Cleared Traditional

K211869 - OGM 1 Polymethylmethacrylate (PMMA) bone cement, OGM 1A Polymethylmethacrylate (PMMA) bone cement (FDA 510(k) Clearance)

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

K211869 · Ormed Grup Medikal Turizm Saglik Hizmetleri Sanayi VE · Orthopedic device
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May 2022
Decision
337d
Days
Class 2
Risk

K211869 is an FDA 510(k) clearance for the OGM 1 Polymethylmethacrylate (PMMA) bone cement, OGM 1A Polymethylmethacrylat.... Classified as Bone Cement (product code LOD), Class II - Special Controls.

Submitted by Ormed Grup Medikal Turizm Saglik Hizmetleri Sanayi VE (Ankara, TR). The FDA issued a Cleared decision on May 19, 2022 after a review of 337 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Ormed Grup Medikal Turizm Saglik Hizmetleri Sanayi VE devices

Submission Details

510(k) Number K211869 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 2021
Decision Date May 19, 2022
Days to Decision 337 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
215d slower than avg
Panel avg: 122d · This submission: 337d
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

Medcer Uluslararasi Medikal Belgelendirme Anonim Sirketi
Mehmet Fatih Ormeci

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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