# K111910: Gladiator Hip Stem

- Pathway: 510(k) (Traditional)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Oct 14, 2011 after 101 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: 6 generations back to K935452 (1994). 25 ancestors in all.
5 later devices descend from it; 3 cite it directly.
2 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100866: Profemur Hip System Modular Necks, Wrightmedicaltechnologyinc (2010) Summary page 1.
- K091423: Profemur Hip System Modular Necks, Wrightmedicaltechnologyinc (2009) Summary page 1.
- K021346: Stem Hip Replacement System, Model PHA002XX, Wrightmedicaltechnologyinc (2002) Summary page 1.
- K012091: Pro-Femur, Wrightmedicaltechnologyinc (2001) Summary page 1.
- K052915: Profemur XTR Hip Stem, Wrightmedicaltechnologyinc (2006) Summary page 1.
- K060358: Profemur TL Hip Stem, Wrightmedicaltechnologyinc (2006) Summary page 1.
- K953111: Corail, Landos, Inc. (1996) Summary page 1.
- K042992: Corail Amt Hip Prosthesis, DePuy Orthopaedics, Inc. (2005) Summary page 1.
- K082924: Dynasty Porous Acetabular Shell, Dynasty Polyethylene Acetabular Liner, Dynasty Metal Acetabular Liner, Wrightmedicaltechnologyinc (2009) Summary page 1.

## Most influential descendants
- K201519: PROFEMUR® GLADIATOR® Cemented Classic Stem (2020), 1 descendant of its own
- K173898: MicroPort Orthopedics Total Hip Systems MR Labeling (2018), 1 descendant of its own
- K240046: Ethylene Oxide Sterilization Supplier Change for MPO Hips (2024), 0 descendants of its own
- K240452: Ceramic Femoral Head (2024), 0 descendants of its own
- K213816: MPO Hip Instruments (2022), 0 descendants of its own

## Indications for use
1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular Inecrosis, ankylosis, protrusio acetabuli, and painful hip dlysplasia; 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 Gladiator cpTi Plasma Sprayed hip stem is intended for cementless hip arthroplasty. The Gladiator Cemented hip stem is intended for cemented hip arthroplasty.

Source page: https://510kreport.com/device/K111910
Methodology: https://510kreport.com/methodology