# K110399: Gladiator Plasma Classic Hip Stem

- Pathway: 510(k) (Traditional)
- Applicant: Wrightmedicaltechnologyinc
- Decided: May 10, 2011 after 88 days
- Product code: KWA (Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component))
- Device class: 3
- Regulation: 21 CFR 888.3330
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K004043 (2001). 4 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 7 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.
- K012091: Pro-Femur, Wrightmedicaltechnologyinc (2001) Summary page 1.
- K004043: Metal Transcend Articulation System, Wrightmedicaltechnologyinc (2001) Summary page 1.
- K060358: Profemur TL Hip Stem, Wrightmedicaltechnologyinc (2006) 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

## Indications for use
The GLADIATOR® Plasma Classic Hip Stem is intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients. Indications for Use: 1. non-inflammatory degenerative joint disease such as osteoarthritis, 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 GLADIATOR® Plasma Classic Hip Stems are intended for use during uncemented hip arthroplasty.

Source page: https://510kreport.com/device/K110399
Methodology: https://510kreport.com/methodology