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510(k) Data Aggregation
K Number
K122336Device Name
Q-FIX SUTURE ANCHOR, 1.8MM Q-FIX ACCESS TOOLS (DRILL GUIDE W/OBTURATOR, DRILL BIT) 1.8MM
Manufacturer
ELEVEN BLADE SOLUTIONS, INC.
Date Cleared
2013-01-09
(160 days)
Product Code
MBI
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
ELEVEN BLADE SOLUTIONS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Eleven Blade Solutions, Inc. Q-Fix™ Suture Anchor System is intended for soft tissue to bone fixation for:
Shoulder
Bankart lesion repair, SLAP lesion repair, Acromio-clavicular repair, Capsular shift/capsulolabral reconstruction, Deltoid repair, Rotator cuff repair, Biceps tenodesis
Foot and Ankle
Medial/lateral repair and reconstruction, Mid and forefoot repair, Hallux valgus reconstruction, Metatarsal ligament/tendon repair or reconstruction, Achilles tendon repair
Elbow
Ulnar or radial collateral ligament reconstruction, Lateral epicondylitis repair, Biceps tendon reattachment
Knee
Extra-capsular repair: MCL, LCL, and posterior oblique ligament, Illiotibial band tenodesis, Patellar tendon repair, VMO advancement, Joint capsule closure
Hand and Wrist
Collateral ligament repair, Sacpholunate ligament reconstruction, Tendon transfers in phalanx, Volar plate reconstruction
Hip
Acetabular labral repair
Device Description
The Q-Fix™ Suture Anchor is an all-suture anchor device designed for soft tissue to bone fixation by expanding against bone when deployed. Made of a polyester sleeve-type structure with one or more strands of UHMWPE suture threaded through it, the anchor is provided preloaded on a disposable inserter. The inserter is used to deploy the anchor into the bone, with the suture remaining slideable within the anchor to facilitate attachment of the soft tissue. The one-time use anchor is provided sterile, preloaded on the inserter. Additional accessory instruments, including a drill bit and drill guide with obturator are single use devices provided sterile for use during the orthopedic procedure.
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