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510(k) Data Aggregation
K Number
K122158Device Name
PBP TOTAL HIP SYSTEM
Manufacturer
PIPELINE BIOMEDICAL PRODUCTS, LLC
Date Cleared
2012-12-11
(144 days)
Product Code
OQG, JDI, LPH, LZO, MEH, OQH, OQI
Regulation Number
888.3358Why did this record match?
Applicant Name (Manufacturer) :
PIPELINE BIOMEDICAL PRODUCTS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PBP Total Hip System is indicated for use in skeletally mature individuals undergoing surgery for total hip replacement due to:
- A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis, or congenital hip dysplasia;
- Acute traumatic fracture of the femoral head or neck; -
- Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty or total .hip replacement.
The PBP Total Hip System hip stems and porous structured acetabular shells are intended for cementless or cemented fixation. The porous structured surface provides biological fixation when used in a cementless application.
The PBP Total Hip System HA porous structured acetabular shells are intended for cementless fixation. The HA porous structured surface provides biological fixation.
Device Description
The PBP Total Hip System is an artificial hip replacement system. The system includes femoral stems, femoral heads, acetabular shells, acetabular liners, acetabular bone screws and dome hole covers (occluders) for the holes in the acetabular shells.
The PBP Femoral Stems are forged titanium alloy and feature a proximal roughened surface (plasma-sprayed CP Titanium), a polished tapered neck, a flat tapered geometry with reduced A/P width (wedge design), and a contoured distal tip and reduced lateral shoulder. The PBP Femoral Stems come in a range of sizes, and are offered in two offset neck options per size.
The PBP Femoral Heads are available in a polished cobalt chromium alloy or a high purity alumina oxide ceramic compound (Biolox® delta). The heads come in a range of diameters and extension options. The variety of head and stem sizes accommodates differences in patient anatomy.
The PBP PST™ (Porous Structured Technology) Acetabular Shells are manufactured from titanium alloy and feature a porous structured surface or an HA porous structured surface. The shells feature a dome hole, are available with or without a cluster screw hole pattern for supplemental bone screw fixation, and come in a range of outer diameter sizes. The porous structured surface provides biologic fixation.
The PBP Acetabular Liners are manufactured from standard UHMWPE, or from highly crosslinked Vitamin E UHMWPE (XLVE™). The liners are mechanically assembled to the mating shells via engagement of the tightly toleranced liner taper and shell bore. The liners are available in a range of sizes and in neutral, high wall, and offset versions.
Optional components include a threaded acetabular dome hole occluder and acetabular bone screws, all manufactured from titanium alloy.
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