# K092150: Cobalt MV with Gentamicin (Aka Cobalt G-MV) Bone Cement

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Oct 27, 2009 after 103 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: 3 generations back to P810020 (1984). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051532: Cobalt G HV Bone Cement, Biomet, Inc. (2005) Summary page 1.
- K014199: Surgical Simplex P with Tobramycin, Howmedica Osteonics Corp. (2003) Summary page 1.

## Most influential descendants
- K192379: Hi-Fatigue G Bone Cement (2019), 0 descendants of its own

## Indications for use
Cobalt TM MV with Gentamicin Bone Cement 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/K092150
Methodology: https://510kreport.com/methodology