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510(k) Data Aggregation
K Number
K161417Device Name
DePuy Synthes MAXFRAME Multi-Axial Correction System
Manufacturer
SYNTHES USA, LLC
Date Cleared
2016-11-10
(171 days)
Product Code
KTT, OSN
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
SYNTHES USA, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DePuy Synthes MAXFRAME™ Multi-Axial Correction System is indicated for the following treatments in adults, and in both children (3-12) and adolescents (12-21) in which the growth plates have fused or will not be crossed with hardware: fracture fixation (open and closed) pseudoarthrosis of long bones limb lengthening (epiphyseal or metaphyseal distraction) joint arthrodesis infected fractures or nonunions correction of bony or soft tissue deformities correction of segmental defects.
Device Description
The DePuy Synthes MAXFRAME™ Multi-Axial Correction System, with adult and pediatric indications, is an external ring fixation system that is combined with web-based software in treatment of soft tissue and bone deformities. In the MAXFRAME system, implanted transfixion wires, Schanz screws and pins are attached to the rings and plates surrounding the deformity using bolts, nuts and connecting plates. Upper and lower rings are then connected to one another using six telescoping struts, creating a "Stewart Platform" type device. Adjusting the strut length allows for correction of length, rotation, and angular deformity at the same time. The modular nature of a ring fixation frame allows multiple frame options. A ring fixation frame is assembled individually by the surgeon to address the different characteristics of each case. The materials of construction for this system include aluminum, elgiloy, stainless steel and various polymeric materials. This system has been validated as MR Conditional.
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K Number
K112030Device Name
SYNTHES RADIAL HEAD PROSTHESIS SYSTEM
Manufacturer
SYNTHES USA, LLC
Date Cleared
2012-06-19
(340 days)
Product Code
KWI
Regulation Number
888.3170Why did this record match?
Applicant Name (Manufacturer) :
SYNTHES USA, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Synthes Radial Head Prosthesis System is intended for:
1. The replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with
a. Joint destruction and/or subluxation visible on x-ray
b. Resistance to conservative treatment
2. Primary replacement after fracture of the radial head.
3. Symptomatic sequelae after radial head resection
4. Revision following failed radial head arthroplasty.
Device Description
The Synthes Radial Head Prosthesis is a two-piece modular system comprised of titanium alloy stem and cobalt chrome head components with an integral screw and side-loading application to allow for in situ assembly. The system consists of a range of lengths and diameters for the stem in both straight and curved configurations as well as heads in a range of diameters and heights to accommodate the surgical need.
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