(398 days)
No
The device description and performance studies focus on the mechanical properties and intended use of soft tissue fixation devices, with no mention of AI or ML.
Yes
The device is intended for the reattachment of soft tissue to bone for various indications, which falls under the definition of a therapeutic intervention designed to treat a medical condition or injury.
No
The device is a medical implant intended for the reattachment of soft tissue to bone, serving a therapeutic purpose rather than providing diagnostic information.
No
The device description clearly states that the device is made of physical materials (PEEK, Ti6Al4V ELI, stainless steel) and includes physical components (anchors, sutures, inserters). It is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for the "reattachment of soft tissue to bone" in various anatomical locations. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as suture anchors made of PEEK or Titanium, with associated sutures and inserters. These are physical implants and surgical tools.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) during surgery.
N/A
Intended Use / Indications for 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
Product codes
MBI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, Elbow, Wrist, Hand, Knee, Foot, Ankle
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
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
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.
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
2
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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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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 |
| Management Representative | |
| Tigon Medical | |
| 303 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 fixation |
| fastener. | |
| 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) |
Page | 1 of 10
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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
Anchor Line | Tigon Medical Tissue
Anchors | Substantial Equivalence |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Codes | MBI | MBI | Yes |
| 510(k) Number | K220464 | K121018 | Yes |
| Indications | 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. | The Tigon Medical Tissue
Anchor System 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),
Acromnioclavicular
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), | Yes, when also considering
the referenced devices.
The Arthrex tenodesis
family (K051726) have the
same added indications as
the tenodesis anchors, a
sub family in the Tigon
Medical Gryphon Anchor
line.
(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 |
| Characteristics | Tigon Medical Gryphon
Anchor Line | Tigon Medical Tissue
Anchors | Substantial Equivalence |
| | Elbow, Wrist, and Hand:
Biceps tendon
reattachment, Ulnar or
radial collateral ligament
reconstruction, Lateral
epicondylitis repair; | Patellar realignment and
tendon repairs (Vastus
medialis obliquous
advancement), Illiotibial
band tenodesis; | ligament reconstructions
and repairs, tendon
transfer in hand/wrist) |
| | 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 | |
| | Foot and Ankle: Hallux
valgus repairs, Medial or
Lateral instability
repairs/reconstructions,
Achilles tendon repairs/
reconstructions, Midfoot
reconstructions,
Metatarsal
ligament/tendon | | |
| Characteristics | Tigon Medical Gryphon
Anchor Line | Tigon Medical Tissue
Anchors | Substantial Equivalence |
| | 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 | | |
| Sizes | The Tigon Medical
Gryphon Anchor Line is
made up of a range of
sizes. | The Tigon Medical Tissue
anchors is made up of a
range of sizes. | Yes, when also considering
the referenced devices.
The tenodesis anchors
have a larger size range |
| Characteristics | Tigon Medical Gryphon
Anchor Line | Tigon Medical Tissue
Anchors | Substantial Equivalence |
| | | | than the Tigon Medical
Tissue Anchors, but this
range is identical to the
range of the referenced
Arthrex Tenodesis Family
anchors (K051726) |
| Mechanical
Strength | The worst case implant in
the Tigon Medical
Gryphon Anchor Line has
a mechanical strength of
262.3 N | The worst-case implant in
the Tigon Medical Tissue
Anchor line has a
mechanical strength of
143.6 N | Yes |
| Fatigue Testing | Up to 500 cycles were
done from unloaded
(5N) to loaded(60N)
condition until failure. | Up to 500 cycles were
done from unloaded (5N)
to loaded(60N) condition
until failure. | Yes |
| Material | PEEK per ASTM F2026 or
Ti-6AL-4V ELI Titanium per
ASTM F-136 | PEEK Per ASTM F2026 | Yes
For Titanium see reference
device Tigon Medical
Button System made from
TI6Al4V ELI Per ASTM F136.
(K211049) |
| Method of
fixation | Interference or screw in | Push in, or screw in | Yes, when also considering
the referenced devices.
The tenodesis anchors
have an identical method
of fixation (interference) as
the referenced Arthrex |
| Characteristics | Tigon Medical Gryphon
Anchor Line | Tigon Medical Tissue
Anchors | Substantial Equivalence |
| | | | Tenodesis Family anchors
(K051726) |
| Inserter | Multi-piece (2 or 3)
reusable inserter.
Anchors may come
preloaded with suture on
an inserter shaft or be
loaded on an inserter at
time of surgery. | Multi-piece (2) reusable
inserter.
Anchors may come
preloaded with suture and will
be loaded on the inserter
at the time of surgery | Yes |
| Drills/Awls | Anchors will be inserted
into pilot holes
appropriate for their size | Anchors are inserted into
pilot holes appropriate to
their size. | Yes |
| Cannulas | Drill Guide | Drill Guide | Yes |
| Supplied | All Implants: Sterile to
assure an SAL of 10-6
One inserter type: Sterile
to assure a Sterile to
assure an SAL of 10-6
All other inserters: Non
Sterile, to be sterilized on
site in tray | All Implants: Sterile to assure
an SAL of 10-6
All other inserters: Non
Sterile, to be sterilized on
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.
9
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.
10
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."
11
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.
12
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.
13
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)