Tigon Medical Gryphon Anchor Line

K220464 · Tigon Medical · MBI · Mar 22, 2023 · Orthopedic

Device Facts

• Record ID: K220464
• Device Name: Tigon Medical Gryphon Anchor Line
• Applicant: Tigon Medical
• Product Code: MBI · Orthopedic
• Decision Date: Mar 22, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

Gryphon Anchor Line comprises four soft tissue fixation anchor families (Tomahawk, Dual, Eye-Deal, Tenodesis); used for reattaching soft tissue to bone. Anchors are inserted into pre-drilled pilot holes using stainless steel inserters; fixation achieved via interference or screw-in mechanisms. Devices are used in orthopedic surgical settings by physicians. Output is the mechanical fixation of soft tissue to bone, facilitating healing and stabilization. Benefits include restored joint stability and tendon function. Anchors are provided sterile; some inserters are reusable and sterilized on-site.

Clinical Evidence

Bench testing only. Testing included axial pullout strength (per ASTM F543), cyclic loading fatigue testing, and insertion performance. Biocompatibility evaluated per ISO 10993-1. Sterilization, endotoxin, and shelf-life testing performed.

Technological Characteristics

Materials: VESTAKEEP i4R PEEK (ASTM F2026) or Ti6Al4V ELI (ASTM F136). Dimensions: 3.75mm x 6mm to 10.5mm x 23mm. Fixation: Interference or screw-in. Inserters: Stainless steel (ASTM F899). Sterilization: Sterile (SAL 10^-6).

Indications for Use

Indicated for reattachment of soft tissue to bone in shoulder, elbow, wrist, hand, knee, and foot/ankle procedures. Specific indications include capsular stabilization, rotator cuff repair, bicep tenodesis, ligament reconstruction, tendon repair, and bunionectomy. Tenodesis sub-family additionally indicated for ACL repair, FHL for Achilles reconstruction, and CMC joint arthroplasty.

Regulatory Classification

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.

Predicate Devices

• Tigon Medical Tissue Anchors (K182507)

Reference Devices

• Tigon Medical Button System (K211049)
• Arthrex Tenodesis Family (K051726)
• Smith and Nephew Bioraptor (K151105)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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;

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 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) | |
|--------------------------------------------------------------------------------|-------------------------------------------------------------------------------|
| <div> <span>☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span>☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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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 Clark<br>Management Representative<br>Tigon Medical<br>303 Najoles Rd.<br>Millersville, MD 21108<br>[phone] |
| 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 fixation<br>fastener. |
| Product Code/Panel: | MBI |
| Predicate Devices: | Tigon Medical Tissue Anchors (K182507)<br>Reference: Tigon Medical Button System (K211049)<br>Reference: Arthrex Tenodesis Family (K051726)<br>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:

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

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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:

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.

#### 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 Gryphon<br>Anchor Line | Tigon Medical Tissue<br>Anchors | Substantial Equivalence |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Codes | MBI | MBI | Yes |
| 510(k) Number | K220464 | K121018 | Yes |
| Indications | The Tigon Medical<br>Gryphon Anchor Line is<br>made up of four families<br>of soft tissue fixation<br>devices: Tomahawk<br>Anchor, Dual Anchor,<br>Eye-Deal Anchor, and<br>Tenodesis Anchors. The<br>entirety of the gryphon<br>anchor line is intended<br>for use for the<br>reattachment of soft<br>tissue to bone for the<br>following indications:<br>Shoulder: Capsular<br>stabilization (Bankart<br>repair, Anterior shoulder<br>instability, SLAP lesion<br>repairs, Capsular shift or<br>capsulolabral<br>reconstructions),<br>Acromioclavicular<br>separation repairs,<br>Deltoid repairs, Rotator<br>cuff repairs, Bicep<br>tenodesis. | The Tigon Medical Tissue<br>Anchor System is intended<br>for use for the<br>reattachment of soft tissue<br>to bone for the following<br>indications:<br>Shoulder: Capsular<br>stabilization (Bankart repair,<br>Anterior shoulder instability,<br>SLAP lesion repairs,<br>Capsular shift or<br>capsulolabral<br>reconstructions),<br>Acromnioclavicular<br>separation repairs, Deltoid<br>repairs, Rotator cuff repairs,<br>Bicep<br>tenodesis;<br>Elbow, Wrist, and Hand:<br>Biceps tendon<br>reattachment, Ulnar or<br>radial collateral ligament<br>reconstruction, Lateral<br>epicondylitis repair;<br>Knee: Extra-capsular repairs<br>(Medial collateral ligament,<br>Lateral collateral ligament,<br>Posterior oblique ligament), | Yes, when also considering<br>the referenced devices.<br>The Arthrex tenodesis<br>family (K051726) have the<br>same added indications as<br>the tenodesis anchors, a<br>sub family in the Tigon<br>Medical Gryphon Anchor<br>line.<br>(In addition to these<br>indications, the Tenodesis<br>Anchors, a sub family of<br>the gryphon anchor line<br>will also be indicated for:<br>Foot and Ankle: Flexor<br>hallucis longus for Achilles<br>tendon reconstructions,<br>tendon transfers in the foot<br>and Ankle<br>Knee: ACL Repair<br>Hand/Wrist:<br>Carpometacarpal joint<br>arthroplasty, carpal |
| Characteristics | Tigon Medical Gryphon<br>Anchor Line | Tigon Medical Tissue<br>Anchors | Substantial Equivalence |
| | Elbow, Wrist, and Hand:<br>Biceps tendon<br>reattachment, Ulnar or<br>radial collateral ligament<br>reconstruction, Lateral<br>epicondylitis repair; | Patellar realignment and<br>tendon repairs (Vastus<br>medialis obliquous<br>advancement), Illiotibial<br>band tenodesis; | ligament reconstructions<br>and repairs, tendon<br>transfer in hand/wrist) |
| | Knee: Extra-capsular<br>repairs (Medial collateral<br>ligament, Lateral<br>collateral ligament,<br>Posterior oblique<br>ligament), Patellar<br>realignment and tendon<br>repairs (Vastus medialis<br>obliquus advancement),<br>Iliotibial band tenodesis; | Foot and Ankle: Hallux<br>valgus repairs, Medial or<br>Lateral instability<br>repairs/reconstructions,<br>Achilles tendon repairs/<br>reconstructions, Midfoot<br>reconstructions, Metatarsal<br>ligament/tendon<br>repairs/reconstructions,<br>Bunionectomy | |
| | Foot and Ankle: Hallux<br>valgus repairs, Medial or<br>Lateral instability<br>repairs/reconstructions,<br>Achilles tendon repairs/<br>reconstructions, Midfoot<br>reconstructions,<br>Metatarsal<br>ligament/tendon | | |
| Characteristics | Tigon Medical Gryphon<br>Anchor Line | Tigon Medical Tissue<br>Anchors | Substantial Equivalence |
| | repairs/reconstructions,<br>Bunionectomy | | |
| | In addition to these<br>indications, the Tenodesis<br>Anchors, a sub family of<br>the gryphon anchor line<br>will also be indicated for: | | |
| | Foot and Ankle: Flexor<br>hallucis longus for Achilles<br>tendon reconstructions,<br>tendon transfers in the<br>foot and Ankle | | |
| | Knee: ACL Repair | | |
| | Hand/Wrist:<br>Carpometacarpal joint<br>arthroplasty, carpal<br>ligament reconstructions<br>and repairs, tendon<br>transfer in hand/wrist | | |
| Sizes | The Tigon Medical<br>Gryphon Anchor Line is<br>made up of a range of<br>sizes. | The Tigon Medical Tissue<br>anchors is made up of a<br>range of sizes. | Yes, when also considering<br>the referenced devices.<br>The tenodesis anchors<br>have a larger size range |
| Characteristics | Tigon Medical Gryphon<br>Anchor Line | Tigon Medical Tissue<br>Anchors | Substantial Equivalence |
| | | | than the Tigon Medical<br>Tissue Anchors, but this<br>range is identical to the<br>range of the referenced<br>Arthrex Tenodesis Family<br>anchors (K051726) |
| Mechanical<br>Strength | The worst case implant in<br>the Tigon Medical<br>Gryphon Anchor Line has<br>a mechanical strength of<br>262.3 N | The worst-case implant in<br>the Tigon Medical Tissue<br>Anchor line has a<br>mechanical strength of<br>143.6 N | Yes |
| Fatigue Testing | Up to 500 cycles were<br>done from unloaded<br>(5N) to loaded(60N)<br>condition until failure. | Up to 500 cycles were<br>done from unloaded (5N)<br>to loaded(60N) condition<br>until failure. | Yes |
| Material | PEEK per ASTM F2026 or<br>Ti-6AL-4V ELI Titanium per<br>ASTM F-136 | PEEK Per ASTM F2026 | Yes<br>For Titanium see reference<br>device Tigon Medical<br>Button System made from<br>TI6Al4V ELI Per ASTM F136.<br>(K211049) |
| Method of<br>fixation | Interference or screw in | Push in, or screw in | Yes, when also considering<br>the referenced devices.<br>The tenodesis anchors<br>have an identical method<br>of fixation (interference) as<br>the referenced Arthrex |
| Characteristics | Tigon Medical Gryphon<br>Anchor Line | Tigon Medical Tissue<br>Anchors | Substantial Equivalence |
| | | | Tenodesis Family anchors<br>(K051726) |
| Inserter | Multi-piece (2 or 3)<br>reusable inserter.<br>Anchors may come<br>preloaded with suture on<br>an inserter shaft or be<br>loaded on an inserter at<br>time of surgery. | Multi-piece (2) reusable<br>inserter.<br>Anchors may come<br>preloaded with suture and will<br>be loaded on the inserter<br>at the time of surgery | Yes |
| Drills/Awls | Anchors will be inserted<br>into pilot holes<br>appropriate for their size | Anchors are inserted into<br>pilot holes appropriate to<br>their size. | Yes |
| Cannulas | Drill Guide | Drill Guide | Yes |
| Supplied | All Implants: Sterile to<br>assure an SAL of 10-6<br>One inserter type: Sterile<br>to assure a Sterile to<br>assure an SAL of 10-6<br>All other inserters: Non<br>Sterile, to be sterilized on<br>site in tray | All Implants: Sterile to assure<br>an SAL of 10-6<br>All other inserters: Non<br>Sterile, to be sterilized on<br>site 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)