# K013014: Block Cement Restrictor (CR) - Titanium

- Pathway: 510(k) (Special)
- Applicant: Medtronic Sofamor Danek, Inc.
- Decided: Oct 4, 2001 after 27 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: 1 generation back to K003718 (2001). 1 ancestor in all.
47 later devices descend from it; 4 cite it directly.
0 of 49 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.

## Most influential descendants
- K020344: RPX Titanium Cemnt Restrictor (2002), 33 descendants of its own
- 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

## Indications for use
The Medtronic Sofamor Danek Block Cement Restrictor (CR) — Titanium is intended for use as a cement restrictor in orthopedic surgeries in the femur and tibia in hip and knee replacement. The Block CR-Titanium is NOT intended for any spinal indications.

Source page: https://510kreport.com/device/K013014
Methodology: https://510kreport.com/methodology