# K243192: iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi Coating

- Pathway: 510(k) (Traditional)
- Applicant: Nextstep Arthopedix, LLC
- Decided: Jun 5, 2026 after 613 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: 16 generations back to K941847 (1994). 289 ancestors in all.
No later device cites it as a predicate yet.
0 of 289 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 6.
- K172501: iNSitu Total Hip System, Theken Companies, LLC (2017) Summary page 6.
- K191936: iNSitu Total Hip System, Thecken Companies, LLC (2019) Summary page 6.
- K191297: iNSitu Bipolar Hip System, Theken Companies, LLC (2019) Summary page 6.
- K241875: TheRay Collared and Collarless Femoral Stem, Nextstep Arthropedix (2024) Summary page 7.

## 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 stems are 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. TheRay Collared and Collarless 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. TheRay Collared and Collarless Total Hip System femoral stems are intended for cementless fixation. The acetabular cup is intended for cementless fixation. The porous structured surfaces on the acetabular cup provide biological fixation in a cementless application. The iNSitu Bipolar Hip System is intended for use in combination with the iNSitu Total Hip System femoral stem for cemented or uncemented primary or revision hemiarthroplasty of the hip. This prosthesis may be used for the following conditions, as appropriate: • Femoral neck and trochanteric fractures of the proximal femur; • Osteonecrosis of the femoral head; • Revision procedures where other devices or treatments for these indications have failed.

Source page: https://510kreport.com/device/K243192
Methodology: https://510kreport.com/methodology