# K014199: Surgical Simplex P with Tobramycin

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: May 6, 2003 after 501 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.
21 later devices descend from it; 4 cite it directly.
0 of 22 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) Surgical Simplex® P Radiopaque Bone Cement (Howmedica Osteonics N-17-004): named in the summary without a submission number
- (no number) Surgical Simplex® P Bone Cement: named in the summary without a submission number

## Most influential descendants
- K033382: Smartset GMV Endurance Gentamicin Bone Cement (2004), 16 descendants of its own
- K033563: Smartset GHV Gentamicin Bone Cement (2004), 9 descendants of its own
- K041656: Modification to Depuy 1 Gentamicin Bone Cement and Smartset GMV Endurance Gentamicin Bone Cement (2004), 8 descendants of its own
- K053002: Depuy CMW 1 Gentamicin Bone Cement (2005), 4 descendants of its own
- K173494: OrthoSteady G Bone Cement (2018), 2 descendants of its own

## Recalls of this device
- Nov 7, 2022 · Class III · Z-0737-2023: 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.
- Nov 7, 2006 · Not classified · Z-0467-2007: The expiration date on the external label is incorrect in that it does not identify the earliest expiration date of the subcomponents. The External label provides for an incorrect longer expiration da

## Indications for use
SimplexTMP with Tobramycin is indicated for the fixation of prostheses to living bone for use in the second stage of a two-stage revision far total joint arthroplasty.

Source page: https://510kreport.com/device/K014199
Methodology: https://510kreport.com/methodology