# K032095: Interpore Cross Cement Restrictor

- Pathway: 510(k) (Special)
- Applicant: Interpore Cross Intl.
- Decided: Aug 8, 2003 after 31 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 its predicate without a number.
- (no number) Interpore Cross Cement Restrictor: named in the summary without a submission number

## Indications for use
The Interpore Cross CEMENT RESTRICTOR is indicated for use as a cement restrictor in the femur, tibia and/or humerus. 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/K032095
Methodology: https://510kreport.com/methodology