# K091608: Cobalt MV Bone Cement

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Manufacturing Corp
- Decided: Sep 17, 2009 after 106 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
Longest line of descent: 2 generations back to P810020 (1984). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051496: Cobalt Bone Cement, Biomet, Inc. (2005) Summary page 1.

## Cited in the summary but kept off the family tree
- K017004: Simplex®g P Radiopaque Bone Cement. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K192394: Hi-Fatigue Bone Cement (2019), 0 descendants of its own

## Recalls of this device
- Jun 26, 2017 · Class II · Z-0066-2018: Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement.
- Jun 26, 2017 · Class II · Z-0065-2018: Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement.

## Indications for use
CobaltTM MV Bone Cement is indicated for use as bone cement in arthroplastic procedures of the hip, knee and other joints to fix plastic and metal prosthetic parts to living bone when reconstruction is necessary because of osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis, nonunion of fractures of the neck,6fof the femur, sickle cell anemia osteoporosis, secondary severe joint destruction following trauma or other conditions (also for fixation of unstable fractures in metastatic malignancies), and revision of previous arthroplasty procedures.

Source page: https://510kreport.com/device/K091608
Methodology: https://510kreport.com/methodology