(24 days)
Not Found
No
The summary describes a mechanical suture anchor and driver system made of biomaterials, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended to reattach soft tissue to bone and stabilize damaged soft tissue throughout the healing period, which directly aligns with the definition of a therapeutic device.
No.
The device is described as a suture anchor system used to reattach soft tissue to bone in orthopedic surgical procedures, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly states it is a sterile, single-use device manufactured from physical materials (polylactide copolymer and ß-Tricalcium Phosphate) and includes a disposable driver, indicating it is a physical medical device, not software-only.
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 device used directly on the patient's body for structural repair.
- Device Description: The device is a suture anchor system made of biomaterials, designed for physical implantation and fixation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) during surgery.
N/A
Intended Use / Indications for Use
The CrossFT™ Knotless Biocomposite 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.
Product codes (comma separated list FDA assigned to the subject device)
MAI
Device Description
The CrossFT™ Knotless Biocomposite Suture Anchors with Disposable Driver are sterile, single use devices. The CrossFT™ Knotless Biocomposite Suture Anchors with Disposable Driver are manufactured from polylactide copolymer (96L/4D PLA) and ß-Tricalcium Phosphate (ß-TCP). 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing has been completed to demonstrate that the CrossFT™ Knotless Biocomposite Suture Anchor with Disposable Driver 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:
Verification Testing
- Reliability
- Ultimate Fixation Strength ●
- Cyclic
- Sterilization ●
- Pyrogenicity ●
- Biocompatibility ●
- Shelf-life ●
Validation Testing
- User Validation
- Packaging ●
- Transportation ●
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached 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/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is a stylized image of three human profiles facing to the right, with a symbol resembling a caduceus or staff with a serpent intertwined.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 17, 2017
ConMed Corporation Diana L. Nader-Martone Regulatory Affairs Specialist 525 French Road Utica. New York 13502
Re: K170501
Trade/Device Name: CrossFT™ Knotless Biocomposite Suture Anchor with Disposable Driver Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: MAI Dated: February 17, 2017 Received: February 21, 2017
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. 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
1
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.
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,
Lori A. Wiggins -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 | |
| Form Approved: | OMB No. 0910-0120 |
| Expiration Date: | January 31, 2017 |
| See PRA Statement below. | |
| 510(k) Number (if known) | K170501 |
| Device Name | CrossFT™ Knotless Biocomposite Suture Anchor with Disposable Driver |
| Indications for Use (Describe) | The CrossFT™ Knotless Biocomposite 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. |
| 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.
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FORM FDA 3881 (8/14)
Page 1 of 1
PSC Publishing Services (301) 443-6740
EF
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Image /page/3/Picture/0 description: The image shows the logo for CONMED Corporation. The logo features a stylized blue "C" shape on the left, followed by the word "CONMED" in black, sans-serif font. Below the word "CONMED" is the word "CORPORATION" in a smaller, sans-serif font, underlined with a blue line.
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: February 17, 2017
II. DEVICE NAME
| Device Name: | CrossFT™ Knotless Biocomposite Suture Anchor with
Disposable Driver |
|----------------------|------------------------------------------------------------------------|
| Common Name: | Bioabsorbable Suture Anchor |
| Classification Name: | Fastener, fixation, biodegradable, soft tissue |
| Regulatory Class: | Class II, per 21 CFR Part 888. 3030 |
| Product Codes: | MAI |
III. PREDICATE/ LEGALLY MARKET DEVICE
| Device Name: | ConMed Linvtec CrossFT™ BC Suture Anchor |
|---|---|
| Company Name: | ConMed Linvatec |
| 510(k) #: | K101100 |
IV. DEVICE DESCRIPTION
The CrossFT™ Knotless Biocomposite Suture Anchors with Disposable Driver are sterile, single use devices. The CrossFT™ Knotless Biocomposite Suture Anchors with Disposable Driver are manufactured from polylactide copolymer (96L/4D PLA) and ß-Tricalcium Phosphate (ß-TCP). The anchors are provided sterile, single use and preloaded on a disposable driver. The anchors are available in three sizes and nine configurations.
V. INTENDED USE/ INDICATIONS FOR USE
The CrossFT™ Knotless Biocomposite Suture Anchor with Disposable Driver is intended to reattach soft tissue to bone in orthopedic surgical procedures.
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Image /page/4/Picture/0 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 a bold, sans-serif font, with a blue line underneath. Below the line is the word "CORPORATION" in a smaller, sans-serif font.
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.
| | CrossFTTM Knotless Biocomposite Suture
Anchor with Disposable Driver
Proposed | ConMed Linvatec CrossFTTM-BC Suture Anchor
(also known as: GENESYSTM CrossFTTM Suture
Anchor)
Predicate |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device
Description | The CrossFTTM Knotless Biocomposite Suture
Anchor with Disposable Drivers are sterile, single
use devices. The CrossFTTM Knotless
Biocomposite Suture Anchor with Disposable
Drivers is manufactured from polylactide
copolymer (96L/4D PLA) and β-Tricalcium
Phosphate (β-TCP). The anchors are provided
sterile, single use and preloaded on a disposable
driver. The anchors are available in three sizes
and nine configurations. | The ConMed Linvatec CrossFTTM-BC Suture
Anchor is a device that is used to assist the
surgeon in reattaching soft tissue to bone. The
device includes anchors, manufactured of 96L/4D
PLA copolymer + β-TCP and two (2), or three (3)
Hi-Fi® sutures manufactured of polyethylene and
polypropylene. The device is bioabsorbable and
is available in sizes between 4.5mm to 6.5mm
and 17mm lengths. A disposable driver is
included to implant the suture anchor. |
| Intended Use | The CrossFTTM Knotless Biocomposite Suture
Anchor with Disposable Driver with Disposable
Driver is intended to reattach soft tissue to bone
in orthopedic surgical procedures. | The CrossFTTM-BC 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
thereby stabilizes the damaged soft tissue, in
conjunction with appropriate postoperative
immobilization, throughout the healing period. | 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. |
| Contraindications | *Pathological conditions of bone which would
adversely affect the CrossFTTM Knotless
Biocomposite Suture Anchor with Disposable
Driver with Disposable Driver.
- Pathological conditions in the 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 | The CrossFTTM BC Suture Anchor is
contraindicated for the following orthopedic
procedures:
- ACL (Anterior Cruciate Ligament), PCL
(Posterior Cruciate Ligament), foot, and hand
procedures |
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Image /page/5/Picture/0 description: The image shows the logo for CONMED Corporation. The logo features a stylized blue "C" shape on the left, followed by the word "CONMED" in black, sans-serif font. Below the word "CONMED" is the word "CORPORATION" in a smaller, sans-serif font, underlined by a thin blue line.
| | CrossFT™ Knotless Biocomposite Suture
Anchor with Disposable Driver
Proposed | ConMed Linvatec CrossFT™-BC Suture Anchor
(also known as: GENESYS™ CrossFT™ Suture
Anchor)
Predicate |
|------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| | * This device is not approved for screw
attachment or fixation to the posterior elements
(pedicles) of the cervical, thoracic or lumbar
spine. | |
| Components | Bioabsorbable anchor
Disposable Driver
Suture and/or Suture Tape
Threader | Bioabsorbable anchor
Disposable driver
Suture |
PERFORMANCE DATA
Testing has been completed to demonstrate that the CrossFT™ Knotless Biocomposite Suture Anchor with Disposable Driver 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:
Verification Testing
- Reliability
- Ultimate Fixation Strength ●
- Cyclic
- Sterilization ●
- Pyrogenicity ●
- Biocompatibility ●
- Shelf-life ●
VIII. CONCLUSION
The CrossFT™ Knotless Biocomposite Suture Anchor with Disposable Driver with Disposable Driver is either substantially equivalent or identical in design, materials, intended use, principles of operation, and technical characteristics to the predicate CrossFTTM BC Suture Anchor. Based upon the findings of our performance testing, the differences present no new issues of safety and efficacy, and the CrossFT™ Knotless Biocomposite Suture Anchor with Disposable Driver with Disposable Driver is substantially equivalent to the CrossFTTM-BC Suture Anchor (K101100).
Validation Testing
- User Validation
- Packaging ●
- Transportation ●