB | CrossFTTM Knotless 4.0 mm Suture Anchor with one 2 mm Hi-Fi® Tape (White/Black) |
|---|---|
| CFK-475S | CrossFTTM Knotless 4.75 mm Suture Anchor |
| CFK-475STA | CrossFTTM Knotless 4.75 mm Suture Anchor with one 2 mm Hi-Fi Tape (Blue) |
| CFK-475STB | CrossFTTM Knotless 4.75 mm Suture Anchor with one 2 mm Hi-Fi Tape (White/Black) |
| CFK-55S | CrossFTTM Knotless 5.5 mm Suture Anchor |
| CFK-55STA | CrossFTTM Knotless 5.5 mm Suture Anchor with one 2 mm Hi-Fi® Tape (Blue) |
| CFK-55STB | CrossFTTM Knotless 5.5 mm Suture Anchor with one 2 mm Hi-Fi® Tape (White/Black) |
V. INTENDED USE/ INDICATIONS FOR USE
The CrossFT™ Knotless Suture Anchor with Disposable Driver 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 CrossFTTM Knotless Suture Anchor with Disposable Driver is substantially equivalent in design, materials, intended use, principles of operation, and technical characteristics to the predicate CrossFT™ Suture Anchors with Disposable Driver and raises no new issues of safety or effectiveness.
The similarities and difference between the predicate and proposed Nonabsorbable Suture Anchors are the following-
| | CrossFT TM Knotless Suture Anchor with
Disposable Driver
Proposed | ConMed Linvatec Soft Tissue to Bone System
(CrossFT TM Suture Anchor with Disposable Driver)
Predicate |
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | CONMED Corporation | ConMed Linvatec |
| 510k | Pending | K091549 |
| Product Code | MBI | MBI |
| Classification | II | II |
| Intended Use | The CrossFT TM Knotless Suture Anchor is
intended to reattach soft tissue to bone in
orthopedic surgical procedures. | The CrossFT TM Suture Anchor is intended to
reattach soft tissue to bone in orthopedic surgical
procedures. |
| 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 | 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 |
| | CrossFTTM Knotless Suture Anchor with
Disposable Driver
Proposed | ConMed Linvatec Soft Tissue to Bone System
(CrossFTTM Suture Anchor with Disposable Driver)
Predicate |
| Contraindications | thereby stabilizes the damaged soft tissue, in
conjunction with appropriate postoperative
immobilization, throughout the healing period.
*Pathological conditions of bone which would
adversely affect the CrossFT Knotless Suture
Anchor.
*Pathological conditions in soft tissue to be
repaired or reconstructed which would
adversely affect suture fixation.
*Physical conditions that would eliminate, or
tend to eliminate adequate implant support or
retard healing.
*Conditions which tend to limit the patient's
ability or willingness to restrict activities or
follow directions during the healing period.
*Attachment of artificial ligaments or other
implants.
*Foreign body sensitivity, known or suspected
allergies to implant and/or instrument materials.
*This device is not cleared for screw
attachment or fixation to the posterior elements
(pedicles) of the cervical, thoracic or lumbar
spine. | thereby stabilizes the damaged soft tissue, in
conjunction with appropriate postoperative
immobilization, throughout the healing period.
*Pathological conditions of bone which would
adversely affect the CrossFT Knotless Suture
Anchor.
*Pathological conditions in soft tissue to be
repaired or reconstructed which would adversely
affect suture fixation.
*Physical conditions that would eliminate, or tend
to eliminate adequate implant support or retard
healing.
*Conditions which tend to limit the patient's ability
or willingness to restrict activities or follow
directions during the healing period.
*Attachment of artificial ligaments or other
implants.
*Foreign body sensitivity, known or suspected
allergies to implant and/or instrument materials.
*This device is not cleared for screw attachment or
fixation to the posterior elements (pedicles) of the
cervical, thoracic or lumbar spine. |
| Handle | Two pieces that consist of a handle and grip | One piece handle |
| Anchor
Dimensions | 4.0 mm, 4.75 mm and 5.5 mm in width
14.5" inches in length | 4.5mm, 5.5mm and 6.5mm in width
9.5" inches in length |
| Suture and/or
Suture Tapes
configurations | CrossFTTM Knotless 4.0 mm Suture Anchor
CrossFTTM Knotless 4.0 mm Suture Anchor
with one 2 mm Hi-Fi Tape (White/Black)
CrossFTTM Knotless 4.75 mm Suture Anchor
CrossFTTM Knotless 4.75 mm Suture Anchor
with one 2 mm Hi-Fi Tape (Blue)
CrossFTTM Knotless 4.75 mm Suture Anchor
with one 2 mm Hi-Fi Tape (White/Black)
CrossFTTM Knotless 5.5 mm Suture Anchor
CrossFTTM Knotless 5.5 mm Suture Anchor
with one 2 mm Hi-Fi Tape (Blue)
CrossFTTM Knotless 5.5 mm Suture Anchor
with one 2 mm Hi-Fi Tape (White/Black) | Cross FT Anchor with two #2 Hi-Fi Suture, 4.5mm
Cross FT Anchor with three #2 Hi-Fi Suture,
4.5mm
Cross FT Anchor with two # 2 Hi-Fi Suture,
5.5mm
Cross FT Anchor with three # 2 Hi-Fi Suture,
5.5mm
Cross FT Anchor with two #2 Hi-Fi Suture,
6.5mm
Cross FT Anchor with two #2 Hi-Fi Suture,
6.5mm |
| Threader | Used to thread Hi-Fi® Tape limbs or Hi-Fi® #2
suture limbs through the anchor and driver
For the 4.0 mm anchor, a maximum of two (2)
Hi-Fi® Tape limbs can be loaded.
For the 4.75 mm and 5.5 mm anchors, a
maximum of two (2) Hi-Fi® Tape limbs plus
two (2) Hi-Fi® #2 suture limbs, or six (6) Hi-
Fi® #2 suture limbs can be loaded. | None |
| Cleat | Available with two (2) suture cleats. The first
cleat is part of the handle design and located on
top of the handle. This cleat is used to wrap the
preloaded suture and/or suture type stands
around for packaging purposes. The second | The suture cleat is used to hold the suture
strands while tensioning the anchor and for
packaging purpose |
| | CrossFTTM Knotless Suture Anchor with
Disposable Driver
Proposed | ConMed Linvatec Soft Tissue to Bone System
(CrossFTTM Suture Anchor with Disposable Driver)
Predicate |
| | cleat is grey in color and has slotted indents on
each side to wrap the suture strands around. The
second cleat is also used to maintain tension on
the suture strands while the anchor is driven
into the bone. | |
| Packaging | Pouch
Tray | Pouch
PETG retaining clip
Tyvek and Nylon/PE Film pouch |
| Single Use/
Reusable | Sterile, Single-Use | Sterile, Single-Use |
| Sterilization | Eto | Eto |
| Components | Bone Punch
Bone Tap
Drill Bit | Bone Punch
Bone Tap |
| Shelf-Life | 18 months | 5 year |
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Image /page/5/Picture/0 description: The image shows the logo for Conmed Corporation. The logo features a blue square with a white curved shape inside, followed by the word "CONMED" in black, bold letters. Below the word "CONMED" is the word "CORPORATION" in smaller, blue letters with a blue line above it.
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Image /page/6/Picture/0 description: The image shows the logo for Conmed Corporation. The logo consists of 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 a blue line underneath, and the word "CORPORATION" in black below the line.
PERFORMANCE DATA
Testing has been completed to demonstrate that the CrossFT™ Knotless Suture Anchor with Disposable Driver performs as intended and is substantially equivalent to the predicate device. The bacterial endotoxin testing was conducted and met the endotoxin limits.
Completed testing includes the following:
- . Reliability
- Packaging .
- Ultimate Fixation Strength ●
- Cyclic ●
- Sterilization ●
- Pyrogenicity
- Verification Testing ●
- . Transportation
- Biocompatibility ●
- User Validation ●
- Shelf-life ●
VIII. CONCLUSION
The CrossFTTM Knotless 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 CrossFT™ 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 CrossFT™ Knotless Suture Anchor with Disposable Driver is substantially equivalent to the CrossFT™ Suture Anchor with Disposable Driver (K091549).