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510(k) Data Aggregation
K Number
K242529Device Name
Tigon Medical All-Suture Anchors (ASA)
Manufacturer
Tigon Medical
Date Cleared
2024-12-20
(116 days)
Product Code
MBI
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
Tigon Medical
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 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
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.
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K Number
K240175Device Name
Tigon Medical Fractures, Instability, and Reconstruction (FIRE)
Manufacturer
Tigon Medical
Date Cleared
2024-10-29
(280 days)
Product Code
HWC, HRS
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
Tigon Medical
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Tigon Medical FIRE System is intended to provide the orthopedic surgeon with a means of bone-to-bone fixation and to assist in the management of reconstructive surgeries.
- Bone Loss Deficiencies/Deformities
- · Latariet
- Free bone block
- Internal bone fixation for bone fractures, fusions, non-unions, and osteotomies in the foot, ankle, hand, and wrist.
Device Description
The Tigon Medical Fractures, Instability, and Reconstruction (FIRE) System includes reconstruction devices that are designed to provide a means of bone-to-bone fixation and to assist in the management of reconstructive surgeries. The system includes instruments that allow for the placement of the reconstruction device and screws. The reconstruction devices and screws are available in various sizes.
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K Number
K220464Device Name
Tigon Medical Gryphon Anchor Line
Manufacturer
Tigon Medical
Date Cleared
2023-03-22
(398 days)
Product Code
MBI
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
Tigon Medical
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 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.
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K Number
K211049Device Name
Tigon Medical Button System
Manufacturer
Tigon Medical
Date Cleared
2021-08-04
(118 days)
Product Code
MBI
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
Tigon Medical
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Indications for Use: The Tigon Medical Button System implants are intended to facilitate fixation of bone or soft tissue to bone. Shoulder: Proximal Biceps Tendon Repair Minor Pectoralis Repair Major Pectoralis Repair Elbow: Distal Biceps Tendon Repair Ulnar Collateral Ligament Reconstruction Knee: Anterior Cruciate Ligament Repair Posterior Cruciate Ligament Repair
Device Description
The Tigon Medical Button System is comprised of reusable instrumentation and button implants designed to interface together in order to secure soft tissue to bone and fixate bone to bone. The reusable instrumentation is designed to operate with any grouping of available buttons within the system. Each button is made of fitanium and designed to be used with #2 suture cable or 1.4 mm to 2 mm sufure tapes. Each button is made up of very similar eyelet geometry and a thickness of 2 mm. The button widths vary from 2.25 mm to 2.7 mm. The lengths of the buttons vary from 6.65 mm to 8 mm. The buttons are designed to function against a single cortex by resting in the intramedullary cavity or against the cortex on the opposite side of the fixation site.
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K Number
K182507Device Name
Tigon Medical Tissue Anchors
Manufacturer
Tigon Medical
Date Cleared
2019-01-21
(131 days)
Product Code
MBI
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
Tigon Medical
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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, Rotator cuff repairs, Bicep tenodesis;
Elbow, Wrist, and Hand: Biceps tendon reattachmnent, 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 medials obliquous advancement), Illiotibial 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
Device Description
The Tigon Medical Tissue Anchor System consists of multiple-sized medial, lateral tissue anchors, and a single sized labral anchor. The medial anchors are threaded and are offered in 5.5 and 6.5 mm outer diameter sizes. The lateral anchors are conically barbed and are offered in 4.8 and 6 mm outer diameter sizes. The lateral anchors also offer unique angled locking slits to eliminate the need for knotting to secure the suture. The labral anchors are also barbed, and are offered in a 2.9 mm outer diameter, and are available with grooves, and two groove-less, knotless varieties (with and without locking slit). Tigon Tissue Anchors can be used with Tigon 2mm CuffTape and Tigon #2CuffCable (sold separately). Each tissue anchor will have a similar inserter.
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