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510(k) Data Aggregation
K Number
K120841Device Name
APPIANFX SUTURE ANCHOR (6MM) (5MM) APPIANFX TISSUE ANCHOR
Manufacturer
KFX MEDICAL
Date Cleared
2012-06-07
(79 days)
Product Code
MBI
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
KFX MEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The KFx APPIANFx™ PEEK Suture Anchors and APPIANFx™ PEEK Tissue Anchors are intended for the fixation of soft tissue to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow. Specifically: Shoulder: Bankart lesion repairs, SLAP lesion repairs, acromio- clavicular separation repairs, rotator cuff repairs, capsular shift or capsulolabral reconstructions, biceps tenodesis, deltoid repairs Foot and Ankle: Hallux valgus repairs, medial or lateral instability repairs/reconstructions, mid-foot reconstructions, metatarsal ligament repair Knee: Medial collateral ligament repair, lateral collateral ligament repair, posterior oblique ligament repair, iliotibial band tenodesis, patellar tendon repair Hand/Wrist/Elbow: Scapholunate ligament reconstructions, ulnar or radial collateral ligament reconstructions, tennis elbow repair, biceps tendon reattachment.
Device Description
The KFx APPIANFx™ PEEK Suture Anchors consist of a fixation device comprised of a body with deployable legs, a wedge, and a disposable suture loop preloaded in a delivery (insertion) handle. The KFx APPIANFx™ PEEK Tissue Anchors consist of a fixation device comprised of a body with deployable legs and a cleated wedge preloaded in a delivery (insertion) handle. Each device is intended for single use and may be used in arthroscopic and open procedures.
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K Number
K101175Device Name
KFX APPIANFX PEEK FEMORAL IMPLANT WITH INSERTER
Manufacturer
KFX MEDICAL
Date Cleared
2010-05-20
(23 days)
Product Code
MBI
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
KFX MEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The KFx APPIANFx PEEK Femoral Implant with Inserter is intended for use in tenodesis procedures with soft tissue grafts. utilizing either arthroscopic or open techniques during Anterior Cruciate Ligament (ACL), Posterior Cruciate Ligament (PCL), Medial Collateral Ligament (MCL), Lateral Collateral Ligament (LCL), and Medial Patellofemoral Ligament (MPFL) reconstruction.
Device Description
KFx APPIANFx PEEK Femoral Implant with Inserter consists of a two body anchor fixation device comprised of a body with deployable arms and a wedge and a disposable suture loop preloaded in a delivery (insertion) handle. Technologically it is similar in design, materials and mode of operation to the KFx PEEK Bone Anchor with Pre-Attached Sutures and Delivery Handle.
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K Number
K083609Device Name
KFX PEEK BONE ANCHOR WITH PRE-ATTACHED SUTURES AND INSERTER HANDLE
Manufacturer
KFX MEDICAL
Date Cleared
2009-03-06
(88 days)
Product Code
MBI
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
KFX MEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The KFx Peek Bone Anchor with Pre-Attached Sutures and Delivery Handle is intended for the fixation of soft tissue to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow.
Specifically:
Shoulder: Bankart lesion repairs, SLAP lesion repairs, acromio-clavicular separation repairs, rotator cuff repairs, capsular shift or capsulolabral reconstructions, biceps tenodesis, deltoid repairs
Foot and Ankle: Hallux valgus repairs, medial or lateral instability repairs/reconstructions. Achilles repairs/reconstructions, mid-foot reconstructions, metatarsal ligament repair.
Knee: Medial collateral ligament repair, lateral collateral ligament repair, posterior oblique ligament repair, Iliotibial band tenodesis, patellar tendon repair.
Hand/Wrist/Elbow: Scapholunate ligament reconstructions, ulnar or radial collateral ligament reconstructions, tennis elbow repair, biceps tendon reattachment.
Device Description
The KFx PEEK Bone Anchor with Pre-Attached Sutures and Delivery Handle is intended for the fixation of soft tissue to bone using Teleflex ForceFiber™ #2 nonabsorbable braided suture. The KFx PEEK Bone Anchor with Pre-Attached Sutures consists of a fixation device pre-loaded with suture in a delivery (insertion) handle. The PEEK bone anchor can be used in open or arthroscopic procedures.
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K Number
K081598Device Name
SUTURE LOCK NAIL BONE ANCHOR WITH WHITE (KFX-W-200) & BLUE (KFX-B-200) FIBERFORCE SUTURE
Manufacturer
KFX MEDICAL
Date Cleared
2008-07-03
(27 days)
Product Code
MBI
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
KFX MEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of the KFx Suture Lock Tissue Fixation System is for the fixation of soft tissue to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow. Specifically:
Shoulder: Bankart lesion repairs, SLAP lesion repairs, acromio-clavicular separation repairs, rotator cuff repairs, capsular shift or capsulolabral reconstructions, biceps tenodesis, deltoid repairs.
Foot and Ankle: Hallux valgus repairs, medial or lateral instability repairs/reconstructions, Achilles repairs/reconstructions, mid-foot reconstructions, metatarsal ligament repair.
Knee: Medial collateral ligament repairs, lateral ligament repairs, posterior oblique ligament repairs, lliotibial band tenodesis, patellar tendon repairs.
Hand, Wrist and Elbow: Scapholunate ligament reconstructions, ulnar or radial collateral ligament reconstructions, tennis elbow repair, biceps tendon reattachment.
Device Description
The KFx Tissue Fixation System consists of a Nail Bone Anchor with two suture leads pre-loaded in a single use insertion handle and a Bone Screw Anchor (also pre-loaded in a single use delivery handle) used to capture the sutures, eliminating the need to tie suture knots. The KFx Tissue Fixation System also includes re-usable surgical instruments for the implantation of the Nail Bone and Bone Screw Anchors.
Devices are provided "STERILE"; sterilization is by Ethylene Oxide (EO) gas and provides a sterility assurance level of 10-6.
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K Number
K080229Device Name
5.5 MM SUTURE LOCK BONE SCREW ANCHOR
Manufacturer
KFX MEDICAL
Date Cleared
2008-02-29
(30 days)
Product Code
MBI, HWC
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
KFX MEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The KFx Tissue Fixation System (comprised of the KFx Suture Lock Bone Screw Anchor and KFx Suture Lock Nail Bone Anchor) and Accessories are intended for the fixation of soft tissue to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow. Specifically:
Shoulder: Bankart lesion repairs, SLAP lesion repairs, acromioclavicular separation repairs, rotator cuff repairs, capsular shift or capsulolabral reconstructions, biceps tenodesis, deltoid repairs
Foot and Ankle: Hallux valgus repairs, medial or lateral instability repairs/reconstructions, Achilles repairs/reconstructions, mid-foot reconstructions, metatarsal ligament repair.
Knee: Medial collateral ligament repair, lateral collateral ligament repair, posterior oblique ligament repair, Iliotibial band tenodesis, patellar tendon repair.
Hand/Wrist/Elbow: Scapholunate ligament reconstructions, ulnar or radial collateral ligament reconstructions, tennis elbow repair, biceps tendon reattachment.
Device Description
The KFx Tissue Fixation System is intended for the fixation of soft tissue to bone using Teleflex ForceFiber® #2 braided suture. The KFx 5.5mm Suture Lock Bone Screw Anchor component of the Tissue Fixation System is used to capture the Nail Bone Anchor sutures, eliminating the need to tie suture knots.
The KFx Nail Bone Anchor and the KFx Suture Lock Bone Screw Anchors are provided "STERILE"; sterilization is by Ethylene Oxide (EO) gas.
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K Number
K072063Device Name
KFX TISSUE FIXATION SYSTEM AND ACCESSORIES
Manufacturer
KFX MEDICAL
Date Cleared
2007-10-26
(91 days)
Product Code
MBI
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
KFX MEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The KFx Tissue Fixation System and optional accessories are intended for the fixation of soft tissue to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow.
Specifically:
Shoulder: Bankart lesion repairs, SLAP lesion repairs, acromio-clavicular separation repairs, rotator cuff repairs, capsular shift or capsulolabral reconstructions, biceps tenodesis, deltoid repairs.
Foot and Ankle: Hallux valgus repairs, medial or lateral instability repairs/reconstructions, Achilles repairs/reconstructions, mid-foot reconstructions, metatarsal ligament repair.
Knee: Medial collateral ligament repair, lateral collateral ligament repair, posterior oblique ligament repair, Iliotibial band tenodesis, patellar tendon repair.
Hand/Wrist/Elbow: Scapholunate ligament reconstructions, ulnar or radial collateral ligament reconstructions, tennis elbow repair, biceps tendon reattachment.
Device Description
The KFx Tissue Fixation System consists of
- KFx Nail Bone Anchor with two suture leads, mounted to a single use handle .
- . KFx Suture Lock Bone Anchor mounted to a single use handle
- . Optional KFx Targeting Grasper
- Optional Suture Management Device(s) .
- . Optional Screw Removal device
- Optional Starter Awl .
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K Number
K061294Device Name
KFX KNOTLESS FIXATION SYSTEM
Manufacturer
KFX MEDICAL
Date Cleared
2006-07-19
(71 days)
Product Code
MBI
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
KFX MEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The KFx Knotless Fixation System and Accessory Targeting Grasper are intended for the fixation of soft tissue to bone during rotator cuff repair.
Device Description
The KFx Knotless Fixation System consists of:
- . KFx Nail Bone Anchor with two suture leads, mounted to a single use handle
- KFx Suture Lock Bone Screw Anchor mounted to a single use handle .
- Optional KFx Targeting Grasper. .
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