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510(k) Data Aggregation
K Number
K222574Device Name
Simparo Anchor Line Fixation System
Manufacturer
Date Cleared
2023-02-04
(163 days)
Product Code
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
Simparo, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Intended Use:
The Simparo Anchor Line Fixation System, when used for fixation of bone or soft-tissue-to-bone, is intended as an anchor fixation system, a distributing suture tension over areas of ligament or tendon repair.
Indications for Use:
Specifically, the Simparo Anchor Line Fixation System is indicated for carpometacarpal (CMC) joint arthroplasty as an adjunct in the suspension of the thumb metacarpal during the healing process of hematoma distraction arthroplasty by providing stabilization at the base of the first and second metacarpals when the trapezium has been excised due to osteoarthritis.
Device Description
The Simparo Anchor Line Fixation System is a dual anchor construct used to provide stabilization of the thumb and index metacarpals for treatment of carpometacarpal (CMC) arthritis. The Anchor Line Fixation System consists of an index anchor (5mm) and a thumb anchor (5mm) connected by a single strand of #2 Teleflex Force Fiber nonabsorbable braided suture. This construct provides a suspension sling as a supportive device to maintain the thumb and index metacarpals in proper alignment during capsular healing, hematoma and scar tissue formation following a trapeziectomy (removal of the trapezium) for the treatment of thumb CMC osteoarthritis. The Anchor Line Fixation System is manufactured from titanium alloys, stainless steel and PEEK.
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