# K053198: Simplex P Speedset Bone Cement

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: Jan 26, 2006 after 71 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
Longest line of descent: 2 generations back to P810020 (1984). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030902: Palacos R, Heraeus Kulzer GmbH & Co. KG (2003) Summary page 2.
- (no number) Simplex P bone cement: named in the summary without a submission number

## Most influential descendants
- K063857: Simplex P Speedset with Tobramycin Bone Cement (2007), 0 descendants of its own

## Indications for use
SimplexTM P SpeedSet bone cement is 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 SpeedSet 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/K053198
Methodology: https://510kreport.com/methodology