Cleared Traditional

K231556 - SPECTRUM® GV Bone Cement (FDA 510(k) Clearance)

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

K231556 · Osteoremedies, LLC · Orthopedic device
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Optimized for regulatory review, auditing and printing
Dec 2023
Decision
204d
Days
Class 2
Risk

K231556 is an FDA 510(k) clearance for the SPECTRUM® GV Bone Cement. Classified as Bone Cement (product code LOD), Class II - Special Controls.

Submitted by Osteoremedies, LLC (Memphis, US). The FDA issued a Cleared decision on December 20, 2023 after a review of 204 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 Osteoremedies, LLC devices

Submission Details

510(k) Number K231556 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 2023
Decision Date December 20, 2023
Days to Decision 204 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
82d slower than avg
Panel avg: 122d · This submission: 204d
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

Mcra, LLC
Hollace Rhodes

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
Devices cleared under the same product code (LOD) and FDA review panel - the closest regulatory comparables to K231556.
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
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