# K062693: Gladiator Bipolar System

- Pathway: 510(k) (Special)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Sep 29, 2006 after 18 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: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
10 later devices descend from it; 4 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K101670: United U2 Bipolar Implant (2010), 5 descendants of its own
- K152439: U2 Bipolar Implant and 22mm Femoral Head (2016), 3 descendants of its own
- K173898: MicroPort Orthopedics Total Hip Systems MR Labeling (2018), 1 descendant of its own
- K162957: U2 Femoral Head (2017), 1 descendant of its own
- K240046: Ethylene Oxide Sterilization Supplier Change for MPO Hips (2024), 0 descendants of its own

## Recalls of this device
- Jan 3, 2007 · Not classified · Z-0572-2007: Product specification failure which could result in improper locking of the cup onto the femoral head.
- Jan 3, 2007 · Not classified · Z-0569-2007: Product specification failure which could result in improper locking of the cup onto the femoral head.
- Jan 3, 2007 · Not classified · Z-0570-2007: Product specification failure which could result in improper locking of the cup onto the femoral head.
- Jan 3, 2007 · Not classified · Z-0571-2007: Product specification failure which could result in improper locking of the cup onto the femoral head.
- Jan 3, 2007 · Not classified · Z-0567-2007: Product specification failure which could result in improper locking of the cup onto the femoral head.
- Jan 3, 2007 · Not classified · Z-0568-2007: Product specification failure which could result in improper locking of the cup onto the femoral head.

## Indications for use
The GLADIATOR TM Bipolar System is indicated for the following conditions: 1) pathological fractures of the femoral neck 2) non-union of femoral neck fractures 3) aseptic necrosis of the femoral head and neck 4) primary pathology in the young involving the femoral head but with a non-deformed acetabulum.

Source page: https://510kreport.com/device/K062693
Methodology: https://510kreport.com/methodology