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510(k) Data Aggregation
K Number
K203855Device Name
CoNextions TR Tendon Repair System
Manufacturer
CoNextions Medical
Date Cleared
2022-04-22
(477 days)
Product Code
GAQ
Regulation Number
878.4495Why did this record match?
Applicant Name (Manufacturer) :
CoNextions Medical
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
CoNextions TR Tendon Repair System is indicated for the repair of severed Tendons in adults (22 years of age or older). The product is intended for the following indications:
- Digital Flexor Tendons
- Digital Extensor Tendons Proximal to the Metacarpophalangeal Joints (Zones 6-8)
Device Description
The CoNextions TR Tendon Repair System consists of a single-use, sterile implant consisting of two identical stainless steel anchors implanted in either end of the injured tendon and connected by two loops of UHMWPE fiber. The implant is provided pre-loaded into an Implant Mechanism and with a Deployment Mechanism to facilitate placement.
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K Number
K200028Device Name
Coronet Soft Tissue Fixation System
Manufacturer
CoNextions Medical
Date Cleared
2020-03-04
(58 days)
Product Code
MBI, HTN, HWC, JDR, KGS, MAI
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
CoNextions Medical
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Coronet Soft Tissue Fixation System is intended for fixation of tissue to bone and tissue to tissue.
This product is intended for the following indications:
- Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
- Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair
- Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair
- Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar and Radial Ligament Reconstruction
- Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar and Radial Ligament Reconstruction
Device Description
The Coronet Soft Tissue Fixation System consists of a single-use, sterile implant used to fixate tissue to bone and tissue to tissue. The implant consists of an anchor and soft tissue washer interconnected via a continuous loop of suture. The implant comes pre-assembled to an inserter, which facilitates concurrent placement of the anchor and soft tissue washer. A drill bit is provided to allow for the creation of a properly sized pilot hole in the bone implantation site.
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