# K121221: Profemur Z Revision Hip Stem

- Pathway: 510(k) (Special)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Aug 9, 2012 after 108 days
- Product code: LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3353
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K893685 (1989). 8 ancestors in all.
3 later devices descend from it; 2 cite it directly.
2 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021346: Stem Hip Replacement System, Model PHA002XX, Wrightmedicaltechnologyinc (2002) Summary page 1.
- K112080: Preserve Hip Stem, Wrightmedicaltechnologyinc (2011) Summary page 1.

## Most influential descendants
- K173898: MicroPort Orthopedics Total Hip Systems MR Labeling (2018), 1 descendant of its own
- K240452: Ceramic Femoral Head (2024), 0 descendants of its own
- K122778: Profemur Z Revision Hip Stem (2012), 0 descendants of its own

## Indications for use
1. non-inflammatory degenerative joint disease such as osteoiarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed. The PROFEMURO Z Revision Hip Stem is intended for cementless hip arthroplasty.

Source page: https://510kreport.com/device/K121221
Methodology: https://510kreport.com/methodology