# K192236: Fitmore Hip Stem

- Pathway: 510(k) (Special)
- Applicant: Zimmer GmbH
- Decided: Nov 5, 2019 after 78 days
- Product code: KWY (Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3390
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K850055 (1985). 45 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071723: Zimmer Porolock Mis Stem, Zimmer GmbH (2008) Summary page 4.

## Most influential descendants
- K200112: Zimmer Hip Joint Replacement (2020), 0 descendants of its own

## Indications for use
This femoral stem is for total hip or hemi-hip arthroplasty and is indicated for the following conditions: Noninflammatory degenerative joint disease (NIDJD), e. g., avascular necrosis, osteoarthritis and inflammatory joint disease (IJD), e. g., theumatoid arthritis. Failed previous hip surgery (not THA) where pain, deformity or dysfunction persists. Optional use in revision: in some medical conditions (e. g., early revision when healthy and good bone stock exists) the surgeon may opt to use primary implants in a revision procedure. This stem is for uncemented use only.

Source page: https://510kreport.com/device/K192236
Methodology: https://510kreport.com/methodology