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510(k) Data Aggregation
K Number
K250021Device Name
Rotium
Manufacturer
Nanofiber Solutions, LLC
Date Cleared
2025-02-27
(55 days)
Product Code
OWW
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
Nanofiber Solutions, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Rotium® is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.
Device Description
Rotium® is composed of two types of polymer fibers: Poly(lactide-co-caprolactone) (PLCL) and Polyglycolic acid (PGA). It is designed to function as a non-constricting, protective layer between the tendon and surrounding tissues. Rotium® is conformable and designed for easy placement between the tendon and surrounding tissue and may be secured in place using standard fixation techniques. Rotium® is provided sterile, non-pyrogenic, for single-use only, in a variety of sizes, ranging from 20mm x 20mm to 70mm x 25mm. Rotium® is designed for stand-alone use. At the discretion of the surgeon, Rotium® may be hydrated with sterile isotonic solution.
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K Number
K241912Device Name
BIOCHARGE
Manufacturer
Nanofiber Solutions, LLC
Date Cleared
2024-07-29
(28 days)
Product Code
MAI
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
Nanofiber Solutions, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K231641Device Name
Rotium Bioresorbable Wick
Manufacturer
Nanofiber Solutions, LLC
Date Cleared
2023-07-05
(30 days)
Product Code
MAI
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
Nanofiber Solutions, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Rotium™ Bioresorbable Wick is intended to be used in conjunction with suture anchors for the reattachment of tendon to bone in rotator cuff repairs.
Device Description
The Rotium™ Bioresorbable Wick is an accessory to be used in conjunction with suture anchors for rotator cuff repair. The wick is placed over the tendon and is designed to facilitate tendon-bone reattachment. The wick is an electrospun, non-woven, microporous, microfiber matrix. The wick is made from two types of polymer fibers: Poly(lactide-co-caprolactone) (PLCL) and Polyglycolic acid (PGA). The wick is packaged in a primary foil pouch with a desiccant pouch, sealed within a secondary Tyvek pouch. The device is supplied gamma-sterilized. The device is single use only.
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K Number
K201414Device Name
Rotium Bioresorbable Wick
Manufacturer
Nanofiber Solutions, LLC
Date Cleared
2020-06-25
(27 days)
Product Code
MAI
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
Nanofiber Solutions, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Rotium™ Bioresorbable Wick is intended to be used in conjunction with suture anchors for the reattachment of tendon to bone in rotator cuff repairs.
Device Description
The Rotium™ Bioresorbable Wick is an accessory to be used in conjunction with suture anchors for rotator cuff repair. The wick is placed between the bone and the tendon and is designed to facilitate tendon-bone attachment. The wick is an electrospun, non-woven, microporous, microfiber matrix. The wick is made from two types of polymer fibers: Poly(lactide-co-caprolactone) (PLCL) and Polyglycolic acid (PGA). The wick is packaged in a primary foil pouch with a desiccant pouch, sealed within a secondary Tyvek pouch. The device is supplied gamma-sterilized. The device is single use only.
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K Number
K183236Device Name
Rotium Bioresorbable Wick
Manufacturer
Nanofiber Solutions, LLC
Date Cleared
2019-03-11
(111 days)
Product Code
MAI
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
Nanofiber Solutions, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Rotium Bioresorbable Wick is intended to be used in conjunction with suture anchors for the reattachment of tendon to bone in rotator cuff repairs.
Device Description
The Rotium™ Bioresorbable Wick is an accessory to be used in conjunction with suture anchors for rotator cuff repair. The wick is placed between the bone and is designed to facilitate tendon-bone attachment. The wick is an electrospun, non-woven, microporous, microfiber matrix. The wick is made from two types of polymer fibers: Poly(lactide-co-caprolactone) (PLCL) and Polyglycolic acid (PGA). The wick is packaged in a primary foil pouch with a desiccant pouch, sealed within a secondary Tyvek pouch. The device is supplied gamma-sterilized. The device is single use only.
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