Cleared Traditional

BonOs Inject, Pedicle screw kits, Cement pusher (K202458) - FDA 510(k) Clearance

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

K202458 · Osartis GmbH · Orthopedic device
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May 2021
Decision
264d
Days
Class 2
Risk

K202458 is an FDA 510(k) clearance for the BonOs Inject, Pedicle screw kits, Cement pusher. Classified as Bone Cement (product code LOD), Class II - Special Controls.

Submitted by Osartis GmbH (Münster, DE). The FDA issued a Cleared decision on May 18, 2021 after a review of 264 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 Osartis GmbH devices

Submission Details

510(k) Number K202458 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 2020
Decision Date May 18, 2021
Days to Decision 264 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
142d slower than avg
Panel avg: 122d · This submission: 264d
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 48
Devices cleared under the same product code (LOD) and FDA review panel - the closest regulatory comparables to K202458.
OGM 1 Polymethylmethacrylate (PMMA) bone cement, OGM 1A Polymethylmethacrylate (PMMA) bone cement
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PALACOS MV pro
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PALACOS R pro, PALACOS R+G pro, PALACOS MV+G pro
K210607 · Heraeus Medical GmbH · Jul 2021
BonOs HV, BonOs MV, BonOs LV
K210120 · Osartis GmbH · Mar 2021
BonOs HV Genta, BonOs MV Genta, BonOs LV Genta
K210125 · Osartis GmbH · Mar 2021
PALACOS R, PALACOS R pro, PALACOS R+G, PALACOS R+G pro, PALACOS MV+G
K202475 · Heraeus Medical GmbH · Nov 2020