510(k) K122158

PBP TOTAL HIP SYSTEM by Pipeline Biomedical Products, LLC — Product Code OQG

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: December 11, 2012
Date Received: July 20, 2012
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented
Device Class: Class II
Regulation Number: 888.3358
Review Panel: OR
Submission Type

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.

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