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510(k) Data Aggregation
K Number
K163585Device Name
Responsive Orthopedics Total Hip Arthroplasty System
Manufacturer
Responsive Orthopedics, LLC
Date Cleared
2017-06-02
(164 days)
Product Code
LZO
Regulation Number
888.3353Why did this record match?
Applicant Name (Manufacturer) :
Responsive Orthopedics, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Responsive Orthopedics Total Hip Arthroplasty System is indicated for cementless use only in the following cases:
- · Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
- · Rheumatoid arthritis;
- · Correction of functional deformity;
- · Revision procedures where other treatments or devices have failed; and
· Nonunions, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
The Responsive Orthopedics Total Hip Arthroplasty System Acetabular screws are indicated for supplemental fixation of Responsive Orthopedics Acetabular Cup.
Device Description
The Responsive Orthopedics Total Hip Arthroplasty (RO THA) System is a total hip system that allows for the restoration of alignment, stability and range of motion, and alleviates pain, by replacing the articulating surfaces of the hip joint. The system includes both femoral and acetabular components. The implants are available in a variety of sizes to accommodate varying patient anatomy.
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