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510(k) Data Aggregation
K Number
K081060Device Name
FERROFIBRE STAINLESS STEEL SUTURES, MODEL 610 SERIES SIZES (USP) 5-0 TO #5
Manufacturer
CORE ESSENCE ORTHOPAEDICS, LLC
Date Cleared
2008-12-24
(254 days)
Product Code
GAQ
Regulation Number
878.4495Why did this record match?
Applicant Name (Manufacturer) :
CORE ESSENCE ORTHOPAEDICS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ferroFibre 14 Stainless Steel Sutures are intended for use in soft tissue approximation and for use in abdominal wound closure, hernia repair, sternal closure and certain orthopaedic procedures including cerclage and tendon repair.
Device Description
The ferroFibre™ Stainless Steel Suture is available in United States Pharmacopocia (USP) sizes 5-0 to #5 in various lengths. The ferroFibre multifilament stainless stecl sutures are supplied storile, armed with cutting needles. The sutures are fabricated from 316 stainless steel that meets ASTM F138-03.
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K Number
K071477Device Name
REVERTO 55 AND 37 SHAPE MEMORY STAPLES
Manufacturer
CORE ESSENCE ORTHOPAEDICS, LLC
Date Cleared
2007-08-15
(78 days)
Product Code
JDR
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
CORE ESSENCE ORTHOPAEDICS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
reVERTO™ Shape Memory Staples are intended for use in:
Fixation of Osteotomies of the Hand, Foot and Tibia
Arthrodesis of the Joints of the Hand and Foot
Fixation of Soft Tissue to Bone, as in the case of the Anterior Cruciate Ligament
reVERTO™ Shape Memory Staples are also indicated for adjunctive fixation of Small Bone Fragments of:
The Upper Extremity, such as the Radius, Ulna, Humerus, Clavicle and Scapula
The Lower Extremity, such as the Tibia, Fibula and the Femur
The Upper Torso, such as the Sternum and the Ribs
Device Description
reVERTO™ Shape Memory Staples are dynamic compression implants that use shape memory metal nickel-titanium alloy called NiTinol (see below for more information on NiTinol). The NiTinol construction causes the legs of the implant to deflect, thereby creating a compressive force across the site of fixation. reVERTO Shape Memory Staples are advantageous to screws and plates in that they require less disruption of the surrounding bone for implantation and provide a 'low-profile' fixation. The most important factor related to the use of NiTinol is its ability to maintain a compressive force across the site of fixation during the healing process.
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K Number
K071520Device Name
RENOVO SUTURE ANCHORS, MODELS 100-2001 THRU 100-5502X
Manufacturer
CORE ESSENCE ORTHOPAEDICS, LLC
Date Cleared
2007-08-10
(67 days)
Product Code
MBI, HWC, JDR
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
CORE ESSENCE ORTHOPAEDICS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
reNOVO Suture Anchors are intended to secure soft tissue to bone of:
The Shoulder:
Bankart Repair SLAP Lesion Repair Acromio-Clavicular Separation Roatator Cuff Repair Capsule Repair Biceps Tenodesis Deltoid Repair
The Elbow:
Ulnar or Radial Collateral Ligament Reconstruction Bicep Tendon Reconstruction Tennis Elbow Repair
The Hand and Wrist:
Scapholunate Ligament Reconstruction Ulnar / Radial Collateral Ligament Reconstruction Collateral Ligaments around the PIP, DIP and MCP Joints Flexor and Extensor Tendons
The Ankle and Foot: Lateral Stabilization Medial Stabilization Achilles Tendon Repair / Reconstruction Hallux Valgus Reconstruction Mid and Rear Foot Reconstruction
Device Description
The reNOVO™ Suture Anchors range in size from 2.0mm to 5.5mm in diameter. The anchor portion consists of a threaded titanium (ASTM F136/ ISO 5832-3) segment that provides a self drilling and self tapping thread. The anchor eyelet provides a means to attach the range of suture sizes utilized on the anchors. The size of sutures used in the reNOVO line range from size 3-0 thru size 2 (USP) nonabsorbable UHMW polyethylene UltraFibre™ sutures. A single use driver and handpiece hold the excess suture and deliver the preloaded anchor into the bone. The suture strands are used to reapproximate and secure the soft tissue to the bone.
The reNOVO™ Suture Anchor will be provided sterile for single use applications.
The sizes and materials are designed to address the indications cited.
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