# K192071: iNSitu Total Hip System

- Pathway: 510(k) (Special)
- Applicant: Theken Companies, LLC
- Decided: Aug 30, 2019 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: 12 generations back to K931641 (1994). 191 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 195 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161184: iNSitu Total Hip System, Theken Companies, LLC (2016) Summary page 4.
- K172501: iNSitu Total Hip System, Theken Companies, LLC (2017) Summary page 4.

## Most influential descendants
- K241690: Logical Liner; World Liner; World Knee Patella (2024), 2 descendants of its own
- K252824: Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head (2026), 0 descendants of its own
- K243162: World Liner (2024), 0 descendants of its own
- K220336: Mg-PSZ Ceramic Femoral Head (2022), 0 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/K192071
Methodology: https://510kreport.com/methodology