# K161184: iNSitu Total Hip System

- Pathway: 510(k) (Traditional)
- Applicant: Theken Companies, LLC
- Decided: Oct 14, 2016 after 170 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: 10 generations back to K931641 (1994). 189 ancestors in all.
19 later devices descend from it; 7 cite it directly.
0 of 208 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131237: Pipeline Total Hip System, Pipeline Orthopedics (2013) Summary page 5.
- K121935: Taperset Hip Small Stems, Consensus Orthopedics, Inc. (2012) Summary page 5.
- K141043: CS2 Multi-Hole Acetabular Shell, Consensus Orthopedics, Inc. (2014) Summary page 5.

## Most influential descendants
- K163577: Ecofit® Hip System (2017), 9 descendants of its own
- K172501: iNSitu Total Hip System (2017), 7 descendants of its own
- K180263: EcoFit Vit E Acetabular System (2018), 5 descendants of its own
- K203420: EcoFit® Hip System (2021), 4 descendants of its own
- K192071: iNSitu Total Hip System (2019), 4 descendants of its own

## Indications for use
The iNSitu 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 iNSitu Total Hip System femoral stem is intended for cementless fixation. The iNSitu Total Hip System acetabular cup is intended for cementless fixation. The porous structured surfaces provide biological fixation in a cementless application.

Source page: https://510kreport.com/device/K161184
Methodology: https://510kreport.com/methodology