# K130353: Pipeline Total Hip System (Line Extension)

- Pathway: 510(k) (Traditional)
- Applicant: Pipeline Orthopedics
- Decided: Jul 1, 2013 after 139 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: 8 generations back to K931641 (1994). 73 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 75 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112802: Pipeline Total Hip System, Pipeline Orthopedics (2012) Summary page 1.
- K061066: Synergy Hip System, Smith & Nephew, Inc. (2006) Summary page 1.
- K022799: Trident Screw Hole Plug and Trident Bone Spike, Howmedica Osteonics Corp. (2002) Summary page 1.

## Cited in the summary but kept off the family tree
- K122802: PBP Total Hip System. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Most influential descendants
- K132626: Pipeline Total Hip System (Line Extension) (2013), 0 descendants of its own

## 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 dlysplasia; 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 PSTTM Acetabular Shell are intended for cementless or cemented fixation. The porous structured surface provides biological fixation when used in a cementless application. The PIPELINE PSTTM Acetabular Shell with HA is intended for cementless fixation. The porous structured surface with HA provides biological fixation.

Source page: https://510kreport.com/device/K130353
Methodology: https://510kreport.com/methodology