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510(k) Data Aggregation
K Number
K212739Device Name
ActiFlip
Manufacturer
Parcus Medical LLC.
Date Cleared
2021-10-06
(37 days)
Product Code
MBI
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
Parcus Medical LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Parcus Actiflip is used for fixation of bone or soft tissue to bone, and is intended as a fixation post, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair in the knee, shoulder, and elbow and may include the following indications: anterior cruciate ligament, posterior cruciate ligament, pectoralis repari (minor/major), biceps tendon repair and reattachment (distal/proximal), acromioclavicular repair, and ulnar collateral ligament reconstruction.
The Parcus ActiFlip is also intended for fixation of suture (soft tissue) to bone in the foot and ankle for midfoot reconstruction and hindfoot reconstruction with the following procedures: FHL Tendon Transfer, Posterior Tibialis Tendon Transfer, Anterior Tibialis Tendon Transfer.
Device Description
The Parcus ActiFlip device consists of a titanium implantable button that is mounted onto an inserter shaft that allows for placement and deployment of the button. ActiFlip is available in three (3) configurations, with or without UHMWPE suture – Naked (without suture), CINCH, WHIP.
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