# K061698: Modification to Life Spine Cement Restrictor

- Pathway: 510(k) (Special)
- Applicant: Life Spine
- Decided: Jul 12, 2006 after 26 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
The Life Spine Cement Restrictor is indicated for use as a cement restrictor in the femur, tibia, or humerus. This device is not intended for spinal indications or acetabular cup surgeries. The safety and effectiveness of this device when implanted in the spine have not been established. WARNING: THIS DEVICE IS NOT INTENDED FOR ANY SPINAL INDICATIONS. THE SAFETY AND EFFECTIVENESS OF THIS DEVICE WHEN IMPLANTED IN THE SPINE HAVE NOT BEEN ESTABLISHED

Source page: https://510kreport.com/device/K061698
Methodology: https://510kreport.com/methodology