# K051371: Interbody Innovations Cement Restrictor

- Pathway: 510(k) (Traditional)
- Applicant: Interbody Innovations, Llp
- Decided: Dec 6, 2005 after 194 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 K003718 (2001). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 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.
- K030871: Fidji Large Cement Restrictor, Spine Next SA (2003) Summary page 1.
- K020836: Rabea Cement Restrictor, Signus Medical, LLC (2002) Summary page 1.

## Indications for use
This device is intended for use in conjunction with Standard PMMA cement. The Interbody Innovations Cement Restrictors are designed to occlude the medullar canal before the introduction of PMMA, in total hip or knee replacement. This device is not intended for use in spine applications. The safety and effectiveness have not been established when implanted into the spine.

Source page: https://510kreport.com/device/K051371
Methodology: https://510kreport.com/methodology