Cleared Traditional

K211163 - Bone Cement Genta, Bone Cement HV, Bone Cement LV (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K211163 · Tecres S.P.A. · Orthopedic device
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Jan 2023
Decision
630d
Days
Class 2
Risk

K211163 is an FDA 510(k) clearance for the Bone Cement Genta, Bone Cement HV, Bone Cement LV. Classified as Bone Cement (product code LOD), Class II - Special Controls.

Submitted by Tecres S.P.A. (Sommacampagna, IT). The FDA issued a Cleared decision on January 9, 2023 after a review of 630 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Tecres S.P.A. devices

Submission Details

510(k) Number K211163 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 2021
Decision Date January 09, 2023
Days to Decision 630 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
508d slower than avg
Panel avg: 122d · This submission: 630d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 71
Devices cleared under the same product code (LOD) and FDA review panel - the closest regulatory comparables to K211163.
Refobacin Bone Cement R (110034355)
K254107 · Biomet France · Apr 2026
SPECTRUM GV Bone Cement
K250760 · Osteoremedies, LLC · Apr 2025
OSTEOPAL® V
K241674 · Heraeus Medical GmbH · Dec 2024
SPECTRUM® GV Bone Cement
K231556 · Osteoremedies, LLC · Dec 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