# K003718: Titanium Cement Restrictor (TCR)

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek, Inc.
- Decided: Feb 14, 2001 after 72 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
No predicates in its family tree.
54 later devices descend from it; 6 cite it directly.
0 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K013014: Block Cement Restrictor (CR) - Titanium (2001), 47 descendants of its own
- 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

Source page: https://510kreport.com/device/K003718
Methodology: https://510kreport.com/methodology