# K170072: Fitmore® Hip Stem

- Pathway: 510(k) (Special)
- Applicant: Zimmer GmbH
- Decided: Feb 7, 2017 after 29 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.
No later device cites it as a predicate yet.
0 of 46 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 3.

## Indications for use
This femoral stem is for total hip or hemi-hip arthroplasty and is indicated for the following conditions: • Non-inflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis. • Failed previous surgery where pain, deformity, or dysfunction persists. • Revision of previously failed hip arthroplasty. • Total hip replacements may be considered for younger patients if any unequivocal indication outweighs the risks associated with the age of the patient and modified demands regarding activity and hip joint loading are assured. This includes severely crippled patients with multiple joint involvement, for whom an immediate need of hip mobility leads to an expectation of significant improvement in the quality of their lives. This stem is for uncemented use only.

Source page: https://510kreport.com/device/K170072
Methodology: https://510kreport.com/methodology