Cleared Traditional

PALACOS MV pro (K213812) - FDA 510(k) Clearance

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

K213812 · Heraeus Medical GmbH · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2022
Decision
57d
Days
Class 2
Risk

K213812 is an FDA 510(k) clearance for the PALACOS MV pro. Classified as Bone Cement (product code LOD), Class II - Special Controls.

Submitted by Heraeus Medical GmbH (Wehrheim, DE). The FDA issued a Cleared decision on February 2, 2022 after a review of 57 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 Heraeus Medical GmbH devices

Submission Details

510(k) Number K213812 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 2021
Decision Date February 02, 2022
Days to Decision 57 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
65d faster than avg
Panel avg: 122d · This submission: 57d
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 K213812.
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
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, BonOs MV, BonOs LV
K210120 · Osartis GmbH · Mar 2021