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510(k) Data Aggregation
K Number
K190543Device Name
Cannulated Hemi Implant
Manufacturer
Vilex in Tennessee, Inc.
Date Cleared
2019-05-31
(88 days)
Product Code
KWD
Regulation Number
888.3730Why did this record match?
Applicant Name (Manufacturer) :
Vilex in Tennessee, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Vilex CHI (cannulated hemi implant), a hemi-arthroplasty implant for the metatarsophalangeal (MTP) joint, is indicated for use in the treatment of patients with degenerative and post-traumatic arthritis in the MTP joint in the presence of good bone stock and integrity of the phalangeal base, along with the following clinical conditions: Hallux Limitus, Hallux Valgus, Hallux Rigidus, and an unstable or painful MTP joint. The Vilex cannulated metallic hemi implant is intended to be used with bone cement. The Vilex cannulated metallic hemi implant is intended for single-use only.
Device Description
The Vilex CHI System includes one-piece cannulated hemi-arthroplasty implants intended to resurface the metatarsal-phalangeal joint. The CHI system includes an MPJ Base and MPJ Head. These are available in standard and lesser options. These components are used for hemi arthroplasty and are not used together to create a total joint.
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K Number
K150211Device Name
EzFuze Implant System
Manufacturer
VILEX IN TENNESSEE, INC.
Date Cleared
2015-11-10
(284 days)
Product Code
HWC
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
VILEX IN TENNESSEE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EzFuze Implants have the following Indications for Use:
Fixation of osteotomies and reconstruction of the lesser toes and lesser fingers following correction procedures for hammertoe, claw toe, mallet toe, and other deformities of the feet and hands.
Device Description
The Vilex EzFuze Implant System includes single-piece devices intended for the fixation of PIP joints in lesser toes and digits. Two styles are offered: EzFuze Implant with barbed prongs on both ends and Hybrid EzFuze Implant with a screw design at one end and the other end includes barbed prongs. The EzFuze and Hybrid EzFuze Implants are offered straight or with a 10° bend.
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K Number
K141937Device Name
TRIDENT FUSION IMPLANT
Manufacturer
VILEX IN TENNESSEE, INC.
Date Cleared
2014-09-10
(55 days)
Product Code
HWC
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
VILEX IN TENNESSEE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Trident Fusion Implant has the following Indications for Use: Fixation of osteotomies and reconstruction of the lesser toes and lesser fingers following correction procedures for hammertoe, claw toe, mallet toe, and other deformities of the feet and hands.
Device Description
The Vilex Trident Fusion Implant is a single-piece cannulated bone screw intended for the fixation of PIP joints in lesser toes and digits. The device is offered straight or with a 10° bend at the joint. It is available in either stainless steel or titanium.
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