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510(k) Data Aggregation
K Number
K153669Device Name
MultiFIX S Ultra Knotless Fixation System
Manufacturer
ArthoCare Corporation
Date Cleared
2016-01-19
(29 days)
Product Code
MBI
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
ArthoCare Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MultiFIX S Ultra Knotless Fixation Device is indicated for use in fixation of soft tissue to bone. Examples of such procedures include:
Shoulder: Bankart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsule-labral reconstruction, biceps tenodesis, and deltoid repair
Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction, and midfoot reconstruction
Foot: Hallux valgus reconstruction
Elbow: Tennis elbow repair, biceps tendon reattachment
Knee: Extra-capsular repairs; reattachment of: medial collateral ligament, posterior oblique ligament or joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions
Device Description
The MultiFIX S Ultra Knotless Fixation System (MultiFIX S Ultra) is an implantable bone anchor with inserter handle designed for use in arthroscopic and orthopedic procedures. The MultiFIX S Ultra is a knotless fixation device, meaning that manually tying surgical knots is not necessary for the fixation of suture to tissue.
The MultiFIX S Ultra consists of two primary parts: an implantable bone anchor and an anchor inserter, which is preloaded with the anchor. The anchor inserter is a disposable tool.
The entire product is packaged in a tray with a Tyvek® lid, and the finished product is sterilized by irradiation. Both the anchor and inserter are designed for single use only.
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K Number
K131182Device Name
MULTIFIX S KNOTLESS FIXATION DEVICE
Manufacturer
ARTHOCARE CORPORATION
Date Cleared
2013-07-29
(94 days)
Product Code
MBI
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
ARTHOCARE CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MultiFIX S Knotless Fixation Device is indicated for use in fixation of soft tissue to bone. Examples of such procedures include:
Shoulder: Bankart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsule-labral reconstruction, biceps tenodesis, and deltoid repair
Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction, and midfoot reconstruction
Foot: Hallux valgus reconstruction
Elbow: Tennis elbow repair, biceps tendon reattachment
Knee: Extra-capsular repairs; reattachment of: medial collateral ligament, posterior oblique ligament or joint capsule closure to anterior proximal tibia: extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions
Device Description
The MultiFIX S Knotless Fixation Device (MultiFIX S) is a bone anchor with inserter handle designed for use in arthroscopic and orthopedic procedures. The MultiFIX S is a knotless fixation device, meaning that manually tying surgical knots is not necessary for the fixation of suture to tissue.
The MultiFIX S consists of two primary parts: a PEEK bone anchor inserter. which is preloaded with the anchor. The anchor inserter is a disposable tool.
The entire product is packaged in a tray with a Tyvek® lid, and the finished product is sterilized by irradiation. Both the anchor and inserter are designed for single use only.
The MultiFIX S Knotless Fixation System consists of the bone anchor and associated instruments for implanting the bone anchor.
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K Number
K120791Device Name
AMBIENT TURBOFLASH 90 IFS
Manufacturer
ARTHOCARE CORPORATION
Date Cleared
2012-12-11
(271 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
ARTHOCARE CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Ambient TurboFlash 90 IFS Wand is indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures including: Ablation and Debridement (ACL/PCL, Acromioplasty, Articular Cartilage, Bursectomy, Chondroplasty, Fascia, Ligament, Notchplasty, Scar Tissue, Soft Tissue, Subacromial Decompression, Synovectomy, Tendon), Excision and Resection (Acetabular Labrum, Articular Labrum, Capsule, Capsular Release, Cartilage Flaps, Cysts, Discoid Meniscus, Frozen Shoulder Release, Glenoid Labrum, Lateral Release, Ligament, Loose Bodies, Meniscal Cystectomy, Meniscectomy, Plica Removal, Scar Tissue, Soft Tissue, Synovial Membrane, Tendon, Triangular Fibrocartilage (TFCC), Villusectomy), and Coagulation (ACL/PCL, Articular Cartilage, Carpal Ligaments, Glenohumeral Capsule, Ligament, Medial Retinaculum, Rotator Cuff, Tendon, Wrist Tendons). These procedures are applicable to specific joints or all joints (ankle, elbow, hip, knee, shoulder, and wrist).
Device Description
The Ambient TurboFlash 90 IFS Wand is a bipolar, sterile, single-use, high frequency electrosurgical device which consists of a distal electrode tip composed of tungsten and titanium, a ceramic spacer-cap, a stainless steel shaft, internal suction tubing, and a molded handle with integrated finger switches. The Ambient TurboFlash 90 IFS is only compatible with the Quantum™ 2 Controller which incorporates a "Use Limiting" feature that prevents the re-use of the device.
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K Number
K123268Device Name
SMARTSTITCH PERFECTPASSER SYSTEM
Manufacturer
ARTHOCARE CORPORATION
Date Cleared
2012-11-07
(19 days)
Product Code
GAT, NBH
Regulation Number
878.5000Why did this record match?
Applicant Name (Manufacturer) :
ARTHOCARE CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SmartStitch® PerfectPasser® System is indicated for use in the placement of suture(s) through soft tissue in arthroscopic and limited access procedures.
Device Description
The SmartStitch PerfectPasser System is a Class II device consisting of the following components: SmartStitch® PerfectPasser® Connector, SmartStitch® Handle, Suture Cartridge containing Suture.
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K Number
K121306Device Name
SMARTSTITCH M-CONNECTOR ULTRA SMARTSTITCH SUTURE DEVICE HANDLE SMARTSTITCH SUTURE DEVICE HANDLE
Manufacturer
ARTHOCARE CORPORATION
Date Cleared
2012-07-12
(72 days)
Product Code
GAT, NBH
Regulation Number
878.5000Why did this record match?
Applicant Name (Manufacturer) :
ARTHOCARE CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SmartStitch® M-Connector Ultra System is indicated for use in the placement of suture(s) through soft tissue in arthroscopic and limited access procedures.
Device Description
The SmartStitch M-Connector Ultra System is an orthopedic/arthroscopic instrument for mechanically delivering sutures through soft tissue based on the basic design concepts of handheld, manual suture passers. The handle is provided non-sterile. The connector and suture cartridge are sterilized by ethylene oxide. The finished products are packaged in a Tyvek® pouch inserted into a chipboard carton.
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K Number
K013334Device Name
ENDOFLIP
Manufacturer
ARTHOCARE CORPORATION
Date Cleared
2001-12-13
(65 days)
Product Code
MBI
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
ARTHOCARE CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Endoflip graft fixation device is intended for use in the fixation of ligament and tendon grafts in cruciate ligament reconstruction surgeries.
Device Description
Endoflip graft fixation device for femoral fixation of hamstrings grafts in cruciate ligament reconstruction.
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