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510(k) Data Aggregation
K Number
K192709Device Name
Fixone All Suture Anchor
Manufacturer
AJU Pharm Co.,Ltd.
Date Cleared
2020-12-15
(445 days)
Product Code
MBI
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
AJU Pharm Co.,Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The non-absorbable suture anchors are intended to reattach soft tissue to bone in orthopedic surgical procedures. The Fixone All Suture Anchors may be used in either arthroscopic or open surgical procedures. After the suture strands are anchored to the bone, they may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. In conjunction with appropriate postoperative immobilization throughout the healing period, the suture anchor systems stabilize the damaged soft tissue.
Device Description
Fixone All suture anchor consists of one "fix Suture" and two or three non-absorbable Sutures. The nonabsorbable suture is manufactured from UHMWPE and PET fibers. Fixone All suture anchor is implanted using its self-punching option. They are pre-loaded on a handled insertion device is provided sterile, for single use only. This device is medical device. Prescription use only. This device is could used with instrument that manufactured by Aju Pharm Co.,Ltd. It is consist of 4 models. It provide non-sterile (user must sterilization before use).
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K Number
K171299Device Name
Fixone Biocomposite Anchor
Manufacturer
AJU Pharm Co.,Ltd.
Date Cleared
2017-08-24
(113 days)
Product Code
MAI
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
AJU Pharm Co.,Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Fixone Biocomposite Anchors are intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee and elbow in the following procedures:
Shoulder: Rotor Cuff Repair, Bankart Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction;
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair;
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, lliotibial Band Tenodesis;
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction.
Device Description
The Fixone Biocomposite Anchor is intended for reattaching soft tissue to bone with sutures. The anchor is manufactured from biodegradable materials (PLGA copolymer and beta-TCP). A nonresorbable suture manufactured from cobraided UHMWPE and PET fibers is inserted into the anchor is implanted using a provided driver.
This device is could used with instrument that manufactured by Aju Pharm Co.,Ltd. It is consist of 18 models. It provide non-sterile (user must sterilization before use).
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K Number
K162070Device Name
JOINIX CANNULAR SYSTEM
Manufacturer
AJU Pharm Co.,Ltd.
Date Cleared
2017-03-16
(232 days)
Product Code
HRX
Regulation Number
888.1100Why did this record match?
Applicant Name (Manufacturer) :
AJU Pharm Co.,Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For introduction of instrumentation through a portal for surgical procedure.
Device Description
This device is intended to puncture the tissue for making the path of surgical instrument in the orthopedic surgery. It is consisted with cannula and trocar. This device is single-use.This device has 3 types. (Threaded type, Smooth type, All smooth type)
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