# K220336: Mg-PSZ Ceramic Femoral Head

- Pathway: 510(k) (Special)
- Applicant: Theken Companies
- Decided: Sep 30, 2022 after 235 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: 13 generations back to K931641 (1994). 195 ancestors in all.
No later device cites it as a predicate yet.
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.
- K912641: Biopro Ziralloy Modular Femoral Heads, Biopro, Inc. (1991) Summary page 4.
- K925682: Biopro Ziralloy Modular Femoral Heads, Modified, Biopro, Inc. (1994) Summary page 4.
- K172501: iNSitu Total Hip System, Theken Companies, LLC (2017) Summary page 4.
- K192071: iNSitu Total Hip System, Theken Companies, LLC (2019) Summary page 4.
- K191936: iNSitu Total Hip System, Thecken Companies, LLC (2019) Summary page 4.

## 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.

Source page: https://510kreport.com/device/K220336
Methodology: https://510kreport.com/methodology