# K051496: Cobalt Bone Cement

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Aug 4, 2005 after 59 days
- Product code: LOD (Bone Cement)
- Device class: 2
- Regulation: 21 CFR 888.3027
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to P810020 (1984). 2 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 6 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.
- K993836: Generation 4 Bone Cement, Biomet, Inc. (2001) Summary page 1.

## Most influential descendants
- K091608: Cobalt MV Bone Cement (2009), 1 descendant of its own
- K192394: Hi-Fatigue Bone Cement (2019), 0 descendants of its own
- K070015: Cobalt V Radiopaque Vertebroplasty Bone Cement (2007), 0 descendants of its own

## Recalls of this device
- Jun 26, 2017 · Class II · Z-0067-2018: Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement.
- Jun 26, 2017 · Class II · Z-0064-2018: Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement.
- Apr 13, 2017 · Class II · Z-2056-2017: Six complaints were filed regarding loss of the Zimmer Biomet applied seal of a sterile Tyvek packaging. A breach in the packaging could lead to loss of sterility of the device.
- Jul 26, 2016 · Class II · Z-2606-2016: The outer packaging was mislabeled on the box indicating "Cobalt HV with Gentamicin". The bone cement does not contain antibiotics.

## Indications for use
CobaltTM HV 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 of 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/K051496
Methodology: https://510kreport.com/methodology