(118 days)
No
The device description and performance studies focus on the mechanical properties and surgical application of a button system for tissue fixation, with no mention of AI or ML technologies.
No
The device is described as an implant system (buttons and instrumentation) to facilitate fixation of bone or soft tissue to bone, which is a structural or supportive function, not a therapeutic (treatment of disease or disorder) one.
No
The device is an implantable system intended to facilitate fixation of bone or soft tissue to bone, which is a therapeutic function rather than a diagnostic one.
No
The device description explicitly states it is comprised of reusable instrumentation and button implants made of titanium, which are physical hardware components.
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 "facilitate fixation of bone or soft tissue to bone" in various anatomical locations (Shoulder, Elbow, Knee). This is a surgical implant used directly in the body.
- Device Description: The description details a system of reusable instrumentation and button implants made of titanium, designed to secure tissue and bone. This is consistent with a surgical device, not a diagnostic test performed on samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical implant used for mechanical fixation within the body.
N/A
Intended Use / Indications for Use
The Tigon Medical Button System implants are intended to facilitate fixation of bone or soft tissue to bone. Shoulder: Proximal Biceps Tendon Repair Minor Pectoralis Repair Major Pectoralis Repair Elbow: Distal Biceps Tendon Repair Ulnar Collateral Ligament Reconstruction Knee: Anterior Cruciate Ligament Repair Posterior Cruciate Ligament Repair
Product codes (comma separated list FDA assigned to the subject device)
MBI
Device Description
The Tigon Medical Button System is comprised of reusable instrumentation and button implants designed to interface together in order to secure soft tissue to bone and fixate bone to bone. The reusable instrumentation is designed to operate with any grouping of available buttons within the system. Each button is made of fitanium and designed to be used with #2 suture cable or 1.4 mm to 2 mm sufure tapes. Each button is made up of very similar eyelet geometry and a thickness of 2 mm. The button widths vary from 2.25 mm to 2.7 mm. The lengths of the buttons vary from 6.65 mm to 8 mm. The buttons are designed to function against a single cortex by resting in the intramedullary cavity or against the cortex on the opposite side of the fixation site.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, Elbow, 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)
Mechanical testing has been done, including cyclical loading and tensile strength which demonstrated the proposed product met the acceptance criteria for the proposed indications.
Tests performed:
Axial Pullout Strength: The device was found to be substantially equivalent to the predicate for maximum pullout strength per ASTM F543
Fatigue Testing: The device was found to be substantially equivalent to the predicate for cyclic loading fatigue testing.
Tray Sterilization Validation: The Tigon Medical Button system was found to be sterile in the Tigon Medical Shoulder Set.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Average mechanical pull out strength of 289.55N. Average failure occurred at 909 cycles (Fatigue Testing, up to 4000 cycles from unloaded (5N) to loaded (225N) condition until failure).
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.
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
August 4, 2021
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
Tigon Medical Jeremy Clark Management Representative 838 Ritchie Hwy, Suite 5 Severna Park, Maryland 21146
Re: K211049
Trade/Device Name: Tigon Medical Button 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 25, 2021 Received: July 2, 2021
Dear Mr. Clark:
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 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/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 mediation-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
Laura C. Rose. Ph.D. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K211049
Device Name Tigon Medical Button System
Indications for Use (Describe) Indications for Use: The Tigon Medical Button System implants are intended to facilitate fixation of bone or soft tissue to bone. Shoulder: Proximal Biceps Tendon Repair Minor Pectoralis Repair Major Pectoralis Repair Elbow: Distal Biceps Tendon Repair Ulnar Collateral Ligament Reconstruction Knee: Anterior Cruciate Ligament Repair Posterior Cruciate Ligament Repair
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
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 Tigon Medical. The logo features a stylized tiger eye on the left, with the words "TIGON MEDICAL" in bold, sans-serif font to the right of the eye. The eye is orange with black stripes, and the text is black.
Submitter Information
| Applicant: | Tigon Medical |
|---|---|
| Contact Person: | Jeremy Clark |
| Management Representative | |
| Tigon Medical | |
| 838 Ritchie Hwy, Suite 5 | |
| Severna Park, MD 21146 | |
| (410) 544-2833 | |
| Date Prepared: | 4/7/2021 |
| Name of Device: | Tigon Medical Button System |
| Common Name: | Fastener, Fixation, Nondegradable, soft tissue |
| Classification Name | 21 CFR 888.3040: Smooth or threaded metallic bone fixation |
| fastener. | |
| Product Code/Panel: | MBI |
| Predicate Devices: | Arthrex Biceps Button (K123341) |
| Intended Use: | The Tigon Medical Button System implants are intended to |
| facilitate fixation of bone to bone or soft tissue to bone. | |
| Shoulder: | |
| Proximal Biceps Tendon Repair | |
| Minor Pectoralis Repair | |
| Major Pectoralis Repair |
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Image /page/4/Picture/1 description: The image shows the logo for Tigon Medical. The logo features a stylized tiger eye on the left, with the words "TIGON MEDICAL" in bold, black letters to the right of the eye. The tiger eye is orange with black stripes.
Elbow:
Distal Biceps Tendon Repair Ulnar Collateral Ligament Reconstruction Knee:
Anterior Cruciate Ligament Repair
Posterior Cruciate Ligament Repair
Device Description:
The Tigon Medical Button System is comprised of reusable instrumentation and button implants designed to interface together in order to secure soft tissue to bone and fixate bone to bone. The reusable instrumentation is designed to operate with any grouping of available buttons within the system. Each button is made of fitanium and designed to be used with #2 suture cable or 1.4 mm to 2 mm sufure tapes. Each button is made up of very similar eyelet geometry and a thickness of 2 mm. The button widths vary from 2.25 mm to 2.7 mm. The lengths of the buttons vary from 6.65 mm to 8 mm. The buttons are designed to function against a single cortex by resting in the intramedullary cavity or against the cortex on the opposite side of the fixation site.
Substantial Equivalence Summary:
The Tigon Medical Button System is substantially equivalent to the predicate devices as the features and intended uses are the same. Button fixation has been shown to be a biomechanically sound method of soft tissue and bone fixation. Mechanical testing has been done, including cyclical loading and tensile strength which demonstrated the proposed product met the acceptance criteria for the proposed indications.
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Image /page/5/Picture/1 description: The image contains the logo for "Tigon Medical". The logo features a stylized tiger eye on the left, with the words "TIGON MEDICAL" in bold, sans-serif font to the right of the eye. The eye is orange and black, while the text is black.
| Characteristics | Tigon Medical Button
System | Arthrex Biceps Button | Substantial Equivalence
(Yes or No) |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Codes | MBI | MBI | Yes |
| 510(k) Number | K211049 | K123341 | |
| Indications | Indications for Use:
The Tigon Medical
Button System implants
are intended to
facilitate fixation of
bone to bone or soft
tissue to bone. | The Suture Button
and RetroButton are
used for fixation of
bone to bone or soft
tissue to bone, and
are intended as
fixation posts, a
distribution bridge, or
for distributing suture
tension over areas of
ligament or tendon
repair. | Yes |
| | Shoulder:
Proximal Biceps Tendon
Repair | The BicepsButton,
Pec Button and
Tenodesis Button are
used for fixation of
bone to bone or soft | |
| | Minor Pectoralis Repair | tissue to bone, and
are intended as | |
| | Major Pectoralis Repair | fixation posts, a
distribution bridge, or | |
| | Elbow: | | |
| | Distal Biceps Tendon
Repair | for distributing suture
tension over areas of
ligament or tendon
repair in the shoulder
and elbow | |
| Characteristics | Tigon Medical Button System | Arthrex Biceps Button | Substantial Equivalence
(Yes or No) |
| | Ulnar Collateral
Ligament
Reconstruction
Knee: | Shoulder:
Pectoralis Repair
(Minor/Major)
Biceps Tendon Repair
(Distal/Proximal)
Ulnar Collateral
Ligament
Reconstruction | |
| | Anterior Cruciate
Ligament Repair | Knee:
ACL Repair | |
| | Posterior Cruciate
Ligament Repair | | |
| Button - Sizes | The Tigon Medical
Button System is made
up of a range of button
sizes. | The Arthex Biceps
Button is made up of
a variety of different
button combinations
and sizes. | Yes |
| Button -
Mechanical
Strength | The Tigon Medical
Button System has an
average mechanical
pull out strength of
$289.55N$ | The Arthrex Biceps
Button has an
average mechanical
pull out strength of
$283.15N$ | Yes |
| Characteristics | Tigon Medical Button | Arthrex Biceps Button | Substantial Equivalence |
| | System | | (Yes or No) |
| Fatigue Testing | Up to 4000 cycles were
done from unloaded
(5N) to loaded (225N)
condition until failure.
Average failure
occurred at 909 cycles. | Up to 4000 cycles
were done from
unloaded (5N)to
loaded (225N)
condition until failure.
Average failure
occurred at 855
cycles. | Yes |
| Button - Material | Ti-6Al-4V ELI Titanium
per ASTM F-136 | Ti-6Al-4V ELI Titanium
per ASTM F-136 | Yes |
| Button - Method
of fixation | Unicortical and
bicortical | Unicortical and
bicortical | Yes |
| Inserter | Multi-piece (3) reusable
inserter.
Button loaded onto
inserter during surgery | Multi-piece (2)
disposable inserter.
Button loaded onto
inserter in packaging
prior to surgery | Yes |
| Drills | (2.6mm - 3.2 mm) Drill
bits for biceps. Drill
appropriate sized holes
to ensure proper button
insertion. | 3.2 mm drill (Biceps
Button), 4 mm drill pin
(Retro Button) | Yes |
| Cannulas | Drill Guide | Drill Guide | Yes |
| Characteristics | Tigon Medical Button
System | Arthrex Biceps Button | Substantial Equivalence
(Yes or No) |
| Supplied | Buttons and instruments
shipped sterile and non-
sterile. | Buttons and
instruments shipped
sterile. | Yes, Buttons shipped
non-sterile to be steam
sterilized such as the
referenced AOS Small
Fragment Plating System
consisting of Titanium
screws (K152732) |
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Image /page/6/Picture/1 description: The image shows the logo for Tigon Medical. The logo features a stylized tiger eye on the left, with the words "TIGON MEDICAL" in bold, sans-serif font to the right of the eye. The eye is orange with black stripes, and the text is black.
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Image /page/7/Picture/1 description: The image shows the logo for Tigon Medical. The logo features a stylized tiger eye on the left, with the words "TIGON MEDICAL" in bold, sans-serif font to the right of the eye. The eye is orange and black, and the text is black.
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Image /page/8/Picture/1 description: The image shows the logo for Tigon Medical. The logo features a stylized tiger eye on the left, with the words "TIGON MEDICAL" in bold, sans-serif font to the right of the eye. The eye is black with an orange iris.
Non-Clinical Testing Summary:
Tigon Medical substantiates that the product is as safe, as effective, and performs as well or better than the legal marketed predicate.
Tests performed:
Axial Pullout Strength: The device was found to be substantially equivalent to the predicate for maximum pullout strength per ASTM F543
Fatigue Testing: The device was found to be substantially equivalent to the predicate for cyclic loading fatigue testing.
Tray Sterilization Validation: The Tigon Medical Button system was found to be sterile in the Tigon Medical Shoulder Set.
Device Comparison Discussion:
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Image /page/9/Picture/1 description: The image contains the logo for Tigon Medical. The logo features a stylized tiger eye on the left, with the words "TIGON MEDICAL" in bold, sans-serif font to the right of the eye. The eye is orange with black stripes, and the text is black.
Substantial equivalence between the Tigon Medical Button System can be demonstrated according to the FDA's Guidelines for Substantial Equivalence Decision Making Process, for at least the following reasons:
- . The Tigon Medical Button System is compared to the Arthrex Biceps Button
- The Tigon Medical Button System has equivalent intended use and indications as ● the Arthrex Biceps Button
- . Major technological characteristics are substantially equivalent between the Tigon Medical Button System and the Arthrex Biceps Button
- . including, but not limited to:
- Substantially equivalent materials O
- Substantially equivalent size range o
- o Substantially equivalent method of fixation
- o Substantially equivalent mechanical strength