# K211163: Bone Cement Genta, Bone Cement HV, Bone Cement LV

- Pathway: 510(k) (Traditional)
- Applicant: Tecres S.P.A.
- Decided: Jan 9, 2023 after 630 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: 5 generations back to K000943 (2001). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143100: NP Cement HV Genta;NP Cement LV Genta;NP Cement HV System Genta;NP Cement LV System Genta, Cossington, Ltd. (2015) Summary page 6.
- K143134: NP Cement HV;NP Cement LV; NP Cement HV System; NP Cement LV System, Cossington, Ltd. (2015) Summary page 6.
- K021715: Cemex RX, Cemex Isoplastic & Cemex XL, Exactech, Inc. (2002) Summary page 6.

## Indications for use
Bone Cement LV and HV are indicated for the fixation of joint prostheses to living bone in orthopedic musculoskeletal surgical procedures for rheumatoid arthritis, sickle cell anemia, osteoarthritis, traumatic arthritis, osteoporosis, avascular necrosis, collagen disease, severe joint destruction secondary to trauma or other conditions and revision of previous arthroplasty. Bone Cement Genta are intended for the fixation of prosthesis to living bone in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared.

Source page: https://510kreport.com/device/K211163
Methodology: https://510kreport.com/methodology