# K063857: Simplex P Speedset with Tobramycin Bone Cement

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: Feb 26, 2007 after 60 days
- Product code: MBB (Bone Cement, Antibiotic)
- 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: 3 generations back to P810020 (1984). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K014199: Surgical Simplex P with Tobramycin, Howmedica Osteonics Corp. (2003) Summary page 2.
- K053198: Simplex P Speedset Bone Cement, Howmedica Osteonics Corp. (2006) Summary page 2.

## Indications for use
Simplex P SpeedSet with Tobramycin Bone Cement is indicated for the fixation of prostheses to living bone for use in the second stage of a two-stage revision for total joint arthroplasty.

Source page: https://510kreport.com/device/K063857
Methodology: https://510kreport.com/methodology