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510(k) Data Aggregation
K Number
K172612Device Name
FiberTak DX
Manufacturer
Arthex, Inc
Date Cleared
2017-09-28
(28 days)
Product Code
MBI
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
Arthex, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The FiberTak DX is intended to be used for suture or tissue fixation in the foot/ankle, knee, hand/wrist, elbow, and shoulder. Specific indications are listed below:
• Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament
Reconstruction
• Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps
Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or
Capsulolabral Reconstruction
• Hand/Wrist: Scapholunate Ligament Reconstruction, Repair/Reconstruction of
collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and
MCP joints for all digits, digital tendon transfers, Carpal Ligament Reconstruction
and Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty)
• Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair,
Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers,
Mid-foot reconstruction
• Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair,
Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band
Tenodesis
Device Description
The FiberTak DX is an "all-suture" soft-tissue fixation device. The anchor and connected sutures are impacted into a pilot hole. The sutures are then manually tensioned to set the anchor by "bulging" the suture sleeve within the pilot hole.
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K Number
K151256Device Name
Arthrex BioSync® Bone Wedge
Manufacturer
Arthex, Inc
Date Cleared
2015-08-12
(92 days)
Product Code
PLF, HRS, HWC
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
Arthex, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Arthrex BioSync Bone Wedge is intended to be used for internal bone fixation for bone fractures, fusions, or osteotomies, in the ankle and foot, such as:
Cotton and Evans Wedges:
- Opening wedge osteotomies of the bones of the foot including osteotomies for Hallux Valgus
- Opening wedge of Medial Cuneiform or Cotton osteotomies
- Lateral Column Lengthening (Evans Lengthening Osteotomy of Calcaneal Z Osteotomy)
- Metatarsal/Cuneiform arthrodesis
Midfoot Wedges:
- Opening wedge osteotomies of the bones of the foot including osteotomies for Hallux Valgus
- Nonunion of arthrodesis of the Midfoot including Metatarsal/Cuneiform arthrodesis (TMT or Lapidus)
This device is intended for use with ancillary fixation. The Arthrex BioSync Bone Wedge is not intended for use in the spine.
Device Description
The Arthrex BioSync Bone Wedge is a family of pre-sized implantable titanium porous metal wedges intended to be used for angular correction of small bones in the ankle and foot. It is offered with varying widths and thicknesses to accommodate a variety of small bone applications.
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