# K112802: Pipeline Total Hip System

- Pathway: 510(k) (Traditional)
- Applicant: Pipeline Orthopedics
- Decided: Mar 9, 2012 after 164 days
- Product code: OQG (Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, 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: 7 generations back to K931641 (1994). 65 ancestors in all.
53 later devices descend from it; 6 cite it directly.
0 of 119 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070369: Regenerx Ringloc + Modular Acetabular Shells, Biomet, Inc. (2007) Summary page 1.
- K060635: Consensus Acetabular Shell System, Hayes Medical, Inc. (2006) Summary page 1.
- K094035: Exp Acetabular Liner, Models SC3342 Non-Hooded 28MM, SC3343 Hooded 28MM, Stelkast Company (2011) Summary page 2.
- K010170: Trident Porous Titanium Acetabular Component, Howmedica Osteonics Corp. (2001) Summary page 2.
- K102487: Novation Femoral Stem, Tapered 12/14 , Standard/Extended Offset, Plasma Coated, Press-Fit, Size 19/20, Exactech, Inc. (2010) Summary page 2.
- K042842: Novation 12/14 Press-Fit Femoral Stem, Exactech, Inc. (2004) Summary page 2.
- K041906: Exactech 12/14 Total Hip System, Exactech, Inc. (2004) Summary page 2.
- K052792: Anthology Hip Stem, Smith & Nephew, Inc. (2005) Summary page 2.

## Most influential descendants
- K122158: PBP Total Hip System (2012), 21 descendants of its own
- K131237: Pipeline Total Hip System (2013), 20 descendants of its own
- K161184: iNSitu Total Hip System (2016), 19 descendants of its own
- K162719: iTotal® Hip Replacement System (2017), 17 descendants of its own
- K141972: Klassic HD Acetabular Insert with E-Link Poly (2014), 14 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, hemniarthroplasty, surface replacement arthroplasty or total hip replacement. The Pipeline Total Hip System is intended for cementless or cemented fixation. The porous structured surface provides biological fixation when used in a cementless application.

Source page: https://510kreport.com/device/K112802
Methodology: https://510kreport.com/methodology