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510(k) Data Aggregation
K Number
K170868Device Name
FIXIT Threaded Anchor System
Manufacturer
S.B.M SAS Science for Bio Materials
Date Cleared
2017-11-30
(252 days)
Product Code
MAI
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
S.B.M SAS Science for Bio Materials
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The FIXIT® threaded anchor system is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow, but not limited to, the following procedures:
Shoulder: Rotator Cuff Repair; Bankart Repair; Biceps Tenodesis; Acromio-clavicular Separation Repair; Deltoid Repair; Capsule Shift or Capsulolabral Reconstruction;
Ankle/Foot: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy Knee: Anterior Cruciate Ligament Repair: Medial Collateral Ligament Repair: Lateral Collateral Ligament Repair: Patellar Tendon Repair ; Posterior Oblique Ligament Repair; Iliotibial Band Tenodesis ;
Wrist/Hand: Scapholunate Ligament Reconstruction: Ulnar or Radial Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction.
Elbow: Biceps Tendon Reattachment: Unar or Radial Collateral Ligament Reconstruction: Temis Elbow Repair and Lateral Epicondylitis Repair
Device Description
FIXIT® is a threaded anchor system made of Duosorb® 30 (β-TCP 30%/ PLDLA 70%), a composite, bioabsorbable material.
The implant is available in 2 different configurations:
- · FIXIT®Knotless: supplied in a holder,
- FIXIT®: pre-loaded on a disposable screwdriver with 2 sutures.
The implant is supplied sterile, ready to use.
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