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

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.

AI/ML Overview

The Tigon Medical Button System is compared to the Arthrex Biceps Button for demonstrating substantial equivalence. The following criteria and results were reported:

1. Table of Acceptance Criteria and Reported Device Performance

Characteristic	Acceptance Criteria (Predicate: Arthrex Biceps Button)	Reported Device Performance (Tigon Medical Button System)
Product Codes	MBI	MBI
Indications	Same as Predicate (fixation of bone to bone or soft tissue to bone, specifically for shoulder, elbow, and knee repairs)	Facilitate fixation of bone to bone or soft tissue to bone for the same indications as the predicate.
Button - Sizes	Variety of different button combinations and sizes	Range of button sizes; widths vary from 2.25 mm to 2.7 mm, lengths from 6.65 mm to 8 mm.
Button - Mechanical Strength	Average mechanical pull out strength of 283.15N	Average mechanical pull out strength of 289.55N
Fatigue Testing	Up to 4000 cycles from 5N to 225N condition until failure; average failure at 855 cycles	Up to 4000 cycles from 5N to 225N condition until failure; average failure occurred at 909 cycles.
Button - Material	Ti-6Al-4V ELI Titanium per ASTM F-136	Ti-6Al-4V ELI Titanium per ASTM F-136
Button - Method of Fixation	Unicortical and bicortical	Unicortical and bicortical
Inserter	Multi-piece (2) disposable inserter; button loaded onto inserter in packaging prior to surgery	Multi-piece (3) reusable inserter; button loaded onto inserter during surgery. (Claimed as substantially equivalent due to functional similarity despite differences in reusability/loading).
Drills	3.2 mm drill (Biceps Button), 4 mm drill pin (Retro Button)	(2.6mm - 3.2 mm) Drill bits for biceps. Drill appropriate sized holes to ensure proper button insertion.
Cannulas	Drill Guide	Drill Guide
Supplied	Buttons and instruments shipped sterile.	Buttons and instruments shipped sterile and non-sterile. (Claimed as substantially equivalent, citing other non-sterile titanium devices cleared for steam sterilization).

2. Sample size used for the test set and the data provenance

The document indicates that "Mechanical testing has been done, including cyclical loading and tensile strength," but does not explicitly state the sample sizes (number of devices tested) for the pull-out strength or fatigue testing. The data provenance is not mentioned, but it can be inferred that these were laboratory-based non-clinical tests rather than human clinical trials.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable as the study involved non-clinical mechanical testing, not a medical imaging or diagnostic device requiring expert interpretation for ground truth.

4. Adjudication method for the test set

This information is not applicable as the study involved non-clinical mechanical testing.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, an MRMC comparative effectiveness study was not done. The study focused on mechanical performance comparison of the device itself, not on human reader performance with or without AI assistance.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

No, a standalone algorithm performance study was not done as this is a mechanical fixation device, not a software or AI product.

7. The type of ground truth used

For mechanical strength and fatigue testing, the "ground truth" was established by measured physical properties (e.g., maximum pullout strength in Newtons, number of cycles to failure) observed under controlled laboratory conditions, compared against the reported performance of a legally marketed predicate device.

8. The sample size for the training set

This information is not applicable. There is no mention of a "training set" as this is a mechanical device, not a machine learning model.

9. How the ground truth for the training set was established

This information is not applicable as there is no "training set."

Summary

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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

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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.

K211049

Submitter Information

Applicant:	Tigon Medical
Contact Person:	Jeremy ClarkManagement RepresentativeTigon Medical838 Ritchie Hwy, Suite 5Severna 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 fixationfastener.
Product Code/Panel:	MBI
Predicate Devices:	Arthrex Biceps Button (K123341)
Intended Use:	The Tigon Medical Button System implants are intended tofacilitate fixation of bone to bone or soft tissue to bone.Shoulder:Proximal Biceps Tendon RepairMinor Pectoralis RepairMajor 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:

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 ButtonSystem	Arthrex Biceps Button	Substantial Equivalence(Yes or No)
Product Codes	MBI	MBI	Yes
510(k) Number	K211049	K123341
Indications	Indications for Use:The Tigon MedicalButton System implantsare intended tofacilitate fixation ofbone to bone or softtissue to bone.	The Suture Buttonand RetroButton areused for fixation ofbone to bone or softtissue to bone, andare intended asfixation posts, adistribution bridge, orfor distributing suturetension over areas ofligament or tendonrepair.	Yes
	Shoulder:Proximal Biceps TendonRepair	The BicepsButton,Pec Button andTenodesis Button areused for fixation ofbone to bone or soft
	Minor Pectoralis Repair	tissue to bone, andare intended as
	Major Pectoralis Repair	fixation posts, adistribution bridge, or
	Elbow:
	Distal Biceps TendonRepair	for distributing suturetension over areas ofligament or tendonrepair in the shoulderand elbow
Characteristics	Tigon Medical Button System	Arthrex Biceps Button	Substantial Equivalence(Yes or No)
	Ulnar CollateralLigamentReconstructionKnee:	Shoulder:Pectoralis Repair(Minor/Major)Biceps Tendon Repair(Distal/Proximal)Ulnar CollateralLigamentReconstruction
	Anterior CruciateLigament Repair	Knee:ACL Repair
	Posterior CruciateLigament Repair
Button - Sizes	The Tigon MedicalButton System is madeup of a range of buttonsizes.	The Arthex BicepsButton is made up ofa variety of differentbutton combinationsand sizes.	Yes
Button -MechanicalStrength	The Tigon MedicalButton System has anaverage mechanicalpull out strength of$289.55N$	The Arthrex BicepsButton has anaverage mechanicalpull 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 weredone from unloaded(5N) to loaded (225N)condition until failure.Average failureoccurred at 909 cycles.	Up to 4000 cycleswere done fromunloaded (5N)toloaded (225N)condition until failure.Average failureoccurred at 855cycles.	Yes
Button - Material	Ti-6Al-4V ELI Titaniumper ASTM F-136	Ti-6Al-4V ELI Titaniumper ASTM F-136	Yes
Button - Methodof fixation	Unicortical andbicortical	Unicortical andbicortical	Yes
Inserter	Multi-piece (3) reusableinserter.Button loaded ontoinserter during surgery	Multi-piece (2)disposable inserter.Button loaded ontoinserter in packagingprior to surgery	Yes
Drills	(2.6mm - 3.2 mm) Drillbits for biceps. Drillappropriate sized holesto ensure proper buttoninsertion.	3.2 mm drill (BicepsButton), 4 mm drill pin(Retro Button)	Yes
Cannulas	Drill Guide	Drill Guide	Yes
Characteristics	Tigon Medical ButtonSystem	Arthrex Biceps Button	Substantial Equivalence(Yes or No)
Supplied	Buttons and instrumentsshipped sterile and non-sterile.	Buttons andinstruments shippedsterile.	Yes, Buttons shippednon-sterile to be steamsterilized such as thereferenced AOS SmallFragment Plating Systemconsisting of Titaniumscrews (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

Regulation Number and Section

§ 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.