# K010529: Titanium Cement Restrictor Material Pldla

- Pathway: 510(k) (Special)
- Applicant: Medtronic Sofamor Danek USA, Inc.
- Decided: Apr 27, 2001 after 63 days
- Product code: JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 2 cite it directly.
0 of 7 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
- K022218: Cadence Cement Restrictor (2002), 4 descendants of its own
- K023647: Cadence Peek Cemeent Restrictor (2002), 2 descendants of its own
- K031318: Traxis Cement Restrictor (2003), 1 descendant of its own
- K051607: Novaspine Cement Restrictor NSCR (2005), 0 descendants of its own
- K041583: Peek Cement Restrictor X-Box (2004), 0 descendants of its own

Source page: https://510kreport.com/device/K010529
Methodology: https://510kreport.com/methodology