The Tigon Medical Gryphon Anchor Line is made up of four families of soft tissue fixation devices: Tomahawk Anchor, Dual Anchor, Eye-Deal Anchor, and Tenodesis Anchors. The entirety of the gryphon anchor line is intended for use for the reattachment of soft tissue to bone for the following indications:

Shoulder: Capsular stabilization (Bankart repair, Anterior shoulder instability, SLAP lesion repairs, Capsular shift or capsulolabral reconstructions), Acromioclavicular separation repairs, Deltoid repairs, Rotator cuff repairs, Bicep tenodesis.

Elbow, Wrist, and Hand: Biceps tendon reattachment, Ulnar or radial collateral ligament reconstruction, Lateral epicondylitis repair;

Knee: Extra-capsular repairs (Medial collateral ligament, Lateral collateral ligament, Posterior oblique ligament), Patellar realignment and tendon repairs (Vastus medialis obliquus advancement), Iliotibial band tenodesis;

Foot and Ankle: Hallux valgus repairs, Medial or Lateral instability repairs/reconstructions, Achilles tendon repairs/ reconstructions, Midfoot reconstructions, Metatarsal ligament/tendon repairs/reconstructions, Bunionectomy

In addition to these indications, the Tenodesis Anchors, a sub family of the gryphon anchor line will also be indicated for:

Foot and Ankle: Flexor hallucis longus for Achilles tendon reconstructions, tendon transfers in the foot and Ankle

Knee: ACL Repair

Hand/Wrist: Carpometacarpal joint arthroplasty, carpal ligament reconstructions and repairs, tendon transfer in hand/wrist

Device Description

The Tigon Medical Gryphon Anchor Line consists of four sub-families of suture anchors: Tomahawk anchors, Dual anchors, Tenodesis anchors, and Eye-Deal anchors. It consists of a range of anchors sizes between 3.75 mm diameter and 6 mm length to 10.5 mm diameter and 23 mm length. The Tomahawk Anchors, Dual Anchors, and Tenodesis anchors are made from VESTAKEEP® i4R PEEK per ASTM F2026 while the Eye-Deal Anchors are made from Ti6Al4V ELI per ASTM F136.

The anchors are available with many configurations of sutures and suture tapes or without suture. All the anchors in this system may be loaded with a combination of USP #2 suture cables and/or tape equivalent while the Dual Anchors and Tenodesis anchors may be loaded with a combination of USP 2 and USP 5 suture cables and/or tape equivalent.

All anchors are inserted with stainless steel inserters per ASTM F899. The shafts that are used with the Tomahawk anchors may be reprocessed and will be available sterile packed and attached to the anchor and suture.

AI/ML Overview

The provided document describes the predicate device and the new device for a 510(k) submission, confirming substantial equivalence through non-clinical testing. However, it does not include the detailed acceptance criteria and a study proving the device meets those criteria in the format requested. Specifically, the document focuses on demonstrating substantial equivalence to a predicate device through mechanical testing, indicating the new device performs "as well as or better than" the predicate. It lacks explicit numerical acceptance criteria for performance metrics beyond a comparative statement with the predicate.

Therefore, for aspects requiring quantitative acceptance criteria, specific study details (sample size for test set, data provenance, number and qualifications of experts, adjudication method, MRMC studies, standalone performance, ground truth types, training set size, and ground truth establishment for training set), the information is not present in the provided text.

Based on the available information:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance	Study Proving Acceptance
Mechanical Strength: Device to be substantially equivalent or better than the predicate's mechanical strength.	The worst-case implant in the Tigon Medical Gryphon Anchor Line has a mechanical strength of 262.3 N, (compared to the predicate's 143.6 N).	Axial Pullout Strength testing per ASTM F543.
Fatigue Testing: Device to be substantially equivalent or better than the predicate for cyclic loading.	Up to 500 cycles were done from unloaded (5N) to loaded (60N) condition until failure, found to be substantially equivalent.	Fatigue Testing.
Insertion Performance: Device to be substantially equivalent to the predicate product.	Found to be substantially equivalent to the predicate product.	Insertion Performance Testing.
Sterilization Validation: Achieve an SAL of 10-6 for sterile components; EO Residual Testing, Sterility Testing, and Bioburden Testing conducted.	Sterilization Validation activities conducted including EO Residual Testing, Sterility Testing, and Bioburden Testing. Implants and one inserter type supplied sterile to assure an SAL of 10-6.	Sterilization Validation activities.
Endotoxin Levels: Continuously monitored on a lot-by-lot basis.	Endotoxin testing has been conducted and will be continuously monitored on a lot-by-lot basis.	Endotoxin testing.
Shelf-Life and Packaging Integrity: Demonstrated through accelerated and real-time testing.	Accelerated Shelf-Life Testing and Packaging Performance/integrity testing conducted; real-time shelf-life testing is ongoing.	Accelerated and real-time shelf-life testing, Packaging Performance/integrity testing.
Biocompatibility: Evaluated per ISO 10993-1.	Evaluated for biocompatibility according to ISO 10993-1.	Biocompatibility Summary.

Missing Information Specifics:

The provided text focuses on demonstrating substantial equivalence to existing predicate devices through mechanical and other non-clinical testing. It explicitly states: "Mechanical testing has been done, including cyclical loading and tensile strength which demonstrated the proposed products met the acceptance criteria for the proposed indications." and "The device was found to be substantially equivalent to the predicate for maximum pullout strength per ASTM F543."

However, the document does not provide the following information from the input request:

Sample size used for the test set and the data provenance: Not specified for any of the tests.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as this is a medical device, not an AI/diagnostic software. The ground truth refers to performance against established engineering standards and predicate devices.
Adjudication method for the test set: Not applicable for performance testing against engineering standards.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a physical medical implant (suture anchors), not an AI diagnostic tool.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable for a physical medical device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For mechanical tests, the ground truth is typically defined by established engineering standards (e.g., ASTM F543) and the performance of legally marketed predicate devices. For biocompatibility, it's ISO 10993-1.
The sample size for the training set: Not applicable as this is a physical medical device and not an AI/ML model.
How the ground truth for the training set was established: Not applicable.

Summary

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March 22, 2023

Image /page/0/Picture/1 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. The logos are simple and professional, and they are likely used to identify the organizations on official documents and websites.

Tigon Medical Jeremy Clark President 303 Najoles Rd Millersville, Maryland 21108

Re: K220464

Trade/Device Name: Tomahawk Anchors, Dual Anchors, Eye-Deal Anchors, Tenodesis Anchors Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: February 24, 2023 Received: February 28, 2023

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.

Sara S. Thompson -S

For

Laurence D. Coyne, Ph.D. Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K220464

Device Name Tigon Medical Gryphon Anchor Line

Indications for Use (Describe)

The Tigon Medical Gryphon Anchor Line is made up of four families of soft tissue fixation devices: Tomahawk Anchor, Dual Anchor, Eye-Deal Anchor, and Tenodesis Anchors. The gryphon anchor line is intended for use for the reattachment of soft tissue to bone for the following indications:

Shoulder: Capsular stabilization (Bankart repar, Anterior shoulder instability, SLAP lesion repairs, Capsular shift or capsulolabral reconstructions), Acromioclavicular separation repairs, Rotator cuff repairs, Bicep tenodesis.

Elbow, Wrist, and Hand: Biceps tendon reattachment, Ulnar or radial collateral ligament reconstruction, Lateral epicondylitis repair;

Knee: Extra-capsular repairs (Medial collateral ligament, Lateral ligament, Posterior oblique ligament), Patellar realignment and tendon repairs (Vastus medialis obliquus advancement), Iliotibial band tenodesis;

In addition to these indications, the Tenodes, a sub family of the gryphon anchor line will also be indicated for:

Foot and Ankle: Flexor hallucis longus for Achilles tendon reconstructions, tendon transfers in the foot and Ankle

Knee: ACL Repair

Hand Wrist: Carpometacarpal joint arthroplasty, carpal ligament reconstructions and repairs, tendon transfer in hand/wrist

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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Image /page/4/Picture/2 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 and white with an orange iris.

Submitter Information

Applicant:	Tigon Medical
Submission Number:	K220464
Contact Person:	Jeremy ClarkManagement RepresentativeTigon Medical303 Najoles Rd.Millersville, MD 21108(410) 544-2833
Date Prepared:	03/22/2023
Name of Device:	Tigon Medical Gryphon Anchor Line
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:	Tigon Medical Tissue Anchors (K182507)Reference: Tigon Medical Button System (K211049)Reference: Arthrex Tenodesis Family (K051726)Reference: Smith and Nephew Bioraptor (K151105)

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Image /page/5/Picture/2 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 primarily black with an orange iris.

Intended Use:

Elbow, Wrist, and Hand: Biceps tendon reattachment, Ulnar or radial collateral ligament reconstruction, Lateral epicondylitis repair;

In addition to these indications, the Tenodesis Anchors, a sub family of the gryphon anchor line will also be indicated for:

Foot and Ankle: Flexor hallucis longus for Achilles tendon reconstructions, tendon transfers in the foot and Ankle

Knee: ACL Repair

Hand/Wrist: Carpometacarpal joint arthroplasty, carpal ligament reconstructions and repairs, tendon transfer in hand/wrist

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Image /page/6/Picture/2 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 eye is orange and black, and the text is in a sans-serif font.

Device Description Summary:

Substantial Equivalence Summary:

The Tigon Medical Gryphon anchor line is made of four sub-families: Tomahawk Anchors, Dual Anchors, Eye-Deal Anchors, and Tenodesis Anchors. All four sub-families are substantially equivalent to the predicate devices as the features and intended use are the same. The indications for use differ between the Tenodesis anchors and the rest of the product family made up by the other Gryphon anchor sub-families. Those additional indications for use are found in the reference device: K051726 (Arthrex Tenodesis Family). Anchor fixation has been shown to be a biomechanically sound method of soft tissue to bone fixation. Mechanical testing has been done, including cyclical loading and tensile strength which demonstrated the proposed products met the acceptance criteria for the proposed indications.

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Image /page/7/Picture/2 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.

Characteristics	Tigon Medical GryphonAnchor Line	Tigon Medical TissueAnchors	Substantial Equivalence
Product Codes	MBI	MBI	Yes
510(k) Number	K220464	K121018	Yes
Indications	The Tigon MedicalGryphon Anchor Line ismade up of four familiesof soft tissue fixationdevices: TomahawkAnchor, Dual Anchor,Eye-Deal Anchor, andTenodesis Anchors. Theentirety of the gryphonanchor line is intendedfor use for thereattachment of softtissue to bone for thefollowing indications:Shoulder: Capsularstabilization (Bankartrepair, Anterior shoulderinstability, SLAP lesionrepairs, Capsular shift orcapsulolabralreconstructions),Acromioclavicularseparation repairs,Deltoid repairs, Rotatorcuff repairs, Biceptenodesis.	The Tigon Medical TissueAnchor System is intendedfor use for thereattachment of soft tissueto bone for the followingindications:Shoulder: Capsularstabilization (Bankart repair,Anterior shoulder instability,SLAP lesion repairs,Capsular shift orcapsulolabralreconstructions),Acromnioclavicularseparation repairs, Deltoidrepairs, Rotator cuff repairs,Biceptenodesis;Elbow, Wrist, and Hand:Biceps tendonreattachment, Ulnar orradial collateral ligamentreconstruction, Lateralepicondylitis repair;Knee: Extra-capsular repairs(Medial collateral ligament,Lateral collateral ligament,Posterior oblique ligament),	Yes, when also consideringthe referenced devices.The Arthrex tenodesisfamily (K051726) have thesame added indications asthe tenodesis anchors, asub family in the TigonMedical Gryphon Anchorline.(In addition to theseindications, the TenodesisAnchors, a sub family ofthe gryphon anchor linewill also be indicated for:Foot and Ankle: Flexorhallucis longus for Achillestendon reconstructions,tendon transfers in the footand AnkleKnee: ACL RepairHand/Wrist:Carpometacarpal jointarthroplasty, carpal
Characteristics	Tigon Medical GryphonAnchor Line	Tigon Medical TissueAnchors	Substantial Equivalence
	Elbow, Wrist, and Hand:Biceps tendonreattachment, Ulnar orradial collateral ligamentreconstruction, Lateralepicondylitis repair;	Patellar realignment andtendon repairs (Vastusmedialis obliquousadvancement), Illiotibialband tenodesis;	ligament reconstructionsand repairs, tendontransfer in hand/wrist)
	Knee: Extra-capsularrepairs (Medial collateralligament, Lateralcollateral ligament,Posterior obliqueligament), Patellarrealignment and tendonrepairs (Vastus medialisobliquus advancement),Iliotibial band tenodesis;	Foot and Ankle: Halluxvalgus repairs, Medial orLateral instabilityrepairs/reconstructions,Achilles tendon repairs/reconstructions, Midfootreconstructions, Metatarsalligament/tendonrepairs/reconstructions,Bunionectomy
	Foot and Ankle: Halluxvalgus repairs, Medial orLateral instabilityrepairs/reconstructions,Achilles tendon repairs/reconstructions, Midfootreconstructions,Metatarsalligament/tendon
Characteristics	Tigon Medical GryphonAnchor Line	Tigon Medical TissueAnchors	Substantial Equivalence
	repairs/reconstructions,Bunionectomy
	In addition to theseindications, the TenodesisAnchors, a sub family ofthe gryphon anchor linewill also be indicated for:
	Foot and Ankle: Flexorhallucis longus for Achillestendon reconstructions,tendon transfers in thefoot and Ankle
	Knee: ACL Repair
	Hand/Wrist:Carpometacarpal jointarthroplasty, carpalligament reconstructionsand repairs, tendontransfer in hand/wrist
Sizes	The Tigon MedicalGryphon Anchor Line ismade up of a range ofsizes.	The Tigon Medical Tissueanchors is made up of arange of sizes.	Yes, when also consideringthe referenced devices.The tenodesis anchorshave a larger size range
Characteristics	Tigon Medical GryphonAnchor Line	Tigon Medical TissueAnchors	Substantial Equivalence
			than the Tigon MedicalTissue Anchors, but thisrange is identical to therange of the referencedArthrex Tenodesis Familyanchors (K051726)
MechanicalStrength	The worst case implant inthe Tigon MedicalGryphon Anchor Line hasa mechanical strength of262.3 N	The worst-case implant inthe Tigon Medical TissueAnchor line has amechanical strength of143.6 N	Yes
Fatigue Testing	Up to 500 cycles weredone from unloaded(5N) to loaded(60N)condition until failure.	Up to 500 cycles weredone from unloaded (5N)to loaded(60N) conditionuntil failure.	Yes
Material	PEEK per ASTM F2026 orTi-6AL-4V ELI Titanium perASTM F-136	PEEK Per ASTM F2026	YesFor Titanium see referencedevice Tigon MedicalButton System made fromTI6Al4V ELI Per ASTM F136.(K211049)
Method offixation	Interference or screw in	Push in, or screw in	Yes, when also consideringthe referenced devices.The tenodesis anchorshave an identical methodof fixation (interference) asthe referenced Arthrex
Characteristics	Tigon Medical GryphonAnchor Line	Tigon Medical TissueAnchors	Substantial Equivalence
			Tenodesis Family anchors(K051726)
Inserter	Multi-piece (2 or 3)reusable inserter.Anchors may comepreloaded with suture onan inserter shaft or beloaded on an inserter attime of surgery.	Multi-piece (2) reusableinserter.Anchors may comepreloaded with suture and willbe loaded on the inserterat the time of surgery	Yes
Drills/Awls	Anchors will be insertedinto pilot holesappropriate for their size	Anchors are inserted intopilot holes appropriate totheir size.	Yes
Cannulas	Drill Guide	Drill Guide	Yes
Supplied	All Implants: Sterile toassure an SAL of 10-6One inserter type: Sterileto assure a Sterile toassure an SAL of 10-6All other inserters: NonSterile, to be sterilized onsite in tray	All Implants: Sterile to assurean SAL of 10-6All other inserters: NonSterile, to be sterilized onsite in tray	Yes

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Image /page/8/Picture/2 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.

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Image /page/9/Picture/2 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/10/Picture/2 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 word "TIGON" is in a larger font size than the word "MEDICAL."

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Image /page/11/Picture/2 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 primarily black with an orange iris.

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Image /page/12/Picture/2 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 as or better than the legally 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.

Insertion Performance Testing: The device was found to be substantially equivalent to the predicate product.

Sterilization Validation activities including EO Residual Testing, Sterility Testing, and Bioburden Testing.

Endotoxin testing has been conducted and will be continuously monitored on a lot-bylot basis.

Accelerated Shelf-Life Testing and Packaging Performance/integrity testing has been conducted and real-time shelf-life testing is on-going.

Biocompatibility Summary:

The device in its final finished form has been evaluated for biocompatibility according to ISO 10993-1.

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Image /page/13/Picture/2 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.

Device Comparison Discussion:

Substantial equivalence between the Tigon Medical Gryphon Anchor Line and the Tigon Medical Tissue Anchors can be demonstrated according to the FDA's Guidelines for Substantial Equivalence Decision Making Process, for at least the following reasons:

. The Tigon Medical Gryphon Anchor Line is compared to the Tigon Medical Tissue Anchors
. The Tigon Medical Gryphon Anchor Line has equivalent intended use and indications as the Tigon Medical Tissue Anchor
. Major technological characteristics are substantially equivalent between the Tigon Medical Gryphon Anchor Line and the Tigon Medical Tissue Anchor
including, but not limited to: ●
- Substantially equivalent materials* o
- Substantially equivalent size range** O
- O Substantially equivalent method of fixation
- Substantially equivalent mechanical strength O

*The Eye-Deal anchor is titanium which is identical to that of the reference device: Tigon Medical Button System (K211049)

**The Tenodesis Anchors exceed the size range of the Tigon Medical Tissue Anchor, but is substantially equivalent to that of the Arthrex Tenodesis Family anchors (K051726). The indications for use of the Tenodesis anchors match that of the Arthrex Tenodesis Family anchors (K051726)

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.