# K022615: Centerpulse, Spine-Tech Division Cement Restrictor

- Pathway: 510(k) (Special)
- Applicant: Centerpulse Spine-Tech, Inc.
- Decided: Oct 29, 2002 after 83 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: 3 generations back to K900138 (1990). 7 ancestors in all.
32 later devices descend from it; 1 cites it directly.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020344: RPX Titanium Cemnt Restrictor, Sulzer Spine-Tech (2002) Summary page 1.
- K010528: Titanium Cement Restrictor Material Peek, Medtronic Sofamor Danek USA, Inc. (2001) Summary page 1.

## Most influential descendants
- 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
- K102597: Piccolo Composite Plate System (2011), 15 descendants of its own

## Indications for use
The Spine-Tech 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.

Source page: https://510kreport.com/device/K022615
Methodology: https://510kreport.com/methodology