(80 days)
No
The summary describes a mechanical fixation device and does not mention any software, algorithms, or AI/ML related terms.
No.
The device is described as providing "suspension fixation for soft tissue to bone" and is used in surgical repair and reconstruction, rather than directly treating a disease or condition with a therapeutic effect.
No
The device is described as an implantable medical device used for surgical fixation of soft tissue to bone, not for diagnosis. Its intended use and device description clearly indicate it is a therapeutic device for repair and reconstruction.
No
The device description explicitly states it is a sterile, single-use device made of titanium alloy, describing physical hardware components (button, cradle, holes for sutures). This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical device used for suspension fixation of soft tissue to bone during ligament and tendon repair or reconstruction. This is a direct surgical intervention on the body.
- Device Description: The device is a physical implant (button and cradle) made of titanium alloy, designed to be threaded with sutures and used in a surgical procedure.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) outside of the body to provide information about a physiological state, health, or disease.
IVD devices are used to perform tests on samples taken from the body (like blood tests, urine tests, genetic tests, etc.) to diagnose, monitor, or screen for conditions. This device is a surgical implant used for mechanical support within the body.
N/A
Intended Use / Indications for Use
The device is intended to provide suspension fixation for soft tissue to bone in the repair of the natural ligament or tendon disruption or reconstruction of a ligament using soft tissue grafts. Examples of such procedures include anterior cruciate ligament, posterior cruciate ligament, lateral collateral ligament, distal biceps tendon rupture, and separations due to coracoclavicular ligament disruptions.
Product codes
MBI
Device Description
The GraftMax™ Button, ALB (Adjustable Loop Button) with Button Cradle and GraftMax™ Button, BTB (Bone-Tendon-Bone) with Button Cradle are sterile, single use devices. The button and cradle used together measure 21mm in length and 6mm in width. The devices are oval shaped and manufactured of titanium alloy. The devices are designed with five (5) holes that sutures can be threaded through.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
The following performance data were provided in support of the substantial equivalence determination.
Completed testing includes the following:
- Reliability ●
- Packaging ●
- Ultimate Fixation Strength ●
- Cyclic ●
- Sterilization
- Verification Testing ●
- . Transportation
- Biocompatibility ●
- User Validation ●
- Shelf-life
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
0
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" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the 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
July 9, 2015
CONMED Corporation Ms. Nyrobia Freeman Regulatory Affairs Specialist 525 French Road Utica, New York 11502
Re: K151037
Trade/Device Name: GraftMax™ Button, ALB with Cradle and GraftMax™ Button, BTB with Cradle Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Class: Class II Product Code: MBI Dated: June 5, 2015 Received: June 10, 2015
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 yours,
Lori A. Wiggins -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)
K151037
Device Name
GraftMax™ Button, ALB with Cradle GraftMax™ Button, BTB with Cradle
Indications for Use (Describe)
The device is intended to provide suspension fixation for soft tissue to bone in the repair of the natural ligament or tendon disruption or reconstruction of a ligament using soft tissue grafts. Examples of such procedures include anterior cruciate ligament, posterior cruciate ligament, lateral collateral ligament, distal biceps tendon rupture, and separations due to coracoclavicular ligament disruptions.
| 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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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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Image /page/3/Picture/0 description: The image shows the logo for Conmed Corporation. The logo features a blue square with a white abstract shape on the left. To the right of the square is the word "Conmed" in black, with the word "Corporation" in smaller blue letters underneath. The logo is simple and modern, and the colors are clean and professional.
510(k) SUMMARY
I. SUBMITTER
CONMED Corporation 525 French Road Utica, New York Phone: 727-399-5416 Fax: 727-399-5264 Date Prepared: June 26, 2015
Company Contact
Nyrobia Freeman Regulatory Affairs Specialist Telephone (727) 399-5416 Fax (727) 399-5264
II. DEVICE
| Trade of Device: | GraftMax™ Button, ALB (Adjustable Loop Button) with
Cradle and GraftMax™ Button, BTB (Bone-Tendon-Bone)
with Cradle |
|----------------------|---------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Titanium Fixation Device |
| Classification Name: | Fastener, Fixation, Non-degradable, Soft-Tissue |
| Regulatory Class: | Class II |
| Product Codes: | MBI |
| Regulation: | 21 CFR Part 888. 3040 |
III. PREDICATE DEVICE
| Device Name: | GraftMax™ Button, ALB (Adjustable Loop Button) and
GraftMax™ Button, BTB (Bone-Tendon-Bone) |
|---------------|------------------------------------------------------------------------------------------------|
| Company Name: | CONMED Corporation |
| 510(k) #: | K070780 |
IV. DEVICE DESCRIPTION
The GraftMax™ Button, ALB (Adjustable Loop Button) with Button Cradle and GraftMax™ Button, BTB (Bone-Tendon-Bone) with Button Cradle are sterile, single use devices. The button and cradle used together measure 21mm in length and 6mm in width. The devices are oval shaped and manufactured of titanium alloy. The devices are designed with five (5) holes that sutures can be threaded through.
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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 curved shape inside, followed by the word "CONMED" in black, with a blue line underneath. Below the line is the word "CORPORATION" in smaller, black letters.
V. INDICATIONS FOR USE
The device is intended to provide suspension fixation for soft tissue to bone in the repair of the natural ligament or tendon disruption or reconstruction of a ligament using soft tissue grafts or bone tendon grafts. Examples of such procedures include anterior cruciate ligament, posterior cruciate ligament, medial collateral ligament, lateral collateral ligament, distal biceps tendon rupture, and separations due to coracoclavicular ligament disruptions.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The GraftMax™ Button ALB with Cradle, and the GraftMax™ Button BTB, with Cradle are identical in intended use and principles of operation to the predicate device with exceptions of dimensions, sterilization and packaging.
| Proposed Device | Predicate Device | |
|---|---|---|
| Dimensions | 21mm x 6mm | 14mm x 4.5mm |
| Sterilization | Implant- Gamma | |
| Cradle- EtO | Implant - Gamma | |
| Packaging | Implant - Sterile, single use | |
| package | ||
| Cradle – Sterile, single use | ||
| package , packaged | ||
| separately | Implant- Sterile, single use | |
| package | ||
VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Completed testing includes the following:
- Reliability ●
- Packaging ●
- Ultimate Fixation Strength ●
- Cyclic ●
- Sterilization
- Verification Testing ●
- . Transportation
- Biocompatibility ●
- User Validation ●
- Shelf-life
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Image /page/5/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 is 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.
VIII. CONCLUSION
The GraftMax™ Button ALB with Cradle, and the GraftMax™ Button BTB, with Cradle are substantially equivalent in design, manufacturing materials, intended use, principles of operation to the predicate GraftMax™ Button ALB, and GraftMax™ Button, BTB and raises no new issues of safety or effectiveness.