# K030086: Palacos R Bone Cement with Gentamicin

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Dec 17, 2003 after 342 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: 1 generation back to P810020 (1984). 1 ancestor in all.
25 later devices descend from it; 2 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P810020: Palacos R Bone Cement, Smith & Nephew Richards, Inc. (1984) Summary page 1.

## Most influential descendants
- K051532: Cobalt G HV Bone Cement (2005), 23 descendants of its own
- K062273: Spacer-G Temporary Hip Prosthesis (2008), 20 descendants of its own
- K101356: Spacer-G and Spacer-K (2011), 19 descendants of its own
- K112470: 2GC Hip/Knee Modular Spacer (2012), 16 descendants of its own
- K183017: Remedy Femoral Component 84mm, Remedy Stemmed Knee Spacer (2019), 5 descendants of its own

## Indications for use
Palacos®G with gentamicin is indicated for use as bone cement in arthroplasty procedures of the hip, knee and other joints to fix plastic and metal prosthetic parts to living bone when reconstruction is necessary because of revision of previous arthroplasty procedures due to joint infection. The cement is intended for use to affix a new prosthesis in the second phase of a two-stage revision after the initial infection has been cleared.

Source page: https://510kreport.com/device/K030086
Methodology: https://510kreport.com/methodology