Cleared Traditional

BonOs HV, BonOs MV, BonOs LV (K210120) - FDA 510(k) Clearance

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

K210120 · Osartis GmbH · Orthopedic device
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Mar 2021
Decision
59d
Days
Class 2
Risk

K210120 is an FDA 510(k) clearance for the BonOs HV, BonOs MV, BonOs LV. Classified as Bone Cement (product code LOD), Class II - Special Controls.

Submitted by Osartis GmbH (Münster, DE). The FDA issued a Cleared decision on March 19, 2021 after a review of 59 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Osartis GmbH devices

Submission Details

510(k) Number K210120 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 2021
Decision Date March 19, 2021
Days to Decision 59 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
63d faster than avg
Panel avg: 122d · This submission: 59d
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 K210120.
PALACOS MV pro
K213812 · Heraeus Medical GmbH · Feb 2022
PALACOS R pro, PALACOS R+G pro, PALACOS MV+G pro
K210607 · Heraeus Medical GmbH · Jul 2021
BonOs Inject, Pedicle screw kits, Cement pusher
K202458 · Osartis GmbH · May 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
G1 40 Radiopaque Bone Cement
K193059 · G21, S.R.L. · Mar 2020