Cleared Traditional

K212729 - Bone Cement-Normal Viscosity (FDA 510(k) Clearance)

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

K212729 · Biomecanica Industria E Comerciode Produtos Ortopedicos Ltda · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2022
Decision
277d
Days
Class 2
Risk

K212729 is an FDA 510(k) clearance for the Bone Cement-Normal Viscosity. Classified as Bone Cement (product code LOD), Class II - Special Controls.

Submitted by Biomecanica Industria E Comerciode Produtos Ortopedicos Ltda (Jau, BR). The FDA issued a Cleared decision on May 31, 2022 after a review of 277 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 Biomecanica Industria E Comerciode Produtos Ortopedicos Ltda devices

Submission Details

510(k) Number K212729 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 2021
Decision Date May 31, 2022
Days to Decision 277 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
155d slower than avg
Panel avg: 122d · This submission: 277d
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 Consultant

Passarini Regulatory Affairs/ PR Servicos
Graziela Brum

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LOD Bone Cement

All 71
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