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510(k) Data Aggregation
K Number
K081122Device Name
FUSION MEDICAL CANNULATED SCREW SYSTEM
Manufacturer
JOHN RICCIO
Date Cleared
2009-05-26
(400 days)
Product Code
HWC
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
JOHN RICCIO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For bone fixation of foot and ankle surgery and hand surgery, following a trauma or osteotomy. Screws and washers are intended for single use only
Device Description
Fusion Medical Cannulated Screw System is comprised of screws in diameters 2.0mm (length 10mm-24mm), 2.5mm (length10mm-38mm),3.0mm (10mm-38mm), 5.0mm (length 30mm-70mm), 6.5mm (length 30mm-120mm) standard bone screw. 2.0mm compression (length 20mm-24mm), 2.5mm compression (length10mm-38mm), 3.0mm compression( length 10mm-38mm), 4.0mm compression (length 22mm-56mm), 6.5mm compression (length 30mm- 120mm), 8.0mm compression (length 75mm-140mm) 9.0mm compression (length 75mm-140mm) compression screws. The Screws are made from implant quality Titanium alloy Ti6a14v. (See attachments for thread length, thread pitch and head geometry of screws.) The screws will be machine finished with a 32RMS roughness. K-wires are provided. K wires are made of 316lss. Screwdrivers, drills, and countersinks shanks are made of 17-4-ph stainless steel, condition H 900 heat treated shanks. They are quick connecting shanks that are interchangeable with the handles. Washers are provided. They are made of implant quality Ti6a14v titanium alloy. (See attachment for drawing of the washers and sizes. Depth gauges, and preparation instruments are part of the system.
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K Number
K081755Device Name
FUSION MEDICAL STI
Manufacturer
JOHN RICCIO
Date Cleared
2009-05-20
(334 days)
Product Code
HWC, PRE
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
JOHN RICCIO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Fusion Medical STI is intended to treat hyperpronated foot, and stabilize the subtalar joint. It is intended to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint motion, but blocking excessive pronation and resulting sequela.
Examples are:
Subtalar instability, painful flat foot, congenital flat foot, paralytic flat foot, tarsal coalitions, posterior tibial tendon deformity and flat foot treatment in children and adolescents.
Device Description
The Fusion Medical STI (Subtalar Implant) is a one-piece device made of titanium (6AL-4V ELI) intended to be implanted into the sinus tarsi of the foot. The implant will be available in 5 sizes. 8mm-12mm diameters. The implant that is used in the treatment of excess motion of the talus relative to the calcaneus acts as a spacer for the joint, maintaining the joint space, allowing for range of motion, but limiting excessive pronation.
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