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510(k) Data Aggregation
K Number
K111471Device Name
EXOSHAPE (TM) INTERFERENCE FIXATION DEVICE MODEL 1100-00-XXXX (VARIES BY SIZE)
Manufacturer
MEDSHAPE SOLUTIONS, INC
Date Cleared
2011-06-10
(14 days)
Product Code
MBI, HWC
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
MEDSHAPE SOLUTIONS, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MedShape Solutions, Inc., ExoShape™-XL Interference Fixation Device is intended for fixation of soft tissue to bone in the following procedures:
Shoulder: Rotator Cuff Repairs, 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, Mid-foot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Anchiles Tendon Reconstruction and Tendon Transfers
Knee: Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction. Radial Collateral Ligament Reconstruction. Carpometacarpal Joint Arthroplasty (basal thumb joint arthroplasty), Carpal Liqament Reconstructions and Repairs and Tendon Transfers
Elbow: Biceps Tendon Reattachment and Ulnar or Radial collateral Ligament Reconstruction
Device Description
The ExoShape™-XL Interference Fixation Device is a line extension offering additional sizes within the current cleared product line and is substantially equivalent to the ShapeLoc (original product name) Soft Tissue Fastener, cleared under K101808. The technological characteristics of the ExoShape™-XL and the ShapeLoc Interference Fixation Devices are equivalent.
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