# K211869: OGM 1 Polymethylmethacrylate (PMMA) bone cement, OGM 1A Polymethylmethacrylate (PMMA) bone cement

- Pathway: 510(k) (Traditional)
- Applicant: Ormed Grup Medikal Turizm Saglik Hizmetleri Sanayi VE
- Decided: May 19, 2022 after 337 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: 4 generations back to P810020 (1984). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202475: PALACOS R, PALACOS R pro, PALACOS R+G, PALACOS R+G pro, PALACOS MV+G, Heraeus Medical GmbH (2020) Summary page 5.
- K023103: Depuy 1 Gentamicin Bone Cement, DePuy Orthopaedics, Inc. (2003) Summary page 5.

## Indications for use
OGM® 1 is a PMMA bone cement intended for use in arthroplastic procedures of the hip, knee and other joints for the fixation of polymer or metallic prosthetic implants to living bone. OGM® 1A is indicated for use 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/K211869
Methodology: https://510kreport.com/methodology