# K132626: Pipeline Total Hip System (Line Extension)

- Pathway: 510(k) (Special)
- Applicant: Pipeline Biotechnology
- Decided: Sep 19, 2013 after 28 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K931641 (1994). 74 ancestors in all.
No later device cites it as a predicate yet.
0 of 75 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130353: Pipeline Total Hip System (Line Extension), Pipeline Orthopedics (2013) Summary page 1.

## Indications for use
PIPELINE 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 PIPELINE Tapered Femoral Stem and PIPELINE PST™ Acetabular Shell are intended for cementless or cemented fixation. The porous structured surface provides biological fixation when used in a cementless application. The PIPELINE PST™ Acetabular Shell with HA is intended for cementless fixation. The porous structured surface with HA provides biological fixation.

Source page: https://510kreport.com/device/K132626
Methodology: https://510kreport.com/methodology