FDA product code · Orthopedic

Cement, Bone, Vertebroplasty, Pre-Formed, Modular

Name: FDA decisions, review times, recalls and adverse event reports for product code OBM
Creator: 510(k) Report

OBMClass II21 CFR 888.3027510(k) required0 decisions0 recalls

0 FDA decisions. No recall names this code.

Reduction of vertebral body fractures in conjunction with PMMA bone cement cleared for vertebroplasty and restoration of vertebral body height.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, orthopedic panel

Twenty years of OBM at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FIG. 1 — OBM by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in OBM? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Related product codes

Other codes under 21 CFR 888.3027.

OBL Cement, Bone, Pre-Formed, Modular, Polymeric…NUD Vertebroplasty Compound, Calcium Based PML Bone Cement, Posterior Screw Augmentation LOD Bone Cement NDN Cement, Bone, Vertebroplasty MBB Bone Cement, Antibiotic