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U.S. Department of Health and Human Services

Product Classification

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Device hip, semi-constrained, cemented, metal/polymer + additive, cemented
Regulation Description Hip joint metal/polymer semi-constrained cemented prosthesis.
Definition 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis. 3. Correction of functional deformity. 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed. Cemented and uncemented use.
Physical State May include: Acetabular Shell Acetabular Liner Femoral Head Femoral Stem Femoral Neck Instrumentation
Technical Method This device is intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene containing an additive such as a-tocopherol and is limited to those prostheses intended for use with bone cement.
Target Area hip
Regulation Medical Specialty Orthopedic
Review Panel Orthopedic
Product CodeOQH
Premarket Review Office of Orthopedic Devices (OHT6)
Joint Arthroplasty Devices (DHT6A)
Submission Type 510(k)
Regulation Number 888.3350
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? Yes
Life-Sustain/Support Device? No
Recognized Consensus Standards
Third Party Review Not Third Party Eligible