# K040276: Quantum Cement Restrictor

- Pathway: 510(k) (Traditional)
- Applicant: Quantum Orthopedics
- Decided: Apr 30, 2004 after 85 days
- Product code: JDK (Prosthesis, Hip, Cement Restrictor)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 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
- K060132: Spinal Usa Cement Restrictor System (2006), 0 descendants of its own
- K050699: Modification to: Vented Cement Restrictor, Model 60102-000-001/004 (2005), 0 descendants of its own

## Indications for use
The Quantum Cement Restrictor is indicated for use as a cement restrictor in the femur, tibia, or humerus. This device is not intended for spinal indications. The safety and effectiveness of this device when implanted in the spine have not been established.

Source page: https://510kreport.com/device/K040276
Methodology: https://510kreport.com/methodology