# K033953: Optimesh 500E Cement Restrictor

- Pathway: 510(k) (Traditional)
- Applicant: Spineology, Inc.
- Decided: Jul 6, 2004 after 197 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)
- K020836: Rabea Cement Restrictor, Signus Medical, LLC (2002) Summary page 1.
- K011943: Impro Vise Absorbable Cement Flow Restrictor, Kensey Nash Corp. (2001)
- K014200: Optimesh, Spineology, Inc. (2003) Summary page 1.

## Indications for use
OptiMesh 500E is intended for use as a cement restrictor in orthopedic surgeries such as those involving the femoral canal or tibial plateau in hip stem and total knee replacement. OptiMesh 500E is not intended for use in spinal indications.

Source page: https://510kreport.com/device/K033953
Methodology: https://510kreport.com/methodology