# K002652: Surgical Simplex P Radiopaque Bone Cement and Acm and Mixevacii

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Corp.
- Decided: Jan 26, 2001 after 154 days
- Product code: LOD (Bone Cement)
- Device class: 2
- Regulation: 21 CFR 888.3027
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
216 later devices descend from it; 4 cite it directly.
0 of 217 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K033801: Kyphx HV-R, Model C01A (2004), 212 descendants of its own
- K041584: Kyphx HV-R Bone Cement, Model C01A (2004), 209 descendants of its own
- K042691: Vertefix Vertebroplasty Procedure Set (2005), 189 descendants of its own
- K060300: Confidence High Viscosity Bone Cement (2006), 176 descendants of its own
- K093828: Kyph X HV-R Bone Cement (2010), 167 descendants of its own

## Recalls of this device
- Nov 7, 2022 · Class III · Z-0736-2023: Instructions for Use (IFU) included in the packaging is missing a translation in the Turkish language. Although the Turkish translation is missing, all content within the IFUs is accurate.

Source page: https://510kreport.com/device/K002652
Methodology: https://510kreport.com/methodology