# K062553: Simplex P Bone Cement

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Orthopaedics
- Decided: Jan 8, 2007 after 131 days
- Product code: LOD (Bone Cement)
- Device class: 2
- Regulation: 21 CFR 888.3027
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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 no predicate by number.

## Most influential descendants
- K170802: TRAUMACEM™ V+ Injectable Bone Cement (2017), 0 descendants of its own

## Indications for use
Simplex P bone cement will be indicated for fixation of prostheses to living bone during orthopaedic musculoskeletal procedures for rheumatoid arthritis, osteoarthritis, traumatic arthritis, osteoporosis, avascular necrosis, collagen disease, severe joint destruction secondary to trauma or other conditions, or revision of a previous arthroplasty. SimplexTM P bone cement is also indicated for the fixation of pathological fractures where loss of bone substance or recalcitrance of the fracture renders more conventional procedures ineffective.

Source page: https://510kreport.com/device/K062553
Methodology: https://510kreport.com/methodology