# K041583: Peek Cement Restrictor X-Box

- Pathway: 510(k) (Traditional)
- Applicant: Innovasis, Inc.
- Decided: Jul 22, 2004 after 41 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
Longest line of descent: 4 generations back to K900138 (1990). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031837: Modification to Fortitude Cement Restrictor, Spinal Concepts, Inc. (2003) Summary page 1.
- K031318: Traxis Cement Restrictor, Spinal Concepts, Inc. (2003) Summary page 1.
- K021719: Fortitude Cement Restrictor, Spinal Concepts, Inc. (2002) Summary page 1.

## Cited in the summary but kept off the family tree
- K001052: Med-Tec (Medical Intelligence) Bodyfix System, Model MT-BFX, Med-Tec,Inc. (2000). Our reading of the summary gave K001052, FDA’s number for Med-Tec (Medical Intelligence) Bodyfix System, Model MT-BFX (Med-Tec,Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Medtronic Sofamor Danek”. Kept off the family tree.

## Indications for use
The INNOVASIS 'X-Box' PEEK Cement Restrictor is intended for use as a cement restrictor in orthopedic surgeries such as those involving the femoral canal and tibial canal in hip stem and total knee replacement. 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/K041583
Methodology: https://510kreport.com/methodology