(116 days)
No
The device description and performance studies focus on mechanical properties and surgical fixation, with no mention of AI/ML or related concepts.
Yes.
The device is intended for the reattachment of soft tissue to bone for various indications across multiple anatomical sites (e.g., Elbow, Shoulder, Hand/Wrist, Foot/Ankle, Knee, Hip), which falls under the definition of a therapeutic purpose (i.e., treating or alleviating a disease or injury).
No
The device is described as a "soft-tissue fixation device" used for "reattachment of soft tissue to bone," which is a treatment rather than a diagnostic function.
No
The device description clearly states it is a physical device ("soft-tissue fixation devices provided sterile, preloaded on an inserter") made of materials like stainless steel, and performance studies involve mechanical testing.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description and Intended Use: The description clearly states that the Tigon Medical All-Suture Anchors are "soft-tissue fixation devices" intended for "reattachment of soft tissue to bone" for various surgical procedures. This is a device used within the body during surgery to physically repair tissues.
The information provided describes a surgical implant, not a diagnostic test performed on a sample.
N/A
Intended Use / Indications for Use
The Tigon Medical All-Suture Anchors are intended for the reattachment of soft tissue to bone for the following indications:
• Elbow: Biceps Tendon Reattachment. Ulnar or Radial Collateral Liqament Reconstruction
• Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Repair
• Hand/Wrist: Scaphulolunate Ligament Reconstruction, Carnal Ligament Reconstruction, Repair/ Reconstruction of Collateral Ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP Joints for all Digits, Digital Tendon Repair
• Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus Reconstruction, Digital Tendon Transfers, Mid-foot Reconstruction
• Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
• Hip: Capsular Repair, Acetabular Labral Repair, Gluteal Tendon Repair
Product codes
MBI
Device Description
The Tigon Medical All-Suture Anchors are soft-tissue fixation devices provided sterile, preloaded on an inserter. The anchor consists of different load configurations consisting of one or more working sutures. The inserters can be reprocessed after use and are made from stainless steel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Elbow, Shoulder, Hand/Wrist, Foot/Ankle, Knee, Hip
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Mechanical testing was performed to verify both the insertion strength and fixation strength of the Tigon Medical All-Suture Anchors as compared to the predicate.
Mechanical testing was performed according to ASTM F543. The mechanical test data demonstrates that the Tigon Medical All-Suture Anchors are substantially equivalent to the predicate device identified.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
ICONIX All Suture Anchor System (K133671)
Reference Device(s)
K171465, K122059, K230311, K220464, K182507
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 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 text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 20, 2024
Tigon Medical Jeremy Clark President 303 Najoles Road Suite 104 Millersville, Maryland 21108
Re: K242529
Trade/Device Name: Tigon Medical All-Suture Anchors (ASA) Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: December 16, 2024 Received: December 16, 2024
Dear Jeremy 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 (the 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 available 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory
2
assistance/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,
CHRISTOPHER FERREIRA -S
Christopher Ferreira, MS 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
3
Indications for Use
Submission Number (if known)
Device Name
Tigon Medical All-Suture Anchors (ASA)
Indications for Use (Describe)
The Tigon Medical All-Suture Anchors are intended for the reattachment of soft tissue to bone for the following indications:
• Elbow: Biceps Tendon Reattachment. Ulnar or Radial Collateral Liqament Reconstruction
· Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Repair
· Hand/Wrist: Scaphulolunate Ligament Reconstruction, Carnal Ligament Reconstruction, Repair/ Reconstruction of Collateral Ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP Joints for all Digits, Digital Tendon Repair
• Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus Reconstruction, Digital Tendon Transfers, Mid-foot Reconstruction
• Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
· Hip: Capsular Repair, Acetabular Labral Repair, Gluteal Tendon Repair
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)
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ASA 510(k) Summary
Image /page/4/Picture/1 description: The image is a 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.
Submitter Information
| Applicant: | Tigon Medical |
|---|---|
| Contact Person: | Jeremy Clark |
| President | |
| Tigon Medical | |
| 303 Najoles Rd. | |
| Millersville, MD 21108 | |
| (410) 544-2833 | |
| Date Prepared: | 15DEC2024 |
| Name of Device: | Tigon Medical All-Suture Anchors (ASA) |
| 510(k) Number | K242529 |
| Common Name: | Fastener, Fixation, Nondegradable, Soft Tissue |
| Classification Name: | 21 CFR 888.3040: Smooth or threaded metallic bone fixation |
| fastener | |
| Regulatory Class: | II |
| Product Code/Panel: | MBI |
| Predicate Devices: | ICONIX All Suture Anchor System (K133671) |
| Reference: Stryker Self-Punching ICONIX (K171465) | |
| Reference: Smith & Nephew SUTUREFIX Ultra Suture Anchor | |
| (K122059) | |
| Reference: Threadstone HyperSuture (K230311) | |
| Reference: Tigon Medical Tomahawk Anchors, Dual | |
| Anchors, Eye-Deal Anchors, Tenodesis Anchors (K220464) | |
| Reference: Tigon Medical Tissue Anchors (K182507) |
K242529
Page 1 of 3
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ASA 510(k) Summary
Image /page/5/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 and orange, and the text is black.
Intended Use:
The Tigon Medical All-Suture Anchors are intended for the reattachment of soft tissue to bone for the following indications:
- Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
- . Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Repair
- . Hand/Wrist: Scaphulolunate Ligament Reconstruction, Carnal Ligament Reconstruction, Repair/Reconstruction of Collateral Ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP Joints for all Digits, Digital Tendon Repair
- . Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus Reconstruction, Digital Tendon Transfers, Mid-foot Reconstruction
- . Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
- . Hip: Capsular Repair, Acetabular Labral Repair, Gluteal Tendon Repair
Device Description Summary:
The Tigon Medical All-Suture Anchors are soft-tissue fixation devices provided sterile, preloaded on an inserter. The anchor consists of different load configurations consisting of one or more working sutures. The inserters can be reprocessed after use and are made from stainless steel.
Substantial Equivalence Summary:
The Tigon Medical All-Suture Anchors are substantially equivalent to the predicate devices as the features and intended uses are the same. Mechanical testing was performed to verify both the insertion strength and fixation strength of the Tigon Medical All-Suture Anchors as compared to the predicate.
K242529 Page 2 of 3
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ASA 510(k) Summary
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 and black, and the text is black.
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.
Mechanical testing was performed according to ASTM F543. The mechanical test data demonstrates that the Tigon Medical All-Suture Anchors are substantially equivalent to the predicate device identified.