# K212729: Bone Cement-Normal Viscosity

- Pathway: 510(k) (Traditional)
- Applicant: Biomecanica Industria E Comerciode Produtos Ortopedicos Ltda
- Decided: May 31, 2022 after 277 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 P960001 (1997). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053003: Depuy CMW 1, 2 and 3 Bone Cements, DePuy Orthopaedics, Inc. (2005) Summary page 4.

## Indications for use
Bone Cement - Normal Viscosity is indicated for fixation of prostheses to live bone in musculoskeletal orthopedic surgical interventions in cases of rheumatoid arthritis, osteoarthritis, traumatic arthritis, osteoporosis, avascular necrosis, collagen disease, severe secondary destruction of the joints after trauma or other conditions and in the review of previous arthroplasty procedures.

Source page: https://510kreport.com/device/K212729
Methodology: https://510kreport.com/methodology