# K051607: Novaspine Cement Restrictor NSCR

- Pathway: 510(k) (Traditional)
- Applicant: Novaspine, LLC
- Decided: Oct 7, 2005 after 112 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). 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)
- K003718: Titanium Cement Restrictor (TCR), Medtronic Sofamor Danek, Inc. (2001) Summary page 1.
- K011443: Threaded Cement Restrictor (CR) Titanium, Medtronic Sofamor Danek USA, Inc. (2001) Summary page 1.
- K012255: Medtronic Sofamor Danek Cement Restrictor, Medtronic Sofamor Danek, Inc. (2001) Summary page 1.
- K013014: Block Cement Restrictor (CR) - Titanium, Medtronic Sofamor Danek, Inc. (2001) Summary page 1.
- K022218: Cadence Cement Restrictor, Spinal Concepts, Inc. (2002) Summary page 1.
- K021719: Fortitude Cement Restrictor, Spinal Concepts, Inc. (2002) Summary page 1.
- K031837: Modification to Fortitude Cement Restrictor, Spinal Concepts, Inc. (2003) Summary page 1.

## Cited in the summary but kept off the family tree
- K03118: Spinal Concepts, Inc.. Number could not be read Summary page 1.

## Indications for use
The NovaSpine Cement Restrictor device is intended for use as a cement restrictor in orthopedic surgeries such as those involving the femoral canal and tibial plateau in hip stem and total knee replacement. The NovaSpine Cement Restrictoris NOT intended for any spinal indications.

Source page: https://510kreport.com/device/K051607
Methodology: https://510kreport.com/methodology