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510(k) Data Aggregation
K Number
K232411Device Name
JuggerKnot Soft Anchor OC
Manufacturer
Riverpoint Medical, LLC
Date Cleared
2023-10-06
(57 days)
Product Code
MBI
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
Riverpoint Medical, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
JuggerKnot Soft Anchor OC are intended for use in soft tissue to bone fixation for the following indications: Knee MPFL Knee Patellar tendon repair Knee MCL Knee Quadriceps tendon repair Hip Acetabular labral repair Hip Proximal hamstring repair Hip Hip Labral reconstruction Foot and Ankle Achilles tendon repair Foot and Ankle Medial/lateral repair and reconstruction Foot and Ankle Plantar plate repair Foot and Ankle Mid- and forefoot repair Foot and Ankle Metatarsal ligament/tendon repair or reconstruction Shoulder Rotator Cuff Shoulder Shoulder Instability Shoulder Biceps Tenodesis Elbow Lateral epicondylitis repair Elbow Biceps tendon reattachment
Device Description
The JuggerKnot Soft Anchor OC is identical to the previously cleared JuggerKnot Soft Anchor OC except for the presence of a bioceramics embedded in the anchor portion of the device. The JuggerKnot Soft Anchor OC is comprised of a suture sleeve structure and working suture. Nonabsorbable braided ultra-high molecular weight polyethylene (UHMWPE) sutures are spliced through a suture anchor sleeve comprised of non-absorbable braided polyester. Up to two nonabsorbable round or flat braided UHMWPE working sutures can be added inside the suture anchor sleeve. The UHMWPE sutures are available undyed (white) and black. The hydroxyapatite and bioceramic particles are embedded in the surface of the suture anchor material. Sutures supplied meet United States Pharmacopeia (USP) requirements for non-absorbable suture except for diameter. Suture dyes are FDA approved. The inserter is comprised of a metallic shaft with over molded handle. The device is sterilized by ethylene oxide gas and is provided sterile for single use. The JuggerKnot Soft Anchor OC are available in common sizes and lengths and will be sold sterile for single use. The device is intended for use in a hospital/clinic/surgical setting.
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K Number
K231078Device Name
All-Suture Anchor
Manufacturer
Riverpoint Medical, LLC
Date Cleared
2023-10-05
(171 days)
Product Code
MBI
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
Riverpoint Medical, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Iconix® HA+™ anchors are intended to be used for soft-tissue to bone fixation in the foot, ankle, knee, hip, 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 Repair
Hand Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, Digital Tendon Repar
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 Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair. Iliotibial Band Tenodesis. Medial Patellofemoral Ligament (MPFL) Repair/ Reconstruction, Quadriceps Tendon Repair
Hip: Capsular Repair, Acetabular Labral Repair, Gluteal Tendon Repair, Proximal Hamstring Repair
Device Description
The Iconix® HA*TM Anchor is comprised of a suture sleeve structure and working suture. Nonabsorbable braided ultra-high molecular weight polyethylene (UHMWPE) sutures are spliced through a suture anchor sleeve comprised of non-absorbable braided polyester and bioceramics. Up to two non- absorbable round or flat braided UHMWPE working sutures can be added inside the suture anchor sleeve. The UHMWPE sutures are available undyed (white) and black.
Sutures supplied meet United States Pharmacopeia (USP) requirements for non-absorbable suture except for diameter. Suture dyes are FDA approved. The inserter is comprised of a metallic shaft with over molded handle. The device is sterilized by ethylene oxide gas and is provided sterile for single use. Iconix® HA*M Anchors are available in common sizes and lengths and will be sold sterile for single use with no components or accessories. The device is intended for use in a hospital/clinic/surgical setting.
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K Number
K231278Device Name
Knotless Suture Anchor
Manufacturer
Riverpoint Medical, LLC
Date Cleared
2023-08-01
(90 days)
Product Code
MBI
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
Riverpoint Medical, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Iconix® Knotless Anchors are intended to be used for soft-tissue to bone fixation in the foot, ankle, knee, hip, 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 Repair
Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, Digital Tendon Repair
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, Medial Patellofemoral Ligament (MPFL) Repair/ Reconstruction, Quadriceps Tendon Repair
Hip: Capsular Repair, Acetabular Labral Repair, Gluteal Tendon Repair, Proximal Hamstring Repair
Device Description
The Iconix® Knotless Anchors are soft-tissue fixation devices, provided preloaded on a disposable inserter. The device is composed of a braided polyester anchor body that contains one working suture, also referred to as the repair strand, and a shuttle strand that is used to shuttle the repair strand around tissue and through the braided anchor body.
Sutures supplied meet United States Pharmacopeia (USP) requirements for non-absorbable suture except for diameter. Suture dyes are FDA approved. The inserter is comprised of metallic shaft with over molded handle. The device is sterilized by ethylene oxide gas and is provided sterile for single use. The anchor size will be available in 1.4mm with working sutures in standard USP size 2. Iconix® Knotless Anchor will be sold sterile for single use with no components or accessories.
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K Number
K220765Device Name
HS Fiber Cerclage
Manufacturer
Riverpoint Medical, LLC
Date Cleared
2023-07-26
(497 days)
Product Code
JDQ, GAT
Regulation Number
888.3010Why did this record match?
Applicant Name (Manufacturer) :
Riverpoint Medical, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
HS Fiber Cerclage sutures are indicated for use in general soft tissue approximation and/or ligation. These sutures may be used in cardiovascular surgeries, and orthopedic surgeries using allograft tissue. When used as a bone fixation cerclage, the sutures are intended for:
- · Trauma surgery indications including olecranon, ankle, patella, and some shoulder rewiring.
- · Repair of long bone fracture due to trauma or reconstruction.
Device Description
The Riverpoint Medical HS Fiber® Cerclage sutures are non-absorbable, sterile, surgical sutures composed of multiple single strands of ultra-high molecular weight polyethylene (UHMWPE) braided together to form the implant. HS Fiber Cerclage sutures are available in common sizes and lengths with or without pre-attached needles. Suture supplied meet United States Pharmacopeia (USP) requirements for non-absorbable suture except for diameter. The device is sterilized by ethylene oxide gas, and is provided sterile for single use. The device is intended for use in a hospital/clinic/surgical setting.
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K Number
K230212Device Name
OrthoButton AL
Manufacturer
Riverpoint Medical, LLC
Date Cleared
2023-02-23
(28 days)
Product Code
MBI
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
Riverpoint Medical, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Riverpoint Medical OrthoButton® AL is intended for use in the fixation of bone and soft tissue in orthopedic procedures requiring ligament or tendon reconstruction.
Device Description
The Riverpoint Medical OrthoButton® AL is comprised of a braided ultra-high molecular weight polyethylene ("UHMWPE") adjustable loop combine with a titanium (Ti-6A1-4V ELI per ASTM F136) plate. The device is provided sterile for single use. The device is intended for use in a hospital/clinic/surgical setting.
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K Number
K202242Device Name
HS Fiber
Manufacturer
Riverpoint Medical, LLC
Date Cleared
2020-09-10
(31 days)
Product Code
GAT
Regulation Number
878.5000Why did this record match?
Applicant Name (Manufacturer) :
Riverpoint Medical, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
HS Fiber sutures are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular surgery, and the use of allograft tissues for orthopedic procedures.
Device Description
The Riverpoint Medical HS Fiber® sutures are non-absorbable, sterile, surgical sutures composed of multiple single strands of ultra-high molecular weight polyethylene (UHMWPE) braided together to form the implant. HS Fiber sutures are available in common sizes and lengths with or without pre-attached needles.
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