# K020344: RPX Titanium Cemnt Restrictor

- Pathway: 510(k) (Traditional)
- Applicant: Sulzer Spine-Tech
- Decided: May 2, 2002 after 90 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: 2 generations back to K900138 (1990). 5 ancestors in all.
33 later devices descend from it; 1 cites it directly.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990345: Rabea Device, Model Pxxxxxx, Signus Medizintechnik GmbH (1999) Summary page 1.
- K013014: Block Cement Restrictor (CR) - Titanium, Medtronic Sofamor Danek, Inc. (2001) Summary page 1.

## Most influential descendants
- K022615: Centerpulse, Spine-Tech Division Cement Restrictor (2002), 32 descendants of its own
- K091425: Quantum M Composite Nailing System (2010), 31 descendants of its own
- K100497: Quantum IM Composite Nailing System (Quantum Nailing System) (2010), 29 descendants of its own
- K102369: Piccolo Composite Nailing System (2011), 16 descendants of its own
- K111056: Piccolo Composite Nailing System (2011), 15 descendants of its own

## Indications for use
The Sulzer Spine-Tech RPX™ Cement Restrictor 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 RPX™ Cement Restrictor 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/K020344
Methodology: https://510kreport.com/methodology