# K231556: SPECTRUM® GV Bone Cement

- Pathway: 510(k) (Traditional)
- Applicant: Osteoremedies, LLC
- Decided: Dec 20, 2023 after 204 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: 6 generations back to K000943 (2001). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172906: REMEDY PLUS Hip Spacer, UNITE PLUS Bone Cement, Osteoremedies, LLC (2018) Summary page 5.

## Most influential descendants
- K250760: SPECTRUM GV Bone Cement (2025), 0 descendants of its own

## Indications for use
SPECTRUM® GV Bone Cement is indicated for the fixation of a REMEDY SPECTRUM® GV Spacer, and for the fixation of prostheses to living bone in the second stage of a two-stage revision of a total hip arthroplasty after the initial infection has been cleared.

Source page: https://510kreport.com/device/K231556
Methodology: https://510kreport.com/methodology