(58 days)
Not Found
No
The document describes a mechanical fixation system (metal buttons and suture) and does not mention any software, algorithms, or data processing related to AI/ML.
No
A therapeutic device is one that treats a disease or condition. This device, the InfinityTM Fixation System, is used to provide suspension fixation for soft tissue to bone in the repair of ligaments, which is a surgical fixation device. While it aids in the healing process, it does not directly treat a disease or condition.
No
The device is a fixation system used in ligament reconstruction procedures to provide suspension fixation of soft tissue to bone. It does not perform any diagnostic function.
No
The device description clearly states it is a family of metal buttons and nonabsorbable suture, which are physical hardware components. The testing also includes verification and validation of hardware aspects like strength, sterilization, and packaging.
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 procedure for fixing soft tissue to bone in ligament or tendon repair. This is an in-vivo (within the living body) application, not an in-vitro (outside the living body) diagnostic test.
- Device Description: The device is described as a system of metal buttons and suture for surgical fixation. This aligns with a surgical implant/device, not a diagnostic reagent or instrument used to analyze samples from the body.
- No mention of diagnostic testing: The document does not mention any analysis of biological samples (blood, urine, tissue, etc.) or any diagnostic purpose.
- Performance Studies: The performance studies focus on mechanical strength, reliability, biocompatibility, and sterilization, which are typical for surgical implants, not diagnostic devices.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The InfinityTM Fixation System 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, medial collateral ligament, and lateral collateral ligament.
Product codes (comma separated list FDA assigned to the subject device)
MBI
Device Description
The CONMED Infinity™ Fixation System is a family of metal buttons and nonabsorbable Hi-Fi suture for suspensory fixation of tendon to bone used in ligament reconstruction procedures. The Infinity™ Fixation System is provided individually packaged, single-use, sterile. The anchor, suture, and disposable driver are EO Sterilized.
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
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 Infinity™ Fixation System 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:
Verification Testing
- Reliability ●
- Ultimate Fixation Strength ●
- Transportation ●
- Cyclic
- Pyrogen ●
- Biocompatibility ●
- Shelf-life ●
Validation Testing
- User Validation ●
- Packaging ●
- Labeling ●
- Sterilization ●
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
§ 888.3040 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/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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
ConMed Corporation Orjada Dervishleri Regulatory Affairs Specialist 525 French Road Utica, New York 13502
Re: K191204
Trade/Device Name: InfinityTM Fixation System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: June 21, 2019 Received: June 21, 2019
Dear Orjada Dervishleri:
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/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
July 3, 2019
1
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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Laurence Coyne, Ph.D. Assistant Director DHT6C: Division of Stereotaxic. Trauma and Restorative Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name InfinityTM Fixation System
Indications for Use (Describe)
The InfinityTM Fixation System is intended to provide suspension fixation for soft tissue to bone in the repair of the natural ligament or tendon disruption of a ligament using soft tissue grafts. Examples of such procedures include anterior cruciate ligament, posterior cruciate ligament, medial collateral ligament, and lateral ligament.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | X |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/1 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 horizontal line underneath. Below the line, the word "CORPORATION" is written in smaller, gray letters.
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 K191204
I. SUBMITTER
CONMED Corporation 11311 Concept Blvd Largo, Florida 33773
Phone: 727-399-5491 Fax: 727-399-5264
Contact Person: Orjada Dervishleri Date Prepared: May 3rd, 2019
II. DEVICE NAME
| Device Name: | Infinity™ Fixation 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: | ConMed Linvatec XO Button |
|---|---|
| Company Name: | ConMed Linvatec |
| 510(k) #: | K070780 |
IV. PREDICATE DEVICE
| Device Name: | GraftMax™ Button, ALB (Adjustable Loop Button) and
GraftMax™ Button, BTB (Bone-Tendon-Bone) |
|---------------|------------------------------------------------------------------------------------------------|
| Company Name: | ConMed Corporation |
| 510(k) #: | K151037 |
V. DEVICE DESCRIPTION
The CONMED Infinity™ Fixation System is a family of metal buttons and nonabsorbable Hi-Fi suture for suspensory fixation of tendon to bone used in ligament reconstruction procedures. The Infinity™ Fixation System is provided individually packaged, single-use, sterile. The anchor, suture, and disposable driver are EO Sterilized.
4
Image /page/4/Picture/1 description: The image shows the logo for Conmed Corporation. The logo features a blue abstract shape on the left, resembling a stylized "C". To the right of the shape is the company name "CONMED" in bold, black letters. Below the company name is the word "CORPORATION" in smaller, lighter font, underlined with a thin blue line.
VI. INTENDED USE/ INDICATIONS FOR USE
- VII. The Infinity™ Fixation System 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, medial collateral ligament, and lateral collateral ligament.
- COMPARISON OF THE TECHNOLOGICAL CHARACTERISTICS WITH THE VIII. PREDICATE DEVICE
The following table represents a summary of the technological characteristics between the proposed and the predicate device.
| | InfinityTM Fixation System
Proposed Device | ConMed Linvatec XO Button
Predicate Device | GraftMax Button, ALB with
Cradle, GraftMax Button,
BTB with Cradle
Predicate Device |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Description | The InfinityTM Fixation System is a family of
metal buttons and non-absorbable Hi-Fi
suture for suspensory fixation of soft tissue
grafts to bone used in ligament
reconstruction procedures. | Same | Same |
| Intended Use /
Indication for Use | The InfinityTM Fixation System 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, medial
collateral ligament, and lateral collateral
ligament. | Same | 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 | 1. Do not use the Infinity™ Fixation System
for fixation of bone-patellar tendon-bone
(BTB) grafts.
2. The Infinity™ Femoral Adjustable Loop
Button is contraindicated for fixation of
soft tissue in the tibial tunnel of ACL and
PCL repairs.
3. Insufficient quantity or quality of cortical
bone for fixation.
4. Blood supply limitations and/or previous
infections, which may tend to retard
healing.
5. Patients with active sepsis.
6. Conditions which tend to limit the
patient's ability or willingness to follow
directions during the healing period.
7. Foreign body sensitivity, known or
suspected allergies to implant materials. | Same | 1.Insufficient quantity or
quality of cortical bone for
fixation.
2.Blood supply limitations
and/or previous infections,
which may tend to retard
healing.
3.Patients with active sepsis.
4.Conditions which tend to
limit the patient's ability or
willingness to follow
directions during the healing
period.
5.Foreign body sensitivity,
known or suspected allergies
to implant materials. |
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Image /page/5/Picture/1 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 a smaller font size underneath. A thin blue line separates the two words.
| Components | Femoral button with pull tab
Tibial buttons (2)
Free loop Suture
Cradle | | Same |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|
| Technological
Characteristics | Providing Suspension Fixation
Pre-attached with sutures
Lead strand suture to manipulate and position
the button but not implanted
Adjustable Loop technique
Free Loop
Adaptor for the button body | Providing Suspension
Fixation
Pre-attached with sutures
Fixed Loop technique | Providing Suspension
Fixation
Pre-attached with sutures
Adaptor for the button
body |
IX. PERFORMANCE DATA
Testing has been completed to demonstrate that the Infinity™ Fixation System 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:
Verification Testing
- Reliability ●
- Ultimate Fixation Strength ●
- Transportation ●
- Cyclic
- Pyrogen ●
- Biocompatibility ●
- Shelf-life ●
Validation Testing
-
User Validation ●
-
Packaging ●
-
Labeling ●
-
Sterilization ●
-
X. CONCLUSION
The Infinity™ Fixation System is either substantially equivalent or identical in design, materials, intended use, principles of operation, and technical characteristics to the predicate ConMed Linvatec XO Button. Based upon the findings of our performance testing, the differences present no new issues of safety and efficacy, and the Infinity™ Fixation System is substantially equivalent to the ConMed Linvatec XO Button (K070780).