Cleared Traditional

K241674 - OSTEOPAL V

K241674 is an FDA 510(k) clearance for OSTEOPAL V, manufactured by Heraeus Medical GmbH. The device is a Class 2 Orthopedic device with product code LOD cleared through the Traditional 510(k) pathway after a 177-day FDA review.

K241674 · Heraeus Medical GmbH · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2024
Decision
177d
Days
Class 2
Risk

K241674 is an FDA 510(k) clearance for the OSTEOPAL® V. Classified as Bone Cement (product code LOD), Class II - Special Controls.

Submitted by Heraeus Medical GmbH (Wehrheim, DE). The FDA issued a Cleared decision on December 5, 2024 after a review of 177 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3027 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Heraeus Medical GmbH devices

FDA 510(k) Submission Details - K241674

510(k) Number K241674 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 2024
Decision Date December 05, 2024
Days to Decision 177 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
55d slower than avg
Panel avg: 122d · This submission: 177d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LOD Device Classification - Class 2, Special Controls

Product Code LOD Bone Cement
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3027
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - LOD Bone Cement

All 52
Devices cleared under the same product code (LOD) and FDA review panel - the closest regulatory comparables to K241674.
Refobacin Bone Cement R (110034355)
K254107 · Biomet France · Apr 2026
SPECTRUM GV Bone Cement
K250760 · Osteoremedies, LLC · Apr 2025
SPECTRUM® GV Bone Cement
K231556 · Osteoremedies, LLC · Dec 2023
Bone Cement Genta, Bone Cement HV, Bone Cement LV
K211163 · Tecres S.P.A. · Jan 2023
Bone Cement-Normal Viscosity
K212729 · Biomecanica Industria E Comerciode Produtos Ortopedicos Ltda · May 2022
OGM 1 Polymethylmethacrylate (PMMA) bone cement, OGM 1A Polymethylmethacrylate (PMMA) bone cement
K211869 · Ormed Grup Medikal Turizm Saglik Hizmetleri Sanayi VE · May 2022