(90 days)
No
The device description and performance studies focus on the mechanical properties and biocompatibility of a titanium screw, with no mention of AI or ML capabilities.
Yes
The device is used for bone-tendon-bone graft fixation in ACL and PCL reconstruction of the knee, which are medical procedures to repair damaged ligaments, indicating a therapeutic purpose.
No
Explanation: The device is an interference screw used for bone fixation in orthopedic procedures, specifically reconstructive surgery for ACL and PCL. It is a tool for treatment, not for diagnosing conditions.
No
The device description clearly describes a physical, implantable screw made of titanium, which is a hardware component. The testing also focuses on physical properties and performance of the screw.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "bone - tendon - bone graft fixation in anterior cruciate ligament (ACL) and posterior cruciate ligament (PCL) reconstruction of the knee." This is a surgical procedure performed in vivo (within the body).
- Device Description: The description details a physical screw designed to be implanted into bone.
- 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, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests in vitro (outside the body) on biological samples. This device is an orthopedic implant used in vivo.
N/A
Intended Use / Indications for Use
EZ Start™ Interference Screws are intended for use in bone - tendon - bone graft fixation in anterior cruciate ligament (ACL) and posterior cruciate ligament (PCL) reconstruction of the knee.
EZ Start™ Interference Screws are used to provide bone fixation in orthopedic procedures, including bone-tendon-bone graft fixation in anterior cruciate ligament (ACL) and posterior cruciate ligament (PCL) reconstruction of the knee.
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
The EZStart™ Interference Screw is a dual threaded titanium interference screw with a tapered tip for easy insertion into bone. The screw is cannulated to allow a guidewire through to assist with placement of the screw into the bone tunnel. The screw is used to maintain the fixation of bone - tendon - bone grafts in orthopedic procedures. The device is Gamma Sterilized.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
knee
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 EZStart™ Interference Screw performs as intended and is substantially equivalent to the predicate device.
Completed testing includes the following:
Verification Testing
- Insertion Torque
- Fixation Strength
- Sterilization
- Biocompatibility
- Pyrogenicity
- Shelf-life
- Post Aging Functional
- Transportation
- MR Safety
Validation Testing
- Device User Validation
- Packaging/Labeling User Validation
Pyrogenicity testing was conducted using a Limulus Amebocyte Lysate (LAL) method with results that met the current FDA and USP requirements,
§ 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/0 description: The image contains 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 is a blue square with the letters "FDA" in white. To the right of the blue square are the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" below it.
January 22, 2019
ConMed Corporation Jeremy Walter Regulatory Affairs Specialist 525 French Road Utica, New York 13502
Re: K182955
Trade/Device Name: EZStart™ Interference Screw Regulation Number: 21 CFR 888,3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: October 22, 2018 Received: October 24, 2018
Dear Mr. Walter:
We have reviewed vour 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
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
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| DEPARTMENT OF HEALTH AND HUMAN SERVICES | ||
|---|---|---|
| Food and Drug Administration | ||
| Indications for Use | ||
| 510(k) Number (if known) | K182955 | Page 1 of 1 Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. |
| Device Name | EZStart™ Interference Screw | |
| Indications for Use (Describe) | ||
| Intended Use | EZ Start™ Interference Screws are intended for use in bone - tendon - bone graft fixation in anterior cruciate ligament (ACL) and posterior cruciate ligament (PCL) reconstruction of the knee. | |
| Indications for Use | EZ Start™ Interference Screws are used to provide bone fixation in orthopedic procedures, including bone-tendon-bone graft fixation in anterior cruciate ligament (ACL) and posterior cruciate ligament (PCL) reconstruction of the knee. | |
| 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:
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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."
| 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 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 the word "CORPORATION" in smaller black 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 K182955.
I. SUBMITTER
CONMED Corporation 11311 Concept Blvd Largo, Florida 33773
Phone: 727-399-5418 Fax: 727-399-5264
Contact Person: Jeremy Walter Date Prepared: December 21, 2018
II. DEVICE NAME
| Device Name: | EZStart™ Interference Screw |
|---|---|
| Common Name: | Bone Screw |
| Classification Name: | Screw, Fixation, Bone |
| Regulatory Class: | Class II, per 21 CFR Part 888. 3040 |
| Product Codes: | HWC |
III. PREDICATE/ LEGALLY MARKETED DEVICE
| Device Name: | Concept Cannulated Interference Screw |
|---|---|
| Company Name: | Linvatec Corporation |
| 510(k) #: | K933352 |
IV. REFERENCE DEVICE
| Device Name: | Guardsman® Interference Screws |
|---|---|
| Company Name: | Linvatec Corporation |
| 510(k) #: | K960962 |
V. DEVICE DESCRIPTION
The EZStart™ Interference Screw is a dual threaded titanium interference screw with a tapered tip for easy insertion into bone. The screw is cannulated to allow a guidewire through to assist with placement of the screw into the bone tunnel. The screw is used to maintain the fixation of bone - tendon - bone grafts in orthopedic procedures. The device is Gamma Sterilized.
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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 inside, followed by the word "CONMED" in black, sans-serif font. Below the word "CONMED" is the word "CORPORATION" in a smaller, sans-serif font, also in black. A thin blue line separates the two words.
VI. INTENDED USE/ INDICATIONS FOR USE
Intended Use:
EZ Start™ Interference Screws are intended for use in bone - tendon - bone graft fixation in anterior cruciate ligament (ACL) and posterior cruciate ligament (PCL) reconstruction of the knee.
Indications for Use
EZ Start™ Interference Screws are used to provide bone fixation in orthopedic procedures, including bone-tendon-bone graft fixation in anterior cruciate ligament (ACL) and posterior cruciate ligament (PCL) reconstruction of the knee.
COMPARISON OF THE TECHNOLOGICAL CHARACTERISTICS WITH THE VII. PREDICATE DEVICE
The following table represents a summary of the technological characteristics between the proposed and the predicate device.
| | EZStart™ Interference Screw
Proposed Device | Concept Cannulated Interference Screw
Predicate Device |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|
| Device
Description | A sterile cannulated titanium
interference bone screw. | Same |
| Intended Use | Intended for use in bone - tendon -
bone graft fixation in anterior
cruciate ligament (ACL) and
posterior cruciate ligament (PCL)
reconstruction of the knee. | Same, excluding PCL. |
| Indication for Use | Used to provide bone fixation in
orthopedic procedures, including
bone-tendon-bone graft fixation in
anterior cruciate ligament (ACL)
and posterior cruciate ligament
(PCL) reconstruction of the knee. | Same, excluding PCL. |
| Contraindications | 1. Insufficient quantity or quality
of bone for attachment.
2. Blood supply limitations and/or
previous infections which may
retard healing.
3. Foreign-body sensitivity -
where material sensitivity is
suspected, appropriate tests
should be made and sensitivity
ruled out prior to implantation.
4. Patients with active sepsis or
Infection.
5. Conditions which tend to limit
the patient's ability or
willingness to restrict activities
or follow directions during the
healing period. | Same |
| Device
Dimensions | Lengths: 15mm – 30mm
Diameters: 6mm -10mm | Same, excluding 15 mm lengths and
10 mm diameters. |
| Technological
Characteristics | Metallic dual-threaded screw-in
design | Same |
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Image /page/5/Picture/0 description: The image shows the Conmed Corporation logo. The logo consists of a blue square with a white curved shape inside, followed by the word "CONMED" in black, with the word "CORPORATION" in smaller black letters underneath. The logo is simple and modern, and the colors are clean and professional.
VIII. PERFORMANCE DATA
Testing has been completed to demonstrate that the EZStart™ Interference Screw performs as intended and is substantially equivalent to the predicate device.
Completed testing includes the following:
Verification Testing
- Insertion Torque
- Fixation Strength ●
- Sterilization ●
- Biocompatibility
- Pyrogenicity ●
- Shelf-life ●
- Post Aging Functional ●
- Transportation ●
- MR Safety ●
Validation Testing
- Device User Validation
- Packaging/Labeling User Validation
Pyrogenicity testing was conducted using a Limulus Amebocyte Lysate (LAL) method with results that met the current FDA and USP requirements,