# K032945: Simplex X

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Corp.
- Decided: May 25, 2004 after 246 days
- Product code: LOD (Bone Cement)
- Device class: 2
- Regulation: 21 CFR 888.3027
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
248 later devices descend from it; 15 cite it directly.
0 of 249 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Stryker Simplex® P: named in the summary without a submission number

## Most influential descendants
- 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
- K102397: Kyphon Xpede Bone Cement (2011), 165 descendants of its own

## Recalls of this device
- Nov 9, 2017 · Class II · Z-1250-2018: Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
- Nov 30, 2011 · Not classified · Z-0862-2012: Product was packaged with a four inch needle in stead of the correct five inch needle. There is a potential that the needle may not be able to reach the fracture site, which may require additional med

## Indications for use
SpineplexTM Radiopaque Bone cement is indicated for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

Source page: https://510kreport.com/device/K032945
Methodology: https://510kreport.com/methodology